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Restaurant chain ditches seed oils 'lurking' in its ingredients

Restaurant chain ditches seed oils 'lurking' in its ingredients

Fox News07-02-2025
True Food Kitchen is on a mission to Make America Healthy Again.
That's been the objective of the Arizona-based restaurant chain ever since Dr. Andrew Weil teamed with restaurateur Sam Fox to open the first location in 2008.
"We have the belief that food can be both good and good for you," True Food Kitchen chief growth officer Daniella Voysey Olson told Fox News Digital.
In support of that belief, all 47 True Food Kitchen locations in 18 states across the nation became 100% seed oil-free beginning this week.
"This is not a trend. This is a long-term promise," Olson said in an original interview.
"Since day one, [True Food Kitchen] really focused on whole, minimally processed foods, serving our guests with food that's good and good for them. So this has been a nearly 20-year commitment for us."
Weil "has been a vocal advocate for really focusing on heart-healthy oils like olive oil and avocado oil," Olson told Fox News Digital.
It was Weil, the director of his namesake Andrew Weil Center for Integrative Medicine at the University of Arizona, who recommended eliminating industrial seed oils from every ingredient on True Food Kitchen's menu, Olson said.
She said that in 2022, True Food Kitchen "moved away from having any seed oils that we were cooking with and moved to cooking 100% with avocado oil and olive oil."
But it was a long process to fully eliminate seed oils from the brand's menus.
"Seed oil is kind of lurking in all of these places that you might not expect."
"It's been a multi-year effort to really weed out all of the different hidden sources of seed oil across the hundreds of ingredients that we use in our restaurants," Olson said.
"What we found is that seed oil is kind of lurking in all of these places that you might not expect."
One such example was the dried cranberries, a core ingredient in True Food Kitchen's chopped salad.
Unable to find an oil-free dried cranberry, True Food Kitchen instead made the decision to swap the ingredient, replacing it with a royal raisin, Olson said.
"This [meant] reviewing hundreds of ingredients across all of our different providers that we work with across the country," Olson said, calling it "a huge lift" for the chefs and the supply-chain team.
Illinois-based fast-casual restaurant chain Steak 'n Shake recently announced that it would begin cooking its shoestring fries in "100% all-natural beef tallow" by the end of February, perhaps signifying a greater awareness of seed oils in American cuisine.
California chef and restaurant owner Andrew Gruel, who has shared his staunch opposition to seed oils in interviews with Fox News, said the "switch away from seed oils shows this movement is here to stay."
"People have researched the effects of seed oils, tried the alternatives and are now demanding their favorite brands make the switch," Gruel told Fox News Digital.
When Olson was asked why more restaurants haven't cut out seed oils by now, she said it likely has to do with money.
"There's a cost impact," she said. "So that's an investment that we've chosen to make for our guests and our brand."
Another potential hindrance, she said, is that it's "really difficult."
Said Olson, "Whether it's in red pepper flakes, whether it was in something like harissa paste, there's all of these places where it's hidden. Even avocado mayo — where it was using avocado oil but also had canola oil as part of that."
Not only does it involve a commitment to finding a new supply chain, creating new recipes and, "in some cases, bringing that in-house," Olson said, it also "requires that investment, both financially, as well as in time, labor and energy, to be able to do that."
Laura Abshire, director of food and sustainability policy with the National Restaurant Association, which is based in Washington, D.C., told Fox News Digital that True Food Kitchen's efforts are one of the reasons that 90% of consumers say they enjoy eating out at restaurants.
"The options give consumers the opportunity to choose dishes that align with their dietary preferences while trying flavors and dishes they can't always make at home," Abshire said.
Vani Hari, an author and food advocate living in Charlotte, North Carolina — and one of the many supporters of Robert F. Kennedy Jr. for the role of HHS secretary — told Fox News Digital that this is the start of a new era in the restaurant industry.
"When I see True Food Kitchen go to a seed oil-free menu, that is going to be the next wave of where restaurants are going to be headed to really provide a healthy alternative to what's available today," Hari said.
Gruel, for his part, said it's "great to see" the direction he believes the industry is headed.
"The market has spoken."
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IMFINZI® (durvalumab) granted Priority Review and Breakthrough Therapy Designation in the US for patients with resectable early-stage gastric and gastroesophageal junction cancers
IMFINZI® (durvalumab) granted Priority Review and Breakthrough Therapy Designation in the US for patients with resectable early-stage gastric and gastroesophageal junction cancers

Business Wire

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IMFINZI® (durvalumab) granted Priority Review and Breakthrough Therapy Designation in the US for patients with resectable early-stage gastric and gastroesophageal junction cancers

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca's supplemental Biologics License Application (sBLA) for IMFINZI ® (durvalumab) has been accepted and granted Priority Review in the US for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. 1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2025. IMFINZI was also recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need. 2 Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-highest leading cause of cancer mortality. 3 In 2024, there were approximately 6,500 drug-treated patients in the US with early-stage and locally advanced gastric or GEJ cancer. 4 Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: 'This Priority Review reinforces the potential for a perioperative approach with IMFINZI to transform care for patients with early gastric and gastroesophageal junction cancers, who frequently face disease recurrence or progression even after curative-intent surgery and perioperative chemotherapy. This novel treatment is the only immunotherapy-based regimen to show a statistically significant reduction in the risk of progression, recurrence or death in this setting, and if approved, is poised to change the clinical paradigm." The sBLA is based on data from the MATTERHORN Phase III trial which was presented during the Plenary Session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine. In the trial, patients were treated with neoadjuvant IMFINZI in combination with chemotherapy before surgery, followed by adjuvant IMFINZI in combination with chemotherapy, then IMFINZI monotherapy. In a planned interim analysis, patients treated with the IMFINZI-based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence or death versus chemotherapy alone (based on an event-free survival [EFS] hazard ratio [HR] of 0.71; 95% confidence interval [CI] 0.58-0.86; P <0.001). Estimated median EFS was not yet reached for the IMFINZI arm versus 32.8 months for the comparator arm. An estimated 78.2% of patients treated with the IMFINZI-based perioperative regimen were event-free at one year, compared to 74.0% in the comparator arm; the estimated 24-month EFS rate was 67.4% versus 58.5%, respectively, signaling a greater magnitude of benefit over time for the IMFINZI-based regimen. For the key secondary endpoint of overall survival (OS), a strong trend was observed in favor of the IMFINZI-based perioperative regimen (HR=0.78; 95% CI 0.62-0.97; P= 0.025). The trial will continue to follow OS, which will be formally assessed at the final analysis. The safety profile for IMFINZI and FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy was consistent with the known profiles of each medicine, and the percentage of patients that completed surgery was similar compared to chemotherapy alone. 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Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. 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IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism): IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. IMFINZI as a Single Agent Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO. Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions. Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. IMFINZI with Carboplatin and Paclitaxel Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel. Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. IMFINZI as a Single Agent Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI. IMFINZI with IMJUDO Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions. Immune-Mediated Nephritis with Renal Dysfunction IMFINZI and IMJUDO can cause immune-mediated nephritis. IMFINZI as a Single Agent Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions. Immune-Mediated Dermatology Reactions IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. IMFINZI as a Single Agent Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions. IMFINZI with IMJUDO Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions. Immune-Mediated Pancreatitis IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions. Other Immune-Mediated Adverse Reactions The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors. Cardiac/vascular: Myocarditis, pericarditis, vasculitis. Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy. Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss. Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis. Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic. Endocrine: Hypoparathyroidism. Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection. Infusion-Related Reactions IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Complications of Allogeneic HSCT after IMFINZI Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT. Embryo-Fetal Toxicity Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO. Lactation There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose. Adverse Reactions Unresectable Stage III NSCLC In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%). In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms. Resectable NSCLC In patients with resectable NSCLC in the AEGEAN study, the most common adverse reactions (occurring in ≥20% of patients) were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash. In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study receiving IMFINZI in combination with platinum-containing chemotherapy (n=401), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6.7% of patients. Serious adverse reactions occurred in 21% of patients. The most frequent (≥1%) serious adverse reactions were pneumonia (2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia (1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of patients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%), myocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death not otherwise specified (0.2%). Of the 401 IMFINZI treated patients who received neoadjuvant treatment and 398 placebo-treated patients who received neoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive surgery due to adverse reactions. In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study receiving IMFINZI as a single agent (n=265), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse reactions occurred in 13% of patients. The most frequent serious adverse reactions reported in >1% of patients were pneumonia (1.9%), pneumonitis (1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the adjuvant phase of the study, including COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease and aortic aneurysm. Metastatic NSCLC In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in ≥20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%). In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of 4.2% of patients. Limited-stage Small Cell Lung Cancer In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), the most common adverse reactions occurring in ≥20% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue (21%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis or radiation pneumonitis and pneumonia. In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), IMFINZI was permanently discontinued due to adverse reactions in 16% of the patients receiving IMFINZI. Serious adverse reactions occurred in 30% of patients receiving IMFINZI. The most frequent serious adverse reactions reported in ≥1% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (12%), and pneumonia (5%). Fatal adverse reactions occurred in 2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac failure, encephalopathy and pneumonitis (0.4% each). Extensive-stage Small Cell Lung Cancer In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%). In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy. Locally Advanced or Metastatic Biliary Tract Cancers In patients with locally advanced or metastatic BTC in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in ≥20% of patients) were fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%). In patients with locally advanced or metastatic BTC in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%) and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients). Unresectable Hepatocellular Carcinoma In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in ≥20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%). In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in 8% of patients who received IMFINZI and IMJUDO, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients. Primary advanced or Recurrent dMMR Endometrial Cancer In patients with advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single-agent (n=44), the most common adverse reactions, including laboratory abnormalities (occurring in >20% of patients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased AST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%). The most common Grade 3 or 4 adverse reactions (≥3%) were constipation (4.5%) and fatigue (4.5%). In patients with advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single-agent (n=44), permanent discontinuation of IMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse reactions occurred in 30% of patients who received IMFINZI with carboplatin and paclitaxel; the most common serious adverse reactions (≥4%) were constipation (4.5%) and rash (4.5%). Muscle-Invasive Bladder Cancer (MIBC) In patients with muscle-invasive bladder cancer (MIBC), the most common adverse reactions, including laboratory abnormalities, in the overall study (occurring in ≥20% of patients) were decreased hemoglobin, decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphate, rash, pyrexia, diarrhea, vomiting and abdominal pain. In patients with MIBC in the neoadjuvant phase of the NIAGARA study receiving IMFINZI in combination with gemcitabine and cisplatin (n=530), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 9% of patients. Serious adverse reactions occurred in 24% of patients; the most frequent (≥1%) serious adverse reactions were pulmonary embolism (1.9%), febrile neutropenia (1.5%), acute kidney injury (1.3%), thrombocytopenia (1.3%), urinary tract infection (1.3%), and pneumonia (1.3%). Fatal adverse reactions occurred in 1.1% of patients including sepsis, myocardial infarction, and pulmonary embolism (0.2% each). One fatal adverse reaction of pneumonia was reported in 1 (0.2%) patient in the post-surgery phase before adjuvant treatment started. Of the 530 patients in the IMFINZI treatment arm and 526 patients in the chemotherapy treatment arm who received neoadjuvant treatment, 1 (0.2%) patient in each treatment arm did not receive surgery due to adverse reactions. The adverse reaction that led to cancellation of surgery in the IMFINZI treatment arm was interstitial lung disease. In patients with MIBC in the adjuvant phase of the NIAGARA study receiving IMFINZI as a single agent (n=383), permanent discontinuation of adjuvant IMFINZI due to an adverse reaction occurred in 5% of patients. Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions (occurring in ≥1% of patients) were urinary tract infection (7%), acute kidney injury (3.7%), hydronephrosis (2.1%), pyelonephritis (2.1%), urosepsis (1.8%) and sepsis (1.6%). Fatal adverse reactions occurred in 1.8% of patients, including COVID-19, severe acute respiratory syndrome, cardiopulmonary failure, gastrointestinal hemorrhage, and chronic hepatic failure (0.3% each). The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients. Indications: IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT). IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations. IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT). IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-approved test. IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). Please see additional Important Safety Information throughout and Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO. You may report side effects related to AstraZeneca products. Notes Gastric and gastroesophageal junction cancers Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-highest leading cause of cancer mortality. 3 Nearly one million new patients were diagnosed with gastric cancer in 2022, with approximately 660,000 deaths reported globally. 3 In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies. 5 In 2024, there were approximately 43,000 drug-treated patients in the US, European Union (EU), and Japan with early-stage and locally advanced gastric or GEJ cancer. 4 Approximately 62,000 patients in these regions are expected to be newly diagnosed in this setting by 2030. 6 GEJ cancer is a type of gastric cancer that arises from and spans the area where the esophagus connects to the stomach. 7 Disease recurrence is common in patients with resectable gastric cancer despite undergoing surgery with curative intent and treatment with neoadjuvant/adjuvant chemotherapy. Approximately one in four patients with gastric cancer who undergo surgery develop recurrent disease within one year, and one in four patients do not survive beyond two years, reflecting a high unmet medical need. 8-9 Additionally, the five-year survival rate remains poor, with less than half of patients alive at five years. 10 MATTERHORN MATTERHORN is a randomized, double-blind, placebo-controlled, multi-center, global Phase III trial evaluating IMFINZI as perioperative treatment for patients with resectable Stage II-IVA gastric and GEJ cancers. Perioperative therapy includes treatment before and after surgery, also known as neoadjuvant/adjuvant therapy. In the trial, 948 patients were randomized to receive a 1500mg fixed dose of IMFINZI plus FLOT chemotherapy or placebo plus FLOT chemotherapy every four weeks for two cycles prior to surgery. This was followed by IMFINZI or placebo every four weeks for up to 12 cycles after surgery (including two cycles of IMFINZI or placebo plus FLOT chemotherapy and 10 additional cycles of IMFINZI or placebo monotherapy). In the MATTERHORN trial, the primary endpoint is EFS, defined as time from randomization until the date of one of the following events (whichever occurred first): RECIST (version 1.1, per blinded independent central review assessment) progression that precludes surgery or requires non-protocol therapy during the neoadjuvant period; RECIST progression/recurrence during the adjuvant period; non-RECIST progression that precludes surgery or requires non-protocol therapy during the neoadjuvant period or discovered during surgery; progression/recurrence confirmed by biopsy post-surgery; or death due to any cause. Key secondary endpoints include pathologic complete response rate, defined as the proportion of patients who have no detectable cancer cells in resected tumor tissue following neoadjuvant therapy, and OS. The trial enrolled participants in 176 centers in 20 countries, including in the US, Canada, Europe, South America and Asia. IMFINZI IMFINZI ® (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses. In GI cancer, IMFINZI is approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer (BTC) and in combination with IMJUDO ® (tremelimumab-actl) in unresectable hepatocellular carcinoma (HCC). IMFINZI is also approved as a monotherapy in unresectable HCC in Japan and the EU. In addition to its indications in GI cancers, IMFINZI is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, IMFINZI is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of IMJUDO and chemotherapy for the treatment of metastatic NSCLC. IMFINZI is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC. Perioperative IMFINZI in combination with neoadjuvant chemotherapy is approved in the US and other countries for patients with muscle-invasive bladder cancer based on results from the NIAGARA Phase III trial. Additionally, in May 2025, IMFINZI plus standard-of-care Bacillus Calmette-Guérin induction and maintenance therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial. IMFINZI in combination with chemotherapy followed by IMFINZI monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). IMFINZI in combination with chemotherapy followed by olaparib and IMFINZI is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan. Since the first approval in May 2017, more than 414,000 patients have been treated with IMFINZI. As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several GI cancers. AstraZeneca in GI cancers AstraZeneca has a broad development program for the treatment of GI cancers across several medicines and a variety of tumor types and stages of disease. In 2022, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths. 11 Within this program, the Company is committed to improving outcomes in gastric, liver, biliary tract, esophageal, pancreatic, and colorectal cancers. In addition to its indications in BTC and HCC, IMFINZI is being assessed in combinations, including with IMJUDO, in liver, esophageal and gastric cancers in an extensive development program spanning early to late-stage disease across settings. Fam-trastuzumab deruxtecan-nxki, a HER2-directed antibody drug conjugate (ADC), is approved in the US and several other countries for HER2-positive advanced gastric cancer. Fam-trastuzumab deruxtecan-nxki is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. Olaparib, a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA -mutated metastatic pancreatic cancer. Olaparib is developed and commercialized in collaboration with Merck & Co., Inc (MSD outside the US and Canada). The Company is also assessing rilvegostomig (AZD2936), a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC, in combination with bevacizumab with or without IMJUDO as a 1st-line treatment in patients with advanced HCC, and as a 1st-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric and GEJ cancers. Rilvegostomig is also being evaluated in combination with fam-trastuzumab deruxtecan-nxki in previously untreated, HER2-expressing, locally advanced or metastatic BTC. AstraZeneca is advancing multiple modalities that provide complementary mechanisms for targeting Claudin 18.2, a promising therapeutic target in gastric cancer. These include sonesitatug vedotin, a potential first-in-class ADC licensed from KYM Biosciences Inc., currently in Phase III development; AZD5863, a novel Claudin 18.2/CD3 T-cell engager bispecific antibody licensed from Harbor Biomed in Phase I development; and AZD6422, an armored autologous chimeric antigen receptor T-cell (CAR T) therapy, currently being evaluated in an investigator-initiated trial (IIT) in collaboration with AbelZeta in China. In early development, AstraZeneca is developing two Glypican 3 (GPC3) armored CAR Ts in HCC. AZD5851, currently in Phase I development, is being developed globally, and C-CAR031 / AZD7003 is being co-developed with AbelZeta in China where it is under evaluation in an IIT. AstraZeneca in immuno-oncology (IO) AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumor immune response and stimulate the body's immune system to attack tumors. AstraZeneca strives to redefine cancer care and help transform outcomes for patients with IMFINZI as a monotherapy and in combination with IMJUDO as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers. AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical program, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit and follow the Company on social media @AstraZeneca. References FDA. Priority Review. Available at: Accessed July 2025 FDA. Frequently Asked Questions: Breakthrough Therapies. Available at: Accessed July 2025. World Health Organization. International Agency for Research on Cancer. Stomach Fact Sheet. Available at: Accessed July 2025. AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Available at: Accessed July 2025. Li Y, et al. Global burden of young-onset gastric cancer: a systematic trend analysis of the global burden of disease study 2019. Gastric Cancer. 2024;27(4):684-700. Kantar Health, validated with SEER stage at diagnosis and Cabasag et al. and Kuzuu et al. 2021. National Cancer Institute. Gastroesophageal junction. Available at: Accessed July 2025. Li Y, et al. Postoperative recurrence of gastric cancer depends on whether the chemotherapy cycle was more than 9 cycles. Medicine. 2022;101(5):e28620. Ilic M, Ilic I. Epidemiology of stomach cancer. World J Gastroenterol. 2022;28(12):1187-1203. Al-Batran SE, et al. Perioperative chemotherapy with fluorouracil plus leucovorin, oxaliplatin, and docetaxel versus fluorouracil or capecitabine plus cisplatin and epirubicin for locally advanced, resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4): a randomized, phase 2/3 trial. Lancet. 2019;393(10184):1948-1957. World Health Organization. World Cancer Fact Sheet. Available at Accessed July 2025. US-103594 Last Updated 7/25

Dr. Cory Franklin: Why the US is better than Europe at preventing heat deaths
Dr. Cory Franklin: Why the US is better than Europe at preventing heat deaths

Chicago Tribune

time3 hours ago

  • Chicago Tribune

Dr. Cory Franklin: Why the US is better than Europe at preventing heat deaths

When it comes to reporting on the comparative health of nations, there is ample bias in the national and international press about American shortcomings. Some of it is justified — disproportionate numbers of obesity and firearm deaths are usually cited by medical and nonmedical sources, as well as the relatively high infant mortality. But no less important are environmental deaths, specifically those related to hot and cold weather, which are rarely cited. The U.S. figures are far more impressive than those of the rest of the industrialized world, and it is inarguable that this country does a much better job of preventing heat and cold deaths than Europe does. First, heat deaths: Comparisons of heat deaths between countries are limited because numbers vary according to how heat deaths are defined, the differences in weather and patient characteristics in various countries, and the sources of the data. The numbers here are a compendium from several sources including Lancet, Nature and several public health and weather websites; mileage may vary. Taking all this into account, the difference in annual heat deaths between Europe and the U.S. is surprising: In the 21st century, European heat deaths on average range from 60 to 200 per 1 million people annually, while American heat deaths average about three to eight per million annually. This means, conservatively, each year, perhaps 20 times as many people die of the heat in Europe as in the U.S. A graphic example: During the recent European heat wave that began in May, one country, Spain, experienced 1,180 deaths in only two months. The data from deaths due to cold weather are even more sobering. Even with a warming Earth, cold continues to kill more people than heat in most parts of the world where there is any kind of cold winter. In Europe, there are 300 to 500 deaths per million due to cold annually in the past three decades, while in the U.S., the number of deaths from cold is in the range of 10 per million. So a conservative estimate would be that for every person who dies as a result of cold weather in the U.S., at least 30 die in Europe. When deaths from heat and cold are combined, Europe has close to 50 times as many deaths as the U.S. — as many as 250,000 to 500,000 more deaths every year. Over a decade, this means several million more people die from heat and cold in Europe than die in the U.S. from those causes. A comparison of the annual numbers shows that the difference in environmental deaths easily surpasses the much more widely reported firearm death comparison. The U.S. has nearly 50,000 firearm deaths annually, and Europe has under 10,000, so the difference in firearm deaths, roughly 40,000, is about 1/10th the difference in environmental deaths. Why is there such a difference in environmental deaths between the U.S. and Europe? The consensus among experts regarding heat deaths is the ubiquity of air conditioning in the U.S. and the relative paucity in Europe. (The majority of deaths in Spain during the May-June heat wave were in the north of the country, where air conditioning is uncommon compared with in the south.) Besides providing comfort, air conditioning saves lives — often many — especially if air conditioning could be made more available in the Global South, where there are even more deaths due to hot weather. Despite the consensus, some environmentalists want to limit air conditioning, citing increased electricity use and carbon dioxide production, which will aggravate greenhouse gas emissions. (In 2022, Spain was one of the countries that put restrictions on air conditioning.) The response to climate change must involve a combination of mitigation, such as reducing levels of heat-trapping greenhouse gases and adaptation — that is, adapting to the consequences of a warming environment. According to Hannah Ritchie, deputy editor of the Our World in Data website, air conditioning currently accounts for about 7% of global electricity use and 3% of carbon dioxide emissions — not negligible but certainly not exorbitant considering how many lives cooling technology saves. While worldwide air conditioning use is expected to increase in the next decade, so is the efficiency of air conditioning units. Air conditioning represents one of the most effective and lifesaving methods of adaptation to a changing climate. The reasons for increased cold weather deaths in Europe relative to the U.S. are harder to divine, but likely include the ubiquity of older homes with poorer insulation throughout Europe. Outside of Scandinavia, there may be less preparedness and an aging population more vulnerable to cold weather snaps on the European continent. Human-made efforts to reduce greenhouse gases are essential, but human-made efforts to adapt to weather extremes would have lifesaving consequences more immediately. Dr. Cory Franklin is a retired intensive care physician and the author of 'The COVID Diaries 2020-2024: Anatomy of a Contagion as it Happened.'

Six back-to-school tips to set students up for success this year
Six back-to-school tips to set students up for success this year

Yahoo

time4 hours ago

  • Yahoo

Six back-to-school tips to set students up for success this year

Believe it or not, school is just around the corner, and these last few weeks of summer are the perfect time for families to start helping their students prepare for the new school year. Here are six tips to set students up for success and make the transition back to school as easy as possible. Make it fun The first day of school can be daunting to students, especially when they're entering a new school. But addressing those feelings of uncertainty before the first day can assure your student that they're ready to take on the challenge. An article from the American Academy of Pediatrics (AAP) encourages families to visit the school campus prior to the first day of school to help students learn their way around, perhaps during a back-to-school night or orientation event. The article even suggests that parents take their students to play on the school's playground a few days before school starts. Parents can also point out the fun aspects of school, like seeing friends or a favorite teacher, which can help the first day seem less scary, the article says. Create a sleep schedule Summer break often brings a more relaxed sleep schedule, but as the start of school nears, it's important to reintroduce some structure. An article from the Mayo Clinic says children aged 6-13 require nine to 11 hours of sleep each night, while ages 13-17 need between eight and 10 hours, and this is especially important during the school year. Johns Hopkins Medicine adds that insufficient sleep increases the risk of health issues like depression, diabetes, hypertension and obesity. The Sleep Foundation suggests that parents incrementally adjust kids' sleep schedules in the weeks leading up to school. Every few days, the foundation's website says, parents should have their child wake up and go to bed 15 minutes earlier until they're sleeping and waking at the desired times for school. It's also a good time to establish a good bedtime routine without electronics, the Sleep Foundation says, including things like taking a shower, brushing teeth and reading in bed. Have conversations and make a plan To help students know what the school year will look like, the AAP article says, it's important to have conversations to set expectations. The article encourages parents to sit down with their children before the school year starts to talk about how they'll get to school each day and what their routine will be once school begins. These conversations are also the perfect time to ask how the student is feeling, the article says. Are they excited about going back to school, or is it a bit scary? What are they most looking forward to once school starts? Do they have any goals for the school year? And, AAP says, it's also important to come up with a plan for dealing with conflict and bullying so that the student knows what to do if they or a classmate is bullied. The AAP website has a page about bullying and how to address it, as well as a first day of school checklist with important reminders to ensure parents and students know what to expect going back to school. Encourage healthy eating The Mayo Clinic website says eating a healthy breakfast with some form of protein each morning helps students prepare for learning because if they're hungry, they're more likely to have trouble focusing. And sending kids to school with water rather than soda will keep them hydrated and help cut down on sugar intake, the AAP article says. Support good study habits Establishing good study habits at the beginning of school will help lay the foundation for the rest of the year, and, AAP says, this includes creating a homework-friendly environment where students can hit the books at home. The article says students should have a quiet place for doing homework free of electronics and other distractions. And if they need some help organizing, AAP says, parents can work with them to come up with a system that helps them stay on task using tools like checklists and timers. The last few weeks of summer are also a good time to go through kids' backpacks to throw away any unneeded items and organize them for the year ahead, the article says. Know your resources Going back to school can be hard, the Johns Hopkins article says, and sometimes it can take a while for students to adjust. But there are resources both in and out of the student's school district if families need a little extra help. It's good to regularly check in with students about how they're feeling, Johns Hopkins says, and keeping their teachers and school administrators in the loop is also important. The Mayo Clinic article adds that if anxiety or depression may be a contributing factor to a student not adjusting well, families can connect with a social worker or counselor at the school, and outside help can be found through a family doctor. Email South Bend Tribune education reporter Rayleigh Deaton at rdeaton@ This article originally appeared on South Bend Tribune: Tips, tricks to make back-to-school transition easier Solve the daily Crossword

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