Latest news with #Trodelvy
CNBC
03-06-2025
- Business
- CNBC
Healthy Returns: AstraZeneca, Pfizer, Gilead and other drugmakers release promising cancer drug data at ASCO
I'm back in New York City after spending the last weekend in Chicago for the American Society of Clinical Oncology annual meeting. More than 5,000 research abstracts were presented or published at ASCO by pharmaceutical giants, biotech companies, researchers and oncologists. They included studies on existing drugs, experimental treatments, AI tools and ideas for improving patient care. Here are some data highlights and executive commentary from the larger companies I follow: AstraZeneca wins big (again) – The blockbuster drug Enhertu from AstraZeneca and Japanese drugmaker Daiichi Sankyo stalled the growth of a common type of breast cancer by more than a year in a large late-stage trial when used as an initial treatment. The results could expand the use of the drug and change the way the disease is treated for the first time in a decade. The study evaluated Enhertu in combination with a standard medicine called pertuzumab as a frontline treatment, meaning it was used in patients newly diagnosed with what's known as HER2-positive metastatic breast cancer. Patients who got the Enhertu combination lived for almost 41 months before their disease spread, while a group who received a standard three-drug treatment lived for about 27 months before the cancer advanced. David Fredrickson, executive vice president of AstraZeneca's oncology business, told CNBC that one in three patients who start treatment for this type of cancer are not able to receive a second type of therapy because their health worsened or they died. But the results show that the Enhertu combination could give "another third of patients a chance to potentially have a longer progression-free survival time and to benefit from a more effective frontline therapy than if you wait till a second one." Pfizer impresses in colorectal cancer – The company's pill Braftovi, combined with two other cancer treatments, doubled survival time for patients with an aggressive form of colorectal cancer compared to a standard treatment in a late-stage trial. It's good news for Pfizer, which has submitted the data to the Food and Drug Administration to expand Braftovi's approval label. The three-treatment combination included a standard chemotherapy, an antibody drug called cetuximab and Braftovi, which targets a cancer mutation called BRAF V600E. That combination also cut deaths by 51% and slashed the risk that the cancer would progress by 47% compared to a standard treatment during the trial. Pfizer's Chief Scientific Officer Chris Boshoff told CNBC that 10% to 15% of colorectal cancer patients have that specific mutation, and noted their survival rates are "particularly poor." "We're very proud of [the data] because for the first time, it really shows a true impact on survival for a disease that's very challenging to treat," he said. Gilead and Merck combo's breast cancer win — The popular drug Trodelvy from Gilead in combination with Merck's blockbuster immunotherapy Keytruda lowered the risk of an aggressive type of breast cancer worsening by 35% when used as an initial treatment in a late-stage trial. Gilead could benefit from higher sales of Trodelvy as it competes with Enhertu. The study examined patients with advanced triple-negative breast cancer whose tumors express PD-L1, the protein targeted by drugs like Keytruda. Around 15% of breast cancer cases are triple negative, making them more aggressive and difficult to treat, according to Gilead. The findings suggest that the combination of Trodelvy and Keytruda "will likely become a new front-line standard of care in this setting," Dr. Jane Lowe Meisel, co-director of breast oncology at Emory University School of Medicine and a designated ASCO expert, said in a statement. A Merck, Daiichi Sankyo drug disappoints in lung cancer – Merck and Daiichi Sankyo on Thursday said they have withdrawn their U.S. application for an experimental treatment after it failed to prolong the lives of lung cancer patients in a late-stage trial. The drug, patritumab deruxtecan, is one of three so-called antibody drug conjugates that Merck has been working on with Daiichi Sankyo as it races to offset Keytruda's upcoming loss of exclusivity. The medication failed the trial's secondary goal of extending overall survival, which is defined as the length of time patients lived from the start of treatment. Those results, along with subsequent discussions with the FDA, led the companies to withdraw the application. But last year, the drug met the study's main goal of helping delay tumor progression compared to chemotherapy in patients who have been previously treated for non-small cell lung cancer with a mutation in a gene called EGFR. Marjorie Greene, Merck's head of oncology global clinical development, told CNBC that the "totality of the data couldn't support" the drug's application for approval. She called it a disappointment but noted that the company is learning from "what worked and what didn't work" and is still "fully investing" in refining the drug. Merck and Daiichi Sankyo plan on advancing the treatment into a late-stage development for breast cancer. Amgen's positive lung cancer data: The company's drug, Imdelltra, reduced the risk of death by 40% compared to chemotherapy for small cell lung cancer patients whose disease had worsened after an initial round of chemotherapy, according to data from a late-stage trial. Imdelltra also extended median overall survival by more than five months compared to the standard-of-care chemotherapy. Amgen said the trial results are intended to support last year's accelerated approval of Imdelltra by the FDA. BONUS: Bristol Myers Squibb inks deal with BioNTech – Bristol Myers Squibb on Monday said it has agreed to pay up to $11.1 billion to partner with BioNTech and develop its next-generation cancer immunotherapy. The drug could take on Keytruda and new treatments in development by Summit Therapeutics and Pfizer. BioNTech is running late-stage studies on the drug in lung cancer and plans to start a phase three trial in triple-negative breast cancer this year. Feel free to send any tips, suggestions, story ideas and data to Annika at The FDA this week approved the first-ever AI platform for breast cancer prediction from Boston-based Clairity, marking a big milestone for women's health tech and potentially for women's health screening. I profiled Clairity's founder Dr. Connie Lehman three years ago, as part of a story on investment in Femtech. At the time, she told CNBC the accuracy of technology can help reduce over-screening for women who are presumed to be at risk, while helping to identify women who might otherwise not be monitored until they've already developed cancer. "By delivering validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women everywhere," she said in the company's announcement of the approval. But to save lives, the next big step is to ensure women have access to the breakthrough technology as a preventive screening. The American Medical Association will first need to issue a billing code, which for some AI-driven tools has been slow to come. That code will be crucial to securing insurance coverage. Feel free to send any tips, suggestions, story ideas and data to Bertha at Amazon Pharmacy on Tuesday announced new updates for caregivers and more than 50 million Medicare Part D beneficiaries. Launched in 2020, Amazon Pharmacy was formed out of the company's 2018 acquisition of the online pharmacy PillPack. The offering is now a full-service, digital pharmacy that can help support patients with both one-off and recurring prescriptions. Prime members in cities like Los Angeles and New York City are eligible for same-day medication deliveries. Amazon said that customers with Medicare insurance can now directly access PillPack's services, which means those with two or more prescriptions can have their medications sorted into individual tear-away packets labeled with the date and time. The company said these monthly shipments will reduce the need for patients to keep track of multiple pill bottles and help them stick to their routines, according to a release. Patients interested in accessing pre-sorted medications through PillPack can sign up by logging into Amazon Pharmacy. Amazon Pharmacy also introduced a new way for verified caregivers to help manage medications on behalf of their loved ones. Around one in every five adults in the U.S. are caring for an aging family member, according to AARP. Patients can invite trusted caregivers to help oversee their medications by submitting their phone number. The caregiver will receive a text with a link, have to confirm details about the patient in question, and then can begin managing the patient's medications through their own account. "These updates deliver what our customers have been asking for—simpler medication management for themselves and their loved ones," John Love, vice president of Amazon Pharmacy, said in a statement on Tuesday. Amazon's online pharmacy is a part of the company's multi-year effort to push into the health-care industry. The company acquired primary care provider One Medical for roughly $3.9 billion in July 2022. Read the full announcement here. Feel free to send any tips, suggestions, story ideas and data to Ashley at
Yahoo
02-06-2025
- Business
- Yahoo
ASCO 2025: Trodelvy and Keytruda to become new standard of care for frontline TNBC
At the American Society of Clinical Oncology (ASCO) Annual Meeting, held 30 May-3 June 2025, primary results were presented from the ASCENT-04/KEYNOTE-D19 study investigating Gilead's Trodelvy, a trophoblast cell surface antigen 2 (TROP 2)-directed antibody-drug conjugate (ADC), in combination with Keytruda (pembrolizumab), versus standard-of-care (SOC) chemotherapy plus pembrolizumab in patients with PD-L1-positive (CPS ≥10) metastatic triple-negative breast cancer (TNBC). The study aimed to determine whether the addition of Trodelvy, currently approved in the third-line setting for TNBC, could enhance the efficacy of Keytruda in the first-line treatment of this aggressive breast cancer subtype. The data demonstrated an improvement in median progression-free survival (PFS), with 11.2 months observed in the ADC-immunotherapy combination arm compared to 7.8 months in the SOC arm, at a median follow-up of 14 months. Notably, patients receiving Trodelvy and Keytruda experienced a 35% reduction in the risk of disease progression (hazard ratio [HR], 0.64). The combination also achieved a higher overall response rate (60% versus 53%) and a longer duration of response (16.5 months versus 9.2 months) compared to SOC. The frequency of treatment-related adverse events (AEs) was comparable between arms; however, only 12% of patients discontinued treatment due to AEs in the Trodelvy-Keytruda arm versus 31% in the SOC arm. These findings support the expectation that Trodelvy combined with Keytruda will become the new SOC in PD-L1-positive TNBC, shifting the frontline treatment paradigm from chemoimmunotherapy to ADC-based immunotherapy - a growing trend across tumour types in the metastatic setting. Gilead is positioning itself as a key player in human epidermal growth factor receptor 2-negative metastatic breast cancer, currently sponsoring several Phase III trials evaluating Trodelvy: as monotherapy for frontline metastatic TNBC patients ineligible for PD-L1-based therapy (ASCENT-03); in combination with Keytruda in early-stage TNBC (ASCENT-05); and in HR-positive patients previously treated with endocrine therapy (ASCENT-07). GlobalData's analyst consensus forecast projects Trodelvy sales to reach $2.2bn by 2030. Gilead will face competition in the frontline PD-L1-ineligible TNBC setting from Daiichi Sankyo's TROP-2-directed ADC, Datroway, currently in Phase III (TROPION-BREAST02), and Bristol Myers Squibb's izalontamab brengitecan, a bispecific EGFRxHER3 ADC entering Phase III in July. Nevertheless, following the positive ASCENT-04 results, Gilead is expected to secure US Food and Drug Administration approval and capture a significant share of the frontline PD-L1-positive TNBC market. "ASCO 2025: Trodelvy and Keytruda to become new standard of care for frontline TNBC" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
02-06-2025
- Business
- Globe and Mail
Gilead Reports Positive Data From Trodelvy, Keytruda Combo Study
Gilead Sciences, Inc. GILD announced positive data on breast cancer drug Trodelvy (sacituzumab govitecan-hziy) from the late-stage ASCENT-04/KEYNOTE-D19 study. Data from the phase III ASCENT-04/KEYNOTE-D19 showed Trodelvy plus Merck 's MRK blockbuster immuno-oncology drug Keytruda reduced the risk of disease progression or death by 35% compared with Keytruda and chemotherapy in first-line PD-L1+ metastatic triple-negative breast cancer (TNBC). Gilead and Merck collaborated in 2021 to evaluate Trodelvy in combination with Keytruda in the phase III ASCENT-04/KEYNOTE-D19 study. Shares of GILD have gained 20% year to date against the industry 's decline of 3.1%. More on GILD's & MRK's ASCENT-04/KEYNOTE-D19 Study The ASCENT-04/KEYNOTE-D19 study is a global, open-label, randomized phase III study evaluating the efficacy and safety of Trodelvy in combination with Keytruda compared with the treatment of chemotherapy plus Keytruda in patients with previously untreated, inoperable locally advanced or metastatic TNBC whose tumors express PD-L1. The study enrolled 443 patients across multiple study sites. Patients were randomized equally in two arms - to receive either Trodelvy (10 mg/kg intravenously on Days one and eight of a 21-day cycle) plus Keytruda (200 mg intravenously on Day one of a 21-day cycle) or chemotherapy plus Keytruda. The chemotherapy regimen included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel. Patients continued treatment until either blinded independent central review (BICR)-verified disease progression or unacceptable toxicity. Importantly, those who progress on chemotherapy can cross over to receive Trodelvy. The primary endpoint of the study is progression-free survival (PFS) as determined by BICR using RECIST v1.1. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to onset of response (TTR), patient-reported outcomes (PROs) and safety. In April 2025, GILD announced that the study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in PFS. A highly statistically significant and clinically meaningful improvement was observed with Trodelvy plus Keytruda, with a 35% reduction in the risk of disease progression or death in the intent-to-treat population compared to the standard of care Keytruda plus chemotherapy combination. A numerically higher overall response rate was observed for the Trodelvy plus Keytruda combination. Additionally, a substantially longer DOR was observed with the combination ofTrodelvy plus Keytruda While data showed encouraging trends in overall survival (OS), it was still immature at the time of PFS primary analysis. OS follow-up remains ongoing and will continue to be monitored as a key secondary endpoint. The safety profile of Trodelvy plus Keytruda in the ASCENT-04 study was consistent with the known safety profile of both drugs. GILD Looks to Expand Trodelvy's Label TNBC is the most aggressive type of breast cancer. In particular, first-line options remain limited for patients with PD-L1–positive metastatic TNBC. Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate. Trodelvy is currently approved in more than 50 countries for second-line or later mTNBC patients and in several countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer. Last month, Gilead posted positive top-line results from another late-stage study, ASCENT-03, on Trodelvy. Data from this phase III study showed highly statistically significant and clinically meaningful improvement in PFS in patients with first-line metastatic TNBC who are not candidates for checkpoint inhibitors. This is the second positive phase III study in first-line mTNBC where Trodelvy has demonstrated a clinically meaningful benefit compared with standard of care chemotherapy. Per GILD, positive data from the ASCENT-03 and ASCENT-04 study demonstrate Trodelvy's potential as the backbone treatment for all patients across first-line mTNBC. Gilead has additional ongoing phase III studies evaluating Trodelvy across HER2 breast cancer, including the ASCENT-07 pivotal trial in patients with HR+/HER2- mBC who have received endocrine therapy, and the ASCENT-05 pivotal trial in patients with early-stage TNBC (eTNBC). The drug is also being evaluated in additional late-stage studies across a range of tumor types, including lung and gynecologic cancers. Gilead's oncology portfolio, comprising the Cell Therapy franchise and breast cancer drug Trodelvy, has diversified its overall business. However, the Cell Therapy franchise, comprising Yescarta and Tecartus, is currently under pressure due to competitive headwinds in the United States and Europe that are expected to continue in 2025. Nonetheless, the potential launch of anito-cel in multiple myeloma and Trodelvy in first-line metastatic TNBC in 2026 will strengthen the company's oncology business. GILD's Zacks Rank and Stocks to Consider Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma/biotech sector are Novartis NVS and Pfizer PFE, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. The Zacks Consensus Estimate Novartis' 2025 earnings per share (EPS) has risen from $8.47 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 20 cents to $9.02 during this timeframe. The stock has risen 18.6% so far this year. Pfizer's 2025 EPS estimate has risen from $2.97 to $3.06 in the past 60 days, while that for 2026 has gone up from $2.99 to $3.09 over the same timeframe. Zacks Names #1 Semiconductor Stock It's only 1/9,000th the size of NVIDIA which skyrocketed more than +800% since we recommended it. NVIDIA is still strong, but our new top chip stock has much more room to boom. With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $803 billion by 2028. See This Stock Now for Free >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novartis AG (NVS): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis Report
Business Insider
02-06-2025
- Business
- Business Insider
Merck announces data from trial studying KEYTRUDA plus Trodelvy
Merck (MRK), known as MSD outside of the United States and Canada, announced that KEYTRUDA plus Trodelvy reduced the risk of disease progression or death by 35% versus KEYTRUDA plus chemotherapy for the first-line treatment of patients with PD-L1+ inoperable locally advanced or metastatic triple-negative breast cancer, TNBC, as determined by an FDA-approved test. KEYTRUDA, when given in combination with Gilead's TROP2 antibody-drug conjugate, ADC, Trodelvy, resulted in a median progression-free survival, PFS, of 11.2 months versus 7.8 months when KEYTRUDA was given in combination with chemotherapy. These data from the pivotal Phase 3 ASCENT-04/KEYNOTE-D19 study will be presented today as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting and were selected for the official ASCO Press Program. A higher objective response rate was observed for the KEYTRUDA plus Trodelvy combination, including 13% and 8% with a complete response, respectively, in the KEYTRUDA plus Trodelvy and KEYTRUDA plus chemotherapy arms. Notably, a substantially longer duration of response was observed with KEYTRUDA plus Trodelvy. Encouraging trends in overall survival were also observed, but data are immature at the time of PFS primary analysis. Overall survival follow-up remains ongoing and will continue to be monitored as a key secondary endpoint.
Business Insider
02-06-2025
- Business
- Business Insider
Gilead announces data on Trodelvy plus Keytruda
Gilead (GILD) Sciences announced Trodelvy plus Keytruda reduced the risk of disease progression or death by 35% versus standard of care Keytruda plus chemotherapy in first-line treatment for patients with PD-L1+ metastatic triple-negative breast cancer, TNBC. Trodelvy when given in combination with Keytruda resulted in a median progression-free survival of 11.2 months vs 7.8 months when Keytruda was given in combination with chemotherapy. These data from the pivotal Phase 3 ASCENT-04/KEYNOTE-D19 study will be presented today as a late-breaking oral presentation at the 2025 ASCO Annual Congress. For the primary endpoint, the median PFS was 11.2 months with Trodelvy plus Keytruda compared to 7.8 months with Keytruda plus chemotherapy, with a median follow-up of 14 months. A highly statistically significant and clinically meaningful improvement was observed with Trodelvy plus Keytruda, showing a 35% reduction in the risk of disease progression or death in the intent to treat population compared to standard of care Keytruda plus chemotherapy combination. The PFS benefit was generally consistent across key prespecified subgroups. A numerically higher overall response rate was observed for the Trodelvy plus Keytruda combination including 13% and 8% with a complete response, respectively, in the Trodelvy plus Keytruda and Keytruda plus chemotherapy arms. Notably, a substantially longer duration of response was observed with Trodelvy plus Keytruda.
