logo
Johnson & Johnson announces new Phase 1b data on bleximenib

Johnson & Johnson announces new Phase 1b data on bleximenib

Yahoo13-06-2025
Johnson & Johnson announced new Phase 1b data showing antileukemic activity and a safety profile for bleximenib in combination with venetoclax and azacitidine for the treatment of acute myeloid leukemia harboring KMT2A gene rearrangements or NPM1 gene mutations. The study evaluated patients with newly diagnosed, intensive chemo-ineligible AML and relapsed or refractory AML. The results were featured in an oral presentation at the 2025 European Hematology Association Congress. Even though AML is the most common type of acute leukemia in adults, it has the lowest survival rate and is associated with poor patient outcomes, despite treatment advances to date – especially for patients with KMT2Ar and NPM1m. The Phase 1b dose-finding study evaluated 125 patients with relapsed or refractory AML and newly diagnosed, intensive chemo-ineligible AML who harbored KMT2Ar or NPM1m. Bleximenib in combination with VEN + AZA was evaluated across multiple dose levels without step-up dosing. Of the 85 relapsed or refractory patients, 36 percent received one, 42 percent received two and 12 percent received three lines of prior treatment; 47 percent had previously been treated with venetoclax. The bleximenib data at 100 mg twice a day in combination with VEN + AZA showed higher efficacy and a similar safety profile in comparison to other dose levels. At the recommended Phase 2 dose, patients with relapsed or refractory AML achieved an overall response rate of 82 percent and a composite complete response rate of 59 percent. The newly diagnosed, intensive chemo-ineligible patient population showed an ORR of 90 percent and a cCR rate of 75 percent. Safety analysis of the study population showed a profile comparable among dose groups, genetic subtypes and disease settings. At the RP2D in combination with VEN+AZA, differentiation syndrome events were reported in two of 49 patients. Bleximenib safety data continued to support a lack of QTc prolongation signal, with no events of Grade 3 or higher and only three Grade 1 events at the RP2D. The most common all-grade treatment-emergent adverse events were nausea, thrombocytopenia, neutropenia and anemia. The most common Grade 3 or higher TEAEs were thrombocytopenia, neutropenia, and anemia.
Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions
Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
See the top stocks recommended by analysts >>
Read More on JNJ:
Disclaimer & DisclosureReport an Issue
RFK Jr. names eight members to vaccine panel, WSJ reports
RFK Jr. names new CDC vaccine advisory panel picks, STAT reports
Johnson & Johnson reports results from Phase 3b APEX study on TREMFYA
Johnson & Johnson Elects Daniel Pinto to Board
Trump Trade: RFK Jr. removes members of vaccine-advising CDC panel
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

RFK Jr's MAHA tour branded 'performative'
RFK Jr's MAHA tour branded 'performative'

Yahoo

time12 hours ago

  • Yahoo

RFK Jr's MAHA tour branded 'performative'

Robert F Kennedy, Jr's (RFK Jr) statewide tour promoting his Make America Healthy Again (MAHA) agenda has been called 'performative' by a US health consultancy. Since taking an axe to the health agencies nested under the US Department of Health and Human Services (HHS) in April, RFK Jr has toured states, including Colorado and Idaho, to promote his MAHA agenda. According to the White House's MAHA report, a key tenet of the initiative is to assist President Trump in addressing what the US health secretary has called the 'childhood chronic disease crisis', and includes vague aims to deliver more nutrient-dense food to the US population. Wellness Equity Alliance CEO Dr Tyler B Evans told Medical Device Network: "What we're witnessing with RFK Jr's roadshow is not leadership, it's theatre. 'The health secretary is cloaking vague rhetoric under the MAHA banner and selling it as reform, but the movement lacks policy substance and remains disconnected from the realities of public health. At best, it's a distraction. At worst, it's a dangerous misdirection that erodes trust in the institutions we need the most.' In April, RFK Jr delivered a speech at the US Food and Drug Administration (FDA), coinciding with the announcement of 10,000 planned job cuts across health agencies, including the FDA and the National Institutes of Health (NIH). The 40-minute speech included a range of baseless claims on various topics, according to a transcript of the speech seen by Politico. During his speech, RFK Jr stated that 'this whole generation is damaged' and claimed that rising rates of chronic disease, allergies and other illnesses were attributable to 'some environmental toxin'. How effective leadership at the HHS should look Evans emphasised that leadership at the HHS should be grounded in science, transparency, and accountability. 'It requires listening to public health professionals, not sidelining them, and to prioritise data over disinformation,' Evans said. 'I've worked on pandemic responses, from Ebola in West Africa to HIV/AIDS in South Africa to Covid-19 in NYC. What I've learned is simple: when health leadership is weak or politicised, people die unnecessarily. RFK Jr's decision to dismantle the department's capacity, especially during ongoing public health crises, is not reform. It is sabotage.' RFK Jr's MAHA tour has continued through July following the passage of Trump's 'One Big Beautiful Bill Act', which the Congressional Budget Office (CBO) estimates will leave 11.8 million people without health insurance by 2034. In a post to X following the bill's success in the Senate, Democratic senator Alexandria Ocasio-Cortez called the outcome 'an absolute and utter betrayal of working families'. To best serve the US's health, Evans said RFK Jr should focus on rebuilding trust with those most harmed by systemic neglect and called the current outcomes under the health secretary's leadership 'deeply troubling'. Evans concluded: 'Rebuilding trust requires investing in public health infrastructure, supporting workforce development, and addressing social determinants like housing, education, and food security. A national tour is not a substitute for that kind of real work.' "RFK Jr's MAHA tour branded 'performative'" was originally created and published by Medical Device Network, 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

Hims & Hers Health (HIMS) Is About to Report Q2 Earnings. Here's What to Expect
Hims & Hers Health (HIMS) Is About to Report Q2 Earnings. Here's What to Expect

Business Insider

timea day ago

  • Business Insider

Hims & Hers Health (HIMS) Is About to Report Q2 Earnings. Here's What to Expect

Hims & Hers Health (HIMS) is scheduled to announce its results for the second quarter of 2025 after the market closes on Monday, August 4. HIMS stock has rallied 171% year-to-date, as investors are confident about the prospects of the health and wellness company, including its continued international expansion. However, Wall Street is cautious on Hims & Hers Health stock due to certain concerns, including the recent fallout with Novo Nordisk (NVO) over the alleged illegal sale of compounded versions of the weight loss drug Wegovy. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Wall Street expects HIMS to report earnings per share (EPS) of $0.15, reflecting a 150% year-over-year growth. Sales are expected to grow by about 75% to $551.67 million. TD Cowen Analyst's Views Ahead of Hims & Hers Health's Q2 Earnings Heading into Q2 results, TD Cowen analyst Jonna Kim reiterated a Hold rating on HIMS stock but raised the price target to $43 from $38. The 4-star analyst expects the company to deliver an EPS beat. Kim expects Q2 sales growth to come above the Street's estimate. However, Kim noted that the latest data points indicate a deceleration in trends, which could lead to management maintaining the full-year outlook. The analyst remains neutral on HIMS stock as comparisons get tougher in the second half of 2025, with uncertainty around compounded GLP-1s. Nonetheless, Kim believes that international growth could be meaningful to HIMS' sales starting in Fiscal 2026. Kim noted the rally in HIMS stock and stated that he sees a lack of substantial upside in the second half of 2025, as the company 'laps outsized growth' from last year. AI Analyst Is Bullish on HIMS Stock Ahead of Q2 Print Interestingly, TipRanks' AI stock analyst has assigned an Outperform rating to HIMS stock with a price target of $73, indicating 16.7% downside risk. Based on TipRanks' AI analysis, HIMS stock reflects significant strength in financial performance and strategic growth plans, supported by favorable earnings call insights. However, high valuation and technical indicators suggest caution, especially given potential overbought conditions and margin pressures. Options Traders Anticipate Major Move on Hims & Hers Health's Q2 Earnings Using TipRanks' Options tool, we can see what options traders are expecting from the stock immediately after its earnings report. The expected earnings move is determined by calculating the at-the-money straddle of the options closest to expiration after the earnings announcement. If this sounds complicated, don't worry, the Options tool does this for you. Indeed, it currently says that options traders are expecting about a 17.3% move in either direction in HIMS stock in reaction to Q2 results. Is HIMS Stock a Good Buy? Currently, Wall Street has a Hold consensus rating on Hims & Hers Health stock based on one Buy, seven Holds, and two Sell recommendations. The average HIMS stock price target of $42.33 indicates 32.3% downside risk from current levels.

These Two Simple Interventions May Cut CRC Recurrence Risk
These Two Simple Interventions May Cut CRC Recurrence Risk

Medscape

time2 days ago

  • Medscape

These Two Simple Interventions May Cut CRC Recurrence Risk

This transcript has been edited for clarity. Hello. I'm Dr David Johnson, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School and Old Dominion University in Norfolk, Virginia. New guidelines have lowered the age to begin screening for colon cancer to 45 years old. Although this change is positive, we're still seeing advanced cancer in younger patients who haven't been screened in time. Once diagnosed, these patients undergo surgery and chemotherapy and often return to us asking, 'What can I do now to help myself?' Two recent studies highlight interventions that are simple, affordable, and actionable today: exercise and aspirin. Let's take a closer look at the results. Exercise's Risk Reduction Potential The idea that exercise reduces cancer recurrence and mortality is supported by observational data. The mechanistic effects behind this have been ascribed to metabolic growth factors, inflammatory changes, immune function changes, and perhaps even positive impact on sleep. A study just published in The New England Journal of Medicine examined structured exercise after adjuvant chemotherapy for colon cancer. The phase 3 randomized CHALLENGE trial, mostly conducted at Canadian and Australian centers, recruited patients with resected stage II or III colon cancer (9.8% and 90.2%, respectively) who had completed adjuvant chemotherapy. Patients with recurrences within a year of diagnosis were excluded, as they were more likely to have highly aggressive, biologically active disease. Patients were randomized to receive healthcare education materials alone or in conjunction with a structured exercise program over a 3-year follow-up period. The exercise intervention, delivered in person or virtually, focused on increasing recreational aerobic activity over baseline by at least 10 metabolic equivalent task (MET). An increment of 10 MET hours per week is not too vigorous. It is essentially the equivalent of adding about 45-60 minutes of brisk walking or 25-30 minutes of jogging 3-4 times a week. Patients were asked to increase MET over the first 6 months and then maintain or further increase the amount over the next 2.5 years. They were permitted to structure their own exercise program by choosing the type, frequency, intensity, and duration of aerobic exercise. The primary endpoint was disease-free survival, with secondary endpoints assessing overall survival, patient-reported outcomes, and other outcomes. Although designed to detect differences at 3 years, follow-up was also performed out to 5 and 8 years. At a median follow-up of 7.9 years, exercise reduced the relative risk of disease recurrence, new primary cancer, or death by 28% ( P =.02). This benefit persisted — and even strengthened — over time, with disease-free survival increasing by 6.4 and 7.1 percentage points at 5 and 8 years, respectively. Musculoskeletal adverse events were slightly higher in the exercise group compared with the health education group (18.5% vs 11.5%, respectively), but only 10% were directly attributed to the exercise. There are considerations when interpreting these results. First, there was an attrition over time for compliance and training. It would be interesting to see whether that impacted the results. Second, it's unclear whether patient pedigree or a genomic pathway may predispose to a benefit here for the exercise group. But overall, this phase 3 trial provides class 1 evidence supporting exercise as a low-cost, high-impact intervention to reduce cancer recurrence. Adjuvant Aspirin in Colon Cancer Subset That's a perfect segue into another recent study looking at the effects of adjuvant aspirin on the prevention of recurrence. The ALASCCA trial— conducted across centers in Sweden, Denmark, Finland, and Norway — assessed patients with stage I-III rectal cancer or stage II-III colon cancer. It focused on a subset of patients with an oncogenic abnormality called PIK3CA (phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha). PIK3CA occurs in approximately a third of colon cancers and is associated with significant chemotherapy resistance and a higher rate of disease progression. Of the included patients, 1103 (37%) had alterations in the PIK3CA pathway. Researchers randomized patients to receive either 160 mg of aspirin or placebo daily for 3 years, starting within 3 months of surgery. Among patients with PIK3CA mutations, aspirin dramatically reduced the risk for time to recurrence by nearly 50% at 3 years ( P =.044). Adverse events associated with aspirin were minimal, including one case each of gastrointestinal bleeding, hematoma, and allergic reaction. There is no evidence that higher aspirin doses provide greater prevention of colorectal cancer recurrence. The 160 mg use in the current study is fairly normal, roughly equivalent to two low-dose (81 mg) aspirin tablets. Now, it's worth noting that the use of aspirin for the primary prevention of cardiovascular disease was initially recommended by the US Preventive Task Services Force in 2016. This recommendation was then recanted in 2022, when the same group reported limited net benefit to this approach. Two Proactive Actions These studies highlight two interventions — exercise and aspirin — that are low cost, accessible, and appeal to patients eager to help prevent their cancer from recurring. Exercise is broadly beneficial and can be recommended immediately. For aspirin, patients should work with their oncologist to determine their PIK3CA mutation status, as this subgroup appears to benefit the most. These findings offer patients meaningful, proactive interventions they can apply to support their recovery and reduce the risk of recurrence. Hopefully these new findings will help guide your clinical conversations. I'm Dr David Johnson. Thanks for listening.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store