Latest news with #Pfizer
Yahoo
14 hours ago
- Business
- Yahoo
Full Arvinas, Pfizer data confirm potential and limits of ‘Protac' drug in breast cancer
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. An experimental breast cancer drug from Arvinas and partner Pfizer modestly slowed disease progression in people whose tumors had changes to a specific gene, but did not provide a clear benefit to others who lacked that mutation. Full study results set to be presented Saturday at the American Society of Clinical Oncology's annual meeting provide a clearer picture of the drug's potential — and its limitations — than were available in March, when the companies shared an overview of trial outcomes. While the findings suggest the drug, an oral pill called vepdegestrant, may be a new option for a subset of breast cancer patients, they likely mean its use will remain narrow, should it win an approval. In their Phase 3 trial, Arvinas and Pfizer tested vepdegestrant against the injectable drug fulvestrant in 624 people who had the most common type of advanced breast cancer — tumors positive for estrogen receptors but negative for a protein called HER2. Trial participants had been treated before with hormone therapy and another type of drug known as a CDK4/6 inhibitor. Two-hundred and seventy participants had mutations in the ESR1 gene, which is known to help tumors develop resistance to treatment. The detailed data unveiled Saturday show vepdegestrant extended progression-free survival in people with ESR1 mutations by a median of five months, compared to 2.1 months for those on fulvestrant. Among study participants overall, however, median progression-free survival was similar: 3.8 months on vepdegestrant versus 3.6 months on fulvestrant. PFS measures the time from a treatment response to when either disease progression or death. Speaking in a briefing with reporters ahead of ASCO, Jane Lowe Meisel, co-director of breast medical oncology at the Winship Cancer Institute of Emory University School of Medicine, described vepdegestrant as an 'exciting option.' Yet she noted in a statement how 'on average, patients did not have prolonged responses on either agent, highlighting the need for combination therapies and continued development in this space.' Fulvestrant, the drug Arvinas and Pfizer tested vepdegestrant against, is a common treatment for advanced breast cancers that are hormone receptor positive and HER2 negative. The drug, which has been on the market for over two decades, blocks growth signaling to tumors through those hormone receptors. But the therapy has drawbacks, such as monthly intramuscular injections and a range of side effects. Vepdegestrant works differently. The oral drug is what's known as a proteolysis-targeting chimera, or PROTAC. It is designed to break down estrogen receptors, thereby cutting off the signals that promote tumor growth. To date, vepdegestrant is the first PROTAC to advance through Phase 3 testing, and the first of its type to tested in people with advanced breast cancer. Study researchers also measured overall survival but data on that score remain 'immature.' Essentially, too few people have died in the trial to draw conclusions about the statistical differences between the vepdegestrant and fulvestrant groups. Side effects for both treatments were common. Just over one-fifth of participants taking vepdegestrant experienced side effects that were rated severe or life-threatening, compared to 17.6% on fulvestrant. More participants on vepdegestrant — 2.9% — stopped treatment due to side effects at 2.9%, compared to 0.7% among those on fulvestrant. While vepdegestrant held no apparent benefit among the overall population, the drug could still hold promise for breast cancer patients with the ESR1 mutation. Such a role would be valuable as treating ESR1-mutated breast cancer remains challenging. Research led by Memorial Sloan Kettering Cancer Center researchers a decade ago found ESR1 mutations change the shape of the estrogen receptor in such a way that keeps pushing the cancer to grow, even in the absence of an estrogen signal. ESR1 mutations are estimated occur in approximately 40% to 50% of patients who undergo first-line therapy for metastatic breast cancer. Testing for the mutation is now done regularly, but typically occurs only after cancer has progressed or returned. It's become more prevalent since the approval of Orserdu, which is cleared for use in people with ER-positive, HER2-negative breast cancer that is positive for ESR1 mutations. Pfizer and Arvinas in March said they will share data from their study with health regulators in support of potential drug approval applications. But since then, the companies have scaled back their development of vepdegestrant, removing plans for two other Phase 3 trials. Arvinas also cut one-third of its staff. Recommended Reading Arvinas gets positive breast cancer data, but finds differentiation a hard sell
Reuters
15 hours ago
- Business
- Reuters
Pfizer-Arvinas breast cancer drug tops AstraZeneca's in delaying progression
May 31 (Reuters) - An experimental treatment by Pfizer (PFE.N), opens new tab and Arvinas (ARVN.O), opens new tab delayed progression of breast cancer by more than three months compared to AstraZeneca's (AZN.L), opens new tab Faslodex in patients with a specific gene mutation, according to trial results announced on Saturday. The findings were presented in Chicago at the annual meeting of the American Society of Clinical Oncology and published in The New England Journal of Medicine. The trial found the experimental drug vepdegestrant increased survival without progression of the disease in patients with ESR1 mutations by five months, compared to about two months for Faslodex. The findings followed initial results of the study in March. Those showed the benefit of vepdegestrant in patients with the mutations but failed to show benefit in a larger set of patients, sending Arvinas' shares to a record low. Saturday's more detailed data showed vepdegestrant increased survival in the larger group of patients by 3.8 months, versus 3.6 months for Faslodex. The late-stage study enrolled 624 previously treated patients with a type of breast cancer that accounts for nearly 70% of all such cancers. Erica Hamilton, one of the authors of the study, said that Faslodex "clearly has some challenges now," adding that it is injected into a muscle, versus vepdegestrant's more convenient oral dosing. Vepdegestrant belongs to a novel class of drugs called PROTAC ER degraders, which are designed to harness the body's natural protein disposal system to specifically target and degrade proteins that spur tumor growth. Breast cancer accounts for about one-third of all new female cancers each year in the U.S., according to the American Cancer Society. Approved treatments for this type of advanced breast cancer include Eli Lilly's (LLY.N), opens new tab Verzenio, Pfizer's Ibrance and Novartis' (NOVN.S), opens new tab Kisqali. Leerink Partners analyst Andrew Berens expects vepdegestrant to earn $576 million in peak sales in 2032. Earlier this month, Arvinas said that it will not move forward with two other planned late-stage studies of the drug.
Yahoo
15 hours ago
- Business
- Yahoo
Roche Gets CHMP Nod for Itovebi Combo in the EU for Breast Cancer
Roche RHHBY announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Itovebi (inavolisib) therapy for breast cancer. A final decision from the European Commission is expected soon. The company is seeking approval for a combination regimen of Itovebi with Pfizer's PFE Ibrance (palbociclib) and AstraZeneca's AZN Faslodex (fulvestrant). The intended treatment population includes adult patients with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. PFE's Ibrance and AZN's Faslodex are both currently approved for breast cancer treatment. Please note that Roche's Itovebi, in combination with Pfizer's Ibrance and AstraZeneca's Faslodex, is currently approved for the same indication as above in several geographies, including the United States, with additional applications under review by other regulatory authorities worldwide. Year to date, shares of RHHBY have surged 13.7% against the industry's decline of 5.7%. Image Source: Zacks Investment Research The favorable CHMP opinion is supported by findings from Roche's phase III INAVO120 study, which demonstrated a 57% reduction in the risk of disease progression or death (progression-free survival) for patients receiving the Itovebi-based regimen compared with those treated with Pfizer's Ibrance and AstraZeneca's Faslodex alone in the first-line setting. This benefit was consistent across all pre-specified subgroups, including patients with more aggressive disease that had spread to three or more locations. Additionally, the regimen was well tolerated, with no new safety concerns identified. In January 2025, positive top-line results from the final overall survival (OS) analysis of the INAVO120 study were announced, confirming a statistically significant and clinically meaningful survival advantage with the Itovebi-based treatment. Although OS data were still maturing at the time of the primary analysis, a clear favorable trend had already emerged. Full OS results are expected to be presented during an oral session at the 2025 American Society of Clinical Oncology Annual Meeting. Per Roche, PIK3CA mutations, which occur in roughly 40% of HR-positive breast cancers, are associated with more aggressive disease and poorer survival outcomes. This highlights the critical need for early PIK3CA mutation testing before initiating first-line treatment, enabling timely access to effective PI3K-targeted therapies for patients with a less favorable prognosis. The Itovebi-based regimen could redefine the standard of care in this first-line setting, where current treatment options remain limited, pending approval. Apart from the INAVO120 study, Roche is simultaneously evaluating various other combinations of Itovebi in three late-stage studies for treating PIK3CA-mutated, locally advanced or metastatic breast cancer. RHHBY is also planning further clinical investigations in breast cancer and other tumor types, aiming to extend the potential benefits of this targeted therapy to a broader population of patients with PIK3CA mutations. Roche Holding AG price-consensus-chart | Roche Holding AG Quote Roche currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Bayer BAYRY, carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Bayer's earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 43.4%. BAYRY's earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%. 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 AstraZeneca PLC (AZN) : Free Stock Analysis Report Roche Holding AG (RHHBY) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
IOL News
16 hours ago
- Health
- IOL News
New US report reveals myocarditis risks linked to Covid vaccines for South Africans
A damning new report by US Senator Ron Johnson reveals that American authorities were alerted to a potential link between the Pfizer and Moderna vaccines and conditions like myocarditis and pericarditis as early as February 2021, yet delayed warning the public for months. Image: Pexels As the world scrambled to roll out Covid-19 vaccines in 2021, millions of South Africans received mRNA jabs with confidence — unaware that top US health officials were sitting on growing concerns about serious heart-related side effects. A damning new report by US Senator Ron Johnson reveals that American authorities were alerted to a potential link between the Pfizer and Moderna vaccines and conditions like myocarditis and pericarditis as early as February 2021, yet delayed warning the public for months. Implications for South Africa Now, as South Africans report similar complications, questions are being raised about whether local authorities were also kept in the dark — and what that has meant for informed consent. As many South Africans continue to report post-vaccine complications, the findings have reignited concerns around the adequacy of information provided to the public during the country's rollout. For those who experienced symptoms like heart inflammation, the silence from health authorities now feels like a betrayal. According to the 54-page interim report, the US Centres for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) were aware of 'large reports of myocarditis' among young vaccine recipients, but only moved to update the vaccine safety labels in late June 2021. This means millions of people across the globe — including in South Africa — received mRNA shots without being informed of these potential risks. 'Even though CDC and FDA officials were well aware of the risk of myocarditis following Covid-19 vaccination, the US administration opted to withhold issuing a formal warning to the public for months about the safety concerns,' the report states. Video Player is loading. Play Video Play Unmute Current Time 0:00 / Duration -:- Loaded : 0% Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Background Color Black White Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Transparent Window Color Black White Red Green Blue Yellow Magenta Cyan Transparency Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Dropshadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. Advertisement Next Stay Close ✕ Ad loading What is Myocarditis? Myocarditis, an inflammation of the heart muscle, and pericarditis, inflammation of the sac around the heart, can cause chest pain, irregular heart rhythms, and in rare cases, long-term cardiac damage. Myopericarditis, a combination of both, has also been reported. While these side effects are rare, they appear more frequently in young males and often emerge shortly after the second dose of the vaccine. South Africa relied heavily on Pfizer's mRNA vaccine during its national rollout. The US report raises concerns about whether international partners like South Africa received the necessary data to make timely and transparent decisions about public health messaging. If US authorities withheld warnings, were local health departments in a position to issue appropriate guidance — or were they operating under incomplete information? One pivotal moment came on 28 February 2021, when an Israeli health official contacted the CDC and FDA to flag 40 cases of post-vaccination myocarditis in young people. Despite the warning and Israel's significantly higher vaccination rate at the time, the US chose not to act publicly for several more months. During this silence, frontline doctors who attempted to raise red flags about the potential risks were reportedly censored or discredited. 'Around the time of internal CDC deliberations over myocarditis,' Senator Johnson writes, 'his office received a growing number of letters from doctors and other healthcare professionals who experienced suppression and censoring of this information they were experiencing.' Eventually, on June 25, 2021, the FDA added warnings to the Pfizer and Moderna labels about the risk of myocarditis and pericarditis. But by then, millions of people — including many South Africans — had already been vaccinated without that knowledge. The report's release comes just a day after the FDA announced tighter requirements for booster shot administration, adding further fuel to the debate about transparency, trust, and accountability in the global vaccine effort. IOL Lifestyle Get your news on the go, click here to join the IOL News WhatsApp channel.
Times
19 hours ago
- Business
- Times
Hvivo blames US trade disruption for halving in share price
Uncertainty caused by trade disruption in the United States and an adverse funding environment has resulted in the cancellation of a big contract for Hvivo, sending shares in the tester of infectious and respiratory disease products sharply lower. The Aim-listed group said that one of its clients had cancelled a 'significant' contract and another had postponed a smaller one, which Hvivo believes was a result of 'current uncertainties in the pharmaceuticals industry', particularly in the US. This had led to an increase in cancellations and delays of clinical trials across the industry, the company said, also citing a 'continued depressed biotech financing market'. Hvivo infects volunteers with safe doses of virus agents then quarantines them before testing the efficacy of vaccines and antivirals in so-called human challenge trials. The company, formerly known as Open Orphan and once a large holding in Woodford Capital's Equity Income Fund, provides clinical development services to clients that include a number of the world's biggest biopharmaceutical groups, such as Pfizer. It said it had £47 million of revenue contracted for the present financial year, including cancellation and postponement fees, and anticipated further contract wins over the course of the year. The company warned, however, that if these contract wins did not materialise then it was likely that the group would fall to a mid-single-digit operating loss for the year. All but one of the contacts for 2025 have started, Hvivo said, giving management confidence that 'there is a low risk of any further cancellations'. Shares in Hvivo more than halved in value during morning trading before paring some losses. They ended the day down 7½p, or 46.3 per cent, at 8¾p. • Biotech boss takes clinical approach to acquiring unloved assets Dr Yamin 'Mo' Khan, chief executive at Hvivo, said: 'Whilst we are disappointed to have received notification from these clients due to matters beyond our control, we still remain confident in the continued growth of human clinical trials and the overall prospects of Hvivo as we also continue to diversify our revenue streams.' Analysts at Shore Capital said concerns of a slowdown in the contract research organisation sector had also been flagged by Hvivo's larger peers, who have cited more cautious spending and clients delaying their decision making. 'Some of the negative narrative towards vaccines from Trump appointees at the US health department and the US Food and Drug Administration has clearly been an added cause for concern,' Sean Conroy, an analyst at Shore Capital, said. 'We would still caution against forming any endemic view towards vaccine development and the longer-term prospects of the human clinical trial business.'
