Latest news with #Braftovi
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
30-05-2025
- Business
- Yahoo
Pfizer CEO: HHS claims of ‘concealed safety concerns' on mRNA vaccines are ‘completely inaccurate'
Pharmaceutical rivals don't often come to each other's defense. But after the US Department of Health and Human Services terminated a contract with drugmaker Moderna to develop an mRNA bird flu vaccine, claiming that 'mRNA technology remains under-tested,' Pfizer's chief executive is speaking up. 'MRNA probably is the most utilized vaccine in the history of humanity,' Pfizer CEO Dr. Albert Bourla said Friday, noting that there have been about 1.5 billion mRNA vaccine doses against Covid-19 administered worldwide from his company alone – not counting those from Moderna. 'So it is extremely well-tested.' HHS said Wednesday that it was canceling at least $590 million in federal funding the previous administration had granted for Moderna to use its mRNA technology to develop pandemic influenza vaccines, including those against H5 avian flu viruses. The H5N1 strain has infected at least 70 people and killed one in the US since last year. 'We concluded that continued investment in Moderna's H5N1 mRNA vaccine was not scientifically or ethically justifiable,' an HHS spokesperson said, claiming, 'the reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public.' Asked his response to those comments, Bourla responded, 'both of them are completely inaccurate.' The pharma giant's chief spoke with CNN on Friday as Pfizer presented new data on a colorectal cancer drug at the American Society of Clinical Oncology, or ASCO, conference in Chicago, the world's largest meeting on cancer research. Pfizer's drug, Braftovi, was shown to double the length of time patients with an aggressive form of colorectal cancer lived with treatment: an average of 30 months compared with 15 in a clinical trial. It's a 'very, very important finding,' Bourla said, noting that colorectal cancer rates, 'particularly among younger people, are skyrocketing right now.' And while Pfizer is making big bets on cancer research, its CEO said he's not taking his foot off the pedal with investment in vaccines either, despite a 'very big gap' between the company and HHS – particularly Secretary Robert F. Kennedy Jr. – on their approaches to the subject. 'The science is proven,' Bourla said. 'The things they will do that will reduce, maybe, vaccination rates will come back and bite us.' Diseases will return, he said, and 'that will not take a long time.' Already, the US is experiencing one of its largest measles outbreaks since the disease was declared eliminated in this country in 2000, and rates of whooping cough, or pertussis, have increased as well. The recurrence of disease probably 'means that immediately they will have to reverse it,' Bourla said, suggesting that there will be public health efforts to increase vaccination rates in response, and 'they will go back to what every country in the world is doing.' Bourla worked with the first Trump administration to advance the company's Covid-19 vaccine through Operation Warp Speed in 2020, although he noted that Pfizer didn't accept federal funding to support vaccine development, only for the purchase of vaccines after the fact. He said that despite the gap on vaccines, 'when you speak with them, including Secretary Kennedy, I have found several topics that we are in, surprisingly, alignment.' Taking on cancer is one key area of agreement, according to the company. Bourla cited executive orders from President Donald Trump encompassing issues like addressing shorter market exclusivity for pills compared with injectable medicines under the Inflation Reduction Act – something the industry calls the 'pill penalty' – drug discounts to hospitals in a program known as 340B, and ratcheting up scrutiny on pharmacy benefit managers' role in drug pricing. 'We are working to address those things as we agree to disagree on the things that divide us,' Bourla said. He noted that he is against the administration's proposed 40% budget cut for the National Institutes of Health, emphasizing that the US is 'the dominant scientific force in biomedical sciences right now, and it is because we have created this ecosystem,' in which NIH funding supports academic research that can lead to new discoveries picked up by the pharmaceutical industry and made into medicines. 'If we break any link of this chain of this large ecosystem,' Bourla said, 'that's not good for us, and actually, it's a gift to our friends in China.' Bourla also took issue with HHS's actions on Covid-19 vaccines in the past two weeks: saying that the US Food and Drug Administration will change the way it approves updated shots for people who aren't in vulnerable groups and that the US Centers for Disease Control and Prevention will no longer recommend Covid-19 vaccines to healthy children and pregnant women. In previous years, Covid-19 vaccines had been updated in a similar way to seasonal flu shots, based on evidence that they generate an immune response; clinical trials that are required to show a vaccine's effect in preventing cases of disease are thought to take too long, potentially, to be feasible every season. What's more, the FDA and its advisers had previously deemed the vaccine updates small enough to not change their safety profile. Asked whether Pfizer would be able to run clinical trials quickly enough to make updated vaccines available to everyone, not just those in vulnerable groups, Bourla said, 'You are raising some very real concerns that we have.' Bourla noted that the implications of the Trump administration's changes to US health agency policies aren't entirely clear. But 'the issue is that that is not based on any scientific data. It's just based on a belief.' 'The appropriate process has not been followed; this is not just: the secretary or someone at a high level issues, let's say, a new rule,' he said. 'You need to follow a process which is reviews, experts, professional staff of FDA and all of that.' Dorit Reiss, a professor of law at UC Law San Francisco, suggested that HHS's 'bad administrative procedure' in announcing the updated CDC recommendations 'will be an issue' if they're challenged in court. Would Pfizer consider filing a lawsuit? 'My initial reaction is that I would prefer to find solutions but not create tensions,' Bourla replied. 'But of course, if we feel that we have to, we will.' Overall, the CEO emphasized that he has found the administration willing to engage in discussions, noting that 'we maintain a very, very close relationship' with the White House. 'I can't complain they don't listen to us,' Bourla said.
Yahoo
30-05-2025
- Business
- Yahoo
ASCO25: Pfizer's Braftovi combo boasts 47% drop in disease progression in mCRC
Pfizer's Braftovi (encorafenib) combination therapy was shown to reduce the risk of death by nearly half compared to standard of care (SOC) for metastatic colorectal cancer (mCRC) patients with BRAF V600E mutation. The company announced the survival benefit in an abstract at the American Society of Clinical Oncology (ASCO) 2025 conference being held in Chicago, Illinois, between 30 May and 3 June. The results will be presented on the first day of the conference by Dr Elena Élez, co-principal investigator of the BREAKWATER trial, including primary progression-free survival (PFS) data and updated analysis of overall survival (OS). The presentation includes new data from Pfizer's Phase III trial (NCT04607421) of Braftovi in combination with Eli Lilly's Erbitix (cetuximab) and mFOLFOX6 chemotherapy (fluorouracil, leucovorin, and oxaliplatin) in mCRC patients with BRAF V600E mutation. In the study, the regimen elicited a 47% decreased risk of disease progression, with median PFS for treated patients at 12.8 months versus 7.1 months with SOC. An updated analysis of the trial's key secondary endpoint also shows the regimen led to a median OS of 30.3 months compared to 15.1 months with SOC, equating to a 51% reduction in risk of death for patients. As per a 30 May press release, Élez said: 'The BREAKWATER results are the first promising survival outcomes ever reported for BRAF-mutant mCRC in the first-line setting.' The combination was previously approved by the US Food and Drug Administration (FDA) for adult mCRC patients with CRAF V600E mutation following prior therapy in April 2020. The regimen has since gained accelerated approval as a first-line treatment in December 2024, based on interim overall response rate (ORR) data from the BREAKWATER study, with the full approval contingent on continued demonstration of efficacy. Braftovi is a small-molecule inhibitor of BRAF, a protein involved in tumour cell growth, while Erbitux is a monoclonal antibody (mAb) targeting the epidermal growth factor receptor (EGFR). GlobalData projects the drugs to generate total annual sales of $1.14bn and $1.98bn by 2031, respectively. GlobalData is the parent company of Clinical Trials Arena. Pfizer's hopes to entrench Braftovi as part of the SOC for mCRC were expressed by the company's chief oncology development officer, Dr Joanna Bendell. Colorectal cancer is the third most common type of cancer globally, and BRAF V600E mutations occur in between 8% and 12% of patients. Presently, this subpopulation of patients exhibits a risk of mortality double that of patients with no known BRAF mutation. "ASCO25: Pfizer's Braftovi combo boasts 47% drop in disease progression in mCRC" was originally created and published by Pharmaceutical Technology, 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 while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
30-05-2025
- Business
- Yahoo
ASCO25: Pfizer's Braftovi combo boasts 47% drop in disease progression in mCRC
Pfizer's Braftovi (encorafenib) combination therapy was shown to reduce the risk of death by nearly half compared to standard of care (SOC) for metastatic colorectal cancer (mCRC) patients with BRAF V600E mutation. The company announced the survival benefit in an abstract at the American Society of Clinical Oncology (ASCO) 2025 conference being held in Chicago, Illinois, between 30 May and 3 June. The results will be presented on the first day of the conference by Dr Elena Élez, co-principal investigator of the BREAKWATER trial, including primary progression-free survival (PFS) data and updated analysis of overall survival (OS). The presentation includes new data from Pfizer's Phase III trial (NCT04607421) of Braftovi in combination with Eli Lilly's Erbitix (cetuximab) and mFOLFOX6 chemotherapy (fluorouracil, leucovorin, and oxaliplatin) in mCRC patients with BRAF V600E mutation. In the study, the regimen elicited a 47% decreased risk of disease progression, with median PFS for treated patients at 12.8 months versus 7.1 months with SOC. An updated analysis of the trial's key secondary endpoint also shows the regimen led to a median OS of 30.3 months compared to 15.1 months with SOC, equating to a 51% reduction in risk of death for patients. As per a 30 May press release, Élez said: 'The BREAKWATER results are the first promising survival outcomes ever reported for BRAF-mutant mCRC in the first-line setting.' The combination was previously approved by the US Food and Drug Administration (FDA) for adult mCRC patients with CRAF V600E mutation following prior therapy in April 2020. The regimen has since gained accelerated approval as a first-line treatment in December 2024, based on interim overall response rate (ORR) data from the BREAKWATER study, with the full approval contingent on continued demonstration of efficacy. Braftovi is a small-molecule inhibitor of BRAF, a protein involved in tumour cell growth, while Erbitux is a monoclonal antibody (mAb) targeting the epidermal growth factor receptor (EGFR). GlobalData projects the drugs to generate total annual sales of $1.14bn and $1.98bn by 2031, respectively. GlobalData is the parent company of Clinical Trials Arena. Pfizer's hopes to entrench Braftovi as part of the SOC for mCRC were expressed by the company's chief oncology development officer, Dr Joanna Bendell. Colorectal cancer is the third most common type of cancer globally, and BRAF V600E mutations occur in between 8% and 12% of patients. Presently, this subpopulation of patients exhibits a risk of mortality double that of patients with no known BRAF mutation. "ASCO25: Pfizer's Braftovi combo boasts 47% drop in disease progression in mCRC" was originally created and published by Pharmaceutical Technology, 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
Yahoo
30-05-2025
- Business
- Yahoo
Advanced colon cancer patients lived twice as long with a Pfizer combo therapy, trial finds
A combination drug treatment doubled survival time for patients with an aggressive form of colorectal cancer, according to late-stage trial data published Friday in The New England Journal of Medicine and presented at the American Society of Clinical Oncology's annual meeting in Chicago. The three-treatment combination included a standard chemotherapy drug, an antibody drug called cetuximab and a pill from Pfizer called Braftovi, which targets a cancer mutation called BRAF V600E. The mutation shows up in about 10% of patients with colorectal cancer, said Dr. Lionel Kankeu Fonkoua, a gastrointestinal oncologist at the Mayo Clinic Comprehensive Cancer Center in Rochester, Minnesota. Patients with the mutation tend to survive for less than a year after diagnosis, and they often don't respond well to standard chemotherapy treatments, said Fonkoua, who wasn't involved with the new trial. According to Pfizer, the risk of death for these patients is more than double compared with those without the mutation. Braftovi was initially approved in 2020 to be used with cetuximab in this group of patients after other treatments had failed. The new trial looked at the drug combination as a so-called first-line therapy. The Food and Drug Administration granted the treatment fast-track approval as a first-line approach in December on the condition that Pfizer provide additional data confirming its effectiveness. The agency often grants fast-track approval to treatments that address serious or life-threatening conditions, especially when there's an unmet medical need. Dr. Christopher Lieu, a professor of medicine at the University of Colorado School of Medicine who wasn't involved with the research, called the results 'very impactful.' 'Patients are clearly living longer, and this represents the new standard of care for this specific subset of patients with this specific mutation,' Lieu said. The trial included more than 600 patients with the mutation who had metastatic colorectal cancer. Patients were randomized to get either the three-drug combination treatment or standard chemotherapy alone. Some of the patients in the latter group were also given bevacizumab, a first-line treatment for metastatic colorectal cancer. The trial found that patients who got the combination treatment lived, on average, about 30 months, compared with about 15 months for those who got standard chemotherapy, with or without bevacizumab. What's more, 47% of patients who got the combination treatment had no disease progression after two years, meaning their cancer didn't grow or spread. The treatment was well-tolerated, with no unexpected safety concerns that would've caused investigators to stop the trial. 'This is a really remarkable finding,' said Dr. Scott Kopetz, a professor of gastrointestinal medical oncology at the MD Anderson Cancer Center in Texas and a co-principal investigator in the trial. 'When we bring this together with standard of care chemotherapy, we get really substantially prolonged survival for these patients that are really unprecedented for this disease type.' More than 141,000 new cases of colorectal cancer are diagnosed in the U.S. each year, making it the fourth most common cancer, according to the Centers for Disease Control and Prevention. About 52,900 people in the U.S. are expected to die from colorectal cancer this year, according to the American Cancer Society. Laurie Ritchie, 61, of St. Louis, got the combination treatment in October 2023. Her results weren't included in the clinical trial analysis. Ritchie had been diagnosed with metastatic colorectal cancer with the BRAF mutation — a diagnosis she describes as 'a huge shock.' Previous colonoscopies hadn't detected cancer; by the time she was diagnosed, the cancer had already reached Stage 4. It eventually spread to her lungs and ovaries. Since she got the combination treatment, she said her blood tests have consistently shown no trace of cancer. While she still worries about the cancer coming back, she says she's now focused on living fully — including going water skiing and downhill skiing. 'I've kind of learned to think of it as something in the trunk, not in the front seat,' she said. 'It still feels a bit like a ticking time bomb inside me, but I think the work I've done on my mental health has really helped me live with it.' This article was originally published on
