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Gilead announces data on Trodelvy plus Keytruda

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.

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Cancer still tops high-cost health claims but muscle and orthopedic conditions are making surprise surge: Sun Life report
Cancer still tops high-cost health claims but muscle and orthopedic conditions are making surprise surge: Sun Life report

Yahoo

timean hour ago

  • Yahoo

Cancer still tops high-cost health claims but muscle and orthopedic conditions are making surprise surge: Sun Life report

13th-annual high-cost claims analysis highlights soaring healthcare expenses with cancer, cardiovascular and musculoskeletal leading the way WELLESLEY, Mass., June 4, 2025 /PRNewswire/ -- Sun Life, the nation's leading independent stop-loss provider for self-funded employers, today released its 13th annual high-cost claim and injectable drugs trend analysis, examining more than 65,000 health claims from 3,000 employers between 2021 and 2024. Overall, million-dollar stop-loss claims are on the rise, increasing by 29% this year when looking at claims-per-million-covered employees, and are up 61% over the past four years. "Sun Life's annual high-cost claims report illustrates the escalating nature of healthcare costs and the growing financial burden on employers and the healthcare system," said Jen Collier, president of Health and Risk Solutions, Sun Life U.S. "By analyzing our clinical data annually, we are able to create solutions with targeted interventions and personalized care navigation that can have a significant impact on both health outcomes and cost containment." Cancer Leads as Top Cost Driver Cancer once again tops the list as the most frequent and costly condition, with malignant neoplasms (solid tumors) generating $1.2 billion in spending across approximately 5,000 claims in 2024—triple the cost of the second-leading condition, cardiovascular. While blood cancers (Leukemia, Lymphoma, Multiple Myeloma) moved down one spot, they remain in the top five categories with nearly 900 members experiencing a high-cost claim annually. Additional Key Findings: Orthopedics/Musculoskeletal (Ortho/MSK) conditions are increasing in frequency, placing the category in the top three for the first time. While the average cost is lower than most categories at $116,000, it is second in claim frequency only to malignant neoplasms. The total spend in the category is $1.18 billion for the reporting period. The average cost for congenital anomaly claims increased 70% since 2021. More than 450 members experienced a congenital anomaly with an average claim cost of $335,000. The highest-cost claim in this category in 2024 was approximately $12 million. Uncategorized drugs' have emerged as one of the highest-cost categories among injectable drugs, driven in part by gene therapies. This category encompasses newly approved medications, compounded formulations, and drugs used in experimental treatments during clinical trials. Even though the average treatment cost is relatively low at $5,900, two members received gene therapies totaling $6.8 million in 2024, catapulting the category to #16 on the list. Eight of the 10 highest-cost drugs are primarily used in the treatment of cancer. Keytruda was the costliest cancer treatment and the highest overall drug with $84.4 million in spend. Durvalumab was added to this year's list due to a spike in utilization over the four-year and one-year views, with 78 members using the drug in 2024. "As a physician, I am keenly aware that factors such as chronic conditions, medical advancements, drug spend, and delayed care are putting pressure on employers and their workforces," said Dr. Miles Varn, chief medical officer, Sun Life U.S. and head of PinnacleCare. "Through Sun Life's dedicated programs and resources, our clinical team can engage members early in their healthcare journey – helping to close care gaps by finding appropriate care and services – ultimately improving the outcomes for individuals while creating more sustainable costs for employers." As a stop-loss provider, Sun Life covers high-cost claims for employers who self-fund their employee health plans. According to KFF, an independent non-profit organization focused on national health issues, 63% of covered workers in the U.S. are in a plan that is self-funded. To learn more, register for Sun Life's High-Cost Claims and Injectables webinar on June 5 featuring Jennifer Collier, Sun Life's president of Health and Risk Solutions, Dr. Miles Varn, chief medical officer, Mike Huppert, AVP, Actuarial and Risk Management, and Ryan Murphy, assistant vice president, Health Capabilities and Strategic Growth. About Sun LifeSun Life is a leading international financial services organization providing asset management, wealth, insurance and health solutions to individual and institutional Clients. Sun Life has operations in a number of markets worldwide, including Canada, the U.S., the United Kingdom, Ireland, Hong Kong, the Philippines, Japan, Indonesia, India, China, Australia, Singapore, Vietnam, Malaysia and Bermuda. As of March 31, 2025, Sun Life had total assets under management of $1.55 trillion. For more information, please visit Sun Life Financial Inc. trades on the Toronto (TSX), New York (NYSE) and Philippine (PSE) stock exchanges under the ticker symbol SLF. Sun Life U.S. is one of the largest providers of employee and government benefits, helping approximately 50 million Americans access the care and coverage they need. Through employers, industry partners and government programs, Sun Life U.S. offers a portfolio of benefits and services, including dental, vision, disability, absence management, life, supplemental health, medical stop-loss insurance, and healthcare navigation. Sun Life employs more than 8,300 people in the U.S., including associates in our partner dental practices and affiliated companies in asset management. Group insurance policies are issued by Sun Life Assurance Company of Canada (Wellesley Hills, Mass.), except in New York, where policies are issued by Sun Life and Health Insurance Company (U.S.) (Lansing, Mich.). Media contact:Anjie 469-938-1050 Connect with Sun Life U.S. View original content to download multimedia: SOURCE Sun Life U.S. 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

Healthy Returns: AstraZeneca, Pfizer, Gilead and other drugmakers release promising cancer drug data at ASCO
Healthy Returns: AstraZeneca, Pfizer, Gilead and other drugmakers release promising cancer drug data at ASCO

CNBC

timea day ago

  • 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

This biotech stock rallying on cancer treatment data has more room to run, analysts say
This biotech stock rallying on cancer treatment data has more room to run, analysts say

CNBC

timea day ago

  • CNBC

This biotech stock rallying on cancer treatment data has more room to run, analysts say

Analysts are closely watching Merus and see more upside ahead coming out of one of the biggest biotechnology conferences in the U.S. Merus shares shot up late last month following the release of promising Phase 2 data for a treatment for head and neck cancer. This has made the Netherlands-based company the talk of the investing set that flocked to Chicago for the American Society of Clinical Oncology's annual meeting , which concludes Tuesday. "They're first in class. We think they're best in class," said Matt Phipps, group head of the biotech equity research team at William Blair. "That's just kind of a combination that a lot of investors really want to be a part of." The stock has popped about 40% in the past month and rallied to a new all-time high on Tuesday. Still, multiple analysts interviewed by CNBC Pro said Merus can surge even higher — with one even suggesting shares can more than double from current levels given there are more catalysts on the horizon. MRUS 1M mountain Merus, 1-month Phipps said Merus' data overshadowed a similar report from Bicara Therapeutics , whose shares have tumbled 24% over the past month. He said Merus' release cemented itself as the best drug in combination with Merck 's Keytruda for head and neck cancer. Guggenheim analyst Michael Schmidt said similar success in Phase 3 data could more than double the value of Merus' shares. To be sure, he noted that investors should be prepared to wait between 12 and 18 months to see this upside given the schedule for data releases that can boost the stock. Beyond that, he said the same drug combination has potential for treating colorectal cancer. While Schmidt acknowledged that its not a major focus of investors yet, he said data from ongoing Phase 2 studies expected in the second half of 2025 is something to keep an eye on. Expectations for this, he said, are "very modest." "It's a stock that we have a lot of conviction on," Schmidt said. "We like this story a lot." Multiple analysts interviewed by CNBC said the name could also be an acquisition target from bigger-name biopharmaceutical companies, which could further drive upside. That can also help explain why Wall Street is so bullish. Every analyst polled by LSEG has a buy or strong buy rating, with an average price target suggesting 45% in upside ahead. "You want to buy it now," said BMO analyst Evan Seigerman, who called the company's data "really compelling." "This is the type of company that a large pharma company would want to acquire." Seigerman said the company has both "great" clinical data and is in an area with "unmet need," which is a combination that can make the stock a winner in what he described as a competitive sector. A boost to Merck? The treatment's success can also have knock-on benefits for Merck shares given the potential sales bump for Keytruda, according to Leerink analyst Andrew Berens. Berens said Keytruda is approved as a monotherapy, but only about 20% of patients respond to it, making the average time spent on the drug about few months. But used in conjunction with Merus' product, he noted that data shows that rate shoots up to the high 60% level and increases duration to nearly a year. "It's a win-win for Merck," Berens said. "This drug has its own activity," he said, "but it also means they can sell more of their flagship drug."

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