Latest news with #Enhertu
Medscape
13 hours ago
- Health
- Medscape
Which Tx Combo Is Best for HER2+ Breast Cancer?
The combination of trastuzumab deruxtecan (Enhertu) with pertuzumab (Perjeta) as a first-line treatment for HER2-positive advanced metastatic breast cancer has been shown to reduce the risk for disease progression or death by more than the current standard-of-care treatment. Sara Tolaney, MD, MPH Sara Tolaney, MD, MPH, of the Dana-Farber Cancer Institute in Boston, presented this finding and other interim results of the phase 3 DESTINY-Breast09 study, at the American Society of Clinical Oncology (ASCO) 2025 annual meeting in Chicago. 'Trastuzumab deruxtecan, or T-DXd, in combination with pertuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, with a 44% reduction in the risk of disease progression or death when compared to a taxane, trastuzumab, and pertuzumab (THP),' said Tolaney, during her presentation. New First-line Standard? Similar results were observed across all patient subgroups, with no new safety signals, Tolaney said. 'These data suggest that T-DXd and pertuzumab may represent a new first-line standard of care for patients with metastatic HER2-positive breast cancer,' she said. The study randomized 1157 patients to three treatment groups: T-DXd 5.4 mg/kg every three weeks plus placebo, T-DXd-pertuzumab, or a taxane plus trastuzumab with pertuzumab (THP). The interim study readout includes only data from the T-DXd-pertuzumab and the taxane plus trastuzumab with pertuzumab groups. Pertuzumab + T-Dxd or Standard of Care? Median progression-free survival (PFS) was 40.7 months in the T-DXd-pertuzumab patients and 26.9 months in the taxane plus trastuzumab with pertuzumab patients ( P < .00001). Tolaney explained that the study was designed to have an interim analysis for PFS after approximately 399 events across the three arms with at least 277 events for comparison. At the time of the interim analysis, she said, only the TDX-pertuzumab and THP groups met the criteria for superiority, a P -value < .00043, which was not met for the comparison of T-DXd plus placebo to THP. The T-DXd-placebo arm remains blinded until the final progression-free survival analysis, Tolaney said. Twenty-one percent of the patients in the T-DXd-pertuzumab arm had discontinued T-DXd due to adverse events, Tolaney said; 9% of patients elected to continue with trastuzumab and pertuzumab after they discontinued T-DXd. Among hormone receptor-positive patients, 13.5% in the T-DXd-pertuzumab group and 38% in the THP group elected to add endocrine treatment. At the data cutoff, 46% of the T-DXd-pertuzumab patients and 33% of those in the THP group remained on study treatment. Median follow-up duration was 29 months. The treatment effect of T-DXd-pertuzumab became evident early in the study, Tolaney said. Six months after starting treatment, 7% of the T-DXd-pertuzumab group vs 12% of the THP group had progressed. The gap continued to widen over time, she said. 'With 26% of patients still on steady treatment with T-DXd and pertuzumab, it suggests that this median is likely to evolve with further follow-up,' she said. Objective response rates were also higher with T-DXd–pertuzumab, 86% vs 79% with THP, Tolaney said. 'The complete response rate for T-DXd and pertuzumab was 15%, which was almost double what was seen with THP (8.5%),' she said. Response duration was also longer with T-DXd-pertuzumab, with 73% remaining in response at 24 months vs 55% in the THP arm. 'Overall survival data are very immature at this timepoint with just 16% of survival events seen, but you can see that there is an early trend favoring T-DXd plus pertuzumab with a hazard ratio of 0.84,' she said. A similar number of patients in both groups had serious treatment-emergent adverse events: 27% for T-DXd-pertuzumab and 25.1% for THP, which Tolaney said, was consistent with the known toxicity profiles of both agents, with no new toxicities identified. The median duration of treatment in the DESTINY-Breast09 study was 21 months. 'A Pivotal Advancement?' Rebecca Dent, MD, deputy CEO at the National Cancer Center Singapore, called the DESTINY-Breast09 results 'a pivotal advancement in the treatment of HER2-positive metastatic breast cancer that is both clinically and statistically significant.' Rebecca Dent, MD HER2-positive metastatic breast cancer was once considered a 'death sentence,' Dent said at a press conference, but now patients can survive on therapy for years, which presents its own challenges. Regarding the T-DXd-plus-pertuzumab regimen, Dent said, 'Is this for all patients at the beginning of their treatment for metastatic disease?' The truth of the matter is we don't know.' Having better biomarkers would provide answers, she said, but for patients with extensive disease with central nervous system metastasis, pertuzumab in combination with other agents 'is clearly your first-line choice.' How to best sequence therapies is another challenge emerging with these evolving treatment regimens, Dent added. 'And then I think finally we do have to appreciate that there are toxicities: One in terms of quality of life but also cost toxicity,' she said. Which Therapeutic Regimen Costs More? Tolaney acknowledged the cost implications of adding pertuzumab to T-DXd, in an interview with Medscape Medical News . 'But I would also note,' Tolaney said, 'that the standard-of-care arm does involve getting continued trastuzumab and pertuzumab therapy.' In the PATINA study, which added palbociclib (Ibrance) to standard maintenance therapy in patients with HER2-positive metastatic breast cancer, the cost profile was similar to those of the treatments used in the newer trial, Tolaney said. 'You are looking at substantial continued cost because we're continuing to suppress the HER2 pathway for years in these patients,' she said. AstraZeneca and Daiichi Sankyo funded the study. Tolaney reported financial relationships with ADi, Ambrx, Artios Biopharmaceuticals, Arvinas, AstraZeneca, Bayer, BeiGene, Bicycle Therapeutics, BioNTech, Blueprint Medicines, Bristol Myers Squibb, Circle Pharma, Cullinan Oncology, Daiichi Sankyo, eFFECTOR Therapeutics, Eisai, Exelixis, Genentech, Gilead Sciences, Hengrui Pharmaceutical (USA), Immunomedics/Gilead, Incyte, Jazz Pharmaceuticals, Johnson & Johnson, Launch Therapeutics, Lilly, Menarini Group, Merck, Mersana, NanoString Technologies, Natera, Novartis, OncoPep, Pfizer, Reveal Genomics, Sanofi, Seagen, Sumitovant Biopharma, Summit Therapeutics, Systimmune, Tango Therapeutics, Zentalis, Zuellig Pharma, and Zymeworks. Dent reported having financial relationships with AstraZeneca, Daiichi Sankyo/Astra Zeneca, DKSH, Eisai, Gilead Sciences, Merck Sharpe and Dohme, Novartis, Pfizer, and Roche.
CNBC
3 days ago
- 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
4 days ago
- Business
- Yahoo
AstraZeneca Highlights Significant Gains Across Three Major Cancer Trials At ASCO
AstraZeneca Plc (NASDAQ:AZN) on Monday released results from three Phase 3 clinical trials at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting: DESTINY-Breast09, MATTERHORN, and SERENA-6. In the DESTINY-Breast09 trial, Enhertu (trastuzumab deruxtecan) combined with pertuzumab was evaluated as a first-line treatment for HER2-positive metastatic breast cancer, compared to a standard regimen of a taxane, trastuzumab, and pertuzumab (THP). Topline data were shared in indicated that the Enhertu combination reduced the risk of disease progression or death by 44%. Median progression-free survival (PFS) reached 40.7 months with the Enhertu regimen versus 26.9 months for THP, a benefit observed across patient subgroups. Investigator-assessed median PFS was 40.7 months for the Enhertu arm and 20.7 months for THP. The confirmed objective response rate was 85.1% for the Enhertu combination and 78.6% for THP, with 58 complete responses in the Enhertu group compared to 33 with THP. The median duration of response was 39.2 months for the Enhertu combination and 26.4 months for THP. Overall survival data was not yet mature, though an early trend favored the Enhertu combination. The MATTERHORN trial assessed Imfinzi (durvalumab) with standard FLOT chemotherapy as a perioperative treatment for resectable, early-stage, and locally advanced gastric and gastroesophageal junction (GEJ) cancers, compared to chemotherapy alone. Topline data were released in March. A planned interim analysis showed that the Imfinzi-based regimen led to a 29% reduction in the risk of disease progression, recurrence, or death. Median event-free survival (EFS) was not reached in the Imfinzi arm, compared to 32.8 months in the chemotherapy-alone arm. The estimated 24-month EFS rate was 67.4% for the Imfinzi regimen and 58.5% for chemotherapy alone. A trend towards improved overall survival was noted for the Imfinzi-based regimen, with formal assessment to follow. The SERENA-6 trial investigated camizestrant combined with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors developed an ESR1 mutation during first-line treatment with an aromatase inhibitor (AI) and a CDK4/6 inhibitor. Topline data were shared in February. The trial compared switching to the camizestrant combination against continuing the AI plus CDK4/6 inhibitor. The camizestrant combination reduced the risk of disease progression or death by 56%. Median PFS was 16.0 months for patients who switched, versus 9.2 months for those continuing the AI combination. The median time to deterioration of global health status was 23.0 months for the camizestrant arm and 6.4 months for the AI combination arm. While data for time to second disease progression and overall survival were immature, a trend favored the camizestrant combination for PFS2. Price Action: AZN stock is trading lower by 0.95% at $72.14 at last checkMonday. Read Next:Photo by Piotr Swat Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? ASTRAZENECA (AZN): Free Stock Analysis Report This article AstraZeneca Highlights Significant Gains Across Three Major Cancer Trials At ASCO originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Bloomberg
5 days ago
- Business
- Bloomberg
Breast Cancer Growth Slowed by 14 Months in New AstraZeneca Drug Study
AstraZeneca Plc and Daiichi Sankyo Co. 's Enhertu delayed the advance of a common type of breast cancer by more than a year in a large study, a result that may lead to expanded use of the medicine. The treatment, already approved for several types of breast cancer, garnered sales of about $3.8 billion last year. It is routinely used as a second choice in roughly 20% of patients whose tumors have high levels of a protein called HER2.
Yahoo
5 days ago
- Business
- Yahoo
Enhertu potential broadens as new data point to frontline breast cancer role
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. CHICAGO — Enhertu, the antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo, year by year proves more indispensable in the treatment of metastatic breast cancer. Already enmeshed in clinical practice as a go-to choice for tumors that have come back once, Enhertu could soon have a role to play in initial treatment as well. On Monday, researchers shared results from a large trial showing Enhertu together with an older drug called Perjeta offer greater benefit in certain tumors than the current first-line standard, which includes Perjeta, the stalwart breast cancer drug Herceptin and chemotherapy. The data will be presented Monday morning at the American Society of Clinical Oncology's annual meeting held here. Known as Destiny-Breast09, the Phase 3 trial focused on people whose breast tumors were either locally advanced or had metastasized, and tested positive for a protein, HER2, that typically signals faster-spreading cancer. About 15% to 20% of breast cancers are HER2-positive and for decades now have been treated by Herceptin, Perjeta and other treatments that home in on the protein. Enhertu is one of the newest — and most powerful — iterations. It consists of a HER2-targeting antibody linked to a tumor-killing toxin. Since winning its first U.S. approval in 2019, the drug has marched upwards through breast cancer treatment lines and into new uses in lung and stomach cancers. Last year, sales reached $3.7 billion. Sales could rise further should findings from Destiny-Breast09 support frontline use in HER2-positive metastatic disease. In the trial, treatment with Enhertu and Perjeta delayed cancer growth for longer than the established regimen of Perjeta, Herceptin and chemotherapy, which is known by the acronym THP. Progression-free survival, which measures time from treatment to disease progression or death, reached a median of nearly 41 months among the 383 patients who received Enhertu and Perjeta, versus 27 months among the 387 given THP. 'That's a phenomenal advantage in progression-free survival and it's definitely practice-changing,' said Vishwanath Sathyanarayanan, a medical oncologist and an academic advisor at Apollo Hospitals in Bangalore, India. Eleonora Teplinsky, head of breast and gynecologic medical oncology at New Jersey's Valley-Mount Sinai Comprehensive Cancer Care, agreed, although she cautioned that Enhertu comes with its own safety risks. 'While keeping an eye on [Enhertu's] toxicity, it's really hard to ignore that data.' About 15% of patients given Enhertu plus Perjeta had a complete response following treatment — meaning no detectable signs of cancer — versus 8.5% among those on THP. Researchers could not yet statistically determine whether the Enhertu regimen offered a benefit in survival, but reported that data are trending in that direction. Patients will continue to be monitored for further analysis later. AstraZeneca and Daiichi Sankyo, which announced Destiny-Breast09 succeeded in late April, have said they plan to share the trial data with regulators. But they haven't clarified when they might seek an approval of Enhertu as part of first-line treatment. Should it win an OK, doctors will have to grapple with a number of trade-offs and unanswered questions, not least of which are Enhertu's side effects. The drug's current labeling carries a 'black box' warning for interstitial lung disease and pneumonitis, which can be life-threatening. In Destiny-Breast09, this side effect occurred in 46 patients treated with Enhertu and Perjeta, compared to only 4 who received THP. While most cases were mild, two of the Enhertu-treated patients died. Most participants in the trial were under 65 years old. As a result, Teplinsky said, it is not clear how well older patients might fare with Enhertu and Perjeta in the first-line setting. Results from another study presented at ASCO suggest that, in mild cases of interstitial lung disease, Enhertu can be reintroduced after the side effect has been brought under control. Moving Enhertu earlier in treatment also raises questions about how long it should be given and, if patients' disease progresses, what should be administered afterwards. 'Is this for all patients at the beginning of treatment? We don't know,' said Rebecca Dent, the deputy clinical chief executive officer at National Cancer Center Singapore, in a press conference with reporters. 'Is there a way to sequence this induction therapy that includes [Enhertu] followed by a maintenance stage of treatment?' Destiny-Breast09 is also evaluating a third group of 387 patients who were given only Enhertu and a placebo. Researchers didn't yet have sufficient data to compare that arm to the other two when they conducted their initial, interim analysis. Evidence supporting Enhertu monotherapy over THP would be significant if it materializes, said Sathyanarayanan, who noted that giving multiple, expensive drugs in combination can be challenging in low- and middle-income countries. AstraZeneca and Daiichi Sankyo are studying Enhertu in even earlier settings, testing whether it could be given before or after surgery to remove a tumor. Last month, the companies said a study called Destiny-Breast11 succeeded, finding Enhertu followed by THP improved complete response rates versus standard of care when used before surgery. And in stomach cancer, study data presented at ASCO on Saturday could help cement Enhertu's place as a second-line treatment option for gastric tumors. Recommended Reading At ASCO, Enhertu cements growing role in stomach cancer care
