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Medscape
3 days ago
- Health
- Medscape
Atezolizumab + Chemo Improves Colon Cancer Survival
The addition of postsurgical atezolizumab immunotherapy to standard-of-care chemotherapy in patients with stage III deficient DNA mismatch repair (dMMR) colon cancer significantly improved survival in the phase 3 ATOMIC trial. 'These data established this combination as a new standard treatment for patients with stage III colon cancer and deficient mismatch repair,' said study author Frank A. Sinicrope, MD, during a press conference at the American Society of Clinical Oncology (ASCO) 2025 annual meeting. 'We regard this as a highly impactful study that will change clinical practice, and it actually represents the first immunotherapy adjuvant study in colon cancer.' The standard treatment for stage III colon cancer, regardless of dMMR status, is surgical resection followed by fluoropyrimidine-oxaliplatin chemotherapy (FOLFOX), but about 15% of patients have dMMR and display resistance to chemotherapy, he explained during a press conference at the meeting. 'These tumors are unable to repair their DNA and therefore accumulate mutations that trigger an immune response that is ineffective due to immune checkpoint proteins. Therefore, the use of immune checkpoint inhibitors is very attractive in this setting,' noted Sinicrope, who is professor of medicine and oncology and co-leader of the GI Cancer Program at Mayo Clinic in Rochester, Minnesota. While approved for dMMR metastatic cancers, it was unknown if an immune checkpoint inhibition would improve outcomes in stage III disease, he added. Study Methods and Results ATOMIC included 712 patients at least 12 years of age, who had resected stage III dMMR colon cancer without prior chemotherapy or radiation. They were randomized within 10 weeks of surgery to FOLFOX chemotherapy alone for 6 months (n = 357) or combined with atezolizumab, which was continued for an additional 6 months (n = 355). For the primary endpoint of disease-free survival, the 3-year rate was 86.4% vs 76.6% in the chemo-immunotherapy arm vs FOLFOX alone arm. 'This corresponds to a hazard ratio of 0.5, which is a 50% reduction in recurrence and death related to the treatment, so a very substantial survival benefit was achieved here,' Sinicrope said. This benefit held up across all subgroup analysis, showing that 'no matter what their age, their sex, their race, their tumor location, their T-stage, or N-stage, they are doing better with the addition of immunotherapy to chemotherapy,' he added. The safety profile 'was in line with the known safety profiles of each drug,' he noted, with an expected but manageable increase in nonfebrile neutropenia in the immunotherapy-containing arm (43% vs 36% for grade 3/4). Regarding immune-related adverse events, there were no clinically significant differences between groups in grade 4 or greater events, but there were notable increases in grades 1 and 2 events in the immunotherapy arm, specifically, hyperglycemia (17.9% vs 9%), hypothyroidism (20.5% vs 3.6%), and maculopapular rash (13.3% vs 6%), he reported. Calling the results 'dramatic,' Joel Saltzman, MD, a hematologist/oncologist and vice chair of Regional Oncology at Taussig Cancer Center, Cleveland Clinic, Cleveland, and an ASCO expert in gastrointestinal cancers, agreed that the study was practice-changing. 'The most important thing is that this is a real population that I'll see this coming week in clinic. We have had patients for years that we've known immunotherapy would likely be helpful, but we just weren't sure if we could integrate that into their care,' he said during the press conference. Discussant Touts Benefits of Neoadjuvant Immunotherapy The discussant for the study, Myriam Chalabi, MD, PhD, a medical oncologist at the Netherlands Cancer Institute in Amsterdam, the Netherlands, suggested that while the FOLFOX-atezolizumab combo 'is an option to consider' for patients who undergo upfront surgery, neoadjuvant immunotherapy 'is generally more effective and allows for de-escalation of chemotherapy, and of surgery, and also of the duration of immunotherapy.' Additionally, 'it would be important to investigate what the added benefit is of neoadjuvant immunotherapy in this patient population compared to surgery alone, and how that balances against the adverse events,' she suggested. Is Chemotherapy Helpful? In the adjuvant setting, Chalabi questioned whether chemotherapy might be abandoned altogether. 'What we haven't talked about is whether chemotherapy could even be blunting the T-cell response,' she said, suggesting a third arm of the study might have evaluated atezolizumab alone. Echoing Chalabi's comments, Anwaar Saeed, MD, emphasized that ATOMIC's results 'should not be viewed as the endpoint, but a launchpad,' and agreed that a critical unanswered question is whether chemotherapy even remains necessary with immunotherapy in this setting. 'Does oxaliplatin-based chemotherapy meaningfully enhance survival when paired with immune checkpoint blockade, or could it be modified — or even omitted — without compromising outcomes? As the field moves forward, future trials must interrogate whether reduced-intensity or chemo-free regimens could offer comparable efficacy with fewer toxicities,' said the associate professor of medicine and the chief of the Gastrointestinal Medical Oncology Program at the University of Pittsburgh, University of Pittsburgh Medical Center (UPMC), and UPMC Hillman Cancer Center in Pittsburgh, in an interview with Medscape Medical News . 'This question is especially relevant in light of the accumulating data from early-phase neoadjuvant studies, many of which suggest that immunotherapy alone may induce profound pathological responses in resectable dMMR [colorectal cancer] CRC. How these findings in the neoadjuvant setting harmonize with ATOMIC's adjuvant strategy remains to be seen, but the direction is clear: Immunotherapy should now be considered foundational in the treatment of resectable dMMR colon cancer,' Saeed said. Saeed also expressed enthusiasm about the study, during the interview. 'The ATOMIC trial represents a watershed moment in the treatment of stage III dMMR colon cancer,' she said. 'This trial effectively redefines the standard of care for this patient population, with definitive phase 3 validation that immunotherapy has earned a place in the adjuvant treatment of dMMR colon cancer. But more importantly, it opens the door to deeper questions that must now guide the next generation of clinical investigation.' The study was funded by the National Institutes of Health, the National Cancer Institute, Genentech, Inc., and the Alliance Foundation. Sinicrope disclosed employment from MedVal, stock, and other ownership interests with Eli Lilly and Company; a consulting or advisory role with Guardant Health and Roche; and research funding from Ventana Medical Systems. He also disclosed patent royalties related to immune markers in colon cancer and a patent jointly held with Roche/Ventana Medical Systems. Saltzman disclosed stock and other ownership interests with Eli Lilly and Company, GoodRx, and Sana Biotechnology. Chalabi disclosed a consulting or advisory role with Bristol Myers Squibb/Celgene, MSD, and Roche/Genentech; research funding from Agenus, Bristol Myers Squibb, MSD, and Roche/Genentech; and travel, accommodations, and expenses from Bristol Myers Squibb. Saeed disclosed a consulting or advisory rolewith Arcus Therapeutics, Astellas Pharma, AstraZeneca, Autem Therapeutics, Bristol Myers Squibb, Exelixis, Pfizer, Regeneron, Replimune, Taiho Pharmaceutical, and Xilio Therapeutics.
Malaysian Reserve
23-04-2025
- Business
- Malaysian Reserve
Metastatic Colorectal Cancer Market Poised for Expansion Across the 7MM During the Forecast Period (2025-2034) as Breakthrough Therapies Gain Traction
The metastatic colorectal cancer (mCRC) market is experiencing significant growth, driven by advancements in targeted therapies, immunotherapies, and personalized medicine. The increasing prevalence of colorectal cancer, along with growing awareness of early diagnosis and treatment options, is fueling demand for innovative treatments. LAS VEGAS, April 23, 2025 /PRNewswire/ — Colorectal cancer (CRC) ranks as the third most prevalent cancer, with metastasis being the leading cause of mortality among affected patients. The liver and peritoneum are the most frequent sites of distant spread. For most individuals, metastatic CRC (mCRC) remains largely incurable, with common metastatic locations including the liver, lungs, lymph nodes, and peritoneum. Seen in approximately 45% CRC patients, KRAS mutations significantly influence the prognosis and treatment outcomes. These mutations are associated with a more aggressive disease course, resistance to chemotherapy and targeted therapies, and overall poorer survival rates. In 2024, the incidence of metastatic colorectal cancer was around 294K cases across the seven major markets, with the United States reporting the highest incidence. This number is expected to rise by 2034. Surgical intervention is the mainstay for resectable CRC, while unresectable cases are typically managed with chemotherapy, radiotherapy, and immunotherapy. These conventional therapies, however, often lack specificity and can harm healthy cells, leading to additional health complications. The treatment paradigm for mCRC involves multiple lines of therapy. First-line (1L) metastatic colorectal cancer treatments include combination chemotherapy regimens such as FOLFOX, FOLFIRI, and CAPEOX, alongside anti-angiogenic agents and targeted therapies like VECTIBIX and ERBITUX, with or without chemotherapy. KEYTRUDA and BRAFTOVI (in combination with ERBITUX and mFOLFOX6) are also approved for use in the first line. In the second-line (2L) setting, treatment options expand to include OPDIVO (± YERVOY), JEMPERLI, TUKYSA (± Trastuzumab), LONSURF (± Bevacizumab), and KRAZATI plus ERBITUX. For third-line (3L) therapy, specific agents such as STIVARGA and FRUZAQLA are utilized. Learn more about the metastatic colorectal cancer treatment landscape @ Metastatic Colorectal Cancer Drugs Market FRUZAQLA (fruquintinib) is a once-daily oral capsule developed by Takeda Pharmaceuticals. It is a kinase inhibitor approved for adult patients with metastatic colorectal cancer who have previously been treated with chemotherapy regimens including fluoropyrimidine, oxaliplatin, and irinotecan, as well as anti-VEGF therapy and, for RAS wild-type patients, anti-EGFR therapy. FRUZAQLA works by selectively targeting and inhibiting VEGFR-1, -2, and -3, thereby disrupting VEGF-driven blood vessel formation and tumor growth. The FDA approved FRUZAQLA for previously treated mCRC in November 2023, followed by the European Commission in June 2024, and Japan in September 2024—marking it as the first new targeted therapy for mCRC in more than ten years in the Japanese market. OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy) is indicated for adult patients with MSI-H or dMMR mCRC that has progressed after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan. It can be used as a standalone treatment or following prior combination therapy with intravenous nivolumab and ipilimumab. This drug works by blocking the PD-1 receptor, preventing its interaction with PD-L1 and PD-L2 to boost immune system activity against cancer cells. In December 2024, the FDA approved OPDIVO QVANTIG as a subcutaneous injection for mCRC, making it the first PD-1 inhibitor available in this form. This new route of administration offers quicker treatment delivery—just 3 to 5 minutes—compared to the traditional 30-minute intravenous infusion of OPDIVO. To know more about metastatic colorectal cancer treatments, visit @ Metastatic Colorectal Cancer Aggressive Treatment Despite several advancements, the metastatic colorectal cancer drug market remains highly competitive, with significant unmet needs for durable and long-term treatment responses. Ongoing research into investigational agents like amivantamab, zanzalintinib, and vactosertib highlights the push for more effective, resistance-targeting, and tumor microenvironment-modifying therapies, signaling a dynamic and evolving future for mCRC treatment. Key companies such as Johnson & Johnson Innovative Medicine, Shanghai Henlius Biotech, Inspirna, Treos Bio, Cardiff Oncology, Agenus, Leap Therapeutics, Arcus Biosciences, Enterome, Tizona Therapeutics, Innovative Cellular Therapeutics, and others are currently active in the metastatic colorectal cancer drug market. Discover which therapies are expected to grab major metastatic colorectal cancer drug market share @ Metastatic Colorectal Cancer Market Report Amivantamab is a bispecific antibody designed to target specific genetic alterations, especially EGFR exon 20 insertion mutations. Its dual mechanism focuses on inhibiting both the Epidermal Growth Factor Receptor (EGFR) and the MET receptor—two key players in cancer cell growth and survival. By binding to these receptors, amivantamab interferes with their signaling pathways, helping to overcome resistance that tumors often develop to other treatments. This dual targeting not only suppresses tumor cell growth but also enhances the body's immune response, leading to greater cancer cell destruction. The drug is currently in Phase III clinical trials for treating metastatic colorectal cancer (mCRC). Zanzalintinib (XL-092) is a third-generation oral tyrosine kinase inhibitor that blocks several cancer-related receptor tyrosine kinases, including VEGF receptors, MET, AXL, and MER. These kinases play a role in normal cell function as well as pathological processes like cancer development, metastasis, angiogenesis, and resistance to therapies such as immune checkpoint inhibitors. Developed by Exelixis, Zanzalintinib builds on the company's experience with cabozantinib, aiming to improve attributes like pharmacokinetic half-life. It is also in Phase III clinical trials for mCRC. DKN-01 is a humanized monoclonal antibody that targets the DKK1 protein and is being developed for treating esophagogastric, gynecologic, and colorectal cancers. Initial findings from Part A of the DeFianCe trial were shared at the 2024 ASCO Gastrointestinal Cancers Symposium. Enrollment for Part B of the DeFianCe trial (NCT05480306) concluded in September 2024. This Phase II, randomized, open-label, controlled study is assessing DKN-01 in combination with bevacizumab and chemotherapy as a second-line treatment for advanced colorectal cancer in patients previously treated with one systemic therapy. The study enrolled 188 patients, with early results anticipated by mid-2025. Discover more about drugs for metastatic colorectal cancer in development @ Metastatic Colorectal Cancer Clinical Trials The anticipated launch of these emerging metastatic colorectal cancer treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the metastatic colorectal cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for metastatic colorectal cancer in the 7MM is expected to grow from USD 13 billion in 2024 with a significant CAGR by 2034. This growth is fueled by advancements in precision medicine, including targeted therapies and immunotherapies, which have shown promise in improving patient outcomes. DelveInsight's latest published market report titled as Metastatic Colorectal Cancer Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the metastatic colorectal cancer country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The metastatic colorectal cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of CRC Gender-specific Cases of CRC Age-specific Cases of CRC Tumor Location-specific Cases of CRC Stage-specific Cases of CRC Total Incident Cases of mCRC Mutation Type-specific Cases of mCRC Total Treated Cases of mCRC by Line of Therapy The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM metastatic colorectal cancer market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this metastatic colorectal cancer market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the metastatic colorectal cancer market. Also, stay abreast of the mitigating factors to improve your market position in the metastatic colorectal cancer therapeutic space. Related Reports Metastatic Colorectal Cancer Pipeline Metastatic Colorectal Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key metastatic colorectal cancer companies, including Shanghai Henlius Biotech, Eisai Inc., Treos Bio, AUM Biosciences, Leap Therapeutics, Inc., Hoffmann-La Roche, Replimune, Qilu Pharmaceutical, Lutris Pharma, Ipsen, Bold Therapeutics, Pacylex Pharmaceuticals, FivepHusion, SystImmune, Inspirna, Inc., Sapience Therapeutics, Exelixis, Daiichi Sankyo, Hutchmed, Merus N.V., REVOLUTION Medicines, Pure Tech Health, Medicenna Therapeutics, Inc., Verastem Inc., Next Cure Inc., Isofol Medical, Zentalis Pharmaceuticals, Oncoinvent, KaryoPharm Therapeutics, Aadi Biosciences, among others. Metastatic Colorectal Cancer Market Metastatic Colorectal Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic colorectal cancer companies, including Johnson & Johnson Innovative Medicine, Shanghai Henlius Biotech, Inspirna, Treos Bio, Cardiff Oncology, Agenus, Leap Therapeutics, Arcus Biosciences, Enterome, Tizona Therapeutics, Innovative Cellular Therapeutics, among others. Colorectal Cancer Market Colorectal Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key colorectal cancer companies, including Mirati Therapeutics, Exelixis, Enterome, Arcus Biosciences, Lyell Immunopharma, AstraZeneca, Novartis Pharmaceuticals, Surgimab, Numab Therapeutics, SOTIO Biotech, Amgen, Sichuan Baili Pharmaceutical, Qilu Pharmaceutical, Bristol-Myers Squibb, NGM Biopharmaceuticals, Takeda, PureTech, Pfizer, Kezar Life Sciences, Salubris Biotherapeutics, among others. Colorectal Cancer Pipeline Colorectal Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key colorectal cancer companies, including Exelixis, Mirati Therapeutics, Merck Sharp & Dohme LLC, Daiichi Sankyo Company, Inspirna, Lyell Immunopharma, Genentech, Cantargia AB, Arcus Biosciences, Inc, Neogap Therapeutics AB, Criterium, Inc, Daiichi Sankyo, Inc, Bristol-Myers Squibb, Celyad Oncology SA, Pfizer, Akeso, Menarini Group, Elpiscience (Suzhou) Biopharma, Ltd., BeyondBio Inc., Shanghai Henlius Biotech, Rottapharm Biotech, Innovative Cellular Therapeutics Inc., BioNTech SE, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur info@ +14699457679 Logo: View original content:
Yahoo
28-01-2025
- Business
- Yahoo
Natera reports new data from Phase III study of colorectal cancer detection test
Natera has reported the latest data from the Phase III CALGB (Alliance)/SWOG 80702 study, indicating that Signatera, a molecular residual disease test could be instrumental in improving treatment outcomes for colorectal cancer patients. This study assessed whether subjects with detectable molecular residual disease post-surgery could benefit from an escalated adjuvant treatment regimen. The trial utilised Signatera to determine the benefits of adding celecoxib to the standard of care adjuvant chemotherapy with FOLFOX for stage III colorectal cancer management. Nearly 1,000 subjects with post-surgical plasma samples were involved in pre-specified analysis and received FOLFOX with or without celecoxib. The study's key findings demonstrated that subjects who were Signatera-positive after surgery had a significant disease-free survival (DFS) and overall survival (OS) benefit when celecoxib was added to their adjuvant FOLFOX therapy. Specifically, the addition of celecoxib significantly improved DFS in comparison to placebo, with a three-year DFS of 44.1% versus 26.6%. The OS results mirrored this benefit. Conversely, no survival advantage was observed for Signatera-negative subjects when celecoxib was added to their chemotherapy regimen. Moreover, the test status post-surgery was highly predictive of cancer recurrence, with positivity being significantly associated with worse DFS and OS outcomes. Natera oncology general manager and corporate chief medical officer Alexey Aleshin said: 'The results from the CALGB (Alliance)/SWOG 80702 study mark an unprecedented moment in personalised medicine for patients with colorectal cancer. 'We demonstrated Signatera's ability to predict a benefit in both disease-free survival and overall survival for Signatera-positive patients from the addition of celecoxib, an extremely accessible, affordable and well-tolerated therapy.' Signatera leverages circulating tumour DNA for identifying and quantifying residual cancer, enabling earlier recurrence detection. The test is used for several malignancies including breast, muscle-invasive bladder, ovarian and colorectal cancer. It has been clinically validated across various cancer types. Last month, the company commenced enrolment in the Phase III SAGITTARIUS trial, aiming to evaluate the Signatera test in personalising adjuvant treatment strategies for stage III and high-risk stage II colon cancer subjects after surgical resection. "Natera reports new data from Phase III study of colorectal cancer detection test" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
