Kapadi’s Post

Summit’s Checkpoint Inhibitor Outperforms Keytruda in Lung Cancer Trial Summit Therapeutics, Inc. has announced that its drug ivonescimab significantly reduced the risk of lung cancer progression or death by nearly 50% compared to Keytruda (pembrolizumab), in a Phase III trial. The results were presented on September 8 at the World Conference on Lung Cancer (WCLC) in San Diego. The HARMONi-2 study, which included 398 Chinese patients with PD-L1-positive advanced non-small cell lung cancer (NSCLC), showed that ivonescimab extended progression-free survival (PFS) to a median of over 11 months, compared to just under six months for patients treated with Keytruda. This difference led to a statistically significant 49% reduction in the risk of cancer progression or death. Ivonescimab, a bispecific antibody targeting both PD-1 and VEGF, was compared directly against Keytruda, marking the first time a Phase III trial in NSCLC has shown such a substantial PFS improvement against the blockbuster drug. Keytruda generated $25 billion in revenue last year, and is expected to hit $33.7 billion by 2028. Summit acquired ivonescimab's rights from Akeso in 2022 for $500 million. The drug could generate up to $1.7 billion in sales by 2030 if approved. #LungCancer #CheckpointInhibitor #SummitTherapeutics #Ivonescimab #Keytruda #PD1Inhibitor #CancerTreatment #Oncology #NSCLC #WCLC2024 #ClinicalTrials #Pharmaceuticals

Discover how monitoring tumor fraction (TF) provides crucial insights into treatment response further reinforcing the value of our next-generation, tissue-free, actionable MRD assay, PredicineBEACON™, in tracking and predicting therapeutic efficacy within Roche's clinical trials for the KRAS G12C inhibitor, Divarasib, in this major breakthrough publication in Clinical Cancer Research, which builds on the significant findings from our previous studies in The New England Journal of Medicine and Nature Medicine.    Our latest study offers deep insights into circulating tumor DNA (ctDNA), specifically examining tumor fraction (TF) and KRAS G12C mutant allele frequency (AF). The analysis of baseline ctDNA profiles and the rapid dynamics observed in patients responding to Divarasib demonstrate a strong correlation with improved treatment outcomes.      Key Highlights:  • Tissue free, baseline blood informed MRD Profiling.   • Therapeutic response and PFS has been captured by PredicineBEACON™ MRD analysis.  • Tumor Fraction is precisely captured by PredicineBEACON™ MRD assay, which is further confirmed by the PredicineWES+™ across whole exome.   • PredicineBEACON™ identified ultra-low frequency ctDNA dynamic, offering clinical potential for treatment monitoring and resistance mechanisms.    PredicineBEACON™ continues to push the boundaries of precision oncology, delivering crucial molecular insights that propel the development and broader adoption of groundbreaking therapies such as Divarasib. Explore how our cutting-edge technology is shaping the future of cancer treatment and driving innovations that enhance therapeutic efficacy.    View the publication here: https://lnkd.in/gHGefM25    Predicine is committed to advancing cancer research and collaborates with leading pharmaceutical companies to transform insights into impactful therapies.    For additional information about Predicine and our biopharma solutions, click below to schedule a meeting with Predicine's team https://lnkd.in/gfAamv7U #diagnostics #oncology #NGS #liquidbiopsy #MRD #ctDNA #CDx 

Recent findings published in JAMA Oncology reveal that less than one-third of FDA-approved molecularly targeted cancer drugs meet the rigorous clinical benefit standards set by the European Society of Medical Oncology (ESMO). This study, conducted by researchers affiliated with Brigham and Women’s Hospital and Harvard Medical School, sheds light on the challenges in assessing the true clinical benefits of these cutting-edge therapies. Key Insights · Only 29% of the studied molecularly targeted cancer drugs demonstrated substantial clinical benefit based on ESMO's Magnitude of Clinical Benefit Score. · The rise in genomic testing has led to a surge in molecularly targeted drug approvals, but the quality of supporting evidence varies significantly. · Many drug trials rely on surrogate endpoints like disease-free survival and progression-free survival, raising questions about the actual clinical benefits of these treatments. The Role of ESMO-MCBS The ESMO-MCBS, developed in 2015, plays a crucial role in evaluating the clinical benefits of cancer drugs. This scale considers factors such as survival rates, toxicities, and quality of life to assign a score that reflects the treatment's efficacy. Moving Forward As the field of oncology continues to evolve, the need for robust data to ensure high-value cancer care becomes increasingly apparent. The ESMO-MCBS and ESCAT frameworks aim to identify molecular therapies with significant value, guiding the prioritization of access to these innovative treatments. For more information, please visit: https://lnkd.in/gN-y2hbz #OncologyDrugs #CancerDrugs #Toxicity #ESMO #CancerCare

🔥 Hot topics at #2024ASCO include this: Five-year data on #Lorbrena makes it a #Blockbuster-to-be, by 2030, says Pfizer. 📅 "Sixty percent of ALK-positive patients with advanced lung cancer who were treated with Lorbrena had no disease progression after five years, according to follow-up results from the company's Phase 3 CROWN trial unveiled at the American Society of Clinical Oncology meeting in Chicago." In the competitive lung cancer space, few notes (not exhaustive): 🔬 Efficacy for those with ALK mutations, thus, more patients to be tested 🌏 From a market opportunity standpoint...see rationale for targeting China (see article) 👨⚕️ How this will shift SOC (such as how this will shift the competitive landscape) such as earlier line use, to replace Xalkori #LungCancer #NSCLC #Pfizer #ASCO #Pharma #Strategy #PersonalizedMedicine #Healthcare https://lnkd.in/e-MvCvkE

Thrilled to represent Domain Therapeutics, the leading GPCR #immunooncology company, at the AACR 2024 oncology partnering event! Engaging in insightful discussions with peers from #biopharma and #biotech sectors reinforces our collective dedication to #cancerresearch and treatment advancements. We are eager to transform these dialogues into tangible outcomes. 🤝 Domain's innovative strategies are rooted in over two decades of solid GPCR expertise, addressing the unmet clinical needs in immuno-oncology. What sets us apart? Our pipeline currently boasts first-in-class and best-in-class drug candidates meticulously designed to target the signaling pathways engaged by GPCRs to beat resistance and defeat cancer: ▪ DT-7012, a pioneering preclinical, a best-in-class Treg-depleting anti-CCR8 monoclonal antibody rapidly evolving toward the clinic ▪ DT-9045, a preclinical candidate, a first-in-class, PAR2 biased ligand Negative Allosteric Modulator, small molecule with unprecedented pharmacological properties ▪ DT-9081, a lead clinical candidate, anEP4R antagonist program, small molecule currently in Phase I ascending dose study 🌎 We envision a future where every patient has access to optimal cancer treatment. Our differentiated and diversified immuno-oncology assets address immunosuppressive tumor microenvironment, targeting different immune cell subpopulations. These assets hold an immense promise for cancer patients resistant to current treatments.  🚀 Interested in learning more about our unique approach or discussing our current projects? Feel free to contact me directly or connect with our highly qualified experts Thibaut Brugat Nathalie Lenne Stephan Schann during our poster presentation 🗓 April 7th, 1:30pm, poster section 27, poster board 30, poster 684 at the AACR Annual Meeting 2024. Together, we can build a brighter future for cancer patients! 🌟 American Association for Cancer Research #drugdevelopment #immunotherapy

🚀 𝐏𝐫𝐨𝐦𝐢𝐬𝐢𝐧𝐠 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐟𝐨𝐫 𝐚 𝐛𝐢𝐬𝐩𝐞𝐜𝐢𝐟𝐢𝐜 𝐚𝐧𝐭𝐢𝐛𝐨𝐝𝐲 𝐢𝐧 𝐋𝐮𝐧𝐠 𝐂𝐚𝐧𝐜𝐞𝐫 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭! 🚀 Summit Therapeutics, Inc. has recently shared encouraging Phase 3 trial data for their experimental drug, 𝐢𝐯𝐨𝐧𝐞𝐬𝐜𝐢𝐦𝐚𝐛, in the treatment of advanced non-small cell lung cancer (NSCLC). This innovative therapy, a 𝐛𝐢𝐬𝐩𝐞𝐜𝐢𝐟𝐢𝐜 𝐚𝐧𝐭𝐢𝐛𝐨𝐝𝐲 targeting both PD-1 and VEGF pathways, has shown remarkable potential when compared to Merck’s Keytruda. 🎯 𝐊𝐞𝐲 𝐓𝐚𝐤𝐞𝐚𝐰𝐚𝐲𝐬: • 𝐏𝐫𝐨𝐠𝐫𝐞𝐬𝐬𝐢𝐨𝐧-𝐅𝐫𝐞𝐞 𝐒𝐮𝐫𝐯𝐢𝐯𝐚𝐥: Ivonescimab nearly doubled the time tumors remained stable (11+ months vs. 6 months for Keytruda). 📊 • 𝐁𝐢𝐬𝐩𝐞𝐜𝐢𝐟𝐢𝐜 𝐌𝐞𝐜𝐡𝐚𝐧𝐢𝐬𝐦: By simultaneously targeting PD-1 and VEGF, ivonescimab may offer enhanced efficacy in halting tumor growth. 💡 • 𝐑𝐞𝐝𝐮𝐜𝐞𝐝 𝐑𝐢𝐬𝐤: A 49% reduction in cancer progression or death was observed in the trial. 🔄 However, while these results are highly promising, there are still 𝐜𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐮𝐧𝐤𝐧𝐨𝐰𝐧𝐬: • ❓The study didn’t include the current standard combination of 𝐊𝐞𝐲𝐭𝐫𝐮𝐝𝐚 + 𝐜𝐡𝐞𝐦𝐨𝐭𝐡𝐞𝐫𝐚𝐩𝐲, which raises questions about the drug’s comparative performance. • 🌍The trial was conducted in China, so the 𝐠𝐞𝐧𝐞𝐫𝐚𝐥𝐢𝐳𝐚𝐛𝐢𝐥𝐢𝐭𝐲 of the results needs further validation. 🔬 𝐅𝐮𝐫𝐭𝐡𝐞𝐫 𝐬𝐭𝐮𝐝𝐢𝐞𝐬 are underway to answer these questions, and the global medical community eagerly awaits more data, including overall survival rates. If successful, ivonescimab could reshape the treatment landscape for lung cancer patients worldwide. #InnovationInOncology #LungCancer #Ivonescimab #ClinicalTrials #CancerResearch #Pharma

United States Dominates Global Pancreatic Cancer Market with 50% Share, Outpacing EU4, UK, and Japan, DelveInsight | AstraZeneca, Merck Sharp & Dohme LLC, Bayer, Roche, Celgene, Bristol Myers Squibb: Pancreatic Cancer Market As per DelveInsight, the Pancreatic Cancer Market is anticipated to grow immensely in the coming years owing to the launch of upcoming therapies and the increase in the incident population of Pancreatic Cancer in the 7MM. DelveInsight’s … Continue reading → #Business #Europe #HealthMedicine #PharmaceuticalsBiotech #US

It seems that AstraZeneca and Daiichi Sankyo's antibody-drug conjugate, datopotomab deruxtecan (dato-DXd), is facing significant hurdles in its approval process. Despite showing some efficacy in delaying disease progression in both lung and breast cancer trials, the fact that it failed to meet its key goal of extending overall survival in the two crucial Phase 3 studies, thereby raising serious concerns about its prospects for regulatory approval. Additionally, dato-DXd’s progression benefit is not a standout, as it aligns with the efficacy observed for Gilead’s competing drug, Trodelvy, in similar breast cancer settings. This similarity might reduce its attractiveness, as it could be seen as offering no clear advantage over existing therapies. These factors together cast doubt on the future of dato-DXd, particularly given the FDA's focus on overall survival as a key marker of clinical benefit in oncology. #AstraZeneca #DaiichiSankyo #ADC #datoDXd #Cancer #Approval https://lnkd.in/gRYdU3mp

🚀 Transformative news in melanoma treatment! At the recent ASCO Annual Meeting, Moderna and MSD unveiled promising three-year follow-up data from the KEYNOTE-942 study, highlighting their groundbreaking cancer vaccine, mRNA-4157, combined with Keytruda. The Phase IIb trial for stage IIIB–IV resected melanoma showed remarkable results: Risk of recurrence or death reduced by 49% compared to Keytruda alone. 2.5-year recurrence-free survival (RFS): 75% for the combination vs. 56% for Keytruda. 62% reduction in distant metastasis risk. Overall survival at 2.5 years was 96% for the combination vs. 90% for Keytruda. These outcomes were consistent across various subgroups, regardless of tumor mutational burden (TMB) and PD-L1 levels. While the most common adverse event was fatigue, most side effects were manageable and low-grade. Moderna and MSD have kicked off the Phase III INTerpath-001 study, aiming for a biologics licensing application (BLA) due to the unique potential of this first-in-class therapy. Beyond melanoma, this combination is being tested for other cancers, including non-small cell lung cancer and cutaneous squamous cell carcinoma, with potential market launch in 2027 and sales exceeding $1 billion by 2030. For more news like this, follow: World Pharmaceutical Frontiers Stay tuned as this collaboration paves the way for new frontiers in cancer treatment! 🌟🔬 #CancerResearch #Immunotherapy #Melanoma #Moderna #MSD #ASCO2024 #ClinicalTrials