COR2ED’s Post

📣 Immunotherapy for HCC: Video update from #ESMO24 📣 How will new data on immunotherapy (IO) and IO-based treatments for HCC impact clinical practice? Dr. Richard Finn joined us at ESMO to share his thoughts on new data presented at the congress and reveal his key clinical takeaways that HCPs need to know. Watch his video update 👇📺 Dr. Finn reviews data from the following studies: ➡️ Five-year overall survival (OS) and OS by tumour response measures from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (uHCC) Rimassa L, et al. (Abstract 947MO, ESMO2024) ➡️ Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC): Expanded analyses from CheckMate 9DW Decaens T, et al. (Abstract 965MO, ESMO 2024) ➡️ Transarterial Chemoembolization (TACE) With or Without Lenvatinib (len) + Pembrolizumab (pembro) for Intermediate-Stage Hepatocellular Carcinoma (HCC): Phase 3 LEAP-012 Study. Llovet J, et al. (Abstract LBA3, ESMO 2024) ➡️ Updated efficacy and safety data from IMbrave050: Phase 3 study of adjuvant atezolizumab (atezo) + bevacizumab (bev) vs active surveillance in patients (pts) with resected or ablated high-risk hepatocellular carcinoma (HCC) (Abstract LBA39, ESMO 2024) Yopp A, et al. Watch this space for the summary slide set coming soon! AstraZeneca has provided a sponsorship grant towards this Independent Programme #MedicalEducation #Oncology

📣 Immunotherapy for HCC: Update from #ESMO24 📣 Dr Richard Finn shares his thoughts on new data presented at ESMO and reveals his key clinical takeaways. How will new data on immunotherapy (IO) and IO-based treatments for HCC impact clinical practice? Watch his video update and download the slides👇📺 https://lnkd.in/etX55wFr Dr Finn reviews data from the following studies: ➡️ Five-year overall survival (OS) and OS by tumour response measures from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (uHCC) Rimassa L, et al. (Abstract 947MO, ESMO2024) ➡️ Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC): Expanded analyses from CheckMate 9DW Decaens T, et al. (Abstract 965MO, ESMO 2024) ➡️ Transarterial Chemoembolization (TACE) With or Without Lenvatinib (len) + Pembrolizumab (pembro) for Intermediate-Stage Hepatocellular Carcinoma (HCC): Phase 3 LEAP-012 Study. Llovet J, et al. (Abstract LBA3, ESMO 2024) ➡️ Updated efficacy and safety data from IMbrave050: Phase 3 study of adjuvant atezolizumab (atezo) + bevacizumab (bev) vs active surveillance in patients (pts) with resected or ablated high-risk hepatocellular carcinoma (HCC) (Abstract LBA39, ESMO 2024) Yopp A, et al. AstraZeneca has provided a sponsorship grant towards this Independent Programme #MedicalEducation #Oncology

Advancing Immunotherapy for Early-Stage Hepatocellular Carcinoma (HCC): Insights from Dr.James J Harding Dr. James J Harding, a gastrointestinal medical oncologist and early drug development specialist at Memorial Sloan Kettering Cancer Center, recently presented findings from two pivotal studies—ImBRAVE050 and EMERALD-1—at the 42nd Annual Chemotherapy Foundation Symposium. These studies are shaping the conversation on the role of immunotherapy-based combinations in early-stage HCC. Highlights: ImBRAVE050: Although the trial did not show an overall survival (OS) or recurrence-free survival advantage with adjuvant atezolizumab (Tecentriq) and bevacizumab (Avastin), it provided critical insights into preventing very early recurrence in high-risk patients. EMERALD-1: This study demonstrated that combining transarterial chemoembolization (TACE) with durvalumab (Imfinzi) and bevacizumab significantly improved progression-free survival (PFS) compared to TACE alone, with promising implications for early-stage management of HCC. Looking Ahead: Dr. James J Harding highlighted the need for continued innovation, exploring bispecific antibodies, triplet regimens, and cellular therapies to improve outcomes for HCC patients. The ultimate goal remains to move the field toward curative therapies that extend survival and enhance quality of life. This post is based on a recent article featured on OncLive®. Read the original here: https://lnkd.in/e93tGPdv #HCC #Immunotherapy #JamesHarding #LiverCancer #OncologyInnovation #ClinicalTrials #MediaMedic

Dr. James J Harding explores immunotherapy combinations for early-stage HCC, highlighting findings from ImBRAVE050 and EMERALD-1 to advance patient outcomes. #HCC #Immunotherapy #JamesHarding #LiverCancer #OncologyInnovation #ClinicalTrials

🚀 Summer approvals in oncology: 1️⃣ Zolbetuximab, in combination with fluoropyrimidine- and platinum-containing chemotherapy, has received a positive opinion from the EMA's CHMP for the 1st-line treatment of HER2-negative, claudin18.2-positive gastric adenocarcinoma. This is based on the #SPOTLIGHT and #GLOW studies, which demonstrated modest improvements in PFS and OS. The decision of the European Commission is forthcoming. Learn more: SPOTLIGHT STUDY: https://lnkd.in/dTmEKyjQ GLOW STUDY: https://lnkd.in/dkQkg9aM EMA PUBLICATION: https://lnkd.in/dz-nRJuq 2️⃣ Dostarlimab in combination with carboplatin + paclitaxel has had its FDA indication expanded for use in MSS endometrial cancer, showing a ~10% increase in 2-year PFS in the #RUBY study. Learn more: RUBY STUDY: https://lnkd.in/dM72nPWg FDA PUBLICATION: https://lnkd.in/g3dqAQ59 3️⃣ The FDA has also granted accelerated approval to Afamitresgene Autoleucel, a CAR T cell product for relapsed/metastatic MAGE-A4+ synovial sarcoma, based on the #SPEARHEAD1 trial results. Learn more: SPEARHEAD1 STUDY: https://lnkd.in/dHQyB53u FDA PUBLICATION: https://lnkd.in/e9_Mh_av These breakthroughs are paving the way for more targeted and effective cancer treatments. Stay tuned for more updates in the world of oncology! #Oncology #CancerResearch #FDAApproval #EMAApproval #Trialing

#Ribociclib(CAS:1211441-98-3) Ribociclib, is a revolutionary anticancer medication specifically designed for the treatment of certain types of breast cancer. As an oral CDK4/6 inhibitor, Ribociclib precisely targets and inhibits Cyclin-Dependent Kinases 4 and 6 (CDK4/6), which play a crucial role in the division and proliferation of cancer cells. By inhibiting the activity of these kinases, Ribociclib can effectively slow down or even stop the growth of tumor cells. Ribociclib is primarily used in combination with other medications, such as aromatase inhibitors, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer patients. This treatment approach is particularly suited for postmenopausal women, but can also be used in male breast cancer patients. Clinical trials have demonstrated that Ribociclib, in combination with endocrine therapy, significantly extends progression-free survival (PFS) and improves the quality of life for patients, offering new hope for those battling breast cancer. However, like all medications, Ribociclib can have potential side effects, including low blood counts, liver function abnormalities, fatigue, nausea, etc., making it essential to closely monitor the patient's health status during treatment. In summary, the advent of Ribociclib represents a significant advancement in the field of breast cancer treatment, providing patients with a new and effective treatment option. #Hyperchem #Ribociclib #oncology #anticancer #breastcancer #pharmaceutical #API #pharmacy

📢 Seagen's Tivdak confirms benefit in recurrent or metastatic cervical cancer with disease progression on or after chemotherapy; AA PMR fulfilled (Pfizer) ➤ Efficacy was evaluated in innovaTV 301 (NCT04697628), an open-label, active-controlled, multicenter, randomized trial that enrolled 502 patients with recurrent or metastatic cervical cancer who had received one or two prior systemic regimens, including chemotherapy with or without bevacizumab and/or an anti-PD-(L)-1 agent ➤ Median OS was 11.5 months (95% CI: 9.8, 14.9) vs. 9.5 months (95% CI: 7.9, 10.7) in the chemotherapy arm (HR 0.70 [95% CI: 0.54, 0.89] p-value 0.0038) ➤ Trial’s results fulfill the post-marketing requirement of the FDA's 2021 accelerated approval for this indication #oncology #biotech #biotechnology #regulatoryaffairs #pharma #drugdevelopment #oncologytrials #oncologyresearch #cancer #oncology #regulatoryintelligence #regulatoryprecedent https://lnkd.in/g_ADYadi

🎉 Big News Alert! 🚀 The FDA just gave the green light to alectinib (marketed as Alecensa by Genentech, Inc.) for post-tumor resection treatment in patients battling anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). A groundbreaking global trial called ALINA (NCT03456076) conducted in patients with ALK-positive NSCLC who underwent complete tumor resection, showed promising results for alectinib. Participants in the trial were randomized to receive either alectinib or platinum-based chemotherapy post-resection. The trial's findings revealed that patients treated with alectinib experienced significantly longer disease-free survival (DFS) compared to those on chemotherapy. In fact, the median DFS was not even reached in the alectinib group overall and in the subgroup of patients with stage II-IIIA NSCLC, showcasing its potential to extend the time patients live without the disease recurring. The recommended dosage for alectinib is 600 mg orally twice daily with food for up to 2 years or until disease recurrence or intolerable side effects occur. This regimen offers hope for patients and healthcare providers alike, providing a new avenue for effective treatment in the fight against ALK-positive NSCLC. #FDAApproval #CancerTreatment #MedicalBreakthrough #HopeForPatients https://lnkd.in/grG8nFiq

The FDA’s recent approval of tisotumab vedotin-tftv (Tivdak) marks a significant milestone in the treatment of recurrent or metastatic cervical cancer. This approval is not only a regulatory green light; it is a beacon of hope for women whose cancer has progressed despite chemotherapy. This targeted therapy, after rigorous trials, demonstrated a significant improvement in both overall survival and progression-free survival compared to existing chemotherapy options. For patients facing limited treatment options, Tivdak opens a new frontier. Its approval enriches the therapeutic landscape, providing a vital option that could alter treatment protocols and fundamentally improve patient outcomes. With its promising efficacy and a manageable safety profile, Tivdak stands out as a crucial addition to oncologists’ arsenal , offering new hope for advanced cervical cancer. This breakthrough is a testament to the relentless pursuit of innovation in cancer care, promising not just more time, but potentially a better quality of life for those affected. #MedicalInnovation #CancerCare #OncologyResearch