🧬🚀Oncology Update: Breakthrough Trials, Drug Approvals & New Therapies.
Get the latest breakthroughs in oncology research!From global trial launches to regulatory milestones and next-gen ADCs, this week’s roundup covers the most critical developments in cancer care, therapeutics, and biotech strategy.
Explore how Merck & Daiichi Sankyo advance a novel B7-H3-targeting ADC in esophageal cancer, why Gilead’s Trodelvy is changing the game in metastatic TNBC, and how XTANDI is raising survival standards in mHSPC. 🏥✨ We bring you the latest across breast, lung, liver, and prostate cancers, with highlights from FDA Fast Track designations, CHMP approvals, and Phase 3 trial initiations—delivering key insights for clinicians, biotech leaders, and oncology innovators.
🔎 Key Highlights:
💊 Merck and Daiichi Sankyo initiate Phase 3 trial of ifinatamab deruxtecan (I-DXd) in previously treated esophageal squamous cell carcinoma; trial to enroll ~510 patients globally.
🧪 PharmaMar submits EU application for lurbinectedin + atezolizumab in extensive-stage SCLC, based on the Phase 3 IMforte trial results.
🚀 Zai Lab’s DLL3-targeting ADC ZL-1310 earns FDA Fast Track designation for SCLC; pivotal trial expected in 2025.
🍁 Tagrisso receives conditional Canadian approval for Stage III EGFR-mutant NSCLC with median PFS of 39.1 months vs. 5.6 months for placebo.
🧬 Kelun-Biotech files NDA in China for Trop2-targeting ADC sacituzumab tirumotecan in HR+/HER2– breast cancer, showing strong PFS benefit over physician’s choice chemo.
✅ Roche’s inavolisib (Itovebi) recommended for EU approval in PIK3CA-mutant, HR+/HER2– breast cancer, with 57 percent PFS risk reduction when used with palbociclib + fulvestrant.
🛡️ Gilead’s Trodelvy meets primary endpoint in ASCENT-03 trial for first-line mTNBC, with strong efficacy in checkpoint inhibitor-ineligible patients.
🏥 Chugai’s TALENTACE trial shows Tecentriq + Avastin + TACE combo outperforms TACE alone in unresectable liver cancer; OS data still maturing.
🔬 Clarity Pharmaceuticals launches Phase 3 AMPLIFY trial using 64Cu-SAR-bisPSMA PET in recurrent prostate cancer across US and Australia (~220 patients planned).
📊 Promontory Therapeutics advances PT-112 to Phase 3 in mCRPC following successful FDA End-of-Phase 2 meeting; interim data may support accelerated approval.
🧓 XTANDI shows five-year survival benefit in mHSPC with a 30 percent mortality risk reduction; 66 percent survival probability vs. 53 percent with standard care.
🌍 Pfizer licenses PD-1/VEGF bispecific antibody SSGJ-707 from 3SBio for NSCLC, CRC, and gynecologic cancers in a deal valued at up to 6 billion dollars, including 1.25 billion upfront.
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