Oncology Weekly News – August 4th 2025

🔬🧬 Oncology Updates: Ivonescimab Approved, Imfinzi Fast Tracked, TEVIMBRA EU Nod and More

From China’s sNDA acceptance for ivonescimab to breakthrough designations in gastric and sarcoma therapies—this week’s oncology roundup showcases global advances in immunotherapy, ADCs, and tumor-targeted innovation.

💡 Key Highlights This Week:

✅ Akeso’s ivonescimab accepted by NMPA for squamous NSCLC based on HARMONi-6 Phase III trial outperforming tislelizumab
✅ BeOne’s TEVIMBRA receives CHMP positive opinion in perioperative NSCLC with 56.2% MPR and 40.7% pCR
🧬 Vivace’s VT3989, a TEAD inhibitor targeting the Hippo pathway, gains FDA Orphan Drug Designation for mesothelioma
🧪 Atossa receives FDA support for (Z)-Endoxifen IND in ER+/HER2- mBC; IND expected Q4 2025 with CDK4/6 combo plan
🚀 AstraZeneca’s Imfinzi receives Priority Review and Breakthrough Therapy Designation for gastric/GEJ cancers with 29% risk reduction
🇹🇼 Opdivo + Yervoy approved in Taiwan for unresectable HCC with 23.7-month median OS in CheckMate -9DW
🎯 Cardiff Oncology’s Onvansertib hits 49% ORR in RAS-mutant mCRC Phase 2 trial, outperforming 30% control group
🔬 Nuvectis shifts focus to NXP900 (SRC inhibitor) after modest NXP800 data in ARID1a-mutated ovarian cancer
⚡ Calidi’s SuperNova (CLD-201) earns FDA Fast Track for sarcoma, with Phase 1 targeting TNBC and head & neck cancers
🧫 Mabwell’s CDH17 ADC 7MW4911 accepted by FDA and NMPA, showing preclinical efficacy in GI cancers including MDR models

🎯 Whether you’re following immunotherapy milestones, targeted ADC innovation, or regulatory wins—this episode delivers essential insights powering the next wave of cancer treatment.

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