🔬🧬 Oncology Updates: Cue’s 50% ORR, ENHERTU’s New Designation, Kisqali’s UK Nod and More
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From FDA Breakthrough Therapy Designations to Korea’s global push for next-gen drug development and pivotal trials in colorectal and ovarian cancer—this week’s oncology roundup delivers high-impact clinical progress across multiple tumor types.
đź’ˇ Key Highlights This Week:
âś… Cue Biopharma reports 50% ORR in HPV+ head & neck cancer; CUE-101 + pembrolizumab shows 88% 12-month OS
✅ Cantargia’s CANFOUR trial reports 91% ORR in NSCLC post-PD-1, with median OS of 26.7 months in non-squamous patients
🇰🇷 SNB-101, a nanoparticle SN-38 formulation, enters global trials backed by Korea Drug Development Fund; gains U.S. Fast Track & Orphan status for SCLC
🌸 ENHERTU + pertuzumab earns U.S. Breakthrough Designation; DESTINY-Breast09 data shows PFS greater than 3 years in HER2+ MBC
🇬🇧 NICE recommends Kisqali for high-risk early breast cancer based on NATALEE trial; 28.5% iDFS reduction in HR+/HER2- eBC
🧪 Alligator Bioscience comments on HLX22 U.S. Phase 3 launch in HER2+ gastric cancer; entitled to 35% of sublicense revenue
🧬 Akeso begins Phase 3 trial of ivonescimab in MSS/pMMR colorectal cancer—covers greater than 95% of mCRC population; Phase 2 data showed 81.8% ORR
🚻 J&J’s TAR-200 receives FDA Priority Review for high-risk NMIBC; Phase 2b shows 82.4% CR and 52.9% 1-year recurrence-free rate
🧑‍⚕️ Kairos Pharma reports strong safety for ENV-105 in mCRPC; no grade 3/4 AEs or DLTs in Phase 2
🧫 Corcept submits NDA for relacorilant + nab-paclitaxel in platinum-resistant ovarian cancer; improved PFS and OS without biomarker requirement
🧬 Amtagvi (lifileucel) shows 49% real-world ORR in melanoma; reaches 60.9% in earlier-line use
🧪 Senhwa doses first patient in NCI-funded $4.8M trial of CX-5461; targets G-quadruplexes in biomarker-driven solid tumor design
🎯 Whether you’re following immuno-oncology, next-gen cytotoxics, or emerging tumor microenvironment strategies—this episode covers the global momentum shaping cancer treatment innovation.
📢 Stay Ahead in Oncology Research!
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