Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 6 days ago
- 1 min read
12/08/2026
NMPA approves ivonescimab + chemo for first‑line advanced squamous NSCLC (Ref)
China’s NMPA approved Akeso Bio & Summit Therapeutics' ivonescimab (PD-1 x VEGF) in combination with chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC)
The approval was based on the significant positive results obtained Ph3 HARMONi-6/AK112–306
Overall Survival (OS): 27.9 mos vs 23.7 mos (HR=0.66, p=0.0017)
Progression-Free Survival (PFS): 11.1 mos vs 6.9 mos (HR=0.60, p<0.0001)
Safety: Comparable to tislelizumab + chemo, with favorable overall profile
Zipalertinib Combo Achieves PFS Milestone in EGFR Exon 20 NSCLC, FDA Filing Planned (Ref)
Cullinan Therapeutics announced that the Phase 3 REZILIENT3 trial of zipalertinib (EGFR inhibitor) + platinum-based chemotherapy in first-line NSCLC patients with EGFR exon 20 insertion mutations, met its primary endpoint of progression-free survival (PFS) at interim analysis
Statistically significant and clinically meaningful improvement in PFS was observed added with manageable safety profile
Next Steps:
Independent Data Monitoring Committee recommended unblinding
Full results to be presented at an upcoming international medical conference
Companies plan to pursue FDA regulatory approval
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