🧪 FDA reviews ivonescimab+chemo in EGFR+ NSCLC

FDA has accepted Summit Therapeutics marketing application for ivonescimab plus platinum-doublet chemotherapy in EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) after progression on a third-generation EGFR TKI, with a decision expected by Nov. 14. The filing is based on overall Phase III HARMONi results (n=420; North America/Europe), where the combo cut risk of progression or death by 48% vs chemo alone, while overall survival showed a positive trend but did not reach statistical significance at the prespecified analysis.

Why It Matters To Oncology

▪ Ivonescimab is a closely watched PD-1/VEGF bispecific antibody; a U.S. review tests whether the class China-led momentum can translate into Western regulatory success.

▪ The HARMONi PFS signal (48% risk reduction) supports dual checkpoint/angiogenesis targeting in EGFR-mutated disease post-TKI, a setting with persistent unmet need after resistance.

▪ OS uncertainty remains the clinical and regulatory pressure point: the trials primary OS analysis trended positive but did not meet statistical significance, potentially shaping label scope and adoption.

The Financials

▪ Summits U.S. submission leverages its 2022 licensing agreement with Akeso, which developed ivonescimab.

▪ China has already de-risked parts of the commercial story: ivonescimab won its first China approval in 2024 (with chemo) based on HARMONi-A, and later expanded into first-line monotherapy after beating pembrolizumab in HARMONi-2.

▪ Investor attention is elevated because this is a “show-me” moment for PD-1/VEGF bispecifics in Western populations, where the class has not yet replicated Chinas level of success.

What They're Saying

▪ Qamar Ghafoor, consultant clinical oncologist at University Hospital Birmingham: “I think that if this were a trial five or 10 years ago, people would not have paid much attention to the Chinese data But I think China is now recognised, actually, as having good trials.”

▪ Summit: the U.S. filing is based on the “overall results” from Phase III HARMONi.

What's Next

▪ FDA decision date: Nov. 14; clinicians and drug developers will watch for how regulators weigh a strong PFS benefit against an OS analysis that did not reach statistical significance.

▪ Expect scrutiny of cross-trial generalizability: HARMONi (North America/Europe) vs multiple China-only Phase III datasets (HARMONi-A, HARMONi-2, HARMONi-6) that have supported approvals and broader use in China.

▪ If approved, competitive positioning vs chemo-alone and immunotherapy-based strategies in post-TKI EGFR-mutated NSCLC will hinge on label language, safety/tolerability, and any postmarketing commitments.