On Thursday, the U.S. Food & Drug Administration (FDA) accepted Summit Therapeutics Inc.’s (NASDAQ:SMMT) Biologics License Application (BLA) seeking approval for ivonescimab in combination with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) post-tyrosine kinase inhibitor (TKI) therapy.
The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of Nov. 14, 2026.
The BLA was submitted based on the overall results of the Phase 3 HARMONi trial, which evaluated ivonescimab plus platinum-doublet chemotherapy compared to placebo plus platinum-doublet chemotherapy in patients with EGFR-mutated, locally advanced or metastatic NSCLC who were previously treated with a 3rd generation EGFR TKI.
The FDA has noted that it intends to perform a complete review of the accepted and filed application.
This includes planned mid-cycle and wrap-up meetings and, subject to the FDA’s review not identifying major deficiencies, proposed labeling before the PDUFA date.
Trial Data
Summit Therapeutics’ partner, Akeso, Inc., published results from the Phase 3 HARMONi-A trial, conducted in China.
Ivonescimab plus chemotherapy demonstrated a median overall survival of 16.8 months vs. 14.1 months in patients on chemotherapy alone.
In October 2025, Summit Therapeutics shared results from the Phase 3 HARMONi-6 trial, conducted in China by its partner, Akeso Inc.
The trial showed that Ivonescimab and chemo reduced the risk of progression or death by 40% compared with BeOne Medicines Inc.'s (NASDAQ:ONC) Tevimbra (tislelizumab) and chemo for locally advanced or metastatic squamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression.
Summit is currently enrolling patients in the HARMONi-3 Phase 3 study to evaluate ivonescimab combined with chemotherapy compared to Merck & Co. Inc.'s (NYSE:MRK) Keytruda (pembrolizumab) combined with chemotherapy for first-line metastatic, squamous and non-squamous NSCLC.
Summit expects to complete enrollment in the squamous cohort of HARMONi-3 in the first half of 2026 and to reach the prespecified number of events for the PFS primary endpoint analysis for this cohort in the second half of 2026.
It also expects to complete enrollment in the non-squamous cohort of HARMONi-3 in the second half of 2026 and to reach the prespecified number of events for the PFS primary endpoint analysis for this cohort in the first half of 2027.
Additionally, Summit initiated a new Phase 3 HARMONi-GI3 study in first-line unresectable metastatic colorectal cancer (CRC).
The company intends to expand its ivonescimab clinical development program with additional Phase 3 clinical studies. The company will provide additional color with respect to these Phase 3 studies in the first quarter of 2026.
Price Action: SMMT stock is up 1.34% at $15.85 at the last check on Thursday, according to Benzinga Pro data.
Photo by Piotr Swat via Shutterstock
