FDA to decide on ivonescimab for EGFR-mutant lung cancer by Saturday

The US Food and Drug Administration is scheduled to decide by Saturday whether to approve ivonescimab, an investigational PD-1/VEGF bispecific antibody from Summit Therapeutics and Akeso, for adults with EGFR-mutated non-small cell lung cancer whose disease has progressed after a third-generation EGFR tyrosine kinase inhibitor. Tech Times reported on Thursday that Summit's biologics license application seeks regular approval, not accelerated approval.

Ivonescimab attaches to both PD-1 and VEGF. When it binds VEGF, the molecule alters its shape, which boosts its affinity for PD-1 by about 18-fold; this effect is strongest in regions of the tumor with the highest VEGF concentrations. The antibody also has an Fc-silent design so it does not eliminate the immune cells it is intended to stimulate, as the report explains.

The pivotal evidence comes from the global Phase III HARMONi trial, which included 438 people whose EGFR-mutated non-squamous non-small cell lung cancer had advanced locally or spread and had worsened despite treatment with a third-generation EGFR tyrosine kinase inhibitor. Participants received either ivonescimab with platinum-based chemotherapy or chemotherapy alone (plus placebo). According to results reported in The Lancet Oncology in September 2026, median progression-free survival was 6.8 months in the ivonescimab arm versus 4.4 months in the control arm, a hazard ratio of 0.52 (95% CI 0.41–0.66; p<0.00001), as stated by Tech Times.

Overall survival was not statistically significant at the primary analysis in April 2025, with a hazard ratio of 0.79 and p=0.057. Two later interim analyses produced hazard ratios of 0.78 in September 2025 and 0.76 in June 2026, but the prespecified significance threshold has not been crossed. The report said Summit shared the June 2026 survival data with the FDA on July 22, after the agency had accepted the application.

On September 28, 2026, AstraZeneca said it would invest $2 billion in Summit Therapeutics, securing shared US commercialization rights to ivonescimab as well as rights in certain other regions. Tech Times noted that this investment does not settle the statistical uncertainty in the overall survival data, but it does imply that AstraZeneca's existing oncology infrastructure would support the drug's launch if the FDA approves it.

The FDA's stance on surrogate endpoints has been under scrutiny. A JAMA study in July 2026 found that only about 8 percent of cancer drugs approved on surrogate endpoints later showed an overall survival benefit. In April 2026, an FDA advisory committee voted 6-3 against AstraZeneca's camizestrant for advanced breast cancer despite positive progression-free survival, citing absent overall survival data; the FDA later granted camizestrant accelerated approval in a narrower biomarker-defined population. Summit is seeking regular approval for ivonescimab, which requires substantial evidence of clinical benefit, the report noted.

The article also cited HARMONi-3, a separate Phase III trial for first-line metastatic non-small cell lung cancer, whose interim analysis for progression-free survival did not meet its target in early 2026. That trial is not included in the current BLA. Tech Times also reported concerns from US lawmakers about Akeso's obligations under Chinese data-security laws, though the FDA has not publicly said whether those factors will enter its decision.

The FDA could grant regular approval, accelerated approval, or issue a complete response letter. If approved, ivonescimab would be the first drug of its class, a PD-1/VEGF bispecific antibody, available to patients in the United States. If rejected, the decision would signal that strong progression-free survival alone is not enough when overall survival has been requested, the report said.