Summit Therapeutics and its partner Akeso reported on Jul. 22 that their PD-1/VEGF-targeting antibody, ivonescimab, continues to show prolonged impact on overall survival for patients with advanced non-squamous non-small cell lung cancer (NSCLC) across different regions.
Newly released data from the global Phase 3 HARMONi trial indicate that a subgroup of Western patients achieved an overall survival hazard ratio of 0.76 at 23.2 months, representing a 24% lower risk of death compared to those receiving standard care. Summit did not disclose whether this result was statistically significant but noted its similarity to findings among Chinese participants in the same study, who showed a hazard ratio of 0.74—or a 26% reduction—at 32.5 months.
The HARMONi study enrolled patients with endothelial growth factor receptor-mutated, advanced non-squamous NSCLC who had previously been treated with third-generation EGFR tyrosine kinase inhibitors. The investigational bispecific antibody was administered alongside chemotherapy.
Analysts from Stifel commented on Wednesday that “the risk that China data would not translate has been a lingering bear argument,” but said the newest results are “a strong counter to that pushback.” Stifel further wrote: “Unlike legacy anti-VEGFs that are known to only right-shift the PFS curve without OS benefit, ivonescimab delivers better immunotherapy, and that shows up in the tail of the OS curve.”
Stifel said it is "encouraged but not surprised" by these findings and believes they "reduce an already-limited" regulatory risk for second-line EGFR-mutated NSCLC treatment. The firm also stated, “Bears can still point to the lack of explicit statistical-significance language, but in our view the more relevant FDA question is whether the global data are consistent, and this update directly addresses that concern.”
Summit has submitted updated analyses to the Food and Drug Administration as part of its Biologics Licensing Application process launched earlier this year; a decision is expected by Nov. 14.
