Summit Therapeutics Inc (NASDAQ:SMMT) and Akeso said ivonescimab, a PD-1xVEGF bispecific antibody, can extend patients' lives for EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) progressed after EGFR-TKI treatment.
Akeso said that the clinical trial’s final overall survival (OS) analysis showed that ivonescimab met the OS clinical endpoint.
A "statistically significant and clinically meaningful" overall survival (OS) benefit has been observed in the final analysis of ivonescimab's phase 3 HARMONi-A study, Akeso said Tuesday in its half-year report.
Detailed results of this study will be presented at an upcoming medical conference.
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The companies shared topline data from the Phase 3 HARMONi trial of ivonescimab plus platinum-doublet chemotherapy compared to placebo plus platinum-doublet chemotherapy met the progression-free survival (PFS) primary endpoint and showed a positive trend in overall survival.
At the prespecified primary data analysis, ivonescimab, in combination with chemotherapy, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, with a hazard ratio of 0.52.
In September 2024, it released data from the primary analysis of the Phase 3 HARMONi-2 trial of ivonescimab conducted in China, sponsored by Akeso. Ivonescimab slashed the risk of disease progression or death by 49% compared with Merck & Co. Inc.’s (NYSE:MRK) Keytruda.
HC Wainwright on Wednesday wrote, “We believe the market is underestimating how momentous Akeso's overall survival (OS) win is in EGFR-mutant NSCLC.”
Analyst Mitchell Kapoor says investors remain overly focused on the narrow EGFR-mutant setting, overlooking that the data confirm China trial results are credible, consistent with prior HARMONi findings showing alignment between China and ex-China studies.
Most notably, ivonescimab delivers a clear OS win over Keytruda, which failed to show an OS benefit.
Analyst Kapoor said this will be the best chance yet to show ivonescimab's strong PFS edge over Keytruda is driving an OS benefit, positioning it to challenge Keytruda's $30 billion-plus franchise.
HC Wainwright raised the price forecast for Summit from $44 to $50, citing a higher probability of approval in NSCLC to 85% (from 80%).
“We believe SMMT could emerge as a compelling acquisition target, especially as global pharma will inevitably need to secure a PD-1 ×VEGF bispecific antibody to remain competitive — much as the PD-1 vs. PD-L1 mono-antibody market evolved into multiple blockbuster franchises,” Kappor said in the investor note on Wednesday.
SMMT Price Action: Summit Therapeutics stock is down 7.80% at $24.88 at publication on Wednesday.
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