Summit’s Ivonescimab Shows Promising Results Over Keytruda in NSCLC, But Global Validation Needed

Clinical Trial Results:
Summit Therapeutics' ivonescimab, a bispecific antibody targeting PD-1 and VEGF, demonstrated a significant reduction in the risk of disease progression or death compared to Merck's Keytruda in patients with non-small cell lung cancer (NSCLC).

Efficacy Data:
The Phase III HARMONi-2 trial showed that ivonescimab reduced the risk of disease progression or death by nearly 50% compared to Keytruda, with a median progression-free survival (PFS) of 11.14 months versus 5.82 months for Keytruda.

Limitations:
The trial was conducted entirely in China, raising concerns about the generalizability of the results to other populations. Analysts suggest that more global data, including U.S. trials, are needed for FDA approval.

Future Plans:
Summit plans to initiate the multi-regional, late-stage HARMONi-7 study in early 2025 to further validate ivonescimab's efficacy in a broader patient population.

Market Impact:
Despite the promising results, the impact of ivonescimab on Merck's Keytruda may be limited due to Keytruda's extensive data and impending patent cliff in 2028.