Summit Therapeutics' Ivonescimab Approved in China for NSCLC

By Bobby Samwell • Saturday, April 26 06:08 • Permanent Link

Summit Therapeutics Inc. (NASDAQ: SMMT) has announced that Ivonescimab, also known as SMT112 in Summit's license territories, has been approved by the Chinese health authorities for a second indication based on the results of the Phase III clinical trial, Harmoni-2 or AK112-303. The trial evaluated monotherapy Ivonescimab against monotherapy Pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression. The interim overall survival analysis requested by the National Medical Products Administration (NMPA) of China shows a clinically meaningful, positive trend favoring Ivonescimab compared to Pembrolizumab, with an overall survival hazard ratio of 0.777 favoring Ivonescimab at 39% data maturity, implying a potential numerical 22% reduction in the risk of death compared to Pembrolizumab.

Last September, for the primary analysis for Harmoni-2, Ivonescimab monotherapy demonstrated a statistically significant improvement in the trial’s primary endpoint, progression-free survival (PFS) by independent radiologic review committee (IRRC), achieving a hazard ratio (HR) of 0.51 (95% CI: 0.38, 0.69; p<0.0001).

Summit is currently enrolling patients in the Harmoni-7 study, a multiregional Phase III clinical trial evaluating monotherapy Ivonescimab against monotherapy Pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

Ivonescimab is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Over 2,300 patients have been treated with Ivonescimab in clinical studies globally.

In addition to the positive results in Harmoni-2, Ivonescimab has also shown positive read-outs in three single-region (China) randomized Phase III clinical trials: Harmoni-A, Harmoni-2, and Harmoni-6.

Summit was founded in 2003 and shares are listed on the NASDAQ Global Market (symbol "SMMT") with headquarters in Miami, Florida, and additional offices in Menlo Park, California, and Oxford, UK. Following these announcements, the company's shares moved -36.1%, and are now trading at a price of $23.46. For the full picture, make sure to review Summit Therapeutics's 8-K report.

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