Summit Therapeutics Inc. has noted that Akeso, Inc. (Akeso, HKEX code: 9926.HK) announced the approval of Ivonescimab by the Chinese health authorities, the National Medical Products Administration (NMPA), for a second indication based on the results of the phase III clinical trial, Harmoni-2 or AK112-303. The interim analysis of Harmoni-2 shows 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.
In the primary analysis for Harmoni-2, Ivonescimab monotherapy demonstrated a statistically significant improvement in the trial’s primary endpoint, progression-free survival (PFS), achieving a hazard ratio (HR) of 0.51 (95% CI: 0.38, 0.69; p<0.0001). A clinically meaningful benefit was demonstrated across clinical subgroups, including those with PD-L1 low expression, PD-L1 high expression, squamous, and non-squamous histologies.
Moreover, 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 non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression.
Ivonescimab, known as SMT112 in Summit’s license territories, and as AK112 in China and Australia, 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.
Summit has begun its clinical development of Ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional phase III clinical trials, Harmoni and Harmoni-3, and the company has begun to activate clinical trial sites in the United States for Harmoni-7.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver* and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Following these announcements, the company's shares moved -36.1%, and are now trading at a price of $23.46. For more information, read the company's full 8-K submission here.
