Summit Therapeutics Inc. has announced that Akeso, Inc. has received approval from the Chinese health authorities for Ivonescimab, a potential first-in-class investigational bispecific antibody. The approval is based on the results of the Phase III clinical trial, Harmoni-2, which compared 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 analysis of Harmoni-2 has revealed an overall survival hazard ratio of 0.777 favoring Ivonescimab at 39% data maturity, suggesting a potential numerical 22% reduction in the risk of death compared to Pembrolizumab. This demonstrates a clinically meaningful, positive trend favoring Ivonescimab. Furthermore, Ivonescimab monotherapy has already been approved by the National Medical Products Administration (NMPA) in China for front-line PD-L1 positive advanced NSCLC.
The company also highlighted that for the primary analysis of Harmoni-2, Ivonescimab monotherapy showed a statistically significant improvement in the trial’s primary endpoint, progression-free survival (PFS), achieving a hazard ratio of 0.51 (95% CI: 0.38, 0.69; p<0.0001). This benefit was demonstrated across various clinical subgroups.
Summit Therapeutics Inc. 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, known as SMT112 in Summit’s license territories, is a novel investigational bispecific antibody designed to combine the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. The intent of this design, together with a half-life of 6 to 7 days after the first dose, is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.
Summit has also commenced its clinical development of Ivonescimab in NSCLC, with enrollment in two multi-regional Phase III clinical trials, Harmoni and Harmoni-3, and the activation of clinical trial sites in the United States for Harmoni-7.
In addition, Akeso has reported positive read-outs in three single-region, randomized Phase III clinical trials for Ivonescimab in NSCLC: Harmoni-A, Harmoni-2, and Harmoni-6.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-friendly medicinal therapies intended to improve quality of life and resolve serious unmet medical needs. The company's shares are listed on the NASDAQ Global Market under the symbol "SMMT," with headquarters in Miami, Florida, and additional offices in Menlo Park, California, and Oxford, UK. The market has reacted to these announcements by moving the company's shares -36.1% to a price of $23.46. For the full picture, make sure to review Summit Therapeutics's 8-K report.
