By Fineline Cube China-based Innovent Biologics (HKG: 1801) has published the results of a Phase I clinical study for its IBI351 monotherapy in advanced solid tumors at the American Association for Cancer Research (AACR) annual meeting.
IBI351: A KRAS G12C Inhibitor Under Assessment
IBI351 (GFH925), a KRAS G12C inhibitor originated by GenFleet Therapeutics Inc., is being evaluated for its safety, tolerability, and preliminary efficacy in advanced malignant tumors with KRASG12C mutations that have failed or are intolerant to standard treatment. As of November 30, 2022, 74 patients with advanced malignant tumors who had previously failed or were intolerant of standard treatment were enrolled in this study, including 67 patients with non-small cell lung cancer (NSCLC), 6 patients with intestinal cancer, and 1 patient with pancreatic cancer.
Positive Clinical Outcomes and Safety Profile
As of February 10, 2023, among 67 evaluable NSCLC patients, the objective response rate (ORR) was 61.2%, and the disease control rate (DCR) was 92.5%. The vast majority of patients in remission are still undergoing continuous treatment. In terms of safety, as of November 30, 2022, overall tolerability was good, with no dose-limiting toxicity (DLT) events observed in each dose group, and the maximum tolerable dose (MTD) was not reached. A total of 94.0% (63/67) subjects had treatment-related adverse events (TRAEs), most of which were grade 1-2. The most common TRAEs were anemia, pruritus, elevated transaminase, fatigue, elevated proteinuria, and bilirubin.
Commercialization Rights and Deal with GenFleet
Innovent Bio struck a USD 312 million deal with GenFleet in September 2021, securing exclusive development and commercialization rights to the drug in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.-Fineline Info & Tech