China-based Keymed Biosciences Inc. (HKG: 2162) has revealed the latest data update from a Phase Ia dosage escalation study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of its CMG901. The study focuses on CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC) for advanced solid tumors. The data is being presented at this week’s ASCO GI annual meeting.
Study Results and Safety Profile
As of August 4, 2022, a total of 27 patients (13 with gastric cancer/adenocarcinoma of gastroesophageal junction, 14 with pancreatic cancer) had been enrolled in the study. Results showed that CMG901 was safe and well-tolerated, with 11.1% of patients experiencing drug-related adverse events of grade 3. No grade 4 or higher events were reported. The dose was successfully increased to 3.4 mg/kg, and the maximum tolerable dose (MTD) was not reached. Only one patient in the 2.2 mg/kg group developed dose-limiting toxicity.
Efficacy Data
In terms of efficacy, the objective response rate (ORR) and disease control rate (DCR) in eight patients with CLDN18.2-positive gastric cancer or gastroesophageal junction adenocarcinoma who received CMG901 treatment were 75% and 100%, respectively. Notably, the ORR for patients in the 2.6, 3.0, and 3.4 mg/kg cohorts was 100%. The median progression-free survival time (mPFS) and median overall survival time (mOS) have not yet been reached. The study demonstrated that CMG901 exhibited encouraging anti-tumor activity and a favorable safety profile in patients with CLDN18.2-positive GC/GEJ at a dose level of ≥ 1.8 mg/kg.
Future Outlook
Keymed Bio completed patient enrollment for the Phase I dosage escalation study in the first half of 2022 and initiated the Phase I dosage expansion study in Q2 of the same year. These advancements position CMG901 as a potential new treatment option for patients with advanced solid tumors, particularly those with CLDN18.2-positive gastric cancer or gastroesophageal junction adenocarcinoma.-Fineline Info & Tech
