Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, presented updates on several pipeline candidates at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
IBI343 Phase I Study:
The study of IBI343, a CLDN18.2 antibody-drug conjugate (ADC), for advanced pancreatic ductal adenocarcinoma or biliary tract cancer (BTC), is being conducted in China and Australia. As of January 15, 2024, out of 35 enrolled patients, 25 subjects underwent at least one post-baseline tumor assessment, with 7 achieving partial response (PR), an objective response rate (ORR) of 28.0%, and a disease control rate (DCR) of 80.0%. IBI343 showed safety and tolerability, with no treatment-related deaths reported.
Phase II TRUST-I Study for Taletrectinib:
The study involves taletrectinib, a next-generation tyrosine kinase inhibitor (TKI) targeting ROS1 and NTRK fusion mutations, in ROS1 positive non-small cell lung cancer (NSCLC). Data from 173 patients showed a confirmed objective response rate (cORR) of 91% by the Independent Review Committee (IRC) in patients initially treated with TKIs. For subjects who previously failed treatment with crizotinib, the cORR was 52%. The median follow-up time and duration of response (DoR) and progression-free survival (PFS) were not reached for patients initially treated with TKIs, while for crizotinib-treated patients, the median DoR and PFS were 10.6 months and 7.6 months, respectively. Taletrectinib’s safety profile aligns with previous reports, with a lower incidence of nervous system-related adverse events.
Phase I Study for IBI363:
IBI363, a PD-1/IL-2 bispecific antibody (BsAb) fusion protein, is being studied in advanced melanoma and colorectal cancer. As of January 11, 2024, the melanoma cohort showed an ORR of 28.1% and a DCR of 71.9% among 57 subjects. Among 52 subjects who had previous immunotherapy, 25 received 1mg/kg Q2W IBI363, with an ORR of 32.0% and a DCR of 80.0%. For the colorectal cancer cohort, as of December 22, 2023, an ORR of 12.7% was observed. Among the 13 subjects with PD-L1 CPS ≥ 1, the ORR was 30.8%, and the DCR was 76.9%. There were no treatment-related deaths.
Phase II Study for KRAS G12C Inhibitor Fulzerasib:
The study combines fulzerasib with cetuximab for newly diagnosed NSCLC patients with KRAS G12C mutation. As of April 19, 2024, 40 patients were enrolled with a median follow-up time of 5.1 months. An ORR of 81.8% and a DCR of 100% were observed in 33 patients who underwent at least one tumor assessment. Among them, the ORR for patients with brain metastases was 70%. DoR has not been reached, and 88% of patients continue treatment. Fulzerasib demonstrated good overall tolerability.- Flcube.com
