Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced the presentation of promising data from a Phase I dosage escalation study (ASKC202-001) for its investigational small-molecule c-MET inhibitor, ASKC202, in advanced solid tumors at the American Association for Cancer Research (AACR) 2024 annual meeting. This development underscores the company’s commitment to advancing targeted therapies for cancer patients.
The Phase I study is an open, multicenter, dose escalation and expansion trial designed to assess the safety, tolerability, and initial efficacy of ASKC202 in patients with advanced solid tumors. As of February 23, 2024, all patients enrolled were those with advanced solid tumors who had previously failed standard treatment or had not received standard treatment. Among the 16 subjects receiving ASKC202 as a monotherapy, 15 had non-small cell lung cancer, and one had pulmonary sarcomatoid carcinoma, with 50% of the subjects having baseline brain metastasis.
In terms of safety, ASKC202 demonstrated good tolerability, with no dose-limiting toxicity (DLT) observed across all dose groups. The majority of treatment-related adverse events were grade 1 or 2. Regarding effectiveness, out of 14 patients with measurable lesions and at least one post-treatment tumor evaluation, 5 patients (with an objective response rate (ORR) of 35.7%) achieved partial response (PR). The median optimal percentage change from baseline for the target lesion of the patient was -51.8%, and three patients had a sustained response time of ≥ 6 months. As of the data cutoff, there are still 4 patients receiving treatment. In patients with cMET amplification or missense mutations, the ORR and disease control rate (DCR) were 62.5% (5/8) and 75.0% (6/8), respectively. Notably, one patient with a cMET missense mutation (p.S186L) had a 67% reduction in intracranial target lesions compared to baseline.
These results from the Phase I study indicate that ASKC202 has the potential to become a significant treatment option for patients with c-MET driven cancers, offering a much-needed alternative for those who have exhausted standard treatment options.- Flcube.com
