Shanghai-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced positive preliminary results from the TORCH-2 study (NCT04337463) for its mTORC1/2 inhibitor ATG-008 (onatasertib) in combination with the programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) for recurrent/metastatic cervical cancer. The company also released data from the TORCH study for ATG-008 monotherapy in hepatitis B virus (HBV) positive hepatocellular carcinoma (HCC) in the 45mg dosage group.
TORCH-2 Study Results
The TORCH-2 study is designed to assess the safety and efficacy of the ATG-008/toripalimab combination in advanced solid tumors. As of October 21, 2022, 21 patients with cervical cancer had received the combination therapy, with 9 patients (42.9%) testing positive for PD-L1 expression. The objective response rate (ORR) was 52.4% across all patients and 77.8% in PD-L1 positive subjects. Ten patients achieved partial remission (PR) and one patient achieved complete remission (CR). The median progression-free survival (PFS) was 5.5 months.
TORCH Study Results
The TORCH study evaluates the pharmacokinetics, safety, tolerance, and efficacy of oral ATG-008 in patients with HBV positive HCC who have previously received at least one systemic therapy but failed in treatment. The study included four dosage groups (15 mg/day, 30 mg/day, 20 mg/day twice, and 45 mg/day) with 73 subjects enrolled. Preliminary data from the 45 mg daily dose group showed that 3 out of 18 subjects achieved PR. The ORR for ATG-008 monotherapy was 16.7%, with a median duration of remission (DOR) of 4.3 months. Side effects were controllable.
ATG-008 Profile
ATG-008 is a dual-target TORC1/2 kinase inhibitor that acts on the mTOR pathway, controlling mTOR binding to other proteins to induce tumor cell apoptosis and inhibit tumor cell proliferation. Antengene secured a licensing agreement with US-based Celgene Corp. (NASDAQ:CELG) in April 2017, obtaining exclusive development and marketing rights for the drug in the Greater China region. The drug, which has shown significant anti-tumor activity in preclinical studies as a monotherapy, is being evaluated in multiple studies for various tumors, including multiple myeloma, glioblastoma, hepatocellular carcinoma, non-small cell lung cancer, and diffuse large B-cell lymphoma.-Fineline Info & Tech
