NANJING, China, Sept. 8, 2022 /PRNewswire/ — InxMed Co., Ltd, a clinical-stage biotechnology company dedicates to developing innovative therapies targeting drug resistance and metastasis for hard-to-treat solid tumors, today announced the dosing of the first patient in its Phase 2 pivotal study evaluating IN10018, a highly potent and selective oral inhibitor of focal adhesion kinase (FAK), in combination with pegylated liposomal doxorubicin (PLD) in patients with platinum-resistant recurrent ovarian cancer (PROC).
The Phase 2 pivotal study is a randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of IN10018 in combination with PLD in patients with PROC. A total of 168 PROC patients will be enrolled and randomized in a 2: 1 ratio to receive IN10018 in combination with PLD or placebo of IN10018 in combination with PLD treatment in a double-blind manner.
Progression-free survival (PFS) as assessed by blinded independent central review (BICR) will be used as primary efficacy endpoint and overall survival (OS) will be used as key secondary efficacy endpoint. Objective remission rate (ORR), overall disease control rate (DCR), duration of remission (DOR), etc. as assessed by BICR and investigator will be other secondary efficacy endpoints.
InxMed previously reported results from its Phase Ib study of IN10018 in combination with PLD on ASCO 2022, demonstrated promising antitumor efficacy and a well-controlled safety profile in the treatment of patients with PROC.
The Phase 2 pivotal study was initiated in August 2022 and is expected to be completed in Q1 2024. The company also has completed a Type B Meeting discussion with U.S. Food and Drug Administration (FDA) and planned to submit US IND for a Phase 2 pivotal study evaluating IN10018 in combination with PLD for PROC in US by September this year.
InxMed set up a global clinical development program for IN10018. Clinical trials currently underway in the US, China and Australia are designed for platinum-resistant recurrent ovarian cancer, NRAS mutant metastatic melanoma, triple-negative breast cancer, head and neck cancer, pancreatic cancer, and other solid tumors that are still lacking effective treatment. IN10018 received fast track designation from the US FDA in August 2021, and breakthrough designation from China National Medical Products Administration (NMPA) in April 2022 for the treatment of patients with platinum-resistant ovarian cancer.
InxMed is a clinical-stage biotech company established in the end of 2018. The company dedicates on developing innovative therapies targeting stroma microenvironment and solid tumor resistance and metastasis, especially new drug development on anti PD-1/PD-L1 treatment drug resistance. InxMed committees to building an efficient engine for clinical translational science and proof of concept platform driven by in-depth understanding of disease biology and being a China based biotech company with global impact. We have built translational medicine and clinical development team across Shanghai, Beijing, Nanjing, United States, Canada and Australia. We have built a highly differentiated pipeline and established partnership with various multinational pharmaceutical companies including Merck, Roche and Boehringer Ingelheim.