MedPacto's 'Bactosertib', Combination Therapy with Keytruda Approved for US Phase 2b and 3 Clinical Trials Plans

MedPacto announced on the 2nd that the U.S. Food and Drug Administration (FDA) has approved the clinical trial plan (IND) for its anticancer drug candidate 'Bactosertib' under development and the existing immuno-oncology drug 'Keytruda (generic name pembrolizumab)' for metastatic colorectal cancer patients in Phase 2b and Phase 3 trials.

[Photo by MedPacto]

This clinical trial will be conducted to evaluate the efficacy of the combination therapy of Bactosertib and pembrolizumab in metastatic colorectal cancer patients who have previously received treatment. The efficacy will be assessed based on overall survival (OS), which is the duration patients survive after treatment. The trial will be conducted as a multinational study including the United States and South Korea.

MedPacto will conduct the trial with free supply of Keytruda under a clinical trial collaboration and supply agreement with MSD, the developer of Keytruda in the United States.

A MedPacto representative stated, "If the clinical trial is successfully conducted, it could provide a new treatment option for metastatic colorectal cancer patients who currently have no suitable therapies."