MedPacto gets FDA OK for colorectal cancer drug clinical trial

South Korea's biotech company MedPacto Inc. announced on Tuesday that it has got approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for a combination therapy using Vactosertib and pembrolizumab (product name: Keytruda)

This trial will focus on patients previously undergoing metastatic colorectal cancer treatment.

It is a phase 2b/3 trial designed to assess the efficacy of the combination therapy with Vactosertib and Pembrolizumab.

The primary endpoint for this trial will be overall survival (OS). The trial is planned as a multi-national effort, including South Korea and the US locations.

MedPacto will conduct this trial with the support of Pembrolizumab provided free of charge by Merck (MSD), under a clinical trial collaboration and supply agreement.

Write to Yoo-Rim Kim at youforest@hankyung.com