MedPacto, a Korean immunotherapy developer, said Wednesday that the U.S. FDA has approved a phase 2b/3 investigational new drug (IND) plan for the combination of its immunotherapy, vactosertib, and MSD’s Keytruda (pembrolizumab), in patients with metastatic colorectal cancer.

For phase 2b/3 study, MedPacto will evaluate the efficacy of vactosertib in patients with previously treated metastatic colorectal cancer, measuring overall survival (OS).

The trial is a multi-country study, including the U.S. and Korea, with pembrolizumab, being provided by MSD at no cost under a clinical collaboration and supply agreement.

The result of phase 2a study for vactosertib and Keytruda combo, presented at the European Society for Medical Oncology (ESMO) 2023 in Madrid, Spain in October last year, showed a median overall survival (mOS) and objective response rate of 15.8 months and 13.33 percent, respectively, in 105 patients.

MedPacto said that the clinical data confirmed the superiority of the treatment over existing standard-of-care therapies and that if the trial proceeds smoothly, the new drug approval is likely to be granted.

“If the clinical trial proceeds successfully, it is expected to provide a new treatment option for patients with metastatic colorectal cancer who have no other treatment options,” a MedPacto official said.