MedPacto Signs Investigator-Initiated Clinical Trial Agreement for Combination Therapy in Melanoma Patients

Phase 2 Clinical Trial of Keytruda in Combination Therapy for the Third Time Underway in the US

[Asia Economy Reporter Eunmo Koo] MedPacto announced on the 18th that it has signed an investigator-initiated clinical trial agreement for the combination therapy of Baktosertib and Keytruda targeting melanoma patients.

This clinical trial is a phase 2 investigator-initiated study conducted at the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center in the United States, involving 24 melanoma patients. The trial on the combination therapy of Baktosertib and Keytruda is led by Dr. Diwakar Davar, MD, from the University of Pittsburgh.

The trial will selectively enroll patients with recurrent or refractory melanoma who have failed immunotherapy but show activated immune responses. Through this, the study aims to confirm the efficacy of the combination therapy and conduct research on the development of the VRGS biomarker.

Melanoma is a malignant tumor arising from melanocytes in the skin. It accounts for 65% of all deaths caused by skin cancer, and approximately 25-33% of patients experience recurrence or refractory disease due to activation of the TGF-β signaling pathway, making complete cure difficult.

MSD’s Keytruda received accelerated approval from the U.S. Food and Drug Administration (FDA) in 2014 as a treatment for melanoma. Since then, Keytruda has been used as adjuvant therapy after surgery; however, due to high recurrence rates, alternative treatments to improve efficacy are needed.

Professor Davar’s research team expects to achieve meaningful results in this combination clinical trial based on the safety evidence of Baktosertib, a TGF-β inhibitor.

MedPacto anticipates that this clinical trial will also contribute to the discovery of the VRGS biomarker, which can select treatment-responsive melanoma patients.

Previously, MedPacto announced the development of the VRGS biomarker at SITC 2020 based on combination clinical trials with MSD involving colorectal cancer patients. In that trial, MedPacto demonstrated the applicability of the biomarker by selecting only VRGS-responsive patients and comparing them with patients currently in the trial, achieving a clinical benefit rate (CBR) of 85.7%.

A MedPacto official stated, “When clinical trials are conducted with biomarker selection, the possibility of early approval increases, so the goal of subsequent trials is to apply VRGS. This trial will serve as a foundation for improving treatment outcomes for melanoma patients while advancing biomarker development.”