MedPacto Submits IND for Phase 2/3 Combination Trial of Bactosertib and Keytruda to US FDA

For Patients with Metastatic Colorectal Cancer

MedPacto announced on the 30th that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a clinical trial of the combination therapy of Bactosertib and Pembrolizumab (brand name Keytruda) in patients with metastatic colorectal cancer.

[Photo by MedPacto]

This clinical trial is a Phase 2b/3 study to evaluate the efficacy of the combination therapy of Bactosertib and Pembrolizumab in patients with metastatic colorectal cancer who have previously received treatment. The trial will be conducted as a multinational study including the United States and South Korea, with a target enrollment of approximately 600 patients. Under the clinical trial collaboration and supply agreement with Merck (MSD) in the U.S., MedPacto will receive Pembrolizumab free of charge to conduct the trial.

MedPacto recently presented clinical data on the combination therapy of Bactosertib (200 mg and 300 mg) and Pembrolizumab in patients with metastatic colorectal cancer at the European Society for Medical Oncology (ESMO 2023) held in Madrid, Spain. According to the clinical data disclosed at ESMO, the median overall survival (mOS) and objective response rate (ORR) of 105 patients treated with the combination of Bactosertib and Pembrolizumab were 15.8 months and 13.33%, respectively. Among them, the patient group treated with 300 mg of Bactosertib combined with Pembrolizumab showed an mOS of 17.35 months and an ORR of 18.75%.

MedPacto explained that this demonstrates a superior therapeutic effect compared to existing standard treatments. The company also added that a favorable safety profile was confirmed in metastatic colorectal cancer patients treated with the combination of Bactosertib and Pembrolizumab.

A MedPacto representative stated, "It has been confirmed that the combination therapy of Bactosertib and Keytruda shows superior therapeutic effects compared to standard treatments in patients with metastatic colorectal cancer. If this clinical trial proceeds successfully, it is expected to become a new standard treatment for patients with metastatic colorectal cancer in the future."

This content was produced with the assistance of AI translation services.