MedPacto, a company specializing in the development of innovative new drugs based on biomarkers, announced on May 18 that it has successfully completed a Type C meeting with the U.S. Food and Drug Administration (FDA) for the global Phase 2b/3 clinical trial of the combination therapy of vactosertib and Keytruda in patients with metastatic colorectal cancer.
A Type C meeting is an ad hoc meeting held at the request of the sponsor (the developer) during the drug development process. It is a meeting where the developer consults with the FDA and receives answers regarding the development and review of a new drug.
MedPacto is conducting a clinical trial of the combination therapy of vactosertib and Keytruda (ingredient: pembrolizumab) in patients with metastatic colorectal cancer, excluding those with high-frequency microsatellite instability (MSI-H), in collaboration with Merck (MSD) in the United States.
Following last year's Pre-IND meeting, the successful completion of this Type C meeting is expected to ensure that the planned global Phase 2b/3 clinical trial IND application will proceed smoothly. In addition, as the recently released topline data from the vactosertib and Keytruda Phase 1b/2a trial demonstrated outstanding therapeutic efficacy, the IND approval is also expected to be secured without difficulty.
Bayer's Stivarga (regorafenib) and Lonsurf (trifluridine/tipiracil) are currently used as standard treatments for patients with metastatic colorectal cancer who have failed previous chemotherapy.
Even when compared to ongoing clinical trials for colorectal cancer, the combination therapy demonstrates superior therapeutic efficacy. The overall survival (OS) for patients with metastatic colorectal cancer treated with the combination of Lonsurf and Avastin, as recently reported, is approximately 10.8 months. Furthermore, the median overall survival (mOS) in a trial combining three drugs-Tecentriq (atezolizumab), Imprime, and Avastin (bevacizumab)-is 5.7 months.
Given that outstanding therapeutic efficacy has been confirmed in the non-MSI-H metastatic colorectal cancer patient group, which does not respond to existing immuno-oncology drugs, if the upcoming clinical trial proceeds successfully, the combination therapy of vactosertib and Keytruda is expected to become a new treatment option for these patients.
A MedPacto representative stated, "Following last year's Pre-IND meeting, the successful completion of this Type C meeting means preparations for the IND application are progressing smoothly." The representative added, "Since the topline data from the Phase 1b/2a study confirmed outstanding therapeutic efficacy, we expect the IND will be approved by the FDA without difficulty."
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
