MedPacto, successfully completed the Type C meeting with the U.S. FDA for its global Phase2b/3 clinical trial of Vactosertib + Keytruda combination therapy
May 18, 2023
In a process of preparing for the global phase 2b/3 IND application ... combination therapy of Keytruda and Vactosertib has shown a median overall survival(mOS) of 15.8 months
[2023-05-18] MedPacto (CEO Seong-jin Kim), a genome-based drug discovery and a clinical-stage biotechnology company, has announced the successful completion of a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the global phase 2b/3 clinical trial of Vactosertib and Keytruda combination therapy for patients with metastatic colorectal cancer.
A Type C meeting with the FDA is a specific type of meeting held during the drug development process. It is an ad hoc meeting requested by the sponsor or developer of a clinical trial or new drug. The purpose of a Type C meeting is to allow the sponsor to obtain clarification or guidance from the FDA on specific issues related to the development and review of the drug.
MedPacto, in partnership with MSD, is currently conducting clinical trials on a combination therapy of Vactosertib and Keytruda for patients with metastatic colorectal cancer who are non-MSI-H (non-Microsatellite Instability-High).
The successful completion of the Type C meeting, following last year's successful Pre-IND meeting, indicates that the investigational new drug application for the global phase 2b/3 clinical trial plan is expected to proceed smoothly.
The recently released top-line data of Vactosertib and Keytruda 1b/2a clinical trial has also demonstrated superior efficacy, suggesting a smooth progression towards phase 2b/3 IND approval.
Based on the analysis of the top-line data, the median overall survival (mOS) for metastatic colorectal cancer patients treated with the combination therapy of Vactosertib and Keytruda is 15.8 months.
Currently, Bayer's 'Stivarga' (regorafenib) and 'Lonsurf' (trifluridine/tipiracil) are accepted as the third-line standard of care for patients with metastatic colorectal cancer who are resistant to conventional chemotherapy. Stivarga obtained new drug approval in 2021, with an objective response rate (ORR) of 1.0% and a median overall survival (mOS) of 6.4 months. Similarly, Lonsurf also received new drug approval in 2015, with an ORR of 1.6% and an mOS of 7.1 months.
"Following last year's successful Pre-IND meeting, the completion of this Type C meeting has paved the way for smooth IND application preparations. We anticipate a smooth approval process once we submit the IND to the FDA.” Stated MedPacto representative.