Vactosertib in combination with KEYTRUDA® (pembrolizumab) for colorectal cancer patients reported a mOS of 15.8 months
Apr 26, 2023
Interim analysis results of phase 1b/2a clinical trial reported today
[2023-04-26] The median overall survival (mOS) of vactosertib in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) was 15.8 months as treatment for patients with metastatic colorectal cancer.
This data will provide the foundation for MedPacto's follow-up investigational new drug (IND) application for a phase 2b/3 study in non-microsatellite instability high (non-MSI-H) type colorectal cancer patients, which is scheduled to submitted to the US Food and Drug Administration (FDA) after discussion with MSD in the first half of the year. In addition, MSD will supply KEYTRUDA for this follow-up, late-stage clinical trial.
MedPacto (CEO Seong-Jin Kim), a biomarker-based innovative new drug development company, released the results of an interim analysis of a phase 1b/2a clinical trial of vactosertib in combination with KEYTRUDA in metastatic colorectal cancer (NCT03724851) on April 26th.
In this clinical trial, 71 patients with metastatic colorectal or gastric cancer were administered vactosertib (200 mg or 300 mg BID) in combination with KEYTRUDA, and safety and efficacy were observed. With the exception of two patients, most patients were non-MSI-H colorectal cancer patients.
According to the analysis results, the mOS of 33 metastatic colorectal cancer patients who received vactosertib (300 mg BID) in combination with KEYTRUDA was 17.35 months .
Currently, Bayer's 'Stivarga' (regorafenib) and 'Lonsurf' (Trifluridine/Tipiracil) are being used as SOC for patients with metastatic colorectal cancer who have failed conventional chemotherapy. Recent results showed a mOS of approximately 10.8 months for patients with metastatic colorectal cancer treated with Lonsurf and Avastin. In 2021, Stivarga received FDA approval, supported by data showing an objective response rate (ORR) of 1.0% and mOS of 6.4 months, and in 2015, Lonsurf received FDA approval supported by data showing an ORR of 1.6% and mOS of 7.1 months. In addition, the mOS for the triplet Tecentriq (atezolizumab), Imprime PGG, and Avastin (bevacizumab) is 5.7 months.
“We’re encouraged by these early efficacy results and continue to be hopeful that the combination of vactosertib and KEYTRUDA may have the potential to become an important new treatment regimen for patients with non-MSI-high colorectal cancer – who are in urgent need of new options that may improve outcomes and prolong survival,” said Dr. Seong-Jin Kim, Founder and Chief Executive Officer of MedPacto.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.