MedPacto, Sharp Stock Drop: "Comparing Other Trials with Bactosertib Combination Trials Is Unreasonable"

by Lee Myeonghwan

Published 04 Jul.2023 15:04(KST)

"Liver Metastasis Presence Affects Treatment Effectiveness"

MedPacto explained that it is unreasonable to directly compare the clinical data of Bactosertib and Keytruda combination therapy with other recently released clinical data that affected the stock market.

Inside the MedPacto headquarters. [Photo by MedPacto]

A MedPacto official stated on the 4th, "Unlike the clinical trial targeting patients without liver metastasis, a significant number of patients in the Bactosertib combination therapy trial have liver metastasis."

In a previously released clinical trial of an immuno-oncology drug candidate by the U.S. biotech company Agenus, the objective response rate (ORR) for metastatic colorectal cancer patients was 23%, and the overall survival (OS) was 20.9 months. In contrast, the topline data from the phase 1b/2a clinical trial of Bactosertib (300 mg) combined with Keytruda showed an ORR of 18.2% and an OS of 17.3 months for metastatic colorectal cancer patients.

However, according to the MedPacto official, a significant portion of patients in the Bactosertib combination therapy trial had liver metastasis. They also added that generally, patients without liver metastasis are known to have higher treatment efficacy.

The reported median overall survival (mOS) for Regorafenib, the standard treatment for metastatic colorectal cancer, is 6.4 months with an ORR of 1.0%. Among patients without liver metastasis, the OS is 22 months and the ORR is 36.4%.

The MedPacto official further explained, "We plan to submit follow-up clinical trials for the Bactosertib and Keytruda combination therapy to the U.S. Food and Drug Administration (FDA)," adding, "Discussions with Merck in the U.S. for this are progressing smoothly."