MedPacto Unveils Clinical Poster on Bactosertib Combination at AACR Pancreatic Cancer Conference

Baektoseotip-Polfox Combination Phase 1b Clinical Trial
mOS 9.3 Months, ORR 23.1%
Confirmed Efficacy Compared to Monotherapy

[Asia Economy Reporter Lee Gwan-joo] MedPacto announced on the 14th that it presented interim clinical data on the combination therapy of Bektosertib for pancreatic cancer at the AACR Special Conference on Pancreatic Cancer.

At this conference, MedPacto disclosed interim data from a Phase 1b (investigator-initiated) clinical trial of Bektosertib combined with FOLFOX for pancreatic cancer.

Specifically, the median overall survival (mOS) of 13 patients who received 200 mg of Bektosertib twice daily was 9.3 months. The objective response rate (ORR) was 23.1%, and 38.5% of patients showed stable disease (SD), meaning the tumor did not grow further. The resulting clinical benefit was 61.5%. Additionally, the median progression-free survival (mPFS) was 4.2 months.

In contrast, for patients who failed gemcitabine treatment, the overall survival (OS) with FOLFOX as a second-line therapy (FIRGEM Study) was 4.3 months, mPFS was 1.7 months, and ORR was 0%. Another clinical trial of FOLFOX monotherapy (SEQUOIA Study) showed mOS of 6.3 months, mPFS of 2.1 months, and ORR of 5.6%.

A MedPacto representative explained, “The clinical data disclosed this time confirmed that the combination therapy of Bektosertib and FOLFOX has significantly superior therapeutic effects compared to existing treatments in pancreatic cancer patients.”

In addition to the clinical trial of Bektosertib and FOLFOX combination therapy, MedPacto is also conducting a Phase 1b investigator-initiated trial of Bektosertib combined with 5FU/LV/Onivyde for pancreatic cancer.

MedPacto plans to apply to the U.S. Food and Drug Administration (FDA) this year for approval of a Phase 1/2 clinical trial of Bektosertib combined with 5FU/LV/Onivyde. Furthermore, it plans to disclose interim data from the Phase 1b (investigator-initiated) clinical trial of Bektosertib and Onivyde combination therapy at the Gastrointestinal ASCO symposium (GI ASCO) to be held in January next year.