MEdPACTO

Median OS was 9.3months…ORR and median PFS also showed an outstanding advantage over monotherapy

 

On September 14th, MedPacto, a genome-based drug discovery and clinical-stage biotechnology company, announced that the interim Phase1b clinical results for Vactosertib combination therapy with FOLFOX were presented at AACR Special Conference on Pancreatic Cancer.

 

AACR Special Conference on Pancreatic Cancer takes place as an in-person event in Boston from September 13th to 16th, 2022. This conference will address the latest developments in all areas of pancreatic cancer research.

 

At the event, MedPacto presented interim clinical results of Phase1b investigator initiated trial for vactosertib in combination with oxaliplatin and 5FU/LV(FOLFOX) in patients with metastatic Pancreatic Ductal Adenocarcinoma who have failed first-line Gemcitabine with Nab-Paclitaxel.

 

To be specific, the median overall survival (mOS) of the 13 patients who received vactosertib 200mg orally twice per day was 9.3 months. Overall response rate (ORR) was 23.1% and stable disease (SD) encompassing a broad range from <20% enlargement to <30% reduction of a tumor, was 38.5%. The clinical benefit rate was 61.5% and the median progression free survival (mPFS) was 4.2 months.

 

FOLFOX as second-line chemotherapy in patients with pretreated metastatic pancreatic cancer from the FIRGEM study pancreatic ductal adenocarcinoma patients who failed first-line gemcitabine showed 4.3 months OS, 1.7 mPFS, 0% ORR. The results from another FOLFOX monotherapy study, SEQUOIA, showed 6.3 months mOS, 2.1 months mPFS and 5.6% ORR.

 

Forming a dense meshwork of collagen fibers around pancreatic ductal adenocarcinoma cells, the extracellular matrix (ECM) impairs tumor perfusion and penetration by anticancer drugs leading to a low response rate to the antitumor treatments. The current five-year survival rate is only 9%. In most cases, patients get delayed diagnoses as there are no symptoms in the early stages and surgery is only viable in 10~15% of the patients.

 

The pancreatic cancer treatment market has shown a steep increase. According to Global Monitor, the pancreatic cancer market is expected to be growing at a CAGR of 5.7% from 2021 to 2027. The size of the market is projected to be worth USD 2.7 billion by 2027 from USD 2.2 billion in 2021.

 

“The updated release is a confirmation in supporting the superior clinical efficacy of Vactosertib combination therapy with FOLFOX over the standard therapy”, stated MedPacto representative.

 

In the meantime, MedPacto is also collaborating in a Phase 1b investigator initiated trial of Vactosertib in combination with 5FU/LV/Onivyde. Its interim clinical results will be presented at the upcoming ASCO GI in January 2023.

 

According to MedPacto’s preclinical data released last April at AACR after administering 5FU/LV/Onivyde for 50 days, the metastasis of cancer cells decreased substantially. Additionally, the combination therapy of Vactosertib and 5FU/LV/Onivyde showed potential to be a new treatment option. A significantly higher survival rate of 84% was observed as opposed to the controlled group and current approved standard of treatment; 23% and 53%, respectively. MedPacto received orphan drug designation for Vactosertib in pancreatic cancer from the U.S. FDA last year.

 

MedPacto plans to submit an Investigational New Drug application to the U.S. FDA to conduct a Phase I/II trial of the combination therapy of Vactosertib and 5FU/LV/Onivyde.