MedPacto Completes Phase 1b/2a Clinical Trial of 'Bactosertib' Combination Therapy

Maximum tolerated dose 300mg, twice daily decided
Similar efficacy compared to monotherapy with existing treatments
"Higher ORR and mOS observed in patients with history of gastrectomy"

(Photo by MedPacto)

[Asia Economy Reporter Chunhee Lee] MedPacto announced on the 28th that it has received the clinical trial report for phases 1b and 2a of the combination therapy of the transforming growth factor (TGF)-β inhibitor 'Vactosertib' with 'Paclitaxel' in patients with metastatic gastric cancer.

This clinical trial was conducted at six medical institutions in South Korea with the purpose of determining the maximum tolerated dose and recommended phase 2 dose of Vactosertib in combination with Paclitaxel in patients with metastatic gastric cancer, as well as confirming the tolerability and safety of Vactosertib combination therapy.

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According to the clinical trial report, regarding the primary objectives of appropriate dosage and safety, no specific safety concerns affecting the investigational drug were observed in any dosing group (100 mg, 200 mg, 300 mg) when Vactosertib was administered twice daily in combination with Paclitaxel. Accordingly, the maximum tolerated dose and recommended phase 2 dose of Vactosertib were determined to be 300 mg, twice daily.

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For the secondary objective of efficacy evaluation, the median overall survival (mOS) was 219 days and the median progression-free survival (mPFS) was 85 days when Vactosertib was combined with Paclitaxel, which was similar to the existing control group treated with Paclitaxel alone. The company explained, "No significant difference was achieved compared to existing treatments," and added, "Further analysis by expanding the sample size according to patient groups is necessary."

However, in detail, the combination therapy of Vactosertib showed significant therapeutic effects in some indicators compared to the Paclitaxel monotherapy group in metastatic gastric cancer patients with a history of gastrectomy. It was explained that the objective response rate (ORR) and median overall survival (mOS) were approximately 2 to 3 times higher than those in patients without a history of gastrectomy.

In terms of safety, the combination therapy of Vactosertib and Paclitaxel in metastatic gastric cancer patients showed a safety profile consistent with previously reported safety data of Vactosertib, indicating good tolerability.

A MedPacto official stated, "There was a difference in treatment effect depending on whether there was a history of gastrectomy," and added, "However, since the number of patients in this trial was not large, we will review the results of other ongoing investigator-initiated clinical trials targeting gastric cancer and decide on future directions." MedPacto plans to disclose related clinical data next year through academic conferences and publications.

This content was produced with the assistance of AI translation services.