Promising Treatment Effect Demonstrated by Progression-Free Survival (PFS) Extension Compared to Other Combination Therapies
[Asia Economy Reporter Eunmo Koo] MedPacto announced on the 15th that the abstract of the early results from the Phase 1b clinical trial for gastric cancer, scheduled to be presented at the European Society for Medical Oncology Annual Meeting (ESMO Congress 2020), has been released.
According to the abstract, MedPacto secured meaningful data demonstrating safety and efficacy by administering a combination of the anticancer drug under development, 'Bactosertib,' and the gastric cancer treatment 'Paclitaxel' to patients with metastatic gastric adenocarcinoma.
In this Phase 1b clinical trial, subjects were divided into three dosage groups of 100mg, 200mg, and 300mg, with Bactosertib administered five days a week (two days off), and Paclitaxel was co-administered once weekly at 80mg/m2.
The presentation reported that the median progression-free survival (PFS) in the 200mg and 300mg dosage groups was 5.5 months. This is an encouraging result compared to the previously reported median PFS of 2.9 months for Paclitaxel monotherapy.
PFS is an indicator of a drug's ability to inhibit disease progression and is one of the metrics used to obtain regulatory approval. The company explained, "This clinical trial targeted patients receiving second-line treatment, and considering the resistance issues to existing anticancer drugs, the meaningful effect achieved was as expected." Notably, one patient who showed a partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) exhibited a complete response (CR) in the target lesion.
MedPacto is currently conducting a Phase 2a clinical trial with an increased recommended phase 2 dose (RP2D) of 300mg, so it is expected that the median PFS may improve further compared to the Phase 1b trial, which involved lower doses and combination administration.
A MedPacto representative stated, "This clinical trial has become an opportunity to demonstrate superior therapeutic effects compared to existing treatments," adding, "If the combination therapy of Bactosertib and Paclitaxel is commercialized in the future, its market potential will be sufficient."
The European Society for Medical Oncology is a prestigious organization in the field of cancer research, attended by approximately 20,000 cancer researchers, oncologists, and pharmaceutical and biotech professionals worldwide. It serves as an academic platform for exchanging information on marketed and investigational anticancer drugs. This year, the event will be held online for three days starting from the 19th.
Meanwhile, 'Bactosertib' was discovered at Ewha Womans University from 2008 to 2013 with support from the Ministry of Education, Science and Technology, and MedPacto previously conducted a Phase 1 clinical trial in collaboration with the National Cancer Center-led National New Anticancer Drug Development Project (designated by the Ministry of Health and Welfare).
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