MedPacto Obtains Joint Phase 2 Clinical Trial Approval for Bactosertib-Kittruda in Non-Small Cell Lung Cancer

Phase 2 Clinical Trial Begins for First-Line Treatment Combining Baektoseoptip and Keytruda
Aiming to Capture $33 Trillion Global Market in Partnership with Keytruda

[Asia Economy Reporter Eunmo Koo] MedPacto announced on the 7th that it has received approval from the Ministry of Food and Drug Safety for a Phase 2 clinical trial plan combining Baektoseptip and Keytruda for first-line treatment of non-small cell lung cancer (NSCLC).

The joint clinical trial between MedPacto and MSD is the second following the colorectal and gastric cancer trials in July 2018. This Phase 2 trial will be conducted on NSCLC patients using a combination of Baektoseptip (TEW-7197) and MSD’s immuno-oncology drug Keytruda (pembrolizumab).

The clinical trial is scheduled to be conducted over approximately two years at five medical institutions including Seoul Samsung Hospital, evaluating the efficacy and safety of the drug combination in 55 patients.

A MedPacto official stated, “This Phase 2 trial is a combination trial aimed at first-line treatment, targeting patients who have not previously received treatment, so stable data and a high objective response rate are expected.”

First-line treatment refers to the medication that patients can use first after being diagnosed with a disease. Especially, patients participating in clinical trials as first-line treatment have no prior experience with drug resistance or side effects, so a high therapeutic effect of the drug can be expected.

Non-small cell lung cancer accounts for about 85% of all lung cancer patients and is one of the diseases that are difficult to diagnose early because symptoms do not appear before the advanced stage. Immuno-oncology drugs are mainly used as first-line treatments, and chemotherapy is combined depending on the patient’s symptoms, but treatment options are limited as drug expression rates vary among patients.

Currently, the immuno-oncology drug Keytruda, used as a first-line treatment, shows remarkable therapeutic effects in patients with PD-L1 protein expression rates of 50% or higher when used alone. However, in patients with expression rates below 50%, it does not surpass the effects of conventional chemotherapy and thus does not receive insurance coverage.

On the other hand, the combination therapy clinical trial of Keytruda and Baektoseptip targets patients with PD-L1 expression rates of 1% or higher, and the company explains that if the trial proceeds smoothly, it is expected to provide a new treatment option for patient groups that have had low response rates so far.

According to GlobalData, the market for NSCLC treatments is expected to expand to about 33 trillion KRW by 2025. MSD holds more than 65% market share in the global lung cancer treatment market, and this year, sales of Keytruda for NSCLC treatment alone are expected to reach 10 trillion KRW.

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