Qurucell CAR-T Therapy 'Anbalsel' Achieves 75% Response Rate in Phase 2 Clinical Trial

Qurucell announced on the 7th that it has received the top-line data from the Phase 2 clinical trial of Anbalsel (CRC01), a next-generation chimeric antigen receptor (CAR)-T therapy for patients with relapsed or refractory diffuse large B-cell lymphoma.

Qurucell Daejeon Headquarters Exterior [Photo by Qurucell]

In the Phase 2 results, the primary efficacy endpoint, the objective response rate, was 75.3%. This means that out of 73 patients included in the efficacy analysis of the clinical trial, 55 patients who received Anbalsel showed an actual response. Among them, 49 patients achieved complete remission, with all cancer cells disappearing, resulting in a complete remission rate of 67.1% among all patients. The company explained that this is the highest complete remission rate compared to the clinical trial results of existing CAR-T therapies on the global market.

This clinical trial was conducted as an open-label, multicenter, single-arm study to evaluate the safety and efficacy of a single administration of Anbalsel in patients with diffuse large B-cell lymphoma who relapsed or were refractory after two or more lines of treatment. It was conducted at six institutions, including Samsung Medical Center, from March 2022 to October last year, involving 79 adult men and women aged 22 to 85.

Based on these clinical results, Qurucell plans to apply for domestic new drug approval in the second half of this year. If approved, the company will become the fourth in the world, following the United States, China, and India, to develop its own CAR-T therapy. After approval, it plans to supply the therapy using the largest CAR-T commercial production facility in Korea (10,636㎡).

Kim Geonsu, CEO of Qurucell, said, "We are very pleased to have successfully completed the clinical trial that we have dedicated ourselves to for the past three years," and added, "Having confirmed the high competitiveness of Anbalsel, we will do our best to ensure that the new drug approval and launch proceed quickly."

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