Hanmi Pharm "BTK Inhibitor Poseltinib, New Indication Confirmed"

Hanmi Pharmaceutical announced on the 12th that the interim results of the Phase 2 clinical trial of the triple combination therapy, a follow-up study of the Bruton's tyrosine kinase (BTK) inhibitor 'Poseltinib,' which was returned by global pharmaceutical company Eli Lilly, were presented at the European Hematology Association (EHA) held in Frankfurt, Germany, from the 8th to the 11th.

This study confirmed the safety and efficacy of the triple combination therapy including Poseltinib in relapsed and refractory diffuse large B-cell lymphoma (DLBCL). The study was supported by Hanmi Pharmaceutical and Genome Opinion, and Professor Jaemin Byun of the Department of Hematology-Oncology at Seoul National University Hospital presented the findings.

Poseltinib is a BTK inhibitor originally developed by Hanmi Pharmaceutical and licensed out to Eli Lilly in 2015 for approximately $690 million. At that time, it failed to demonstrate efficacy in a Phase 2 clinical trial targeting rheumatoid arthritis patients, leading to the return of rights in January 2019. After the rights were returned, Hanmi Pharmaceutical expressed its intention to continue the development of Poseltinib and signed a joint development agreement with Genome Opinion in October 2021.

This clinical trial, named the 'GPL study' after the initials of the drugs used in the triple therapy, is being conducted as a multi-center study mainly at institutions affiliated with the Lymphoma Research Society of the Korean Society of Hematology. As of May 2023, 19 patients have been enrolled, and additional patients are currently being recruited.

In the interim results presented at EHA, the research team confirmed the safety and efficacy of the GPL therapy. Among the 14 patients evaluated for response after the start of the clinical trial, the objective response (OR) rate, which is the efficacy evaluation criterion, reached 79%. Despite being early data, complete remission (CR), where cancer cells disappeared, was observed in 36% of patients. The cohort evaluated for safety did not show any specific adverse reactions.

The research team assessed that the GPL combination therapy could broadly control the carcinogenic mechanisms of DLBCL compared to existing treatments, holding potential as a new treatment option for patients. Professor Seongsu Yoon, the overall clinical trial coordinator and a hematology-oncology specialist at Seoul National University Hospital, stated, "We expect this therapy to provide new hope for patients with relapsed and refractory DLBCL who have failed standard treatments, including chimeric antigen receptor (CAR)-T therapy."

A Hanmi Pharmaceutical official said, "Since the safety and efficacy of the combination therapy of Poseltinib and bispecific antibodies have been confirmed, we expect to offer healthcare professionals new treatment options through the final clinical trial results."

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