Hanmi’s failed arthritis drug proven effective against DLBCL in phase 2 study

Hanmi Pharm said Monday its investigational drug, which failed to prove effectiveness in rheumatoid arthritis clinical trials, demonstrated efficacy against diffuse large B-cell lymphoma (DLBCL).

The company said it disclosed the interim results from the phase 2 clinical trials of three-drug combination therapy including Bruton's tyrosine kinase (BTK) inhibitor poseltinib, which was returned by global pharmaceutical giant Eli Lilly, at the European Hematology Association (EHA) 2023 Congress in Frankfurt, Germany, from June 8 to 11.

Poseltinib is an oral treatment for autoimmune diseases and blood cancers that works by selectively inhibiting BTK, an enzyme involved in signaling the activation of B lymphocytes.

The phase 2 study confirmed the safety and efficacy of the three-drug combo -- poseltinib, CD3xCD20 bispecific antibody glopitamab, and immunomodulator lenalidomide --  in relapsed or refractory DLBCL, Hanmi said.

The study was supported by Hanmi and another Korean firm Genome Opinion.

Professor Byun Ja-min of Hematology and Oncology at the Seoul National University Hospital presented the study. 

In the study, of the 14 patients whose responses were evaluated after the start of the trial, 79 percent met the objective response (OR). Despite the early data, 36 percent had a complete response (CR), Hanmi said.

"We expect this treatment to provide new hope for patients with relapsed or refractory DLBCL who have failed standard treatments, including CAR-T (chimeric antigen T cells)," said Yoon Sung-soo, a professor of hematology and oncology at SNUH who coordinated the study.

Hanmi developed poseltinib and licensed it out to Eli Lilly in 2015.

However, Eli Lilly returned the rights in 2019 after the drug failed to demonstrate efficacy in a phase 2 study in patients with rheumatoid arthritis.

Afterward, Hanmi continued to work on poseltinib.

According to Hanmi, the obesity/diabetes treatment HM12525A, which was returned by Janssen in 2019, was licensed out to Merck in the U.S. in 2020 for about 1 trillion won ($774.5 million) with an indication change to non-alcoholic steatohepatitis (NASH).

MSD (outside North America) will present the results of global phase 2a trials of HM12525A at the meeting of the European Association for the Study of the Liver (EASL) on June 21, Hanmi said.