Trials to Test Abexinostat in Heavily Treated DLBCL, Follicular Lymphoma

Xynomic Pharma is preparing two new Phase 2 trials in China to explore the activity of its investigational HDAC inhibitor, abexinostat, as third-line therapy for diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

The trials were approved by an independent ethics committee and will be conducted at the Cancer Hospital Chinese Academy of Medical Sciences in Beijing, the company announced in a press release.

Abexinostat is a new type of inhibitor that blocks the activity of several histone deacetylase (HDAC) enzymes, preventing the growth and division of cancer cells.

In a prior Phase 2 clinical trial (EudraCT-2009-013691-47) the treatment promoted anti-cancer responses in 28% of participants, including 5% complete responses.

The trial included 100 non-Hodgkin’s lymphoma or chronic lymphocytic leukemia patients who had undergone several unsuccessful rounds of treatment. Eighteen patients had follicular lymphoma, 17 diffuse large B-cell lymphoma, 16 mantle cell lymphoma, 18 T-cell lymphoma, 15 marginal zone lymphoma and other types, and 16 chronic lymphocytic leukemia.

Participants received 80 mg of oral abexinostat, two times a day for 14 days, followed by a week of treatment. This was repeated until cancer progressed or patients had unacceptable side effects.

In the entire study group, the treatment was given for a median of 2.8 months. However, those with follicular lymphoma continued for a median of 5.6 months. Response rates were also the best for those with follicular lymphoma (56%), followed by T-cell lymphoma (40%), and DLBCL (31%).

Xynomic is also exploring abexinostat as a fourth-line therapy for follicular lymphoma patients in the FORERUNNER Phase 2 trial (NCT03600441). The trial, expected to enroll 139 patients, is running across several clinical sites in the United States, but the company has requested authorization to expand this study to clinical sites in Europe and China.

FORERUNNER is primarily designed to assess responses to abexinostat. Duration of response, time to disease progression or death, quality of life, and overall survival will be assessed as secondary measures.

For more information, including contacts and locations, visit the study’s webpage.

The company is also planning to launch a fourth clinical trial testing abexinostat in combination with Janssen’s Imbruvica (ibrutinib) for the treatment of DLBCL and mantle cell lymphoma patients who have failed prior lines of treatment.