Xynomic Pharma is launching two pivotal clinical trials in China to test its investigational HDAC inhibitor, abexinostat, as a third-line therapy for two types of non-Hodgkin’s lymphoma: diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma,
The announcement came after China’s National Medical Products Administration (NMPA) approved the trials, which will be conducted at 24 clinical sites across China. Patient enrollment is expected to conclude within the next 12 months.
“We are truly excited to receive the approval from NMPA of China, world’s second largest market for oncology drugs. Currently in China there are virtually no approved treatment options for DLBCL and [follicular lymphoma] patients once the patients’ disease progress after R-CHOP treatment,” Y. Mark Xu, Xynomic’s chairman and CEO said in a press release.
R-CHOP is the current standard of care for both DLBCL and advanced follicular lymphoma patients. It consists of a combination of Rituxan (rituximab), an engineered anti-CD20 antibody that targets B-cells, and four chemotherapy drugs: cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone.
However, patients whose disease relapses after R-CHOP have few therapeutic alternatives.
Abexinostat is a new kind of histone deacetylase (HDAC) inhibitor — a class of medicines that prevents tumor suppressor genes from being “turned off” and has been used successfully to treat several cancers.
In a prior Phase 2 trial (EudraCT-2009-013691-47), including 100 non-Hodgkin’s lymphoma patients who had failed multiple prior lines of treatment, abexinostat promoted anti-cancer responses in 28% of participants, including 5% complete responses.
The treatment was given for an average of 2.8 months, but follicular lymphoma patients continued the treatment for an average of 5.6 months. These patients also showed the best treatment responses (56%), followed by people with T-cell lymphoma (40%), and those with diffuse large B-cell lymphoma (31%)
“Our abexinostat has demonstrated both safety and efficacy in these settings in prior Phase 1/2 trials. We look forward to completing these trials expeditiously and have also started preparation for commercial launch,” said Xu.
Xynomic also is exploring abexinostat as a fourth-line therapy for follicular lymphoma in the ongoing FORERUNNER Phase 2 trial (NCT03600441). This open-label study has enrolled about 140 people at clinical sites in the United States, France, and Spain.
An ongoing Phase 1/2 trial (NCT03939182) is testing a combination of abexinostat plus Janssen’s Imbruvica (ibrutinib) for DLBCL and mantle cell lymphoma patients who have failed prior lines of treatment.