Epizyme, in the midst of a partial clinical hold on a test for its experimental med tazemetostat, has hired a new chief medical officer.
The company, which focuses on epigenetic therapies, has nabbed Shefali Agarwal as CMO from her former role as CMO at SQZ Biotech, where she built and led the biotech’s clinical development.
She’s also had stints at Curis and Tesaro, as well as Covidien, AVEO Oncology and Pfizer. At Epizyme, she will oversee all of the company’s work on its leading drug tazemetostat, a selective, orally available EZH2 inhibitor, as well as other pipeline candidates.
One of the first steps will be to continue working with the FDA, which slapped a partial clinical hold in April on tests for the drug after a young patient developed a secondary lymphoma.
The hold, short of a full clinical hold, specifically stops the company from enrolling patients with genetically-defined solid tumors and blood cancers into clinical trials for tazemetostat. While the company’s shares dipped on news of the hold, analysts were confident they would bounce back.
The Cambridge, Massachusetts-based biotech then last month announced interim data for a phase 2 trial in patients with relapsed or refractory follicular lymphoma, one of several non-Hodgkin lymphomas that Epizyme is targeting.
The study tested the drug in heavily pretreated patients, or those who had already undergone at least two lines of therapy. Patients were divided into two groups based on EZH2 status. Of the 82 evaluable patients, 28 had an EZH2-activating mutation, while the remaining 54 had wild-type EZH2.
The EZH2 mutant group had a 71% overall response rate, with 11% achieving a complete response and 61% having a partial response. None of the patients’ disease progressed and their median duration of response was 32 weeks. The wild-type group had a lower ORR of 33%, with 6% and 28% having complete and partial responses respectively. The median duration of response was 76 weeks.
However, the data for the mutant group has yet to mature, since the clinical hold prevented it from fully enrolling and the patients in that group started treatment later than those in the wild-type group, Epizyme CEO Robert Bazemore said in June.
Epizyme says it is working to resolve the FDA hold—for example, it has updated the investigator brochure and consent forms for the study—although its first NDA will not be in follicular lymphoma. That distinction goes to epithelioid sarcoma, a molecularly defined solid tumor. The company expects to report updated data in this indication in the second half of the year and to file an NDA in the fourth quarter.
“Dr. Agarwal’s distinguished career in both academia and the biotech industry make her an ideal candidate to lead our clinical organization and oversee the development of innovative therapies to potentially treat a range of solid tumor and hematological malignancies for which significant needs exist,” said Bazemore of his new CMO.
“Her proven leadership and understanding of the patient community, as well as the healthcare providers who care for them, will be instrumental as we continue to advance our lead product candidate, tazemetostat.”
“I look forward to joining this dynamic management team and leading the next phase of clinical development for tazemetostat, as well as for EZM8266, our novel agent that targets G9a for the treatment of sickle cell disease, as we prepare it to enter the clinic,” added. Agarwal.
“I believe that Epizyme’s scientific vision and innovative approach will drive the continued success of the company, as we work together to deliver promising new options for underserved patients.”