Epizyme, Inc. (NASDAQ:EPZM) announced that it has dosed the first patient in a phase II study on tazemetostat for the treatment of adults with mesothelioma, characterized by BAP1 loss-of-function.
The study will first evaluate the safety and pharmacokinetic profile of the candidate in patients (n=12) with relapsed or refractory mesothelioma, regardless of BAP1 status. This will be followed by a two-stage study in patients (n=55) with relapsed or refractory mesothelioma characterized by BAP1 loss-of-function.
As per the company’s press release, about 12,000 individuals are affected by mesothelioma each year in the major markets. Out of this, 40–60% of individuals have tumors characterized by BAP1 loss-of-function. Median overall survival for patients with mesothelioma ranges from 8 to 14 months from the time of diagnosis.
We note that the most commonly used first-line treatment for mesothelioma is Eli Lilly and Company’s (NYSE:LLY) Alimta (approved in 2004 for mesothelioma1), used in combination with cisplatin or carboplatin.
We remind investors that Epizyme is currently evaluating tazemetostat in a phase II study in adults with relapsed or refractory non-Hodgkin lymphoma, in a phase II study in adults and in a phase I study in children with certain genetically-defined solid tumors, including INI1-negative or SMARCA4-negative rhabdoid tumors, renal medullary carcinoma, epithelioid sarcoma, other INI1-negative tumors and synovial sarcoma.
Moreover, a couple of combination studies on tazemetostat are expected to begin in 2016. Under a collaboration agreement with Roche Holding (SIX:ROG) AG’s (OTC:RHHBY) Genentech, Epizyme will evaluate tazemetostat, in combination with Tecentriq (atezolizumab), for the treatment of patients with diffuse large B-cell lymphoma. The company will also evaluate the candidate in combination with R-CHOP for the same indication, in collaboration with the Lymphoma Study Association.
Meanwhile, Aduro BioTech, Inc. (NASDAQ:ADRO) is currently evaluating its immunotherapy candidate, CRS-207, in combination with Alimta and cisplatin, as the front-line treatment for patients with unresectable malignant pleural mesothelioma.
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