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ARTICLE | Clinical News

Portola reports response data in Phase IIa of cerdulatinib in B cell malignancies

June 23, 2017 8:27 PM UTC

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) reported interim data from the Phase IIa portion of a Phase I/IIa trial evaluating oral cerdulatinib (PRT062070, PRT2070) to treat relapsed or refractory B cell malignancies. In 18 evaluable patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL), cerdulatinib led to 12 partial responses (PRs). In 9 evaluable patients with relapsed or refractory follicular lymphoma, cerdulatinib led to 5 PRs. In 7 evaluable patients with other indolent non-Hodgkin's lymphoma (NHL), including marginal zone lymphoma and Waldenstrom's macroglobulinemia, cerdulatinib led to 1 PR. Cerdulatinib also led to a complete response in the first evaluable patient with relapsed or refractory peripheral T cell lymphoma (PTCL). Cerdulatinib was generally well tolerated but led to 2 cases of grade 5 infections and 1 case of grade 3 pancreatitis in patients receiving twice-daily 35 mg cerdulatinib. Data were presented at the International Conference on Malignant Lymphoma in Lugano.

The dose-escalation Phase I portion of the open-label, U.S. trial is evaluating once-daily cerdulatinib starting at a 15 mg dose in about 43 patients. The Phase IIa portion is evaluating twice-daily cerdulatinib starting at 30 mg dose plus Rituxan rituximab in about 240 patients. The primary endpoint is maximum tolerated dose (MTD). Secondary endpoints include dose-limiting toxicities (DLTs), objective response rate (ORR), duration of response, progression-free survival (PFS), time to treatment response, lymph node response, clinical benefit rate (CBR), pharmacokinetics and safety...