Portola presents new interim Phase 2a data from study of cerdulatinib
Portola Pharmaceuticals announced new interim results from the Company's ongoing Phase 2a study of cerdulatinib, an investigational, oral SYK/JAK inhibitor, in patients with relapsed/refractory follicular lymphoma receiving cerdulatinib alone or in combination with rituximab. The data will be presented today during a poster session at the 61st American Society of Hematology Annual Meeting in Orlando. Data included safety and efficacy findings as of November 2019 for 42 patients who received single agent cerdulatinib at 30 mg twice daily and 21 patients who received cerdulatinib at 30 mg twice daily in combination with a standard dosing regimen of rituximab. The number of prior treatment regimens including anti-CD20 antibody, bendamustine and other alkylating agents, and PI3K inhibitors ranged from one to 10, with a median of three. Among the 42 patients in the cerdulatinib-only cohort, the overall response rate (ORR) was 48%; 7 patients achieved a complete response, 13 patients achieved a partial response and 10 patients achieved stable disease. To date, 16 of the 42 patients in the cerdulatinib-only cohort have been on study drug for at least 10 months. Among the 21 patients evaluated for efficacy in the cerdulatinib and rituximab combination cohort, the ORR was 76%; 5 patients achieved a CR, 11 patients achieved a PR and 5 patients achieved SD. Of the 11 patients in this combination cohort who have been on one to three prior therapies, the ORR was 91% with a complete response rate of 36%. Cerdulatinib was generally well-tolerated and the safety profile appeared similar in both the cerdulatinib-only and rituximab combination cohorts. The most common adverse events occurring in greater than or equal to5% of all evaluable study patients were lipase increase, neutropenia, diarrhea and amylase increase. The most common AEs in the combination cohort included lipase increase, neutropenia and diarrhea. The lipase and amylase changes were generally asymptomatic and not associated with pancreatitis. Additionally, there was no emergence of late-stage colitis, cardiac or liver abnormalities, or other evidence of cumulative toxicity.