– Interim Phase 2a Data Highlight Efficacy and Safety Results of Cerdulatinib Alone and in Combination with Rituximab –
– Data Presented at the 15th International Conference on Malignant Lymphoma (ICML) –
Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today 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 (FL) receiving cerdulatinib alone or in combination with rituximab. Data were presented this month in a poster session at the 24th Congress of the European Hematology Association (EHA) in Amsterdam (June 13-16) and during an oral session today at the 15th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland (June 18-22).
Data included safety and efficacy findings for 40 patients who received single agent cerdulatinib at 30 mg twice daily (with the exception of two patients who initiated treatment at 35 mg) and 17 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 anthracyclines ranged from one to nine, with a median of three.
Among the 40 patients in the cerdulatinib-only cohort, the objective response rate (ORR) was 45%; five patients (13%) achieved a complete response (CR), 13 patients (33%) achieved a partial response (PR) and 10 patients (25%) achieved stable disease (SD). Of the 27 patients with a PR or SD at first evaluation in the single agent cerdulatinib cohort, 17 (63%) had a further reduction in tumor volume at a subsequent efficacy evaluation. To date, 15 of the 40 patients (38%) in the cerdulatinib-only cohort have been on study drug for at least 10 months.
Among the 13 patients evaluated for efficacy in the cerdulatinib and rituximab combination cohort, the ORR was 62%; one patient (8%) achieved a CR, seven patients (54%) achieved a PR and five patients (39%) achieved SD. To date, 10 of the 13 patients have been on study drug from three to 10 months.
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