BioCentury
ARTICLE | Clinical News

DI-Leu16-IL2: Phase I/II data

January 25, 2016 8:00 AM UTC

An open-label, dose-escalation, U.S. Phase I/II trial showed that thrice-weekly 0.5, 1 and 2 mg/m 2 subcutaneous DI-Leu16-IL2 every 3 weeks led to tumor regression or stabilization in 12 of 13 evaluable patients with relapsed or refractory B cell CD20-positive NHL who received 2 cycles of therapy, including 1 complete response after 2 cycles. Of 8 evaluable patients who received 6 cycles of DI-Leu16-IL2, there were 2 complete responses, 2 partial responses and 4 cases of stable disease. There was 1 additional complete response in a patient who had not yet received 6 cycles of treatment. Additionally, 3 patients had durable responses of >=11 months. DI-Leu16-IL2 was well tolerated with no dose-limiting toxicities (DLTs) reported. The most common treatment-related adverse events reported were transient skin reactions with erythema, painless induration of injection site, pruritus, edema, chills, low-grade fever, fatigue and low appetite. Two grade 3 non-DLT toxicities -- diarrhea and QTc prolongation -- resulted in dose reduction. The trial is enrolling about 66 patients to receive thrice-weekly 0.5, 1, 2, 4, 6, 8 or

10 mg/m 2 DI-Leu16-IL2 every 3 weeks for 6 cycles, or 18 total doses. Data were presented at the American Society of Hematology meeting in Orlando. ...