BioCentury
ARTICLE | Clinical News

TRU-016: Phase Ib/II data

November 12, 2012 8:00 AM UTC

Top-line data from 12 patients in the open-label Phase Ib portion of a Phase Ib/II trial showed that 15 and 20 mg/kg TRU-016 plus Treanda bendamustine each produced 2 complete responses. The best ORR at any time was 100%, with 9 responses occurring during the first cycle of treatment. Reported >=grade 3 adverse events were neutropenia and febrile neutropenia. Data will be presented at the American Society of Hematology meeting in Atlanta in December. Patients in the Phase Ib portion received 15 and 20 mg/kg TRU-016 weekly for the first 2 cycles and bi-weekly for the next 4 cycles in combination with Treanda. The Phase II portion is comparing the dose selected in the first portion plus Treanda vs. Treanda alone in up to 100 patients.

TRU-016 has Orphan Drug designation from FDA for CLL. Earlier this year, Abbott Laboratories (NYSE:ABT, Abbott Park, Ill.) terminated a 2009 deal to co-develop and commercialize the product as a result of a portfolio prioritization process, according to Emergent. Abbott gained rights to TRU-016 through its 2010 acquisition of Facet Biotech Corp., which received rights from Trubion Pharmaceuticals Inc. Emergent acquired Trubion in 2010 (see BioCentury, April 26, 2010; Aug. 16, 2010 & Jan. 2, 2012). ...