Pharmacyclics Imbruvica shows durable responses in CLL patients

US biotech firm Pharmacyclics (Nasdaq: PCYC), the subject of a $21 billion takeover bid from AbbVie (NYSE: ABBV), beating Johnson & Johnson (NYSE: JNJ) and perhaps Novartis (NOVN: VX) in the bidding process (The Pharma Letter March 5), has released positive new data on its lead drug Imbruvica (ibrutinib).

Imbruvica follow-up data in treatment-naive (TN) and relapsed/refractory (R/R) patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL, respectively) demonstrated that, with up to 45 months of follow-up, the 94 patients (27 TN and 67 R/R) who received Imbruvica 420mg experienced a 91% overall response rate (ORR) and 14% of all patients achieved a complete response (CR) (26% TN, 9% R/R).

These data are an analysis of outcomes from the Phase I/IIb study (PCYC-1102) and the ongoing extension study (PCYC-1103) and were presented in an oral presentation yesterday at the American Association of Cancer Research (AACR) Annual Meeting in Philadelphia, PA by Steven Coutre, Professor of Medicine, Stanford University School of Medicine, Stanford, California. Imbruvica is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of US health care giant Johnson & Johnson (NYSE: JNJ).