Venclexta plus Rituxan combo meets in Phase III for CLL

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) and AbbVie Inc. (NYSE:ABBV) reported data from the Phase III MURANO trial in 389 patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who had received one to three prior therapies showing that Venclexta venetoclax (ABT-199, RG7601) plus Rituxan rituximab met the primary endpoint of improving investigator-assessed progression-free survival (PFS) vs. Treanda bendamustine plus Rituxan. Specifically, investigator-assessed median PFS was not reached in the Venclexta arm vs. 17 months in the Treanda arm (HR=0.17, 95% CI: 0.11, 0.25, p<0.0001). Venclexta plus Rituxan led to a 24-month PFS rate of 84.9% vs. 36.3% for Treanda plus Rituxan. Additionally, Venclexta plus Rituxan led to an overall response rate (ORR) of 93.3% vs. 67.7% for Treanda plus Rituxan.

On independent review committee (IRC)-assessed endpoints, median PFS was not reached in the Venclexta arm vs. 18.1 months in the Treanda arm (HR=0.19, 95% CI: 0.13, 0.28, p<0.0001). Venclexta plus Rituxan led to an IRC-assessed 24-month PFS rate of 82.8% vs. 37.4% for Treanda plus Rituxan. Additionally, Venclexta plus Rituxan led to an IRC-assessed ORR of 92.3% vs. 72.3% for Treanda plus Rituxan. Data were presented at the American Society of Hematology meeting in Atlanta...