ARTICLE | Clinical News

Gazyva: Additional Ph III GALLIUM data

December 30, 2016 1:39 AM UTC

Additional data from 1,202 patients with previously untreated follicular lymphoma in the open-label, international Phase III GALLIUM trial showed that induction therapy with Gazyva plus chemotherapy followed by maintenance therapy with Gazyva alone improved investigator-assessed PFS, the primary endpoint, by 34% at a median follow-up of 34.5 months vs. Rituxan rituximab plus chemotherapy followed by Rituxan alone (HR=0.66; 95% CI: 0.51, 0.85, p=0.0012). Median PFS has not yet been reached. By independent review committee (IRC) assessment, Gazyva improved PFS by 29% vs. Rituxan (HR=0.71, 95% CI: 0.54, 0.93, p=0.0138). On a secondary endpoint, Gazyva led to an ORR of 88.5% at the end of induction vs. 86.9% for Rituxan. Gazyva also improved OS by 25% vs. Rituxan (HR=0.75, 95% CI: 0.49, 1.17, p=0.21). Additionally, Gazyva led to investigator- and IRC-assessed 3-year PFS rates of 80% and 81.9%, respectively, vs. 73.3% and 77.9% for Rituxan. Three-year OS rates were 94% for Gazyva vs. 92.1% for Rituxan. Data were presented at the American Society of Hematology meeting in San Diego. Roche previously reported that Gazyva plus chemotherapy followed by Gazyva alone met the primary endpoint of improving investigator-assessed PFS vs. Rituxan plus chemotherapy followed by Rituxan alone (see BioCentury, July 11, 2016)...