Gazyva: Additional Phase III data

Additional data from the open-label, international Phase III GADOLIN trial in 413 patients with indolent NHL refractory to Rituxan rituximab showed that median PFS as assessed by an IRC, the primary endpoint, has not yet been reached for the Gazyva plus Treanda bendamustine followed by Gazyva alone arm vs. 14.9 months for Treanda alone (HR=0.55, 95% CI: 0.4, 0.74, p=0.0001). Gazyva plus Treanda followed by Gazyva alone led to an investigator-assessed median PFS, a secondary endpoint, of 29.2 months vs. 14 months for Treanda alone (HR=0.52, 95% CI: 0.39, 0.7, p<:0.0001). Data were presented at the American Society of Clinical Oncology meeting in Chicago. In an abstract released ahead of the meeting, data showed that there were no significant differences between the Gazyva arm vs. the Treanda alone arm in IRC-assessed ORR (69.1% vs. 63%), complete response rate at the end of induction treatment (11.2% vs. 12.2%), IRC-assessed best ORR up to 12 months from the start of treatment (78.6% vs. 76.6%) or in preliminary median OS (not reached in either treatment arm). In February, GADOLIN was stopped early after a pre-planned interim analysis by an independent DMC showed that Gazyva plus Treanda followed by Gazyva alone met the primary endpoint of improving median PFS vs. Treanda alone (see BioCentury, Feb. 16). ...