By RAMSEY BAGHDADI
It seems like everyone who sees the results of the CATT comparative study of Roche/Genentech’s Lucentis
(ranibizumab) vs. off-label Avastin (bevacizumab) for age-related macular degeneration comes away with a unique interpretation of the results.
Top government officials are no different.
At a June 8 meeting, Improving Medical Decisions Using Comparative Effectiveness Research and hosted by the Friends of Cancer Research, three leading regulators/policymakers came away with three different reactions to CATT.
“NIH felt this was an important issue to get resolved, we funded the study and it came out with a result that appears both [drugs] are equivalent,” NIH Director Francis Collins said. “That resolves an issue that was hanging in the air.”
That may be wishful thinking. Roche/Genentech has highlighted safety risks associated with use of Avastin off-label as the major takeaway from the study: patients prescribed Avastin experienced more non-specific serious adverse events, primarily hospitalizations—24% to 19%—compared to patients on Lucentis.
“We thought it was great,” Collins later added regarding the CATT results. “The study had four arms, two different drugs each of which was dosed either monthly or as needed. When they broke the code it was pretty clear there weren’t any significant differences between the four different results.”
Collins remarked that CATT “was a bit controversial” because the two drugs were made by Roche/Genentech and “you can imagine that they were hoping the more expensive one would win.” But, “when it came out equivalently, that’s not the answer they were hoping for. But it was a randomized trial and I think it would be a very difficult to get this answer without that particular study design.”
Agency for Healthcare Research & Quality (AHRQ) Director Carolyn Clancy lamented the absence of an observational/registry arm as part of CATT.
FDA Center for Drug Evaluation & Research Director Janet Woodcock had an altogether different reaction: she praised the efforts involved in conducting the study but highlighted its weakness.
“I’ll tell Francis, ‘congratulations, welcome to my world,’ because the trial, although heroic and very well designed, it was probably not long enough to look at the long-term safety outcomes,” Woodcock said.
Clancy interjected: “Well, that’s where an observational arm would have helped.” Woodcock gave a skeptical chuckle.
While Collins believes the issue over Lucentis vs. Avastin to be “resolved,” the questions over what to make of the CATT results may not be answered to everybody’s satisfaction.