Roche places 'stronger gates' on phase 3 pipeline to reduce failure rate

Roche has installed “stronger gates” to ensure that drug candidates only make it into phase 3 trials if they have a high likelihood of success, CEO Thomas Schinecker has revealed.

Pointing to a slump in the success rate of phase 3 trials by the Swiss Big Pharma in recent years, Schinecker told attendees at the company’s Pharma Day in London that Roche is now making more of an effort to ensure that assets “only make it into phase 3 that clear the bar which we’re setting.”

“This bar includes multiple factors,” the CEO explained in his presentation, which was attended by Fierce Biotech. “How convincing is the data? What's the probability of success, and also what's the value? Because you may take different risk-value ratios depending on that.”

Schinecker was responding to a slide that showed that while Roche has typically closely matched the phase 3 success rate of its peers in the past decade and a half, the five-year rolling average for 2018-22 saw the Swiss company’s late-stage success rate drop to just 58% compared to a peer average of 76%.

“That tells you we're putting too much risk from phase 2 into phase 3,” he said. “Some of these projects should probably have stopped earlier in phase 2.”

The CEO blamed part of this downturn in late-stage clinical success rates on Tecentriq, where there had been a “push to go directly into phase 3, skipping phase 2, in order to catch up.” Tecentriq is one of many immune checkpoint inhibitors that got caught up in a PD-1/L1 land grab as Merck & Co.'s Keytruda rose to prominence. 

Despite having now secured its place as a cancer blockbuster, Tecentriq has certainly been involved in some high-profile phase 3 fails in its time, including a major shock back in 2017 for second-line bladder cancer that nearly put the PD-L1 inhibitor’s future in doubt.

Roche has been implementing a “forerunner” to its plans to more strictly gatekeep its phase 3 pipeline for some time, Roche’s Chief Medical Officer Levi Garraway, M.D., Ph.D., told attendees at today’s event. “So you won’t suddenly see in one quarter a dramatic reduction in [programs],” he said. “But certainly we will try and do more of that in terms of having a stringent look ... particularly moving into phase 3.”