Roche stated that it has taken significant steps to improve the success rate of its phase 3 clinical trials by implementing more stringent criteria – or ‘stronger dates’ – for candidate selection. This strategic shift was announced at Roche’s Pharma Day event in London, where Schinecker addressed the company’s recent challenges in late-stage clinical trials.
Schinecker placed significant emphasis on the importance of elevating the standards for candidates progressing into the pivotal phase 3 trials. In his detailed explanation, he shed light on Roche’s meticulous implementation of a comprehensive evaluation framework. Within this framework, thorough considerations are given to the quality of available data, the probability of achieving success, and the holistic value of the asset under evaluation. The ultimate goal is to shepherd through only those candidates demonstrating the utmost promise, thus securing the efficacy of the pivotal phase 3.
The CEO’s presentation featured a revealing slide that compared Roche’s five-year rolling average for late-stage success rates from 2018 to 2022, which stood at just 58%, with a peer average of 76%.
Schinecker attributed part of this decline in success rates to Tecentriq, a significant product in Roche’s portfolio. He noted that there had been a rush to move Tecentriq directly into phase 3, bypassing phase 2, in an attempt to compete with Merck & Co.’s Keytruda, a prominent immune checkpoint inhibitor. While Tecentriq has ultimately become a blockbuster cancer therapy, it faced major setbacks during phase 3 trials, including a significant failure in second-line bladder cancer back in 2017, which cast doubts on its future.
Roche’s Chief Medical Officer, Levi Garraway, M.D., Ph.D., also weighed in on the company’s efforts to enhance phase 3 candidate selection. He mentioned that Roche had been working on a preliminary version of its gatekeeping strategy for some time. This gradual approach aims to avoid a sudden reduction in programs, ensuring a smoother transition towards stricter candidate evaluation.
In separate news for the company, Schinecker has expressed willingness to consider significant acquisitions, emphasizing that such moves must align with scientific and financial objectives. This stance comes following Roche’s $20.7 billion share buyback from Novartis last year, which has left the Swiss pharmaceutical giant financially unburdened.
This news follows reports of Roche’s discussions with U.S. biotech firm Roivant Sciences regarding a potential acquisition valued at over $7 billion, focusing on an experimental drug for inflammatory bowel diseases like ulcerative colitis and Crohn’s disease.
