Recent Clinical Trial Failures: Roche, AbbVie, and Cassava Sciences Face Setbacks
Key Insights
Roche's anti-TIGIT drug, tiragolumab, failed to demonstrate a life-extending benefit in a Phase 3 trial for non-small cell lung cancer (search), raising concerns about the TIGIT inhibitor class.
AbbVie (search)'s emraclidine, a muscarinic agonist for schizophrenia (search) acquired from Cerevel Therapeutics, failed in two mid-phase clinical trials, performing no better than placebo.
Cassava Sciences (search)' simufilam, targeting filamin-A (search) for Alzheimer's, failed in a Phase 3 trial, with patients showing no improvement on functional or cognitive measures.
Recent clinical trial results have delivered significant setbacks for several pharmaceutical companies, impacting their pipelines and market valuations. Roche, AbbVie (search), and Cassava Sciences (search) have each faced high-profile failures, raising questions about the future of their respective drug candidates.
Roche's Anti-TIGIT Drug Disappoints
Hopes were high for Roche's tiragolumab, an anti-TIGIT oncology contender developed by Genentech. However, a Phase 3 trial failure has cast doubt on the entire class of investigational immunotherapy cancer drugs. The trial, evaluating tiragolumab in combination with Roche's PD-L1 checkpoint inhibitor Tecentriq in non-small cell lung cancer (search) patients, failed to demonstrate a statistically significant life-extending benefit compared to Tecentriq alone. This setback adds to previous failures, including a head-to-head loss against Merck's Keytruda in non-squamous non-small cell lung cancer. While tiragolumab is still being tested in other cancers, the recent results temper expectations for its potential. Despite the overall negative trend in TIGIT inhibitors, Gilead and Arcus Biosciences' domvanalimab shows promise in improving outcomes for non-small cell lung cancer when combined with the checkpoint inhibitor zimberelimab.
AbbVie's Schizophrenia Drug Fails to Impress
AbbVie (search)'s emraclidine, a muscarinic agonist for schizophrenia (search), failed to outperform placebo in two mid-phase clinical trials. This outcome was unexpected, particularly following the FDA approval of Bristol Myers Squibb's Cobenfy, a new schizophrenia drug with a novel mechanism of action. Emraclidine, acquired from Cerevel Therapeutics in a multibillion-dollar deal, was anticipated to offer similar efficacy with a potentially improved side effect profile and less frequent dosing. The failure resulted in a significant market cap loss for AbbVie and a corresponding increase for BMS, solidifying BMS's position in the schizophrenia market. The results may also impact other companies developing schizophrenia drugs in the same class.
Cassava Sciences' Alzheimer's Drug Stumbles
Cassava Sciences (search)' simufilam, a drug targeting filamin-A (search) for Alzheimer's disease (search), failed in a Phase 3 trial. Patients in the trial did not show improvement on functional or cognitive measures. This setback follows an SEC investigation into allegations of data manipulation in earlier trials. The company recently settled with the SEC for $40 million. The failure of simufilam represents another challenge in the Alzheimer's drug development landscape, which has seen both successes and controversies in recent years. While drugs like Leqembi and Kisunla have shown promise in slowing disease progression, questions remain about their overall value and impact.