Mixed Results for Cancer and Neurological Drugs, Regulatory Scrutiny Intensifies for PBMs
核心洞察
Daiichi Sankyo and AstraZeneca's Dato-DXd failed to improve overall survival in the TROPION-Breast01 (搜索) trial, despite earlier reports of delaying tumor progression in certain breast cancers.
Black Diamond Therapeutics reported a 42% tumor response rate for BDTX-1535 in EGFR (搜索)-mutated non-small cell lung cancer (搜索) resistant to Tagrisso.
Biohaven's troriluzole met its primary endpoint in a Phase 3 trial for spinocerebellar ataxia (搜索), with plans for FDA submission after a previous rejection.
Daiichi Sankyo and AstraZeneca's experimental cancer treatment, Dato-DXd, has failed to prolong the survival of participants in the TROPION-Breast01 (搜索) clinical trial. This Phase 3 trial aimed to assess the efficacy of Dato-DXd in patients with metastatic HR-positive, HER2-low or negative breast cancer. While the drug had previously shown promise in delaying tumor progression, the final overall survival results did not meet the study's primary endpoint.
Black Diamond Therapeutics Announces Positive Preliminary Results
Black Diamond Therapeutics reported encouraging preliminary results from a mid-stage study of its experimental drug, BDTX-1535. The study, focusing on patients with EGFR (搜索)-mutated, non-small cell lung cancer (搜索) resistant to AstraZeneca's Tagrisso, showed a 42% tumor response rate. These findings suggest that BDTX-1535 could offer a potential treatment option for patients who have developed resistance to standard-of-care therapies.
Biohaven's Troriluzole Shows Promise in Spinocerebellar Ataxia
Biohaven Pharmaceuticals (搜索) announced that its experimental drug, troriluzole, achieved the primary goal in a Phase 3 study for spinocerebellar ataxia (搜索), a rare neurodegenerative disease. The study demonstrated that troriluzole significantly slowed the progression of the disease compared to a historical control group. Biohaven plans to submit troriluzole for FDA approval by the end of the year, following a previous rejection by the agency in 2023.
FTC Sues Pharmacy Benefit Managers
The Federal Trade Commission (FTC) has filed a lawsuit against CVS Caremark (搜索), Express Scripts (搜索), and OptumRx (搜索), the three largest pharmacy benefit managers (PBMs), alleging anticompetitive practices that have artificially inflated insulin prices. The FTC contends that these practices limit patient access to life-saving medications. Regulators are seeking reforms to increase competition and lower drug prices, while the PBMs maintain they have taken steps to improve insulin accessibility.