This week, Roche’s RHHBY late-stage Alzheimer’s disease study on key pipeline candidate, gantenerumab failed to meet the primary endpoints. The FDA approved AstraZeneca’s AZN Imfinzi/Imjudo cancer combination for a lung cancer indication. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended the approval of AstraZeneca and partner Merck’s MRK cancer drug Lynparza and AstraZeneca’s two other cancer drugs Enhertu and Imfinzi for expanded use. Sanofi’s SNY Enjaymo was approved to treat hemolytic anemia in adult patients with cold agglutinin disease (CAD) in Europe.
Recap of the Week’s Most Important Stories
Roche’s Alzheimer’s Study Fails to Meet Goal: Roche’s phase III GRADUATE I and II studies on is key pipeline candidate, gantenerumab failed to meet the primary endpoint of slowing clinical decline in people with early Alzheimer’s disease. In the study, participants treated with gantenerumab showed a slowing of the clinical decline of -0.31 and -0.19, respectively in the GRADUATE I and GRADUATE II studies from the baseline score on the Clinical Dementia Rating-Sum of Boxes scale. However, this decline was not statistically significant in either of the studies. This represents a relative reduction in the clinical decline of 8% in GRADUATE I and 6% in GRADUATE II compared with placebo. The level of beta-amyloid removal by gantenerumab was less than expected. Beta-amyloid is the protein that builds up to make plaques in the brains of people with Alzheimer's disease. Roche was developing the candidate in collaboration with MorphoSys.
Sanofi’s Rare Anemia Drug Gets Approval in Europe: The European Commission approved Sanofi’s Enjaymo (sutimlimab), its C1 protein inhibitor, to treat hemolytic anemia in adult patients with cold agglutinin disease (CAD), a rare type of autoimmune hemolytic anemia. Enjaymo is now the first and only therapy approved for treating patients with CAD in Europe. Enjaymo was approved in the United States in February this year. Enjaymo’s approval in Europe was based on data from two phase III studies, CADENZA and CARDINAL.
FDA Approves AstraZeneca’s Imfinzi+Imjudo Combo for Lung Cancer: The FDA approved AstraZeneca’s dual immunotherapy regimen, comprising PD-L1 inhibitor Imfinzi plus CTLA-4 antibody Imjudo (tremelimumab), combined with platinum-based chemotherapy, for treating adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). This FDA approval of the Imfinzi+Imjudo combo was based on data from the phase III POSEIDON study. Imfinzi plus Imjudo is already approved by the FDA for treating unresectable hepatocellular carcinoma in adult patients. Imfinzi, either as a monotherapy or as a combination regimen, is already approved for Stage III NSCLC patients following chemotherapy, extensive-stage small cell lung cancer and biliary tract cancer (BTC) indications.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approving AstraZeneca and partner Merck’s blockbuster PARP inhibitor Lynparza for the first-line treatment of metastatic castration-resistant prostate cancer (mCRPC) in Europe. The regulatory application in Europe seeks approval for Lynparza in combination with Zytiga (abiraterone), and corticosteroid prednisone or prednisolone formCRPC in patients for whom chemotherapy is not clinically indicated. The regulatory filing was based on data from the phase III study — PROpel. A similar application is under priority review in the United States, with an FDA decision expected in the fourth quarter of 2022.
The CHMP also recommended approving AstraZeneca and partner Daiichi Sankyo’s Enhertu for patients with previously treated HER2-positive advanced gastric cancer for patients who have received a prior trastuzumab-based regimen. The CHMP also recommended the approval of Imfinzi plus chemotherapy for the first-line treatment of unresectable or metastatic BTC based on the TOPAZ-1 phase III study.
The NYSE ARCA Pharmaceutical Index declined 0.7% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, Pfizer gained the most (2.3%), while Roche declined the most (5.5%).
In the past six months, Lilly has gained the highest (26.1%), while Novartis declined the most (5.4%).
(See the last pharma stock roundup here: Q3 Earnings of BAYRY, AZN, EU Nod for AZN, SNY RSV Vaccine)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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