When Pfizer bought Array Biopharma for $11.4 billion three years ago, the focus was on its FDA-approved cancer drug. The acquisition also comes with drug candidates in development for other diseases, and for one of them, it’s the end of the road.
Pfizer is stop working On PF-07265893, the drug has reached Phase 3 testing for symptomatic dilated cardiomyopathy, a heart muscle disease. Oral small molecules are designed to address forms of disease that arise from specific genetic mutations.
Symptoms of dilated cardiomyopathy include fatigue and shortness of breath. There is no specific FDA-approved treatment for this condition, which can also lead to potentially fatal heart failure. Pfizer drugs are designed to block pathways associated with disease progression. In the open-label Phase 2 test, the results showed an improvement as measured by a test that measures the distance a patient could walk in six minutes.
The six-minute walk test was also the primary objective of the placebo-controlled, 24-week Phase 3 study of PF-07265893. Secondary objectives included assessment of 6-minute walking at weeks 4 and 12 and changes in scores according to the Cardiomyopathy Questionnaire. Pfizer said late Wednesday that an interim analysis found the study was unlikely to achieve its main goal. The company did not release specific results from the analysis, but said the decision to stop the drug’s study was not based on any safety concerns. More detailed data from the clinical trial will be presented at a future medical meeting, the company said.
“This development confirms the complexity of advancing new treatments for rare cardiovascular diseases and the need to further increase knowledge in the field,” Chris Boshoff, chief development officer of oncology and rare diseases at Pfizer, said in a prepared statement.
A Phase 3 trial of PF-07265803 started under Array Biopharma. The Boulder, Colorado-based company has commercialized two cancer drugs, Braftovi and Mektovi, as combination treatments for melanomas characterized by specific genetic mutations. Pfizer to acquire Array in 2019 This was followed by positive Phase 3 data testing the drug combination in colorectal cancer.
Braftovi received additional approval for colorectal cancer in 2020. Neither Braftovi nor Mektovi have been big sellers under Pfizer. Braftovi had $187 million in revenue last year, according to Pfizer’s 2021 annual report. Mektovi’s sales were $155 million.
Pfizer said it is working with regulators, clinical trial investigators and community groups to conclude the PF-07265893 clinical trial.
Photo: Dominica Reuters/AFP, via Getty Images
