In a confrontation with AstraZeneca, Pfizer publishes solid and very familiar data on breast cancer PhIII for talazoparib – ENDPOINTS NEWS



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Jennifer Litton, MD Anderson Cancer Center

Pfizer $ PFE arrived with positive numbers for her phase III study of her PARP inhibitor talazoparib in advanced bad cancer, lining up with Lynparza, the leading rival of $ AZN from AstraZeneca . And the results position Pfizer to join the PARP lineup as the fourth player to reach the market threshold, although perhaps not in the leadership position that was promised when the pharmaceutical giant bought the drug last year.

Analysts have been waiting to see how the Pfizer drug, pocketed in the $ 14 billion acquisition of Medivation, will have a price relative to the competition. It is a widely disapproved approach by experts, but market badysts love to combine data from two different studies of the same disease, offering warnings about what might be important distinctions in trial designs, patient populations, and endpoints.

In this case, which calls for a comparison, the numbers are close enough to Lynparza's reading at the beginning of the year that he will probably emphasize how comparable these therapies can be, including the competition in Tesaro $ TSRO (Zejula) and Clovis $ CLVS (Rubraca).

The Pfizer researchers concluded that there was a 45.8% reduction in the risk of disease progression in the EMBRACA study, which enrolled women with HER2-negative bad cancer with a BRCA mutation in the germ line. The median PFS was 8.6 months, compared to 5.6 months in the control group.

The overall response rate was 62.6% in the group of drugs compared to only 27.2% in the control group. There were also 12 complete responses, with no visible signs of the disease, for talazoparib, compared to none in control.

"The most notable aspect of this study was not only the improvement to date of the SSP, but the time to clinical deterioration, which was 24.3 months for patients on talazoparib, compared to 6.3 months for those who received standard chemotherapy, "said Jennifer Litton of MD Anderson.

Compare that with the 42% reduction in the risk of progression of Lynparza, a 7-month period versus 4.2-PFS at one month – or a range of 2.8 months versus 3 months for talazoparib – and 59.9% talazoparib versus 28.8% ORR chemotherapy.

Both studies compared their medication against standard chemotherapy.

Former Medivation CEO David Hung sold this difficult drug in driving the deal to sell his company to Pfizer for $ 14 billion last year, claiming it was clearly superior to everything there is. That would be an even more difficult sales job today, with the latest data on the screen.

Tesaro launched the Phase III BRAVO study to see how his drug worked in a similar population of bad cancer, but noticed in March that it could not. It does not serve as a registry study after the patients withdrew, preferring to obtain a PARP marketed instead of chemotherapy. Biotechnology continued to say that it is studying its drug in combination with a checkpoint therapy in bad cancer.

Image: Shutterstock


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