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Jump to Key Points Sept 11 (Reuters) - AstraZeneca's breast cancer pill failed to meet the main goal of improving progression-free survival in a late-stage trial, the company said on Friday, a week after the treatment received U.S. approval.
U.S.-listed shares of AstraZeneca fell 3% in aftermarket trading.
The drug camizestrant, sold as Etcamah, when tested in combination with Pfizer's cancer drug Ibrance, showed only a numerical, but not statistically significant, improvement in progression-free survival in previously untreated patients with a form of advanced breast cancer, the company said.
The results represent a "manageable setback" that largely clears a near-term uncertainty for investors, without fundamentally changing the long-term investment case for camizestrant, RBC Capital analyst Trung Huynh said.
- Camizestrant + Ibrance: no statistically significant PFS benefit.
- Trial enrolled 1,371 previously untreated advanced HR+/HER2- breast cancer pts.
- Comparator: Ibrance + hormone-lowering therapy.
- FDA granted accelerated approval last week for ESR1-mutant tumors.
- Full trial data to be presented at upcoming medical meeting.
In March, a similar drug combination from Swiss drugmaker Roche failed to significantly slow disease progression in newly diagnosed patients.
Barclays analyst James Gordon described the update as "well anticipated by the market", given the prior failure of Roche's drug and cautious commentary on the trial from AstraZeneca.
The Etcamah-Ibrance combination was compared against Ibrance and treatments that lower hormones fueling the cancer.
The trial involved 1,371 patients with the most common type of advanced breast cancer in which hormones such as estrogen fuel cancer growth. These cancers lack high levels of HER2, another cancer driver.
Last week, the U.S. Food and Drug Administration granted accelerated approval to the Etcamah combination for treating breast cancer patients whose tumors develop a mutation called ESR1.
According to Jefferies, the company sees peak annual sales potential of more than $5 billion for the drug, adding the majority of this revenue is likely encompassed within the early breast cancer setting.
AstraZeneca said the full trial data will be shared at an upcoming medical meeting.
(Reporting by Christy Santhosh and Mariam Sunny in Bengaluru; Editing by Tasim Zahid and Shailesh Kuber)
