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AstraZeneca's Breast Cancer Drug Fails in Late-Stage Trial

The 1,371-patient SERENA-4 study found only a numerical benefit, raising questions about the drug’s first-line role despite recent accelerated approval.

  • On Friday, AstraZeneca announced that Etcamah failed its late-stage trial for first-line advanced breast cancer treatment, missing the primary progression-free survival goal just one week after gaining separate approval.
  • The SERENA-4 trial enrolled 1,371 patients with ER-positive, HER2-negative advanced breast cancer to test the combination of Etcamah and Pfizer's Ibrance against standard hormone-lowering treatments.
  • AstraZeneca's drug showed only numerical, not statistically significant, improvement in progression-free survival, mirroring a similar failure by Swiss drugmaker Roche in newly diagnosed patients earlier this month.
  • US-Listed shares of AstraZeneca fell 3% following the announcement, though Barclays analyst James Gordon described the update as "well anticipated by the market" given Roche's prior failure.
  • RBC Capital analyst Trung Huynh called the results a "manageable setback" that clears near-term uncertainty, as Jefferies reports peak annual sales potential of more than $5 billion remains largely intact.
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Compared to the standard treatment, the drug could not stop the progression of the disease more strongly. The result could dampen the optimism for the drug.

·Düsseldorf, Germany
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Reuters broke the news in London, United Kingdom on Friday, September 11, 2026.
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