Astrazeneca's Etcamah trial fails to meet primary endpoint.
Drugmaker Astrazeneca said on Monday that its SERENA‑4 Phase III trial of breast cancer treatment Etcamah (camizestrant) in combination with palbociclib did not meet its primary endpoint, although a numerical improvement in progression‑free survival was observed, as the company reaffirmed confidence in the drug's broader development programme.
Source: Sharecast
Astrazeneca's study evaluated Etcamah plus palbociclib as an upfront first‑line treatment for patients with ER‑positive, HER2‑negative advanced breast cancer who had not previously received systemic therapy.
The FTSE 100-listed firm stated the outcome sharpened its focus on maximising use of Etcamah in settings where benefit has already been demonstrated, notably in patients with emergent ESR1 mutations based on the SERENA‑6 trial.
Astrazeneca stated the safety profile of Etcamah with palbociclib was consistent with known effects of both medicines, with no new concerns identified. Full data will be shared later. Etcamah combined with a CDK4/6 inhibitor was already approved in the US, EU, Japan and other markets for HR‑positive, HER2‑negative advanced breast cancer upon detection of ESR1 mutation during first‑line endocrine therapy.
AZN also added that Etcamah was being advanced through what it described as the most comprehensive oral SERD programme in early breast cancer, with CAMBRIA‑1 and CAMBRIA‑2 Phase III trials enrolling around 10,000 patients across intermediate‑ and high‑risk adjuvant settings
As of 1015 BST, Astrazeneca shares were up 1.67% 11,904p.
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