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AstraZeneca Breast Cancer Drug Etcamah Misses Primary Trial Goal
AstraZeneca tested a breast cancer medicine called Etcamah in a large clinical trial.
The medicine was given with another drug called palbociclib.
The trial compared this treatment with anastrozole plus palbociclib.
The main goal was to help patients live longer without their cancer getting worse.
The trial did not reach that goal in a statistically significant way.
However, patients receiving the Etcamah combination showed a numerical improvement in one first-line treatment group.
AstraZeneca said no new safety problems were found.
The company is continuing to study Etcamah in other trials involving patients with early breast cancer.
AstraZeneca said the Phase III SERENA-4 trial of Etcamah with palbociclib failed to achieve a statistically significant improvement in progression-free survival.
The combination showed a numerical improvement in first-line treatment for patients with ER-positive, HER2-negative advanced breast cancer.
SERENA-4 compared Etcamah and palbociclib with anastrozole and palbociclib in patients without prior systemic treatment for advanced disease.
AstraZeneca said Etcamah’s safety profile was consistent with the known profiles of the medicines, with no new safety concerns.
Etcamah remains under evaluation in the Phase III CAMBRIA-1 and CAMBRIA-2 trials involving approximately 10,000 patients with early breast cancer.
- Who
- AstraZeneca, led in the statement by Susan Galbraith, reported the trial result.
- What
- The Phase III SERENA-4 trial of Etcamah with palbociclib did not meet its primary progression-free-survival goal.
- Where
- When
- The report provides a time of 15:40 but no calendar date.
- Why
- The trial tested whether Etcamah plus palbociclib improved progression-free survival compared with anastrozole plus palbociclib.
Key facts
- Company
- AstraZeneca
- Drug
- Etcamah, also known as camizestrant
- Trial
- Phase III SERENA-4
- Primary outcome
- No statistically significant improvement in progression-free survival
- Patient group
- Patients with ER-positive, HER2-negative advanced breast cancer
- Safety
- No new safety concerns were identified
- Other studies
- CAMBRIA-1 and CAMBRIA-2 are evaluating Etcamah in early breast cancer
- Additional trial size
- The CAMBRIA trials encompass approximately 10,000 patients at intermediate and high risk of recurrence
Quotes
Susan Galbraith
Executive Vice President of Oncology Haematology R&D at AstraZeneca
“Whilst we are disappointed by the SERENA-4 outcome, it sharpens our focus on maximising the number of patients who can benefit from Etcamah today based on SERENA-6 and reinforces the importance of ESR1 testing for patients on first-line therapy”
m.rediff.com
Sources
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