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AZN's Etcamah Fails Late-Stage Study for First-line Breast Cancer
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Key Takeaways
AstraZeneca's Etcamah combination failed to significantly improve PFS in the SERENA-4 study.
Etcamah's recent FDA approval covers a switch strategy for patients with ESR1 resistance mutations.
AstraZeneca continues testing Etcamah in CAMBRIA-1 and CAMBRIA-2 to expand its potential use.
AstraZeneca (AZN - Free Report) announced that a phase III study evaluating a combination therapy involving its recently approved breast cancer pill Etcamah (camizestrant) failed to meet its primary endpoint of progression-free survival (PFS).
The late-stage study, called SERENA-4, evaluated Etcamah plus Pfizer’s (PFE - Free Report) blockbuster CDK4/6 inhibitor Ibrance (palbociclib) against the aromatase inhibitor anastrozole plus Ibrance as first-line treatment for estrogen receptor (ER)-positive, HER2-negative advanced breast cancer.
While the results did show a numerical improvement in PFS, they were not statistically significant. AstraZeneca did not report any safety concerns. It intends to share data from the study in due course.
The SERENA-4 results come just a week after Etcamah secured its first approval. Earlier this month, the FDA approved the drug under the accelerated pathway in combination with a CDK4/6 inhibitor to treat patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer. Etcamah is to be used in combination with either Ibrance, Novartis’ (NVS - Free Report) Kisqali (ribociclib) or Eli Lilly’s (LLY - Free Report) Verzenio (abemaciclib).
Importantly, this recent approval is specifically for a "switch" strategy — used only when patients develop an ESR1 resistance mutation while on initial standard therapy (aromatase inhibitor plus a CDK4/6 inhibitor). The SERENA-4 study tested the drug upfront in all patients regardless of mutation status, meaning this failure does not affect Etcamah's approved indication. However, AstraZeneca will be required to conduct a confirmatory study to turn this accelerated approval into a traditional one.
AZN Stock Performance
Year to date, shares of AstraZeneca have lost 13% against the industry’s 5% growth.
Image Source: Zacks Investment Research
More on AZN’s Etcamah
Etcamah is a potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. SERDs work by binding to and degrading the ER, helping block estrogen-driven signaling involved in the growth of HR-positive breast cancer.
AstraZeneca is evaluating Etcamah across a broad clinical development program, including the phase III CAMBRIA-1 and CAMBRIA-2 studies. These studies are evaluating the drug as a monotherapy or in combination with CDK4/6 inhibitors in different treatment settings for patients with HR-positive, HER2-negative breast cancer, supporting the company’s efforts to expand the potential use of the drug beyond its current indication.
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AZN's Etcamah Fails Late-Stage Study for First-line Breast Cancer
Key Takeaways
AstraZeneca (AZN - Free Report) announced that a phase III study evaluating a combination therapy involving its recently approved breast cancer pill Etcamah (camizestrant) failed to meet its primary endpoint of progression-free survival (PFS).
The late-stage study, called SERENA-4, evaluated Etcamah plus Pfizer’s (PFE - Free Report) blockbuster CDK4/6 inhibitor Ibrance (palbociclib) against the aromatase inhibitor anastrozole plus Ibrance as first-line treatment for estrogen receptor (ER)-positive, HER2-negative advanced breast cancer.
While the results did show a numerical improvement in PFS, they were not statistically significant. AstraZeneca did not report any safety concerns. It intends to share data from the study in due course.
The SERENA-4 results come just a week after Etcamah secured its first approval. Earlier this month, the FDA approved the drug under the accelerated pathway in combination with a CDK4/6 inhibitor to treat patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer. Etcamah is to be used in combination with either Ibrance, Novartis’ (NVS - Free Report) Kisqali (ribociclib) or Eli Lilly’s (LLY - Free Report) Verzenio (abemaciclib).
Importantly, this recent approval is specifically for a "switch" strategy — used only when patients develop an ESR1 resistance mutation while on initial standard therapy (aromatase inhibitor plus a CDK4/6 inhibitor). The SERENA-4 study tested the drug upfront in all patients regardless of mutation status, meaning this failure does not affect Etcamah's approved indication. However, AstraZeneca will be required to conduct a confirmatory study to turn this accelerated approval into a traditional one.
AZN Stock Performance
Year to date, shares of AstraZeneca have lost 13% against the industry’s 5% growth.
Image Source: Zacks Investment Research
More on AZN’s Etcamah
Etcamah is a potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. SERDs work by binding to and degrading the ER, helping block estrogen-driven signaling involved in the growth of HR-positive breast cancer.
AstraZeneca is evaluating Etcamah across a broad clinical development program, including the phase III CAMBRIA-1 and CAMBRIA-2 studies. These studies are evaluating the drug as a monotherapy or in combination with CDK4/6 inhibitors in different treatment settings for patients with HR-positive, HER2-negative breast cancer, supporting the company’s efforts to expand the potential use of the drug beyond its current indication.
AstraZeneca PLC Price
AstraZeneca PLC price | AstraZeneca PLC Quote
AZN’s Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.