AstraZeneca AZN 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 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 Kisqali (ribociclib) or Eli Lilly’s LLY 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.
Zacks' Research Chief Names "Stock Most Likely to Double"
Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.
Of course, all our elite picks aren't winners, but this one could far surpass earlier Zacks' Stocks Set to Double like D-Wave Quantum, which shot up +680.1%.
Free: See Our Top Stock And 4 Runners UpWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
AstraZeneca PLC (AZN): Free Stock Analysis Report
Novartis AG (NVS): Free Stock Analysis Report
Pfizer Inc. (PFE): Free Stock Analysis Report
Eli Lilly and Company (LLY): Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).