Subscribe to Entrepreneur for $5
Subscribe

AstraZeneca, Merck's Lynparza Prostate Cancer Study Meets Goal

AstraZeneca (AZN) and Merck (MRK) announce that their PARP inhibitor Lynparza succeeds in meeting the primary endpoint in a late-stage study, evaluati...

By
This story originally appeared on Zacks

AstraZeneca AZN and partner Merck MRK announced that their phase III study — PROpel — evaluating a combination regimen of their PARP inhibitor, Lynparza (olaparib), as a first-line treatment for metastatic castration-resistant prostate cancer (mCRPC) met its primary endpoint.

- Zacks

The late-stage study evaluated Lynparza in combination with J&J’s JNJ prostate cancer drug, Zytiga (abiraterone), and corticosteroid prednisone in mCRPC patients with or without homologous recombination repair (HRR) gene mutations. These patients have also not received any prior therapy in the first-line setting, including new hormonal agents (NHAs) or chemotherapy.

Following a planned interim analysis conducted by an Independent Data Monitoring Committee, data from the study showed that treatment with the Lynparza combo achieved a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS), the study’s primary endpoint, compared to Zytiga plus prednisone in the aforementioned patient population. Data from the study also demonstrated a favorable trend for improvement in overall survival (OS). However, the data were immature during the interim analysis. The companies will continue to evaluate the Lynparza combo regimen in the study with OS as the key secondary endpoint.

Please note that Lynparza is approved for treating mCRPC with HRR gene mutation in patients who received prior treatment with Zytiga or Pfizer’s PFE Xtandi (enzalutamide).

Another PARP inhibitor, Clovis Oncology’s PARP inhibitor, Rubraca, is approved for treating BRCA-mutated mCRPC in the second-line setting. Lynparza faces competition from Rubraca and Glaxo’s Zejula in the ovarian cancer segment.

The positive data from the PROpel study will likely help the company gain FDA approval in the first-line treatment setting in prostate cancer. If approved for first-line mCRPC, Lynparza will be the only PARP inhibitor approved for this indication. A potential approval to the Lynparza combo regimen for first-line mCRPC treatment will help AstraZeneca to maintain its lead in the PARP inhibitor segment easily.

This year so far, AstraZeneca’s shares have risen 20.7% compared with the increase of 9.1% for the industry.

Zacks Investment Research

Image Source: Zacks Investment Research

Lynparza is approved in four tumor types — ovarian, breast, pancreatic, and prostate cancer. Lynparza is being evaluated as a monotherapy and in combination with other drugs in earlier line settings for these tumor types.

Lynparza, which is being jointly developed and commercialized by AstraZeneca and Merck, generated product sales of $1.13 billion in the first half of 2021.

Zacks Rank

AstraZeneca currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.



Zacks Names "Single Best Pick to Double"

From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.

You know this company from its past glory days, but few would expect that it's poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks' Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.

Free: See Our Top Stock and 4 Runners Up >>



Want 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

 

Johnson & Johnson (JNJ): Free Stock Analysis Report

 

Pfizer Inc. (PFE): Free Stock Analysis Report

 

Merck & Co., Inc. (MRK): Free Stock Analysis Report

 

To read this article on Zacks.com click here.

 

Zacks Investment Research