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AstraZeneca, Merck's Lynparza Prostate Cancer Study Meets Goal

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AstraZeneca (AZN - Free Report) and partner Merck (MRK - Free Report) 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.

The late-stage study evaluated Lynparza in combination with J&J’s (JNJ - Free Report) 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 - Free Report) 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.

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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.

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


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