AstraZeneca and Merck – Results From Phase 3 PROpel Trial of LYNPARZA (olaparib) Plus Abiraterone in First-Line Metastatic Castration-Resistant Prostate Cancer Published in NEJM Evidence

RAHWAY, N.J.AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that the results from the Phase 3 PROpel trial have been published in NEJM Evidence. Results from the trial showed that LYNPARZA in combination with abiraterone plus prednisone significantly improved radiographic progression-free survival (rPFS) versus abiraterone plus prednisone, a standard of care, as first-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene mutations.

Globally, prostate cancer is the second most common cancer in patients assigned male at birth, with an estimated 1.4 million patients diagnosed worldwide in 2020. Approximately 10-20% of patients with advanced prostate cancer are estimated to develop CRPC within five years, and at least 84% of these patients may develop metastases at the time of CRPC diagnosis. Patients with advanced prostate cancer have a particularly poor prognosis, and the five-year survival rate remains low.

Dr. Noel Clarke, urological surgeon and professor of urological oncology at The Christie/Salford Royal Hospitals and University of Manchester, joint chief investigator of the PROpel trial and joint lead author of the NEJM Evidence manuscript, said, ‘It is critically important that we identify new first-line treatment options for patients with mCRPC. The data published in NEJM Evidence emphasize the therapeutic potential of combining olaparib with abiraterone and prednisone and demonstrate efficacy in a wider group of patients beyond those with documented DNA repair deficiency.’

Cristian Massacesi, chief medical officer and oncology chief development officer, AstraZeneca, said, ‘These data demonstrate that the combination of LYNPARZA with abiraterone and prednisone afforded patients a median radiographic progression-free survival of over two years, regardless of biomarker status. If approved, the combination will offer patients with and without HRR gene mutations a new treatment option.’

Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, ‘Publication of the PROpel data in NEJM Evidence reflects the benefit seen with the combination of LYNPARZAplus abiraterone and prednisone in the first-line setting of mCRPC, and we are pleased that these data have been selected for one of the first issues of this new journal.’

In September 2021, at a planned interim analysis, the independent Data Monitoring Committee concluded that the PROpel trial met its primary endpoint of rPFS. The results were presented in February 2022 at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, and additional data on safety and tolerability as well as pharmacokinetics were presented at the 2022 ASCO Annual Meeting on June 6.

As previously reported, in the Phase 3 PROpel trial, LYNPARZA in combination with abiraterone plus prednisone (n=399) reduced the risk of disease progression or death by 34% (HR=0.66 [95% CI, 0.54-0.81]; p

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