Merck and AstraZeneca present final results from Phase 3 PROpel Trial
Drug Approval

Merck and AstraZeneca present final results from Phase 3 PROpel Trial

Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival

  • By IPP Bureau | February 18, 2023

AstraZeneca and Merck announced results from the final analysis of the key secondary endpoint of overall survival (OS) from the Phase 3 PROpel trial evaluating LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred), compared to placebo plus abi/pred.

Noel Clarke, urological surgeon and professor of urological oncology at Manchester’s Christie/Salford Royal Hospitals and Manchester University, and a senior investigator in the PROpel trial, said, “From the primary radiographic progression-free survival analysis presented at ASCO GU last year to the updated overall survival data presented today, the data reinforce the therapeutic potential of olaparib plus abiraterone and prednisone for patients with metastatic castration-resistant prostate cancer in the overall trial population and across subgroups. The results of PROpel are important for patients and the oncology community alike, providing support for this combination as a potential and critically needed new treatment option in metastatic castration-resistant prostate cancer.”

Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, said, “Both PARP, the target of LYNPARZA, and the androgen receptor are important for providing DNA repair in prostate cancer. The results in the overall trial population from PROpel illustrate how the combination of LYNPARZA and abiraterone can exploit the dependency of the androgen receptor’s role in DNA repair on PARP to provide greater anticancer activity than abiraterone alone. Based on the totality of the data, it is notable to see this combination delivering a meaningful benefit in a broad population of patients in this setting, which is further underscored by the recent indication approved in the European Union.”

Dr Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, “Prostate cancer is the second most commonly diagnosed cancer in patients assigned male at birth, and mortality is estimated to almost double over the next 20 years. With limited treatment options for these patients, we recognize the critical need for therapies that can delay disease progression. We are proud of our collaboration with AstraZeneca, as we work together to advance pending regulatory reviews and bring a new treatment option to the prostate cancer community.”

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