AstraZeneca and Merck revealed further positive results from the Phase 3 PROfound trial evaluating LYNPARZA in men with metastatic castration-resistant prostate cancer (mCRPC).
KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced further positive results from the Phase 3 PROfound trial evaluating LYNPARZA in men with metastatic castration-resistant prostate cancer (mCRPC) who have a homologous recombination repair gene mutation (HRRm) and whose disease had progressed on prior treatment with new hormonal agent (NHA) treatments (e.g. enzalutamide or abiraterone).
Results from the trial showed a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS) with LYNPARZA vs. enzalutamide or abiraterone in men with mCRPC selected for BRCA1/2 or ATM gene mutations, a subpopulation of HRR gene mutations.
The Phase 3 PROfound trial had met its primary endpoint in August 2019, showing treatment with LYNPARZA significantly improved radiographic progression-free survival (rPFS) in men with mutations in BRCA1/2 or ATM genes, and had met a key secondary endpoint of rPFS in the overall HRRm population.
Dose interruptions due to an AE of any grade occurred in 45% of patients receiving LYNPARZA and 19% of those receiving an NHA; dose reductions due to an AE occurred in 22% of LYNPARZA patients and 4% of patients who received an NHA. Discontinuation due to AEs occurred in 16% of LYNPARZA patients and 9% in patients who received an NHA.
Dr. José Baselga, executive vice president, oncology R&D, AstraZeneca, said, “Overall survival in metastatic castration-resistant prostate cancer has remained extremely challenging to achieve. We are thrilled by these results for LYNPARZA and we are working with regulatory authorities to bring this medicine to patients as soon as possible.”
Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “LYNPARZA has demonstrated significant clinical benefit across key endpoints in PROfound, including overall survival for patients with BRCA or ATM mutations, and this reinforces its potential to change the treatment standard for patients with metastatic castration-resistant prostate cancer. These data further support Merck and AstraZeneca’s commitment to uncovering the ways in which LYNPARZA can help patients impacted by cancer.”
These data will be presented at a forthcoming medical meeting.
LYNPARZA was granted Priority Review by the U.S. Food and Drug Administration for patients with HRRm mCRPC in January 2020, with regulatory reviews ongoing in the European Union and other jurisdictions. AstraZeneca and Merck are exploring additional trials in prostate cancer, including the ongoing Phase 3 PROpel trial, with first data expected in 2021, evaluating LYNPARZA as a first-line therapy for patients with mCRPC in combination with abiraterone acetate.