Lynparza delivered the result in the PROfound trial, which is being carried out in men with metastatic castration-resistant prostate cancer (mCRPC) who have a homologous recombination repair gene mutation (HRRm) and whose condition had progressed on prior treatment with new hormonal agent (NHA) treatments.
The poly ADP-ribose polymerase (PARP) inhibitor delivered a statistically significant and clinically meaningful improvement in OS, which is a key secondary endpoint of the late-stage trial. This was in comparison to enzalutamide or abiraterone in men with mCRPC selected for BRCA1/2 or ATM gene mutations, which is a subpopulation of HRR gene mutations.
In August 2019, the PROfound trial met its primary endpoint with Lynparza shown to have improved radiographic progression-free survival (rPFS) by a significant extent in men with mutations in BRCA1/2 or ATM genes. The PARP inhibitor also met a major secondary endpoint of rPFS in the overall HRRm population.
Merck Research Laboratories chief medical officer, senior vice president and global clinical development head Roy Baynes 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.”
According to AstraZeneca and Merck, Lynparza’s safety and tolerability profile in the PROfound trial has been on par with those observed in previous trials.
Earlier this year, the PARP inhibitor was given priority review by the US Food and Drug Administration for patients having HRRm mCRPC. AstraZeneca and Merck are exploring more trials for the PARP inhibitor in prostate cancer, which includes the ongoing phase 3 PROpel trial, which is studying it as a first-line therapy for mCRPC patients in combination with abiraterone acetate.