Lynparza has been granted priority review by the US Food and Drug Administration for patients with HRRm mCRPC
The AstraZeneca R&D facility in Mölndal, Sweden. (Credit: Erik031/Wikipedia.)
AstraZeneca and Merck have unveiled positive results from the Phase 3 PROfound trial of Lynparza for a type of metastatic castration-resistant prostate cancer (mCRPC) in men.
The Phase 3 PROfound trial evaluated Lynparza in mCRPC patients who have a homologous recombination repair gene mutation (HRRm) and whose disease had progressed on prior treatment with new hormonal agent (NHA) treatments.
In January 2020, Lynparza has been granted priority review by the US Food and Drug Administration for patients with HRRm mCRPC.
AstraZeneca oncology R&D executive vice president José Baselga 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.”
Lynparza demonstrated a meaningful improvement in overall survival (OS)
The clinical trial results demonstrated a statistically significant and clinically meaningful improvement in the secondary endpoint of overall survival (OS) with Lynparza, compared to enzalutamide or abiraterone in men with mCRPC.
The Phase 3 PROfound trial has reached its primary endpoint, showing treatment with Lynparza improved radiographic progression-free survival (rPFS), and has also met a key secondary endpoint of rPFS in the overall HRRm population.
The other secondary endpoints of the study include OS, objective response rate, time to pain progression, rPFS in patients with HRRm genes, and safety. The safety and tolerability profile for the drug was generally consistent with previous trials, said the company.
The most common adverse events for Lynparza in the trial include anaemia, nausea, fatigue and asthenia, decreased appetite, and diarrhoea, and Grade 3 or above AEs including anaemia, fatigue and asthenia, vomiting, dyspnea, urinary tract infection, nausea, decreased appetite and diarrhoea.
Merck Research Laboratories 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.”