AstraZeneca said on Friday that a prostate cancer treatment it is developing with MSD has passed the next stage of its trial, showing positive high-level results.
In a statement, the pharmaceutical company said the trial also showed a trend in an interim analysis towards improved overall survival.
“Results from the PROpel Phase III trial showed AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) versus standard-of-care abiraterone as a 1st-line treatment for men with metastatic castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene mutations,” AstraZeneca said.
The statement also said that the Independent Data Monitoring Committee (IDMC) concluded that the trial met “the primary endpoint of rPFS in men with mCRPC” who had not received treatment in the first-line setting, including with new hormonal agents (NHAs) or chemotherapy.
However, AstraZeneca said the data from the trial is still in its early stages and it will continue to assess overall survival as a key secondary end point.
Prostate cancer is the second-most common cancer in men and despite an increase in the number of available treatments for those with mCRPC, five-year survival remains low, the company said.
“Today, men with metastatic castration-resistant prostate cancer have limited options in the 1st-line setting, and sadly often the disease progresses after initial treatment with current standards of care,” Susan Galbraith, executive vice president, oncology research and development, said.
“These exciting results demonstrate the potential for Lynparza with abiraterone to become a new first-line option for patients regardless of their biomarker status and reach a broad population of patients living with this aggressive disease. We look forward to discussing the results with global health authorities as soon as possible,” she added.
Roy Baynes, senior vice president and head of global clinical development – and chief medical officer at MSD research laboratories – said the results build on MSD and AstraZeneca’s partnership goal.
“We are encouraged by the PROpel results and the clinical benefit Lynparza in combination with abiraterone demonstrated versus abiraterone alone as a first-line treatment option for men with metastatic castration-resistant prostate cancer. Today’s results build on MSD and AstraZeneca’s commitment to bring Lynparza earlier in lines of treatment and to more patients with advanced prostate cancer,” he said.