AstraZeneca and Merck detailed results from the Phase 3 SOLO-1 trial testing Lynparza 300 mg tablets twice daily as a maintenance treatment for patients with newly-diagnosed advanced BRCA-mutated (BRCAm) ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy.
Results of the trial confirm the statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for Lynparza as compared to placebo, reducing the risk of disease progression or death by 70 percent (HR=0.30 [95 percent CI, 0.23-0.41]; p<0.001). At 41 months of follow-up, the median PFS for patients treated with Lynparza was not reached compared to 13.8 months for patients treated with placebo. Of those receiving Lynparza, 60.4 percent remained progression-free at 36 months, compared to 26.9 percent of women in the placebo arm.
Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca, said, “There is currently a significant unmet need in the treatment of advanced ovarian cancer because 70 percent of women relapse within the first three years after their initial treatment. The remarkable results of the SOLO-1 trial, which showed that 60 percent of women with newly-diagnosed, advanced BRCA-mutated ovarian cancer remained progression-free at three years, highlight the potential of Lynparza as a first-line maintenance therapy in this setting.”
Dr. Roy Baynes, senior vice president and head of Global Clinical Development, chief medical officer, Merck Research Laboratories, said, “Our collective goal in oncology research is to improve long-term outcomes for people living with cancer. Based on the SOLO-1 trial results, Lynparza is the only PARP inhibitor to have demonstrated a significant and clinically-meaningful improvement in reducing the risk of progression or death for newly-diagnosed patients with advanced BRCA-mutated ovarian cancer following platinum-based chemotherapy. We are working with regulatory authorities as quickly as possible to seek approval of Lynparza for these patients.”
Kathleen Moore, co-principal investigator of the SOLO-1 trial and associate director, Stephenson Cancer Center at The University of Oklahoma, Oklahoma City, Oklahoma, said, “Women with ovarian cancer are often diagnosed with advanced disease, which unfortunately is associated with poor long-term survival rates. The newly-diagnosed setting is our best opportunity to achieve a sustained remission, since once a patient’s ovarian cancer recurs, it is typically incurable. The SOLO-1 results demonstrate the potential of Lynparza maintenance therapy earlier in the treatment pathway and reinforce the importance of identifying a patient’s BRCA mutation status at the time of diagnosis—these results could change the way we treat women with advanced BRCA-mutated ovarian cancer.”
Moore added that “the median PFS for patients who received placebo was only 13.8 months while the median PFS for those who received [Lynparza] was not reached, but looks to be approximately three years longer than the placebo group.” Moore also noted that the improvement in PFS was “maintained even after [Lynparza] is stopped at two years,” suggesting that the findings “herald a new era in treatment.”
AstraZeneca and Merck are exploring additional trials in ovarian cancer, including the ongoing GINECO/ENGOTov25 Phase 3 trial, PAOLA-1. This trial is testing the effect of Lynparza in combination with bevacizumab as a maintenance treatment for patients with newly-diagnosed advanced ovarian cancer regardless of their BRCA status. Results are expected during the second half of 2019.
Lynparza is a first-in-class poly ADP-ribose polymerase (PARP) inhibitor approved in the U.S. since 2014. Lynparza has a broad clinical development program and AstraZeneca and Merck are working together to deliver Lynparza as quickly as possible to more patients across multiple cancer types.
Lynparza is not currently FDA-approved for advanced BRCAm ovarian cancer treatment in the first-line maintenance setting. Lynparza is indicated for the maintenance treatment of recurrent ovarian cancer in response to platinum-based chemotherapy regardless of BRCAmutation status, and for the treatment of advanced ovarian cancer patients with a germline BRCA mutation previously treated with three or more lines of chemotherapy. Physicians should select advanced ovarian cancer patients for therapy based on a FDA-approved companion diagnostic. Please see complete indications below.
Filed Under: Oncology