LYNPARZA Phase III SOLO-1 results show improved outcome for patients with advanced BRCA-mutated ovarian cancer

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., (Merck: known as MSD outside the US and Canada) today announced detailed results from the Phase III SOLO-1 trial testing LYNPARZA® (olaparib) 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 1st-line standard platinum-based chemotherapy.

Results of the trial confirm the statistically significant and clinically meaningful improvement in progression-free survival (PFS) for LYNPARZA compared to placebo, reducing the risk of disease progression or death by 70% (HR 0.30 [95% CI 0.23-0.41], P<0.001). With median 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% remained progression-free at 36 months, compared to 27% of women in the placebo arm. The data were presented at the Presidential Symposium of the ESMO 2018 Congress (European Society for Medical Oncology) in Munich, Germany, and published simultaneously online in the New England Journal of Medicine (NEJM).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, AstraZeneca said: "There is currently a significant unmet need in the treatment of advanced ovarian cancer because 70% of women relapse within the first three years after their initial treatment. The remarkable results of the SOLO-1 trial, which showed that 60% of women with newly diagnosed, advanced BRCA-mutated ovarian cancer remained progression-free at three years, highlight the potential of LYNPARZA as a maintenance therapy in the 1st-line setting."

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 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 for Clinical Research, 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."

The SOLO-1 safety profile was in line with that observed in prior clinical trials. The most common adverse events (AEs) ≥20% in patients taking LYNPARZA in the trial were nausea (77%), fatigue/asthenia (63%), vomiting (40%), anemia (39%), diarrhea (34%), constipation (28%), dysgeusia (26%), arthralgia (25%), abdominal pain (25%), neutropenia (23%), headache (23%), dizziness (20%) and decreased appetite (20%). The most common Grade ≥3 adverse reactions were anemia (22%) and neutropenia (9%). Seventy-two percent of patients on LYNPARZA remained on the recommended starting dose. Additionally, 88% of patients on LYNPARZA continued treatment without an AE-related discontinuation. Further, 48% of patients on LYNPARZA did not have a dose interruption as a result of an AE.

Per SOLO-1 protocol guidelines, patients who demonstrated a complete response (no radiological evidence of disease) at 2 years stopped treatment with LYNPARZA; patients who demonstrated a partial response and who in the opinion of the treating physician can derive further benefit from continuous treatment, were treated beyond 2 years.

AstraZeneca and Merck are exploring additional trials in ovarian cancer, including the ongoing GINECO/ENGOTov25 Phase III 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 US 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, including prostate and pancreatic cancers.

LYNPARZA is not currently FDA-approved for advanced BRCA-mutated 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 BRCA mutation 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 an FDA-approved companion diagnostic. Please see complete indications below.

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