AstraZeneca and Merck presented full results from the Phase 3 SOLO3 trial which evaluated LYNPARZA, compared to chemotherapy, for the treatment of platinum-sensitive relapsed patients with germline BRCA1/2-mutated (gBRCAm) advanced ovarian cancer, who have received two more prior lines of chemotherapy.
The results were presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
The results from the trial showed a statistically-significant and clinically-meaningful improvement in objective response rate (ORR) in the LYNPARZA arm compared to the chemotherapy arm (ORR; 72.2% for LYNPARZA vs 51.4% for chemotherapy; 95% CI: 1.40 to 4.58; p=0.002).
The key secondary endpoint of progression-free survival (PFS) was also significantly increased in the LYNPARZA arm (13.4 months) compared to the chemotherapy arm (9.2 months; PFS HR 0.62 [p=0.013]).
José Baselga, executive vice president, Oncology R&D, AstraZeneca, said, “This trial shows that LYNPARZA has the potential to provide a much-needed improvement and alternative over standard-of-care chemotherapy for certain patients with relapsed BRCA-mutated advanced ovarian cancer. This is the fourth positive Phase 2 or Phase 3 trial in advanced ovarian cancer for LYNPARZA across multiple lines of therapy. We look forward to discussing these results with regulatory authorities.”
Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “LYNPARZA is the first and only PARP inhibitor to demonstrate efficacy versus chemotherapy in relapsed BRCA-mutated advanced ovarian cancer following two or more prior lines of chemotherapy. The positive SOLO3 results reaffirm AstraZeneca and Merck’s ongoing commitment to explore potential treatment options beyond standard-of-care for BRCA-mutated patients with advanced stage disease.”
The safety and tolerability profile of LYNPARZA in SOLO3 was consistent with previous trials. The most common adverse events (AEs) ≥ 20% were nausea (64.6%), fatigue/asthenia (52.2%), anemia (51.1%), vomiting (38.2%), diarrhea (28.1%) and abdominal pain (21.3%). The most common ≥ Grade 3 AEs were anemia (21.3%), neutropenia (9.6%), fatigue/asthenia (4.5%) and thrombocytopenia (3.9%). AEs led to dose interruption in 48% percent of patients on LYNPARZA vs. 42% in the chemotherapy arm, while 7% of patients discontinued treatment vs. 20% in the chemotherapy arm.
LYNPARZA is currently approved in 64 countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status. It is approved in the U.S. as first-line maintenance treatment in BRCAm advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in 38 countries, including the U.S., countries in the EU and Japan, for germline BRCAm HER2-negative metastatic breast cancer previously treated with chemotherapy; in the EU this includes locally advanced breast cancer. Regulatory reviews are underway in other jurisdictions for both ovarian cancer and breast cancer.