The Phase 3 SOLO-1 trial demonstrated 67% of advanced ovarian cancer patients with BRCA mutations receiving LYNPARZA were alive at seven years versus 47% of placebo patients
AstraZeneca and Merck, known as MSD outside of the United States and Canada, today announced long-term follow-up results from the Phase 3 PAOLA-1 and SOLO-1 trials in first-line advanced ovarian cancer, which represent the longest-term data for any PARP inhibitor in this setting.
These results were presented on Sept. 9 at the European Society for Medical Oncology (ESMO) 2022 Congress, and the SOLO-1 results were published in the Journal of Clinical Oncology.
The Phase 3 PAOLA-1 trial evaluated LYNPARZA in combination with bevacizumab as first-line maintenance therapy in patients with advanced ovarian cancer, who were without evidence of disease after surgery or following response to platinum-based chemotherapy. Final overall survival (OS), a key secondary endpoint, in those who received LYNPARZAplus bevacizumab was 56.5 months versus 51.6 months with bevacizumab alone (HR=0.92 [95% CI, 0.76-1.12]; p=0.4118) in patients with newly diagnosed advanced ovarian cancer. These OS results were not statistically significant.
The Phase 3 SOLO-1 trial evaluated LYNPARZA as monotherapy as first-line maintenance therapy in patients with advanced ovarian cancer, who were without evidence of disease after surgery or following response to platinum-based chemotherapy. In the trial, LYNPARZA demonstrated a clinically meaningful improvement in OS versus placebo in patients with germline BRCA-mutated (gBRCAm) newly diagnosed advanced ovarian cancer, reducing the risk of death by 45% (HR=0.55 [95% CI, 0.40-0.76]; p=0.0004) versus placebo (not statistically significant). Median OS was not reached with LYNPARZA versus 75.2 months with placebo. At the seven-year descriptive OS analysis, 67% of LYNPARZA patients were alive versus 47% of placebo patients (44% of whom had a subsequent PARP inhibitor), and 45% of LYNPARZA patients versus 21% of placebo patients were alive and had not received a first subsequent treatment.
Professor Isabelle Ray-Coquard, principal investigator from the PAOLA-1 trial and president of the GINECO group said, “For women facing an advanced ovarian cancer diagnosis who are HRD-positive, a targeted treatment in the first-line maintenance setting is critical to helping them live longer. These latest results at the five-year landmark demonstrate that olaparib with bevacizumab reduces the risk of death by 38% in HRD-positive patients compared to bevacizumab alone, further reinforcing the clinically meaningful long-term survival benefit of this combination. This should be promising news for both clinicians and patients, as we see these additional data show that this combination may allow patients more time with family and loved ones. These results also highlight the importance of biomarker testing as part of a precision medicine approach to guide treatment decisions in ovarian cancer patients.”
Professor Paul Di Silvestro, investigator from the SOLO-1 trial and director of the program in women’s oncology at Women and Infants Hospital in Providence, Rhode Island, said, “The long-term results from SOLO-1 confirm that LYNPARZA continues toelicit a clinically meaningful improvement in overall survival in the first-line maintenance setting for more than seven years. Achieving long-term survival for patients with newly diagnosed advanced ovarian cancer is critical because the first-line setting offers the greatest potential to impact patient survival.”
Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, said, “Historically, the five-year survival rate of newly diagnosed patients with advanced ovarian cancer is 30-50%. In that context, it is phenomenal to share the long-term overall survival data from both PAOLA-1 and SOLO-1, with two out of three patients still alive in these trials. We continue to believe in LYNPARZA’s ability to help biomarker-selected patients with advanced ovarian cancer to achieve better outcomes.”
Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, “These latest data from the PAOLA-1 and SOLO-1 trials further highlight the importance of HRD testing, including for BRCA1/2 mutations, for all newly diagnosed advanced ovarian cancer patients at the point of diagnosis. Maintenance therapy with LYNPARZA may provide certain patients with HRD-positive or BRCA-mutated advanced ovarian cancer the opportunity to live longer.”
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