- AstraZeneca plc AZN and Merck & Co Inc MRK announced long-term follow-up results from the Phase 3 PAOLA-1 and SOLO-1 trials in first-line advanced ovarian cancer evaluating Lynparza (Olaparib) as a combination and monotherapy.
- The companies said the data represents the longest-term data for any PARP inhibitor in this setting.
- The Phase 3 PAOLA-1 trial evaluated Lynparza combined with bevacizumab as first-line maintenance therapy.
- Final overall survival (OS) in Lynparza plus bevacizumab was 56.5 months versus 51.6 months with bevacizumab alone in newly diagnosed advanced ovarian cancer patients.
- These OS results were not statistically significant.
- Lynparza plus bevacizumab also improved median progression-free survival (PFS) to nearly four years (46.8 months) versus 17.6 months with bevacizumab plus placebo.
- The Phase 3 SOLO-1 trial evaluated Lynparza as monotherapy.
- 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% 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.
- Price Action: AZN shares are up 1.09% at $60.97, and MRK stock is up 0.34% at $87.71 on the last check Friday.