Study results suggest an improvement in overall survival (OS) for patients with ovarian cancer treated with olaparib (Lynparza) maintenance therapy following platinum-based chemotherapy.
The update from Study 19 was presented at the American Society of Clinical Oncology (ASCO) congress in Chicago. This comes after olaparib was made available to NHS patients in England and Wales from 27th April, for the treatment of women with platinum-sensitive relapsed (PSR) BRCA-mutated (BRCAm) high-grade serous ovarian cancer who have had three or more courses of platinum-based chemotherapy.
Olaparib received European Marketing Authorisation for platinum-sensitive relapsed (PSR) BRCA-mutated (BRCAm) high-grade serous ovarian cancer patients, who have had two or more courses of platinum-based chemotherapy on the basis of Study 19. These latest data are from a third interim analysis of the study, and are based on a 77% data maturity conducted after more than five years follow-up. The results support the previously reported benefits of olaparib for patients with BRCAm ovarian cancer in progression-free survival (PFS) compared to placebo, which was the primary endpoint of the trial. OS was a secondary endpoint of the trial.
A 27% reduction in risk of death compared to placebo was seen in the overall trial population. For patients with BRCAm, there was a 38% reduction in the risk of death compared to placebo. As this was the third analysis of survival, the nominal p-values did not meet the criterion for statistical significance and therefore the treatment effect observed for OS can only be considered descriptive. A number of patients continue to benefit from olaparib maintenance therapy, with 15% of BRCAm patients receiving olaparib for over five years.
Professor Jonathan Ledermann, Professor of Medical Oncology at the University College London Cancer Institute and lead author of Study 19 said: “These results are extremely encouraging. The data show that some ovarian cancer patients receive benefit from this treatment for over five years, which is significant for patients with limited treatment options.”
Ovarian cancer is a serious and life-threatening condition that causes more than 4,000 women in the UK to die each year. Up to 21% of women with the most aggressive form of ovarian cancer have the genetic BRCAm and it is this patient group for whom olaparib is licensed in Europe.