02 Jun LYNPARZA Demonstrates Improved Overall Survival in BRCA-Mutated, Platinum-Sensitive Relapsed Ovarian Cancer
MedicalResearch.com Interview with:
US Franchise Head
Women’s Cancer & DNA Damage Response
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: SOLO2 is a Phase III, randomized, double-blind, multicenter trial designed to determine the efficacy and safety of LYNPARZA tablets as a maintenance monotherapy compared with placebo, in patients with platinum-sensitive relapsed or recurrent gBRCA-mutated (BRCAm) ovarian cancer. The trial included 295 patients with germline BRCA1 or BRCA2 mutations who had received at least 2 prior lines of platinum-based chemotherapy and were in complete or partial response. The trial met its primary endpoint in October 2016, showing maintenance treatment with LYNPARZA significantly improved progression-free survival to a median of 19.1 months vs 5.5 months with placebo (a hazard ratio of 0.30; a 95% confidence interval of 0.22 to 0.41; a p value of <0.0001).
MedicalResearch.com:? What are the main findings?
Response: The latest results from SOLO-2 show that patients taking LYNPARZA had a median Overall Survival of 51.7 months vs. 38.8 months for patients on placebo, a difference of nearly 13 months, and reduced the risk of death by 26% (equal to a hazard ratio of 0.74 and p-value of 0.0537; not statistically significant). At five years, 42% of patients who received LYNPARZA were alive versus 33% on placebo, and 22% of patients who began the trial are still receiving treatment with LYNPARZA.
MedicalResearch.com: What should readers take away from your report?
Response: Overall Survival improvements in advanced ovarian cancer have not been seen since the introduction of chemotherapy almost two decades ago. The final Overall Survival analysis from the SOLO-2 trial adds to the broad set of evidence supporting the clinical value of LYNPARZA in women with ovarian cancer.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: The results from this study are promising and further our understanding of LYNPARZA in women with BRCA-mutated, platinum-sensitive relapsed ovarian cancer. We have a broad clinical trial program that will continue to explore how LYNPARZA impacts PARP-dependent tumors across multiple cancer types.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: LYNPARZA is the only PARP inhibitor with seven indications across 4 different tumor types: ovarian, breast, pancreatic and prostate cancers. As we continue to follow the science in advancing targeted cancer treatment through biomarker-driven approaches, we hope to meet our goal of maximizing positive outcomes for patients living with DNA-deficient cancers.
Citation: ASCO 2020
Abstract #6002: Final OS results from the Phase III SOLO2 trial for LYNPARZA® (olaparib) maintenance treatment in patients with BRCA-mutated platinum-sensitive relapsed ovarian cancer in an oral presentation. LYNPARZA is developed and commercialized in collaboration with Merk & Co., Inc. (Merck: known as MSD outside the US and Canada)
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