Women with BRCA-mutated relapsed ovarian cancer whose tumors responded to platinum-based chemotherapy took significantly longer to see their disease progressing when given AstraZeneca’s Lynparza (olaparib) as a maintenance therapy, compared to placebo.
In addition to showing a 70 percent reduction in the risk of disease progression, the SOLO-2 Phase 3 trial (NCT01874353) revealed that Lynparza treatment did not reduce patients’ quality of life, as reported by patients.
The study, “Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial,” was published in the journal Lancet Oncology.
Lynparza belongs to a group of pharmaceuticals known as PARP inhibitors. It targets an enzyme, called PARP, which plays a role in repairing DNA errors in cells. The drug is particularly effective in cancers with mutations in other DNA-repairing genes, like BRCA 1 and BRCA2, which rely mainly on the PARP enzymes to counteract DNA damage.
“Given the few treatment options available for patients with platinum-sensitive, relapsed ovarian cancer, the data for olaparib as maintenance therapy in SOLO2 are notable,” the authors stated.
Lynparza was approved this month by the U.S. Food and Drug Administration as a maintenance therapy for relapsed ovarian cancer, following results from two trials: The SOLO-2 Phase 3 trial, and the Study 19 Phase 2 trial (NCT00753545).
The SOLO2/ENGOT-Ov21 trial, funded by AstraZeneca, randomized 295 patients in a 2:1 ratio to receive either Lynparza 300 mg tablets twice daily, or placebo.
After a median follow-up of roughly 22 months, the time to disease progression or death was 19.1 months in the Lynparza group, and 5.5 months in the placebo group. This represented a 70 percent reduction in the risk of disease progression. Additionally, patients in the two groups reported no significant differences in their quality of life.
Serious adverse events occurred in 35 (18 percent) patients in the Lynparza group and eight (8 percent) patients in the placebo group, with anemia being the most common in the treatment group. Anemia is caused by a drop in the amount of red blood cells (RBCs) or hemoglobin in the blood, or a reduced ability of the blood to carry oxygen.
At the time of the analysis, 112 patients in the treatment group had discontinued either because of cancer progression or due to the toxicity of the drug.
The authors note that it is too early to say whether Lynparza can provide direct survival benefit, and new analyses of these patients are planned in the future.
“Our results confirm that olaparib can achieve a significant prolongation of progression-free survival in this patient population with no appreciable detrimental effect observed for patients’ quality of life,” lead author Eric Pujade-Lauraine, MD, PhD, University of Paris Descartes, and co-investigators, wrote. “The favorable safety profile in SOLO2 enabled most patients receiving olaparib to maintain full dosing throughout their maintenance treatment.”
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