Certain ovarian cancer patients with BRCA mutations may benefit from maintenance treatment with the PARP inhibitor Lynparza (olaparib). The therapy significantly increases progression-free survival, according to the results of a Phase 3 trial recently released by AstraZeneca.
Lynparza was the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer. It works by inducing damage in DNA molecules and is particularly effective in tumors that have DNA repair deficiencies, such as BRCA-mutated tumors. This allows the agent to preferentially kill cancer cells, leaving healthy cells with functional DNA repair pathways unharmed.
The SOLO-2 Phase 3 trial (NCT01874353), a double-blind and placebo-controlled study, was designed to assess the effectiveness of Lynparza as a maintenance therapy in BRCA-positive ovarian cancer patients who were sensitive to platinum-based chemotherapy but relapsed following at least two prior lines of treatment.
The study, conducted by the European Network for Gynaecological Oncological Trial Groups (ENGOT) and Groupe d’Investigateurs National pour l’Etude des Cancers de l’Ovaire et du sein (GINECO), enrolled 295 patients with BRCA1 or BRCA2 mutations who were randomized to receive either Lynparza tablets or a placebo until disease progression.
Results revealed a significant clinical improvement in progression-free survival in the Lynparza arm compared to the placebo arm. The progression-free survival in the Lynparza arm was also substantially higher than in a prior Phase 2 trial (Study 19) that evaluated Lynparza as a maintenance monotherapy in platinum-sensitive relapsed ovarian cancer. The drug’s safety profile was similar to what was observed in previous studies.
AstraZeneca will present the full results from the SOLO-2 study at an upcoming medical meeting.
“These results support earlier studies that demonstrate Lynparza’s significant and clinically meaningful benefits, including potentially prolonging life in this small and well-defined patient population,” Mark Findlay, vice president of the company’s Patient Access & Established Brands in Canada, said in a news release. “Canadian women living with BRCA-mutated relapsed ovarian cancer deserve access to this meaningful advancement in treatment.”
More than 45 countries have approved Lynparza, several provided accelerated approval. Earlier this year, Canada joined the list. Health Canada issued a Notice of Compliance with Condition, approving the agent as a maintenance monotherapy for platinum-sensitive relapsed BRCA-mutated ovarian cancer, fallopian tube cancer, or peritoneal cancer patients who responded to platinum-based chemotherapy. The approval was based on data from Study 19.
But despite its wide regulatory approval and the critical need for access to new ovarian cancer treatment options, the pan-Canadian Oncology Drug Review decided not to recommend Lynparza for provincial reimbursement stating that the drug’s clinical benefits were uncertain.
AstraZeneca is now hopping that the positive results from the SOLO-2 study will change that decision.
“Given the positive results of the SOLO-2 study, and the treatment gap in Canada for women with ovarian cancer, we urge pCODR to collaborate with AstraZeneca to re-evaluate Lynparza on an urgent basis,” Findlay said. “Ovarian cancer is deadly and impacts women in the prime of their lives. Extending time for these women is of critical importance. Provincial governments must act swiftly to ensure Canadian women with ovarian cancer are not left behind when it comes to accessing this innovative, targeted treatment.”