Results of a Phase 3 clinical trial show that Lynparza (olaparib) tablets met the primary goal of significantly improving the objective response rate, which is the percentage of patients whose cancer shrinks or disappears after treatment. The results also found that Lynparza extended the time advanced ovarian cancer patients lived without the disease progressing.
The SOLO-3 study (NCT02282020), which compared Lynparza to standard of care chemotherapy, included patients with a germline (inherited) mutation in the BRCA genes and whose disease returned after two or more prior lines of chemotherapy.
“We are very excited about SOLO-3, which is the first Phase III trial for a PARP inhibitor to demonstrate a positive result versus chemotherapy in advanced ovarian cancer where effective options are needed. We look forward to sharing the full results at a forthcoming medical meeting,” Sean Bohen, said in a press release. Bohen is executive vice president of global medicines development and chief medical officer at AstraZeneca,.
Lynparza, which is jointly developed by AstraZeneca and Merck (MSD outside North America and Canada) is a PARP enzyme inhibitor that works by preventing cells from repairing their DNA errors.
SOLO-3, a randomized, double-blind, placebo-controlled study, included 266 participants to study if Lynparza was better than chemotherapy at treating BRCA-mutated advanced ovarian cancer.
The study’s primary goal was to determine if more patients responded to Lynparza. Secondary endpoints included the time patients lived without disease worsening, overall survival, time to subsequent therapy, and safety.
Participants were randomized to Lynparza tablets, given twice daily, or to one of several a single agent platinum-based chemotherapies: Taxol (paclitaxel), Hycamtin (topotecan), pegylated liposomal doxorubicin, or gemcitabine.
The trial met its primary goal, with more patients achieving a partial or complete response to Lynparza than to chemotherapy. Also, patients on Lynparza lived longer without signs of disease worsening. The data supporting that finding, however, has not been disclosed.
SOLO-3 is the fourth trial confirming that Lynparza benefits ovarian cancer patients — the therapy is approved for platinum-sensitive relapsed ovarian cancer — regardless of patients’ BRCA mutation status.
It also is used in women with BRCA-mutated advanced ovarian cancer who have been treated with at least three chemotherapy treatments, and as a maintenance therapy for women with BRCA-mutated relapsed ovarian cancer whose tumors responded to platinum-based chemotherapy.
In December 2018, Lynparza’s label was extended to include the maintenance treatment of BRCA-mutated advanced ovarian cancer patients who responded to first-line platinum-based chemotherapy, making it the first PARP inhibitor approved for this indication.
“Following on the U.S. approval of Lynparza as first-line maintenance therapy for certain patients with BRCAm [mutated] advanced ovarian cancer, the results of SOLO-3 further reinforce the efficacy of Lynparza in relapsed patients with g [germline] BRCAm advanced ovarian cancer following multiple lines of chemotherapy,” said Roy Baynes, senior vice president and head of global clinical development, and chief medical officer at Merck Research Laboratories.