Lynparza (olaparib), a PARP inhibitor, significantly prevents ovarian cancer from progressing or returning in women who responded to their first-line chemotherapy treatment, results from a Phase 3 trial show.
The randomized, double-blind, placebo-controlled study, called SOLO-1 (NCT01844986), assessed Lynparza as a maintenance therapy for patients with advanced ovarian cancer, who had a BRCA mutation in their tumor, and were at a high risk of progressing. Patients were still responding — partially or completely — to first-line platinum-based chemotherapy.
Lynparza is the first PARP inhibitor showing benefits as a first-line maintenance treatment.
Now that the trial has met its primary goal, AstraZeneca and Merck — which are jointly developing and commercializing Lynparza — are planning to submit the data to health authorities.
“For the first time, we see a significant and clinically-impactful improvement in progression-free survival in the 1st-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a press release.
“The SOLO-1 data reinforce the importance of knowing BRCA status at diagnosis, as this may enable women with BRCA-mutated ovarian cancer to receive Lynparza earlier. We would like to thank the investigators, hospitals and most of all, the patients who took part in this trial, without whom medical advancements would not be possible,” he said.
Lynparza acts by preventing cells from repairing their DNA errors. Because cancer cells divide at a faster pace, they accumulate errors faster than healthy cells, leading to their death. Lynparza is particularly effective in cancers with mutations in other DNA-repairing genes, such as BRCA1 and BRCA2.
The therapy is approved for women with BRCA-mutated, advanced ovarian cancer who received at least three prior chemotherapy treatments. It is also indicated as a maintenance treatment for women with BRCA-mutated relapsed ovarian cancer whose tumors responded to platinum-based chemotherapy.
While the medicine can be used as maintenance in patients whose tumor returned, its effect on patients who had responded to first-line chemotherapy was not known.
SOLO-1 thus enrolled 391 patients with BRCA mutations who had achieved a complete or partial response to their first-line platinum-based chemotherapy. Patients were randomly assigned to get either Lynparza tablets or a placebo twice daily for up to three years.
Patients taking Lynparza lived significantly longer without signs of disease worsening, compared with those in the placebo group, researchers found.
Lynparza also showed a safety profile similar to that observed in prior clinical trials.
“Building on the strong data we’ve seen with Lynparza to date, the data from SOLO-1 reinforces Lynparza’s ability to provide meaningful disease control with a well-characterized safety and tolerability profile,” said Roy Baynes, senior vice president and head of global clinical development and chief medical officer of Merck Research Laboratories.
“We look forward to presenting the full data set for SOLO-1 at a future medical meeting and working with regulatory authorities to bring Lynparza to women with ovarian cancer in the 1st-line maintenance setting as quickly as possible,” he said.