The US Food and Drug Administration (FDA) has approved olaparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy, as detected by an FDA-approved companion diagnostic test.

This is the first regulatory approval for a PARP inhibitor in the 1st-line maintenance setting for BRCAm advanced ovarian cancer.

The approval was based on positive results from the pivotal Phase III SOLO-1 trial in which olaparib reduced the risk of disease progression or death by 70 percent in patients with BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy (HR 0.30 [95% CI 0.23-0.41], p<0.0001) compared to placebo following platinum-based chemotherapy.

The safety profile of olaparib was consistent with previous trials.

Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit, AstraZeneca, said: “Women with ovarian cancer are often first diagnosed with advanced disease, which is associated with poor outcomes. In SOLO-1, olaparib in the first-line maintenance setting reduced the risk of disease progression or death by 70 percent for patients with BRCAm advanced ovarian cancer. Today’s approval is a critical advancement and brings us closer to our goal of helping these patients achieve long-term remission.”

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “The expanded approval of olaparib based upon the SOLO-1 trial has the potential to change medical practice and reinforces the importance of knowing a woman’s BRCA status at diagnosis.”  

In the SOLO-1 trial, with median 41 months of follow-up, the median progression-free survival (PFS) for patients treated with olaparib was not reached compared to 13.8 months for patients treated with placebo.

Sixty percent of patients receiving olaparib remained progression-free at three years compared to 27 percent of patients receiving placebo.

The data from the SOLO-1 trial can be found in the New England Journal of Medicine.

Kathleen Moore, co-principal investigator of the SOLO-1 trial and Associate Director for Clinical Research, Stephenson Cancer Centre at The University of Oklahoma, Oklahoma City, Oklahoma, said: “SOLO-1 is truly a landmark trial in gynecologic cancer. This approval will likely change the way we treat women with BRCA-mutated advanced ovarian cancer. The ability to offer this important first-line maintenance treatment option to eligible patients may slow down or even stop the natural course of disease progression.”

Additional trials in advanced ovarian cancer include the ongoing GINECO/ENGOTov25 Phase III trial, PAOLA-1.

This trial is testing the effect of olaparib in combination with bevacizumab as a maintenance treatment for patients with newly-diagnosed advanced ovarian cancer, regardless of their BRCA status.

Results are expected during the second half of 2019.

Source: AstraZeneca