AZ/MSD pursue wider indication for Lynparza on trial success

AstraZeneca and MSD have unveiled trial results showing that Lynparza significantly extended the time patients with ovarian cancer lived without their disease worsening in the first-line maintenance setting, which could significantly expand the drug’s reach.

Top-line data from the Phase III SOLO-1 trial showed that women with BRCA-mutated (BRCAm) advanced ovarian cancer treated first-line with Lynparza (olaparib) maintenance therapy had a "statistically-significant and clinically-meaningful improvement" in progression-free survival compared to placebo.

Safety and tolerability of the drug was also found to be consistent with previous trials.

The firms noted that Lynparza is the only PARP inhibitor to demonstrate significant activity in the first-line maintenance setting and that, based on the new data, they plan to initiate discussions with health authorities regarding regulatory submissions for the drug in this setting.

"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," said Sean Bohen, AZ’ chief medical officer.

The efficacy of Lynparza in combination with Roche’s Avastin (bevacizumab) is also currently being tested as first-line maintenance treatment in women with newly-diagnosed advanced ovarian cancer, regardless of their BRCA status, in the Phase III GINECO/ENGOTov25 trial. Results are expected next year.

The drug was originally approved in capsule formulation in Europe in 2014 for maintenance treatment of women with ovarian cancer carrying the BRCA mutation, and last month in tablet form for maintenance therapy for patients with platinum-sensitive relapsed (PSR) high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status. Lynparza is also currently under review for breast cancer.

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