The U.S. Food and Drug Administration (FDA) has approved Lynparza for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (BRCAm) 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.
Lynparza is being jointly developed and commercialized by AstraZeneca and Merck & Co., Inc., which is known as MSD outside the U.S. and Canada. The FDA approval was described by AstraZeneca’s head of oncology Dave Fredrickson as a critical advancement in the goal of helping the ovarian cancer patients achieve long-term remission.
The FDA move marks the the first regulatory approval for a PARP inhibitor in the 1st-line maintenance setting for BRCA-mutated advanced ovarian cancer.
The approval was based on positive results from the pivotal Phase III SOLO-1 trial in which Lynparza reduced the risk of disease progression or death by 70 percent in patients with BRCA-mutated advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy compared to placebo following platinum-based chemotherapy.
Following Wednesday’s approval, the two companies today announced positive results from the randomized, open-label, controlled, Phase III SOLO-3 trial of Lynparza tablets in 266 patients with relapsed ovarian cancer after two or more lines of treatment.
The SOLO-3 trial was conducted as a post-approval commitment in agreement with the FDA and represented the fourth Phase III trial to demonstrate a positive result for drug.
Results from the trial showed BRCAm advanced ovarian cancer patients treated with Lynparza following two or more prior lines of chemotherapy demonstrated a “statistically significant and clinically meaningful” improvement in the primary endpoint of objective response rate and the key secondary endpoint of progression-free survival compared to chemotherapy, according to the companies.
The safety and tolerability profile of Lynparza in SOLO-3 was consistent with previous trials and AstraZeneca and Merck said they plan to discuss the results with the FDA.
“Following on the U.S. approval of Lynparza as first-line maintenance therapy for certain patients with BRCAm advanced ovarian cancer, the results of SOLO-3 further reinforce the efficacy of Lynparza in relapsed patients with (germline BRCAm) advanced ovarian cancer following multiple lines of chemotherapy,” Roy Baynes, chief medical officer, MSD Research Laboratories, said.
In July 2017, AstraZeneca and Merck & Co. announced a global strategic oncology collaboration on Lynparza. Working together, the companies will develop Lynparza and selumetinib in combination with other potential new medicines and as monotherapies.
Selumetinib is a drug that was discovered by Array BioPharma and was licensed to AstraZeneca. It is being investigated for the treatment of various types of cancer, such as non-small cell lung cancer and thyroid cancer.
Independently, the companies will develop Lynparza and selumetinib in combination with their respective PD-L1 and PD-1 medicines.
AstraZeneca and Merck at present are exploring additional trials in advanced ovarian cancer, including the ongoing GINECO/ENGOTov25 Phase III trial, PAOLA-1. That trial is testing the effect of Lynparza 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.
Filed Under: Oncology