The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that Lynparza (olaparib) be approved to prevent disease progression and relapse in ovarian cancer patients who responded to platinum-based chemotherapy, AstraZeneca and Merck announced.
Lynparza inhibits the poly ADP-ribose polymerase (PARP) enzyme, which is required for the proper repair of DNA errors. While the medicine is particularly effective in cells with defective DNA damage repair, like those with a BRCA mutation, the recommendation is for patients with or without BRCA mutations.
The U.S. Food and Drug Administration approved the medicine for a similar indication in August 2017. Both decisions are based on the results of two trials, the SOLO-2 Phase 3 trial (NCT01874353) and the Study 19 Phase 2 trial (NCT00753545).
The SOLO-2 trial assessed Lynparza tablets (300 mg twice daily) as a maintenance therapy for ovarian cancer patients with BRCA mutations who had responded either partially or completely to at least two treatments of platinum-based chemotherapy.
While women who received placebo had disease progression only 5.5 months after entering the trial, women receiving Lynparza remained alive and progression-free for 19.1 months. This represented a 70% reduced risk of disease progression or death.
Study 19’s results showed that Lynparza reduced the risk of disease progression or death by 65% compared to placebo. The trial enrolled 265 patients with the most common ovarian cancer type, the so-called high-grade serous ovarian cancer, with or without BRCA mutations.
“The data show that Lynparza provides long-term disease control, delaying the need for further chemotherapy for this broader group of women with platinum-sensitive relapsed ovarian cancer, irrespective of their BRCA status. It also offers a well-characterized safety and tolerability profile, which is critical to help enable patients to stay on treatment,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a press release.
Roy Baynes, senior vice president and head of global clinical development, chief medical officer, MSD Research Laboratories, said Merck welcomes CHMP’s “positive opinion based upon data which indicate the potential impact for Lynparza as maintenance therapy for women with platinum-sensitive relapsed ovarian cancer.
“We look forward to our continued work with AstraZeneca to bring Lynparza to patients in the EU,” Baynes added.