Maintenance treatment with Lynparza (olaparib) is now recommended after response to the first round of platinum-based chemotherapy in women with advanced ovarian cancer on England’s National Health Service (NHS).
The decision by the National Institute for Health and Care Excellence (NICE) means that patients with BRCA mutations may receive Lynparza earlier, as three different chemotherapies were required under the previous recommendation. Similar decisions were announced in the United States, European Union, and Japan.
Treatment with Lynparza will typically last up to two years, but longer courses are possible if the cancer is detected and doctors think it may be beneficial. Approximately 700 patients in the United Kingdom are expected to benefit from Lynparza yearly, according to NICE.
Rose Gray, Cancer Research UK’s policy manager, said this was “fantastic news” that “will offer new hope” to patients.
“Patients and clinicians told NICE there is a real need for new treatments for this cancer type, and that using [Lynparza] earlier in patients’ treatment could mean the drug offers greater benefit,” she said.
This broader availability will be paid for through the Cancer Drugs Fund (CDF), and covers patients with advanced ovarian cancer and gynecological cancers of the fallopian tube and the peritoneum — the layer lining the abdominal cavity.
Treatments funded by the CDF in England are usually funded by the NHS in Wales and Northern Ireland. Coverage in Scotland is decided separately by the Scottish Medicines Consortium.
Lynparza, a PARP enzyme inhibitor, is intended to prevent cancer cells from repairing their DNA errors, leading to their death. Its efficacy is especially high in cancers with mutations in DNA-repairing genes, such as BRCA1 and BRCA2. The therapy was developed jointly by AstraZeneca and Merck, known as MSD outside North America and Canada.
The revised recommendation was based on early findings from an ongoing Phase 3 trial (NCT01844986), named SOLO-1. A total of 391 patients with a BRCA mutation participated in the trial. They had high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, and were responding to their first-line chemotherapy.
After a median 41 months of follow-up, 60% of women taking Lynparza were alive with no signs of cancer recurrence or progression, compared with 27% of those taking a placebo. This represented a 70% lower risk of disease progression or death with Lynparza.
Susana Banerjee, a consultant medical oncologist at The Royal Marsden Hospital and an investigator in the trial, said maintenance treatment with Lynparza “heralds a new era for women with ovarian cancer.” She said the “dramatic improvements” in the time without disease progression seen in SOLO-1 are unprecedented.
“This means that more women will have a longer time before relapse, time of chemotherapy, and the possibility of increased survival,” Banerjee said.
An assessment of Lynparza’s full benefits will only be done when the trial concludes, which is expected by August 2025. But the current recommendation for the CDF means that patients will have access to the treatment in the meantime, Gray said. According to NICE, a potential longer survival could mean that Lynparza is cost-effective for the NHS.