After an initial rejection due to cost-effectiveness concerns, the U.K.’s National Institute of Health and Care Excellence (NICE) has reversed its decision and is expanding the use of Lynparza (olaparib) tablets to include maintenance therapy for relapsed ovarian cancer patients who responded to platinum-based chemotherapy.
The recommendation is for adults within the National Health System (NHS) of England and Wales, with epithelial ovarian, fallopian tube, or peritoneal cancer, who carry a BRCA mutation.
Lynparza tablets will be made available via routine commissioning for patients who received three or more courses of platinum-based chemotherapy, or via the Cancer Drugs Fund — NHS’s reserve to fund cancer therapies — to patients in England if they have had two courses of platinum-based chemotherapy.
The treatment had been approved as a first-line maintenance therapy, and is now the first PARP inhibitor available in the U.K. for all lines of maintenance treatment.
Of note, the capsule formulation was available for patients who had received at least three prior chemotherapy lines, but required them to take eight capsules of Lynparza twice a day. These patients may now switch to the tablet formulation, involving two capsules twice-daily.
“This decision is positive news for patients because it means that we now have access to olaparib tablets for BRCA-mutated ovarian cancer across all lines of therapy. Not only does this mean that we have an additional treatment option that offers significant clinical benefits to patients, it also means that all patients currently being treated with olaparib can now access the tablet formulation instead of the capsules,” Jonathan Ledermann, MD, professor of medical oncology at the University College London Cancer Institute, said in a press release.
The decision to recommend Lynparza was supported by clinical data from the SOLO-2 Phase 3 trial (NCT01874353), where Lynparza tablets cut the risk of disease progression or death by 70% compared to a placebo, without reducing patients’ quality of life.
SOLO-2 included 295 patients with relapsed, BRCA-mutated advanced ovarian cancer that responded to their last line of chemotherapy and randomly assigned them to receive Lynparza or a placebo. Treatment was given twice-daily until their disease progressed or signs of serious toxicity appeared.
The trial met its primary goal of progression-free survival, with patients on Lynparza living a median of 19.1 months without signs of cancer progression, compared to 5.5 months for placebo. At two years, three times more patients on Lynparza remained progression-free than those on placebo — 43% vs. 15%.
A later analysis also showed that the delay in death and disease progression came without sacrificing quality of life, a finding that is particularly important in patients receiving maintenance treatments, as most are well and have no cancer-related symptoms.
“We are delighted to have reached an arrangement with NICE to enable expanded access to olaparib tablets as maintenance treatment for women with advanced ovarian cancer who have had two or more lines of chemotherapy,” said Mohit Manrao, business unit director of oncology at AstraZeneca UK. “As a UK-based company, it’s great to see this product of British science become more widely available, therefore helping more women across England and Wales.”
Lynparza, developed by AstraZeneca and MSD (known as Merck in the U.S. and Canada), is a PARP enzyme inhibitor intended to prevent cancer cells from repairing their DNA errors, leading to their death. It is particularly effective in cancers with mutations in DNA-repairing genes, such as BRCA1 and BRCA2.