AstraZeneca and MSD’s Lynparza™ is now available in Scotland as the companies announce that olaparib monotherapy is now accepted for use by the Scottish Medicines Consortium (SMC) as an option for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
Patients with newly diagnosed advanced ovarian cancer are the only patients with ovarian cancer in whom treatment has curative potential; however, with current standard treatments, 70% of women will relapse within three years.
Just over 600 women are diagnosed with ovarian cancer in Scotland every year and two thirds are diagnosed when the disease is more advanced (Stage II-IV), where the chances of survival are lower. Survival rates for ovarian cancer in Scotland are behind those for other cancers, including breast, bowel and womb with over 350 women dying of the disease in Scotland each year. Approximately 22% of ovarian cancer patients carry a BRCA mutation, which can be identified via genetic testing upon referral by a healthcare professional.
The acceptance was based on the results of the SOLO-1 trial, which confirms the statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for olaparib compared to placebo and reduction in the risk of disease progression or death by 70% (Hazard Ratio 0.30 [95% Confidence Interval 0.23-0.41], p<0.001). At 41 months of follow-up, the median PFS for patients treated with olaparib was not reached compared to 13.8 months for patients treated with placebo. Of those receiving olaparib, 60% remained progression-free at 36 months compared to 27% of patients in the placebo arm.
Professor Charlie Gourley, UK Lead of the SOLO-1 Clinical Trial, Clinical Director of the Cancer Research UK Edinburgh Centre and Director of the Nicola Murray Centre for Ovarian Cancer Research at the University of Edinburgh, said: “Olaparib is a practice changing treatment that exploits the Achilles’ heel of BRCA-mutated ovarian cancer. The unprecedented results of the SOLO-1 clinical trial show that giving olaparib after surgery and chemotherapy to patients who are newly diagnosed with BRCA-mutated ovarian cancer result in approximately three additional years before their disease progresses, giving them longer before further rounds of chemotherapy are needed. Although the data are immature, we are hopeful that this treatment may also increase overall survival in the future. It is now imperative that all women with ovarian cancer are tested for the BRCA mutation to give them the benefit of this therapy wherever possible.”
Marie-Claire Platt, Head of Public Affairs and Research at Ovarian Cancer Action, said: “Today’s news marks a significant advancement in how we can treat BRCA-mutated ovarian cancer in Scotland. Genetic testing is vital for women to access this treatment but despite guidelines, we know 29% of ovarian cancer patients across the UK are missing out. Addressing this inequality must be a Government priority to ensure women do not miss out on treatment.”
Annwen Jones OBE, Chief Executive of Target Ovarian Cancer, said: “For the first time, eligible women with ovarian cancer in Scotland with a BRCA mutation will be able to access a PARP inhibitor following their first round of platinum-based chemotherapy treatment. Expanding the number of treatment options available for patients is important news and we welcome the SMC’s decision.”
Mohit Manrao, Business Unit Director, Oncology at AstraZeneca UK said: “We are delighted with today’s decision which means that, for the first time, women with newly diagnosed BRCA-mutated advanced ovarian cancer have access to a medicine specifically designed for their type of cancer. We made olaparib available to these patients in the UK via an early access programme since December 2018 and, now that it will be available within NHS Scotland, we hope that this product of British science will help to improve outcomes for these patients.”