NHS approval for ovarian cancer drug, olaparib

Olaparib, a maintenance therapy for ovarian cancer, may prolong the benefit of initial treatment in BRCA1/2 mutated ovarian cancer patients who had a complete or partial clinical response after platinum-based chemotherapy.

Most ovarian cancer sufferers’ relapse within three years, and it is typically incurable, but olaparib has been shown to impede further progression of the cancer in a specific patient population¹. Now, olaparib has been approved for the early treatment of ovarian cancer patients in the NHS by the National Institute for Health & Care Excellence (NICE) and could benefit around 700 patients per year². Previously, only being prescribed to patients who had already received three courses of platinum-based chemotherapy, olaparib can now be given to patients who are BRCA1/2 mutated and have responded to the first round of platinum-based chemotherapy, opening up this option to more patients.

Discussing the SOLO-1 trial (NCT01844986)³, which investigated the use of olaparib in the treatment of ovarian cancer, Kathleen Moore, MD, Principle Investigator, from the Stephenson Cancer Center, Oklahoma City, OK, tells VJOncology about the use of this therapy at the ESMO 2018 Congress, held in Munich, Germany:

“We know that the majority of patients will recur after three years, and once they recur, they are considered incurable… The use of olaparib maintenance reduces the risk of recurrence by 70%… It’s really an unprecedented improvement in progression-free survival, we’ve never seen anything close to this in frontline ovarian cancer, and so it will be immediately practice-changing for our patients.“

If patients have a BRCA1/2 gene mutation (either germline or somatic), the cancer cells are heavily reliant on poly(ADP–ribose) polymerase (PARP) molecules to repair DNA damage. Olaparib acts as a PARP inhibitor and hence stops the cancer cell from being repaired, eventually causing it to die. Olaparib (brand name Lynparza, produced by AstraZeneca)⁴ is produced as an oral medication, and the new evidence produced from the SOLO-1 trial indicates that it provides a possible, and preferable, option to surgery and standard chemotherapy.

In newly diagnosed patients with ovarian cancer, this drug could have curative potential, but further research and follow-ups are needed to understand the potential of olaparib fully. In this Phase III study, olaparib has been shown to lower risk of disease progression and death by 70%  (P<0.001 vs. the placebo group) as well as significantly increasing the time to second disease progression, and hence could hugely improve the lives of many ovarian cancer patients.¹

References

1. Moore K, Colombo N, Scambia G et al. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018 Dec. 27;379(26):2495-2505.

2. National Institute for Health and Care Excellence (NICE) (2016). Olaparib for maintenance treatment of relapsed, platinum-sensitive, BRCA mutation-positive ovarian, fallopian tube and peritoneal cancer after response to second-line or subsequent platinum-based chem. Available: https://www.nice.org.uk/guidance/ta381. Last accessed 06/08/2019.

3. ClinicalTrials.gov (2019). Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First-Line Platinum-Based Chemotherapy. (SOLO-1). Identifier: NCT01844986. Available: https://clinicaltrials.gov/ct2/show/NCT01844986. Last accessed 26/07/2019.

4. European Medicines Agency (2019). Lynparza. Available: https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza#product-information-section. Last accessed 06/08/2019.

Written by Alexandra Hay & Thomas Southgate

Edited by Cally Cameron Smith