The European Commission (EC) has granted marketing authorisation for olaparib tablets (300mg twice daily) for use as a maintenance therapy for adult patients with platinum-sensitive relapsed (PSR) high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.

Olaparib tablets are recommended for treatment in this setting regardless of patients’ BRCA gene mutation status.

Approximately 7,400 women are diagnosed with ovarian cancer every year in the UK.

It is the 6th most common cancer in females and causes more than 4,000 deaths every year.

The UK has the worst five-year survival rate for ovarian cancer in Europe.

As there is no cure for relapsed ovarian cancer, the primary aim of treatment is to slow progression of the disease for as long as possible and improve or maintain the patient’s quality of life.

Olaparib was initially licensed in a capsule formulation by the EC in 2015 to treat the one in five women with relapsed ovarian cancer who had the genetic BRCA mutation.

The new tablet formulation is licensed for use in all women with PSR high-grade ovarian cancer, regardless of BRCA status.

Approximately 1,200 women in the UK could now be eligible for this treatment.

Dr Susanna Banerjee, Consultant Medical Oncologist at Royal Marsden NHS Foundation Trust said “Until recently, beyond chemotherapy, there have been limited treatments for women with relapsed ovarian cancer. The EMA approval gives many more ovarian cancer patients the opportunity to benefit from olaparib; previously it was only available for women with a mutation in BRCA genes. Clinical trials have shown that women with platinum-sensitive relapsed ovarian cancer can have better outcomes with olaparib compared to no active treatment. This is fantastic news for women with relapsed ovarian cancer regardless of BRCA mutation status.”

Laurent Abuaf, Country President, AstraZeneca UK said “We are proud to be launching this new formulation for olaparib which was discovered, developed and trialled in the UK and is manufactured in Macclesfield. This could help hundreds of women with ovarian cancer. We will now work closely with NICE and NHS England to ensure that all appropriate ovarian cancer patients in the UK can benefit from this treatment.”

The approval was based on two randomised trials, SOLO-2 and Study 19 which showed olaparib reduced the risk of disease progression or death for platinum-sensitive relapsed ovarian cancer patients compared to placebo.

In the Study 19 trial, nearly a quarter of patients on olaparib remained on treatment for more than two years and 13% remained on treatment for longer than five years.

The Study 19 trial was a Phase II study of olaparib in capsule form as maintenance therapy for PSR high-grade serous ovarian cancer in 265 patients with and without a BRCA mutation.

The data showed olaparib demonstrated significantly prolonged progression-free survival (PFS) and reduced the risk of disease progression or death compared to placebo by 65% in patients with or without a BRCA mutation [HR = 0.35 (95% CI 0.25-0.49 P<0.001).

PFS was significantly longer with olaparib than with placebo (median, 8.4 months vs 4.8 months from randomisation on completion of chemotherapy).

The SOLO-2 trial was a Phase III study of olaparib in tablet form as maintenance therapy for PSR ovarian cancer in 294 patients with a BRCA mutation.

The data showed olaparib significantly improved PFS compared to placebo, reducing the risk of disease progression or death by 70%.

The median PFS was 19.1 months in the olaparib group, compared with 5.5 months in the placebo group [HR = 0.30, (95% CI 0.22 – 0.41, p<0.0001).

Olaparib has been associated with adverse reactions generally of mild or moderate severity and generally not requiring treatment discontinuation.

The most frequently observed adverse reactions across clinical trials in patients receiving olaparib monotherapy (≥ 10%) were nausea, vomiting, diarrhoea, dyspepsia, fatigue, headache, dysgeusia, decreased appetite, dizziness, and anaemia.

Source: Astra Zeneca