NICE Recommends Olaparib Maintenance in Relapsed, Platinum-Sensitive Ovarian Cancer

The National Institute for Health and Care Excellence (NICE) has recommended the use of olaparib (Lynparza) as a maintenance treatment in adults with relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.¹

Olaparib is specifically recommended as a maintenance treatment option for adult patients with relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy only if they harbor a BRCA1/2 mutation, they received ≥3 courses of platinum-based chemotherapy, and the manufacturer provides the agent according to the commercial arrangement.

Moreover, the PARP inhibitor has also been recommended for use within the Cancers Drugs Fund as a maintenance treatment option in this patient population if they harbor a BRCA1/2 mutation, they previously received 2 courses of platinum-based chemotherapy, and the conditions in the managed access agreement for the PARP inhibitor are followed.

The agency noted that the recommendations should not impact any treatment with olaparib that had been initiated in the National Health Service prior to the published guidance.

Maintenance therapy with olaparib led to a 70% reduction in the risk of progression or death versus placebo in patients with platinum-sensitive, relapsed BRCA-positive disease, according to data from the phase III SOLO-2 trial.² Median investigator-assessed progression-free survival (PFS) was 19.1 months with olaparib versus 5.5 months with placebo (HR, 0.30; 95% CI, 0.22-0.41; P <.0001).

Additionally, data from a prespecified analysis of PFS by a blinded central review committee demonstrated a median PFS of 30.2 months versus 5.5 months with olaparib and placebo, respectively; this translated to a 75% reduction in the hazard for progression and death (HR, 0.25; 95% CI, 0.18-0.35; P <.0001).³

Evidence from clinical trials indicates that treatment with olaparib lengthens the time until disease progression versus routine surveillance, even in patients with BRCA-mutant disease. However, AstraZeneca, which co-develops olaparib with Merck, has offered a commercial arrangement that applies to olaparib tablets for use in patients who harbor a BRCA mutation and have undergone 2 courses of platinum-based chemotherapy, the agent is only cost effective when used for the subgroup of patients with BRCA mutations, according to the agency.

For patients with BRCA-mutant disease who received ≥3 courses of platinum-based chemotherapy, the agent meets NICE’s end-of-life criteria. In this group of patients, the PARP inhibitor is cost effective. As such, olaparib is recommended for use in the NHS in these patients.

However, for those with BRCA-mutant disease who have only had 2 courses of platinum-based chemotherapy, the agent does not meet the agency’s criteria. Because overall survival (OS) data from “the most relevant clinical trial” are not yet available for review, cost-effectiveness estimates are unclear.

“Olaparib has the potential to be cost effective if further data confirm the OS benefit estimated using the company’s alternative model,” the agency concluded. “Olaparib is therefore recommended for use within the Cancer Drugs Fund, for people with a BRCA mutation who have had 2 courses of platinum-based chemotherapy, while more data are collected.”

In August 2019, NICE recommended the PARP inhibitor for use within the Cancer Drugs Fund as a maintenance treatment option for adult patients with BRCA-mutant, advanced, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer that is sensitive to first-line platinum-based chemotherapy. The recommendation was contingent on if the conditions of the managed access agreement for the agent were followed.

References

1. Technology appraisal guidance [TA620]: Olaparib maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer. National Institute for Health and Care Excellence. Published January 15, 2020. bit.ly/2FTnZfS. Accessed January 15, 2020.
2. Pujade-Lauraine E, Ledermann JA, Selle F, et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Oncol. 2017;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2.
3. Lynparza phase III SOLO-2 data demonstrate progression-free survival benefit in BRCA-mutated ovarian cancer as maintenance therapy [news release]. AstraZeneca; March 14, 2017. bit.ly/2TtfFew. Accessed January 15, 2020.