Olaparib maintenance therapy may become a new treatment option for Asian patients with platinum-sensitive recurrent ovarian cancer

The preliminary results of the phase III study L-MOCA conducted by the team of Academician Martin of Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, a Chinese scholar, were recently published in CLINICAL CANCER RESEARCH (2020 IF: 12.
531).
The study evaluated the efficacy of olaparib maintenance therapy in Asia Efficacy and safety in patients with platinum-sensitive recurrent ovarian cancer, study details are presented below
.

Background In patients with platinum-sensitive recurrent (PSR) ovarian cancer (OC), olaparib monotherapy maintenance therapy significantly improved progression-free survival (PFS) compared with placebo
.

However, no trials have evaluated the use of olaparib maintenance therapy in Asian patients with PSR OC
.

The L-MOCA study is the first to evaluate the efficacy and tolerability of maintenance therapy with olaparib in Asian patients with PSR OC
.

Methods Due to the limited placebo effect and significant clinical benefit of olaparib in previous studies, and the rapid approval of olaparib in China, this phase III study was designed as an open-label single-arm test
.

Recruitment conditions for the study include patients aged ≥18 years, ECOG score of 0-1, must have received at least two lines of platinum-based chemotherapy and achieved partial response (PR) or complete response (CR), in addition, enrolled must be platinum-based chemotherapy Sensitive recurrent OC patients
.

The patient received a regimen of oral olaparib 300 mg twice daily until disease progression or intolerable toxicity
.

The primary endpoint of the study was median PFS (mPFS), and secondary endpoints included overall survival (OS), time to study treatment discontinuation, time to first subsequent treatment, time to second progression, and time to second subsequent treatment
.

In a safety quest, patients were assessed for adverse events (AEs) and serious AEs
.

When the data reached 60% maturity, a preliminary analysis of PFS was performed using the Kaplan-Meier method
.

Results Between 2018 and 2020, a total of 225 patients were recruited, of which 224 received olaparib maintenance therapy, of which 91.
5% were from China
.

Of all patients, 35.
7% had previously received third-line or more chemotherapy; 35.
3% achieved a CR in the last line of platinum-based chemotherapy; and 41.
1% had a platinum-free interval of ≤12 months
.

PFS for all patients At the primary data cutoff on December 25, 2020, mPFS for all patients was 16.
1 months (95% CI 13.
3-18.
3), and the 6-month and 12-month PFS rates were 76.
0% (95%), respectively CI 69.
8-81.
2) and 57.
1% (95% CI 50.
2-63.
5), as shown in Figure 1
.

Figure 1.
PFS status of all patients.
Subgroup analysis of patient PFS showed that the mPFS of patients with BRCA mutation was better than that of BRCA wild group (21.
2 months vs.
11.
0 months), as shown in Figure 2
.

In the subgroup analysis for HRR genotype, the mPFS was 18.
3 months (95%CI 14.
5-24.
1) in the HRR mutant group and 13.
3 months (95%CI 8.
3-16.
5) in the HRR wild group, Patients in the mutation group also performed better in mPFS
.

Figure 2 Safety of PFS in BRCA subgroups The incidence of all-grade AEs was 99.
1%, with the most common being anemia (76.
4%), nausea (54%), and leukopenia (24.
1%)
.

Grade 3 or higher AEs occurred in 48.
7%, serious AEs in 25.
4%, treatment-related serious AEs in 17.
4%, and 9.
4% of patients discontinued treatment due to treatment-related adverse events
.

Conclusion The results of the L-MOCA study show that for Asian PSR OC patients, regardless of BRCA status, olaparib maintenance therapy shows significant efficacy and is well tolerated
.

The findings of this study are in line with previous findings from a global scale, and the authors recommend the use of olaparib maintenance therapy in clinical practice in Asian PSR OCs
.

References Gao Q, Zhu J, Zhao W, et al.
Olaparib Maintenance Monotherapy in Asian Patients with Platinum-Sensitive Relapsed Ovarian Cancer: Phase III Trial (L-MOCA) [J].
Clinical Cancer Research, 2022.