Real-world (rw) data on the outcomes of pts with EOC receiving 1Lm niraparib are limited. The CHAR1ZMA study characterizes TTNT for pts with EOC prescribed 1Lm niraparib monotherapy in the US using a rw database.
Pts diagnosed with EOC on or after 01Jan2011, who were ≥18 years old at initial diagnosis, treated with 1L platinum-based chemotherapy, and received 1Lm niraparib monotherapy between 01Jan2017–03Mar2022 were included from the nationwide electronic health record-derived de-identified Flatiron Health database and followed until last clinical activity or end of the data period. Index date was defined as the end of 1L platinum-based chemotherapy. TTNT (proxy for rwPFS) was defined as time from index date to start of 2L treatment/death and was estimated using the Kaplan-Meier method. Results were stratified by age, BRCA status, homologous recombination (HR) deficiency status, and residual disease (RD) status following cytoreductive surgery.
Of 414 eligible EOC pts, 83.3% were diagnosed with stage III/IV disease and 42.5% had no visible RD following cytoreductive surgery. Median age at index was 67 years, 80.7% had an ECOG performance of 0–1, and 83.6% were BRCA wild-type. Median follow-up time was 13.8 months. Overall, observed median TTNT was 13.3 months (95% CI 12.0, 15.8). Observed TTNT varied by demographic and clinical characteristics (Table). Longest median TTNT was observed in pts with a BRCA mutation (BRCAm), followed by HR deficiency (HRd), <75 years of age, and those with no visible RD following cytoreductive surgery.
RW TTNT in EOC pts receiving 1Lm niraparib by subgroups
| Number of pts (%) | TTNT, median, months (95% CI) | |
| Overall | 414 (100) | 13.3 (12.0, 15.8) |
| Age at index, years | ||
| <75 | 310 (74.9) | 15.3 (12.4, 18.4) |
| ≥75 | 104 (25.1) | 11.7 (8.6, 13.6) |
| BRCA statusa,b | ||
| Mutated | 48 (11.6) | 44.3 (18.0, not reached) |
| Wild-type | 346 (83.6) | 12.4 (11.7, 14.6) |
| HR deficiency statusb | ||
| HRd | 68 (16.4) | 19.8 (13.1, 26.5) |
| HRp | 71 (17.2) | 11.7 (9.4, 17.3) |
| RD status following initial surgeryb | ||
| No visible RD | 176 (42.5) | 15.3 (12.1, 20.2) |
| Visible RD | 92 (22.2) | 12.4 (10.1, 15.8) |
| No cytoreductive surgery | 59 (14.3) | 8.1 (6.3, 12.4) |
aIncludes somatic and germline mutations
bUnknown categories excluded in the KM analyses
CI, confidence interval; HRp, HR proficient
This rw study of 1Lm niraparib monotherapy in pts with EOC demonstrates the importance of considering pt characteristics and reinforces the PFS benefit first observed in the PRIMA trial.
Editorial support by Claire Kelly, Fishawack Health, funded by GSK.