KEY TAKEAWAYS
- Phase III VELIA trial explored Veliparib as maintenance therapy for patients at stage III–IV high-grade serous, epithelial ovarian, primary peritoneal, or fallopian tube cancer, either alone or in combination with Carboplatin and Paclitaxel.
- The stratification of the participants was based on medical (treatment history) as well as non-medical grounds (geographical).
- The study’s primary outcome measures were to determine the PFS in the BRCA-deficient Population, in the Homologous Recombination Deficiency Cohort, and in the Intention-to-treat Population.
- Japanese patients in the veliparib arm showed numerically longer median PFS with comparable pharmacokinetics.
- Subgroup data were not powered for statistical significance but to guide future research.
In individuals with stage III–IV high-grade serous ovarian cancer, the phase 3 VELIA trial assessed Veliparib in combination with Carboplatin/Paclitaxel and as maintenance therapy. A 1:1:1 randomization was used to assign the eligible patients who had not previously received treatment to the control group (placebo with Carboplatin/Paclitaxel and placebo maintenance), the Veliparib-combination-only group (Veliparib with Carboplatin/Paclitaxel and placebo maintenance), or the Veliparib-throughout group (Veliparib with Carboplatin/Paclitaxel). Other randomization stratification factors were geographic factors (Japan versus North America or the rest of the world).
Investigator-assessed median progression-free survival served as the primary endpoint. An examination of pharmacokinetics, safety, and efficacy was conducted in a subset of Japanese patients. The three treatment groups—control (n = 23), Veliparib-combination-only (n = 30), and Veliparib-throughout (n = 25)—were randomly assigned to the seventy-eight Japanese patients.
The median progression-free survival for those taking Veliparib-throughout versus controls in the Japanese cohort was 27.4 and 19.1 months, respectively (hazard ratio, 0.46; 95% confidence interval, 0.18-1.16; p = 0.1 [not significant]). Japanese patients were more likely to develop grade 3/4 leukopenia, neutropenia, and thrombocytopenia in the Veliparib-throughout group (32%/88%/32%) than non-Japanese patients (17%/56%/28%). Patients who were not Japanese (65%) had greater rates of grade 3/4 anemia than Japanese (48%) patients. Olanzapine’s potent antiemetic efficacy may make it possible to delay Veliparib’s premature discontinuation during the maintenance period of Veliparib monotherapy.
Japanese patients in the Veliparib-throughout versus control arm had a numerically longer median progression-free survival, which aligned with the findings for the entire research population. Japanese and non-Japanese patients had similar pharmacokinetics. The data for the Japanese patients’ subgroup was not powered to demonstrate statistical relevance but to direct further research.
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9823063/
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT02470585
Mizuno, M., Ito, K., Nakai, H., Kato, H., Kamiura, S., Ushijima, K., Nagao, S., Takano, H., Okadome, M., Takekuma, M., Tokunaga, H., Nagase, S., Aoki, D., Coleman, R. L., Nishimura, Y., Ratajczak, C. K., Hashiba, H., Xiong, H., Katsumata, N., Enomoto, T., & Okamoto, A. (2023). Veliparib with frontline chemotherapy and as maintenance in Japanese women with ovarian cancer: a subanalysis of efficacy, safety, and antiemetic use in the phase 3 VELIA trial. International journal of clinical oncology, 28(1), 163–174. https://doi.org/10.1007/s10147-022-02258-x
