Pamiparib Monotherapy for Patients with Germline BRCA1/2-Mutated Ovarian Cancer Previously Treated with at Least Two Lines of Chemotherapy: A Multicenter, Open-Label, Phase II Study.

Abstract

PURPOSE:

Phase I results of this phase I/II study showed that pamiparib 60 mg twice a day had antitumor activity and an acceptable safety profile in Chinese patients with advanced cancer, including epithelial ovarian cancer.

PATIENTS AND METHODS:

This open-label phase II study was conducted in China and enrolled adult (≥18 years) patients with platinum-sensitive ovarian cancer (PSOC; disease progression occurring ≥6 months after last platinum treatment) or platinum-resistant ovarian cancer (PROC; disease progression occurring <6 months after last platinum treatment). Eligible patients had known or suspected deleterious germline BRCA mutation (gBRCAmut) and had previously received ≥2 lines of therapy. Pamiparib 60 mg orally twice a day was administered until disease progression, toxicity, or patient withdrawal. The primary endpoint was objective response rate (ORR) assessed by independent review committee (IRC) per RECIST version 1.1.

RESULTS:

In the total patient population (N = 113; PSOC, n = 90; PROC, n = 23), median age was 54 years (range, 34-79) and 25.6% of patients received ≥4 prior systemic chemotherapy lines. Median study follow-up was 12.2 months (range, 0.2-21.5). Eighty-two patients with PSOC and 19 patients with PROC were evaluable for efficacy. In patients with PSOC, 8 achieved a complete response (CR) and 45 achieved a partial response (PR); ORR was 64.6% [95% confidence interval (CI), 53.3-74.9]. In patients with PROC, 6 achieved a PR; ORR was 31.6% (95% CI, 12.6-56.6). Frequently reported grade ≥3 adverse events were hematologic toxicities, including anemia and decreased neutrophil count.

CONCLUSIONS:

Pamiparib 60 mg twice a day showed antitumor activity with durable responses in patients with PSOC or PROC with gBRCAmut, and had a manageable safety profile.

• Authors: Xiaohua Wu, Jianqing Zhu, Jing Wang, Zhongqiu Lin, Rutie Yin, Wei Sun, Qi Zhou, Songling Zhang, Danbo Wang, Hong Shi, Yunong Gao, Yi Huang, Guiling Li, Xiuli Wang, Ying Cheng, Ge Lou, Qinglei Gao, Li Wang, Xiuping Du, Mei Pan, Xiyan Mu, Li Li, Miao Li, Song Mu, Beihua Kong
• Journal: Clinical cancer research : an official journal of the American Association for Cancer Research (Clin Cancer Res) Vol. 28 Issue 4 Pg. 653-661 (02 15 2022) ISSN: 1557-3265 [Electronic] United States
• PMID: 34844979 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: ©2021 The Authors; Published by the American Association for Cancer Research.

Chemical References

• BRCA1 Protein
• BRCA1 protein, human
• Fluorenes
• Poly(ADP-ribose) Polymerase Inhibitors
• pamiparib

Topics

• Adult
• BRCA1 Protein (genetics)
• Carcinoma, Ovarian Epithelial (drug therapy, genetics)
• Female
• Fluorenes
• Germ Cells
• Humans
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Ovarian Neoplasms (drug therapy, genetics, pathology)
• Poly(ADP-ribose) Polymerase Inhibitors