Niraparib Plus Pembrolizumab in Recurrent Platinum-Resistant Ovarian Carcinoma
Posted: Tuesday, September 3, 2019
When women with recurrent ovarian cancer develop resistance to platinum-based therapy, treatment options become limited. However, according to the TOPACIO/KEYNOTE-162 trial published in JAMA Oncology, the combination of niraparib and pembrolizumab appears to be a tolerable option with “promising” antitumor activity for patients with platinum-resistant disease. “This study has shown that the combination treatment of niraparib and an anti–PD-1 antibody appears to be well tolerated and potentially provides clinical activity by tumor shrinkage and disease stabilization in patients with recurrent ovarian carcinoma,” stated Panagiotis A. Konstantinopoulos, MD, PhD, of the Dana-Farber Cancer Institute and Harvard Medical School, Boston, and colleagues.
The single-arm, phase I and II trial enrolled patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian carcinoma, regardless of BRCA mutation status. Due to the similarity in the phase I (n = 9) and II (n = 53) ovarian carcinoma populations, the data were pooled for analysis. Participants received 200 mg of oral niraparib once daily and 200 mg of intravenous pembrolizumab on day 1 of each 21-day cycle.
Of the 60 evaluable patients, the objective response rate was 18%. The 65% of women who achieved disease control included 3 (5%) with confirmed complete responses, 8 (13%) with confirmed partial responses, and 28 (47%) with stable disease; the remaining 20 (33%) patients had progressive disease. The 6- and 12-month progression-free survival rates were estimated to be 31% and 12%, respectively.
Objective response was consistent across subgroups based on platinum-based chemotherapy sensitivity, previous bevacizumab treatment, or tumor BRCA status. The combination appeared to be well tolerated, with no new toxicity signals emerging.
Disclosure: All study authors’ disclosure information can be found at jamanetwork.com.