Breast Cancer Coverage from Every Angle

Niraparib Plus Pembrolizumab in Advanced Triple-Negative Breast Cancer

By: Sara Tewksbury
Posted: Wednesday, September 25, 2019

For patients with advanced or metastatic triple-negative breast cancer, combined therapy of the PARP inhibitor niraparib plus the anti–PD-1 inhibitor pembrolizumab may prove to be an effective treatment option. Shaveta Vinayak , MD, of Fred Hutchinson Cancer Research Center, Seattle, and colleagues conducted the phase II TOPACIO/KEYNOTE-162 single-arm study and published their findings in JAMA Oncology.

“Combination niraparib plus pembrolizumab provides promising antitumor activity in patients with advanced or metastatic triple-negative breast cancer, with numerically higher response rates in those with tumor BRCA mutations,” the investigators reported. “The combination therapy was safe with a tolerable safety profile, warranting further investigation.”

A total of 47 evaluable patients from multiple sites throughout the United States were given 200 mg of oral niraparib once daily along with 200 mg of intravenous pembrolizumab on day 1 of each 21-day cycle. Of the 47 patients, 5 had a confirmed complete response, 5 had a partial response, 13 had stable disease, and 24 experienced disease progression.

Of the 15 patients who had BRCA mutations, 7 had an objective response. Of the 27 patients with BRCA wild-type tumors, 3 had a response.

The most common treatment-related adverse events of grade 3 or higher were anemia (18%), thrombocytopenia (15%), and fatigue (7%). Eight patients reported immune-related adverse events, with the most common one being hypothyroidism. Two patients experienced grade 3 adverse events of adrenal insufficiency and polymyalgia rheumatica.

Disclosures: The study author’s disclosures can be found at

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