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Association details:
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A phase II, single-arm, open label, Simon two-stage study of pembrolizumab in patients with metastatic HER2-negative breast cancer: Evaluation of impact of germline variants in APOBEC3B (AUROR)

Published date:
05/26/2022
Excerpt:
In this open label, single arm Phase II study of single agent pembrolizumab in metastatic HER2-receptor negative breast cancer patients with germline deletion in A3B...Complete response (CR) was observed in one patient, while partial response (PR) was observed in 4 patients, with an ORR of 22.7% (5 over 22 subjects) in stage I, meeting the pre-defined criteria to proceed to stage II. Notably, the patient with complete response had received 2 prior lines of chemotherapy, whereas of the patients with partial response, 1 had received 1 prior line and 3 had received 3 prior lines of chemotherapy in a metastatic setting. As the observed ORR was greater than the value of r1 (13.6%)...Single agent pembrolizumab demonstrates promising efficacy in germline A3Bdel carriers...
DOI:
10.1200/JCO.2022.40.16_suppl.1026
Trial ID: