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- Title
Pembrolizumab monotherapy in patients with previously treated metastatic high-grade neuroendocrine neoplasms: joint analysis of two prospective, non-randomised trials.
- Authors
Vijayvergia, Namrata; Dasari, Arvind; Deng, Mengying; Litwin, Samuel; Al-Toubah, Taymeyah; Alpaugh, R. Katherine; Dotan, Efrat; Hall, Michael J.; Ross, Nicole M.; Runyen, Melissa M.; Denlinger, Crystal S.; Halperin, Daniel M.; Cohen, Steven J.; Engstrom, Paul F.; Strosberg, Jonathan R.
- Abstract
<bold>Background: </bold>Metastatic high-grade neuroendocrine neoplasms (G3NENs) have limited treatment options after progression on platinum-based therapy. We addressed the role of Pembrolizumab in patients with previously treated metastatic G3NENs.<bold>Methods: </bold>Two open-label, phase 2 studies enrolled patients with G3NEN (Ki-67 > 20%) to receive Pembrolizumab at 200 mg I.V. every 3 weeks. Radiographic evaluation was conducted every 9 weeks with overall response rate as the primary endpoint.<bold>Results: </bold>Between November 2016 and May 2018, 29 patients (13 males/16 females) with G3NENs were enrolled. One patient (3.4%) had an objective response and an additional six patients (20.7%) had stable disease, resulting in a disease control rate of 24.1%. Disease control rate (DCR) at 18 weeks was 10.3% (3/29). There was no difference in the DCR, PFS or OS between the PD-L1-negative and -positive groups (p 0.56, 0.88 and 0.55, respectively). Pembrolizumab was well tolerated with only 9 grade 3, and no grade 4 events considered drug-related.<bold>Conclusions: </bold>Pembrolizumab can be safely administered to patients with G3NENs but has limited activity as a single agent. Successful completion of our trials suggest studies in G3NENs are feasible and present an unmet need. Further research to identify active combination therapies should be considered.<bold>Clinical Trial Registration Number: </bold>NCT02939651 (10/20/2016).
- Subjects
RESEARCH; RESEARCH methodology; MONOCLONAL antibodies; METASTASIS; PROGNOSIS; EVALUATION research; MEDICAL cooperation; COMPARATIVE studies; NEUROENDOCRINE tumors; RESEARCH funding; TUMOR markers; LONGITUDINAL method; TUMOR grading
- Publication
British Journal of Cancer, 2020, Vol 122, Issue 9, p1309
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/s41416-020-0775-0