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Pembrolizumab alone and pembrolizumab plus chemotherapy in previously treated, extrapulmonary poorly differentiated neuroendocrine carcinomas
- Raj, Nitya;
- Chan, Jennifer A;
- Wang, Stephanie J;
- Aggarwal, Rahul R;
- Calabrese, Susan;
- DeMore, April;
- Fong, Lawrence;
- Grabowsky, Jennifer;
- Hope, Thomas A;
- Kolli, Kanti Pallav;
- Mulvey, Claire K;
- Munster, Pamela N;
- Perez, Kimberly;
- Punn, Sippy;
- Reidy-Lagunes, Diane;
- Von Fedak, Sofia;
- Zhang, Li;
- Bergsland, Emily K
- et al.
Published Web Location
https://doi.org/10.1038/s41416-023-02298-8Abstract
Background
To date, single-agent immune checkpoint inhibitor (CPI) therapy has proven to be ineffective against biomarker-unselected extrapulmonary poorly differentiated neuroendocrine carcinomas (EP-PDNECs). The efficacy of CPI in combination with chemotherapy remains under investigation.Methods
Patients with advanced, progressive EP-PDNECs were enrolled in a two-part study of pembrolizumab-based therapy. In Part A, patients received pembrolizumab alone. In Part B, patients received pembrolizumab plus chemotherapy.Primary endpoint
objective response rate (ORR). Secondary endpoints: safety, progression-free survival (PFS) and overall survival (OS). Tumours were profiled for programmed death-ligand 1 expression, microsatellite-high/mismatch repair deficient status, mutational burden (TMB), genomic correlates. Tumour growth rate was evaluated.Results
Part A (N = 14): ORR (pembrolizumab alone) 7% (95% CI, 0.2-33.9%), median PFS 1.8 months (95% CI, 1.7-21.4), median OS 7.8 months (95% CI, 3.1-not reached); 14% of patients (N = 2) had grade 3/4 treatment-related adverse events (TRAEs). Part B (N = 22): ORR (pembrolizumab plus chemotherapy) 5% (95% CI, 0-22.8%), median PFS 2.0 months (95% CI, 1.9-3.4), median OS 4.8 months (95% CI, 4.1-8.2); 45% of patients (N = 10) had grade 3/4 TRAEs. The two patients with objective response had high-TMB tumours.Discussion
Treatment with pembrolizumab alone and pembrolizumab plus chemotherapy was ineffective in advanced, progressive EP-PDNECs.Clinical trial registration
ClinicalTrials.gov NCT03136055.Many UC-authored scholarly publications are freely available on this site because of the UC's open access policies. Let us know how this access is important for you.
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