American Association for Cancer Research
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Supplementary Table 7 from Phase II, Randomized Study of Spartalizumab (PDR001), an Anti–PD-1 Antibody, versus Chemotherapy in Patients with Recurrent/Metastatic Nasopharyngeal Cancer

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posted on 2023-03-31, 23:14 authored by Caroline Even, Hung-Ming Wang, Shau-Hsuan Li, Roger K-C Ngan, Arunee Dechaphunkul, Li Zhang, Chia-Jui Yen, Po Chung Chan, Somvilai Chakrabandhu, Brigette B.Y. Ma, Suebpong Tanasanvimon, Victor H.F. Lee, Pei-Jen Lou, Zujun Li, Alexander I. Spira, Ammar Sukari, Joël Guigay, Steven McCune, Juan Gonzalez-Maffe, Sebastian Szpakowski, Yao Yao, Hongzi Liang, Jennifer Mataraza, Romain Séchaud, Luigi Manenti, Darren W-T. Lim

Supplemental Table S7. Primary PK parameters for spartalizumab



No standard treatment exists for platinum-refractory, recurrent/metastatic nasopharyngeal cancer (NPC). This phase II study (NCT02605967) evaluated progression-free survival (PFS) of spartalizumab, an antiprogrammed cell death protein-1 (PD-1) monoclonal antibody, versus chemotherapy, in NPC. Patients with nonkeratinizing recurrent/metastatic NPC who progressed on/after platinum-based chemotherapy were enrolled. Spartalizumab was dosed 400 mg once every 4 weeks, and chemotherapy was received per investigator's choice. Patients were randomized to receive either spartalizumab (82 patients) or chemotherapy (40 patients). The most common spartalizumab treatment-related adverse events were fatigue (10.3%) and pruritus (9.3%). Median PFS in the spartalizumab arm was 1.9 months versus 6.6 months in the chemotherapy arm (P = 0.915). The overall response rate in the spartalizumab arm was 17.1% versus 35.0% in the chemotherapy arm. Median duration of response was 10.2 versus 5.7 months in the spartalizumab versus chemotherapy arms, respectively. Median overall survival was 25.2 and 15.5 months in the spartalizumab and chemotherapy arms, respectively. Tumor RNA sequencing showed a correlation between response to spartalizumab and IFNγ, LAG-3, and TIM-3 gene expression. Spartalizumab demonstrated a safety profile consistent with other anti–PD-1 antibodies. The primary endpoint of median PFS was not met; however, median overall survival and median duration of response were longer with spartalizumab compared with chemotherapy.

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