Even, Caroline , Li, Hung-Ming , Ngan, Roger , Dechaphunkul, Arunee , Zhang, Li , Jui Yen, Chia , Chan, Po Chung , Chakrabandhu, Somvilai , Ma, Brigette , Tanasanvimon, Suebpong , Lee, Victor , Lou, Pei-Jen , Li, Zujun , Spira, Alexander , Ammar , Sukari, Guigay, Joël , McCune, Steven , Lim, Darren Wan-Teck, Szpakowski, Sebastian, Yao, Yao, Liang, Coco, Mataraza, Jennifer, Sechaud, Romain and Manenti , Luigi (2021) Phase II, randomized study of spartalizumab (PDR001), an anti-PD-1 antibody, vs chemotherapy in patients with recurrent/metastatic nasopharyngeal cancer. Clinical cancer research. ISSN 1557-3265; 1078-0432

Abstract

Background: 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 anti-programmed cell death protein-1 (PD-1) monoclonal antibody, versus chemotherapy, in NPC.
Patients and Methods: Patients with non-keratinizing 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.
Results: 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 (DOR) was 10.2 versus 5.7 months in spartalizumab versus chemotherapy arms, respectively. Median overall survival (OS) was 25.2 and 15.5 months in spartalizumab and chemotherapy arms, respectively. Tumor RNA sequencing showed a correlation between response to spartalizumab and IFN-γ, LAG-3, and TIM-3 gene expression. Conclusion: Spartalizumab demonstrated a safety profile consistent with other anti-PD-1 antibodies. The primary endpoint of median PFS was not met, however , median OS and median DOR were longer with spartalizumab compared with chemotherapy.

Item Type:	Article
Keywords:	nasopharyngeal cancer; phase II; programmed cell death protein-1; spartalizumab; immuno-oncology
Date Deposited:	14 Sep 2021 00:45
Last Modified:	14 Sep 2021 00:45
URI:	https://oak.novartis.com/id/eprint/44262