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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Tuesday, October 22, 2024
The phase III SAFFRON-301 trial revealed similar efficacy and a higher incidence of treatment-emergent adverse events with the anti–PD-1 antibody tislelizumab plus the tyrosine kinase inhibitor sitravatinib vs docetaxel alone in patients with previously treated unresectable locally advanced or metastatic non–small cell lung cancer (NSCLC). Yi-Long Wu, MD, , of Guangdong Provincial People’s Hospital, Guangzhou, China, and colleagues presented these findings during the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC; Abstract OA06.03).
Patients who were previously treated with up to two lines of systemic chemotherapy and/or anti–PD-1/PD-L1 antibodies were randomly assigned in a 1:1 ratio to receive either 200 mg of tislelizumab intravenously once every 3 weeks in combination with 100 mg of sitravatinib orally once daily (n = 187) or 75 mg/m2 of docetaxel intravenously every 3 weeks (n = 190). Follow-up data were provided for a median of 8.0 and 7.6 months, respectively.
The median overall survival was 11.5 months with tislelizumab plus sitravatinib and 11.4 months with docetaxel (hazard ratio [HR] = 1.02). Patients treated with the combination regimen demonstrated a longer median independent review committee–assessed progression-free survival (4.4 vs 2.9 months; HR = 0.82). The independent review committee–assessed objective response rates were 12.3% and 12.6% with tislelizumab plus sitravatinib and docetaxel, respectively.
The incidence rate of treatment-emergent adverse events was higher with tislelizumab plus sitravatinib vs docetaxel (98.4% vs 91.5%). The most frequently reported treatment-emergent adverse events of grade 3 or higher were hypertension (tislelizumab plus sitravatinib: 13.4%; docetaxel: 1.1%), pneumonia (9.1% vs 8.5%), palmar plantar erythrodysesthesia syndrome (6.5% vs 0%), hypokalemia (5.4% vs 2.3%), decreased white blood cell count (0% vs 29.4%), decreased neutrophil count (0.5% vs 28.8%), neutropenia (0.5% vs 7.3%), and febrile neutropenia (0% vs 5.6%). The trial was prematurely terminated because of safety risks and an unfavorable benefit-risk analysis.
Disclosure: For full disclosures of the study authors, visit wclc2024.iaslc.org.
2024 World Conference on Lung Cancer
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