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Axitinib plus pembrolizumab in patients with advanced renal-cell carcinoma: Long-term efficacy and safety from a phase Ib trial

2021; Elsevier BV; Volume: 145; Linguagem: Inglês

10.1016/j.ejca.2020.12.009

1879-0852

Michael B. Atkins, Elizabeth R. Plimack, Igor Puzanov, Mayer Fishman, David F. McDermott, Daniel C. Cho, Ulka N. Vaishampayan, Saby George, Jamal Tarazi, William Duggan, Rodolfo F. Perini, Mahgull Thakur, Kathrine C. Fernandez, Toni K. Choueiri,

Pancreatic and Hepatic Oncology Research

BackgroundAxitinib plus pembrolizumab showed superior overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) versus sunitinib in a randomised phase III trial in patients with advanced renal-cell carcinoma (RCC). We report long-term efficacy and safety of the axitinib/pembrolizumab from the phase I trial (NCT02133742), after 46–55 months from study initiation (data cut-off date, 23rd July 2019).MethodsFifty-two treatment-naïve patients with advanced RCC were treated with oral axitinib 5 mg twice daily and intravenous pembrolizumab 2 mg/kg every 3 weeks. PFS, duration of response (DoR) and OS were summarised using the Kaplan–Meier method.ResultsAt a median follow-up of 42.7 months (95% confidence interval [CI]: 41.1–44.1), median OS was not reached; 38 (73.1%) patients were alive. The probability of being alive at 4 years was 66.8% (95% CI: 49.1–79.5). Median PFS in the overall population was 23.5 months (95% CI: 15.4–30.4). ORR was 73.1%; five patients had complete response. Median DoR was 22.1 months (95% CI: 15.1–34.5). Grade III/IV adverse events (AEs) were reported in 38 (73.1%) patients and 20 (38.5%) discontinued treatment because of AEs: 17 (32.7%) discontinued axitinib, 13 (25.0%) discontinued pembrolizumab, and 10 (19.2%) discontinued both drugs. Common AEs included diarrhoea (84.6%), fatigue (80.8%), hypertension (53.8%), cough (48.1%) and dysphonia (48.1%). There were no new AE terms reported and no treatment-related deaths.ConclusionsIn patients with advanced RCC with ~4 years of follow-up, combination axitinib/pembrolizumab continued to demonstrate clinical benefit, with no new safety signals.