Results from the INMUNOSUN-SOGUG trial: a prospective phase II study of sunitinib as a second-line therapy in patients with metastatic renal cell carcinoma after immune checkpoint-based combination therapy.

The INMUNOSUN trial had the objective of prospectively evaluating the efficacy and safety of sunitinib as a pure second-line treatment in patients with metastatic renal cell carcinoma (mRCC) who have progressed to first-line immune checkpoint inhibitor (ICI)-based therapies.

A multicenter, phase II, single-arm, open-label study was carried out in patients with a histologically confirmed diagnosis of mRCC with a clear-cell component who had progressed to a first-line regimen of ICI-based therapies. All patients received sunitinib 50 mg once daily orally for 4 weeks, followed by a 2-week rest period following package insert instructions. The primary outcome was the objective response rate.

Twenty-one assessable patients were included in the efficacy and safety analyses. Four patients [19.0%, 95% confidence interval (CI) 2.3% to 35.8%] showed an objective response (OR), and all of them had partial responses. Additionally, 14 (67%) patients showed a stable response, leading to clinical benefit in 18 patients (85.7%, 95% CI 70.7% to 100%). Among the four assessable patients who showed an OR, the median duration of the response was 7.1 months (interquartile range 4.2-12.0 months). The median progression-free survival (PFS) was 5.6 months (95% CI 3.1-8.0 months). The median overall survival (OS) was 23.5 months (95% CI 6.3-40.7 months). Patients who had better antitumor response to first-line ICI-based treatment showed a longer PFS and OS with sunitinib. The most frequent treatment-emergent adverse events were diarrhea (n = 11, 52%), dysgeusia (n = 8, 38%), palmar-plantar erythrodysesthesia (n = 8, 38%), and hypertension (n = 8, 38%). There was 1 patient who exhibited grade 5 pancytopenia, and 11 patients experienced grade 3 adverse events. Eight (38%) patients had serious adverse events, four of which were considered to be related to sunitinib.

Although the INMUNOSUN trial did not reach the pre-specified endpoint, it demonstrated that sunitinib is active and can be safely used as a second-line option in patients with mRCC who progress to new standard ICI-based regimens.

ESMO open. 2022 Apr 08 [Epub ahead of print]

E Grande, T Alonso-Gordoa, O Reig, E Esteban, D Castellano, X Garcia-Del-Muro, M J Mendez, J García-Donas, M González Rodríguez, J A Arranz-Arija, P Lopez-Criado, J Molina-Cerrillo, B Mellado, C Alvarez-Fernandez, G De Velasco, M A Cuéllar-Rivas, R M Rodríguez-Alonso, J F Rodríguez-Moreno, C Suarez-Rodriguez

Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain. Electronic address: ., Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain., Medical Oncology, Hospital Clinic and Translational Genomics and Targeted Therapies in Solid Tumors Group, August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain., Medical Oncology, Hospital Universitario Central de Asturias, Oviedo, Spain., Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain., Medical Oncology, Institut Català d'Oncologia (ICO Bellvitge) Idibell, University of Barcelona, Barcelona, Spain., Medical Oncology, Maimonides Institute for Biomedical Research of Córdoba (IMIBIC) Hospital Universitario Reina Sofia (HURS), Córdoba, Spain., Medical Oncology, Clara Campal Comprehensive Cancer Center, Madrid, Spain., Medical Oncology, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Barcelona, Spain., Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain., Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.