286P - Nivolumab in renal cell carcinoma patients in India

Abstract

Background: Nivolumab is a human IgG4 programmed death-1 immune checkpoint inhibitor antibody approved for use in multiple cancers like lung, melanoma, head and neck and renal cell cancers. Immunotherapy with Nivolumab is approved for use as second line therapy in Renal cell cancers (RCC), and has recently become available for use in India. There is no data about use of Nivolumab in Indian patients. Methods: We retrospectively reviewed RCC patients who received treatment with Nivolumab in a tertiary hospital in the second and later lines setting. The objective was to study efficacy and safety of Nivolumab. Results: 7 patients received Nivolumab at 3mg/kg dose, every 2 weeks, between May 2016 and June 2017. Median age of patients was 53 years (range 42-66 years). ECOG status at presentation ranged between 1-3. All patients had received oral TKIs as first line therapy- 3 patients received Sunitinib, 4 patients received Pazopanib. 2 patients also received Everolimus as 2nd line therapy. Response was assessed by RECIST criteria at 2 months. 2 patients (28.6%) achieved partial response, 2 had stable disease (28.6%) and 3 patients (42.8%) had progressive disease. The 2 patients who had partial response are continuing treatment for 13 months and 11 months without any progression. The median progression free survival (PFS) is 4 months. Adverse events occurred in 3 patients (42%). The common adverse events were fatigue in 28.5% (grade 1) and skin rash in 14.2% (grade 1). There were no grade 3,4 adverse events and no treatment related discontinuation. Conclusions: Nivolumab is an effective second line regimen in selected patients with metastatic RCC. Long-term responses have been seen in responding patients. Immunotherapy with Nivolumab is well tolerated, and would need to be studied in more patients with longer followup to know the PFS and Overall survival (OS) benefit. Legal entity responsible for the study: Dr Amit Rauthan Funding: None Disclosure: A. Rauthan: Advisory board- Roche, Merck, BMS All other authors have declared no conflicts of interest.