Advertisement

Utilization and Safety of Ipilimumab Plus Nivolumab in a Real-World Cohort of Metastatic Renal Cell Carcinoma Patients

Published:December 10, 2021DOI:https://doi.org/10.1016/j.clgc.2021.12.003

      Introduction

      Ipilimumab plus nivolumab was associated with a survival benefit in a phase III clinical trial of first-line treatment for metastatic renal cell carcinoma (mRCC). In this study, mRCC patients from the Canadian Kidney Cancer Information System (CKCis) database who received first-line ipilimumab plus nivolumab were analyzed to determine the safety and outcomes in a real-world setting.

      Patients and Methods

      Patients who received ipilimumab plus nivolumab as first-line therapy for mRCC in CKCis, were identified, and the amount of treatment received, discontinuation rates, and reasons for discontinuing treatment were determined. Toxicity data, including type and grade, were collected. Efficacy outcomes of interest included overall survival (OS), progression-free survival (PFS), and overall response rate (ORR).

      Results

      The cohort included 195 patients, the majority with clear cell histology (74%). All 4 cycles of ipilimumab plus nivolumab were administered in 124 patients (64%). Progressive disease (n = 87; 45%) and toxicity (n = 36; 18%) were the most common causes for discontinuing treatment. Several patients (n = 18) did not receive all 4 doses of ipilimumab but received single agent nivolumab. The estimated median OS was 54.5 months (95% CI, 17.7 - NE) and 12-month OS was 72.2% (95% CI, 65.0 - 79.3). Median PFS was 7.4 months (95% CI 5.3 - 10.2) and ORR was 42.5%. Patients who received all 4 cycles of ipilimumab plus nivolumab had better ORR (50% vs. 28%) and a longer PFS and OS than those who received less than 4 cycles (P < .0001). Ninety-five AEs were documented in 72 patients who required dose reduction/change, with colitis being the most frequent.

      Conclusion

      In this real-world cohort of treatment-naïve mRCC patients, outcomes, and safety were comparable to previously reported clinical trial data.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Clinical Genitourinary Cancer
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Motzer R.J.
        • Tannir N.M.
        • McDermott D.F.
        • et al.
        Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma.
        N Engl J Med. 2018; 378: 1277-1290https://doi.org/10.1056/NEJMoa1712126
        • Motzer R.J.
        • Escudier B.
        • McDermott D.F.
        • et al.
        Survival outcomes and independent response assessment with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma: 42-month follow-up of a randomized phase 3 clinical trial.
        J Immunother Cancer. 2020; 8: 1-12https://doi.org/10.1136/jitc-2020-000891
        • Tajzler C.
        • Tanguay S.
        • Mallick R.
        • et al.
        Determining Generalizability of the Canadian kidney cancer information system (CKCis) to the entire Canadian kidney cancer Population.
        Can Urol Assoc J. 2020; 14: 499-506https://doi.org/10.5489/cuaj.6716
        • Heng D.Y.C.
        • Xie W.
        • Regan M.M.
        • et al.
        External validation and comparison with other models of the international metastatic renal-cell carcinoma database consortium prognostic model: a population-based study.
        Lancet Oncol. 2013; 14: 141-148https://doi.org/10.1016/S1470-2045(12)70559-4
        • Gan C.L.
        • Dudani S.
        • Wells J.C.
        • et al.
        Outcomes of first-line (1 L) immuno-oncology (IO) combination therapies in metastatic renal cell carcinoma (mRCC): results from the International mRCC database consortium (IMDC).
        J Clin Oncol. 2021; 39: 276https://doi.org/10.1200/JCO.2021.39.6_suppl.276
        • Tanaka T.
        • Hatakeyama S.
        • Numakura K.
        • et al.
        Efficacy and safety of first-line nivolumab plus ipilimumab in patients with metastatic renal cell carcinoma: a multicenter retrospective study.
        Int J Urol. 2020; 27: 1095-1100https://doi.org/10.1111/iju.14363
        • Allison J.
        • Griffiths R.
        • Waddell T.
        • Pillai M.R.
        Ipilimumab and nivolumab (I+N) as first-line treatment of metastatic renal cell carcinoma (mRCC): a real-world review in North West of England, United Kingdom.
        J Clin Oncol. 2021; 39: 295https://doi.org/10.1200/JCO.2021.39.6_suppl.295
        • Dolladille C.
        • Ederhy S.
        • Sassier M.
        • et al.
        Immune checkpoint inhibitor rechallenge after immune-related adverse events in patients with cancer.
        JAMA Oncol. 2020; 6: 865https://doi.org/10.1001/jamaoncol.2020.0726
        • Grimm M.-.O.
        • Schmidinger M.
        • Duran Martinez I.
        • et al.
        Tailored immunotherapy approach with nivolumab in advanced renal cell carcinoma (TITAN-RCC).
        Ann Oncol. 2019; 30: v892https://doi.org/10.1093/annonc/mdz394.051
        • Atkins M.B.
        • Jegede O.
        • Haas N.B.
        • et al.
        Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced renal cell carcinoma (RCC) (HCRN GU16-260).
        J Clin Oncol. 2020; 38: 5006https://doi.org/10.1200/JCO.2020.38.15_suppl.5006
        • McKay R.R.
        • McGregor B.A.
        • Xie W.
        • et al.
        Optimized management of nivolumab and ipilimumab in advanced renal cell carcinoma: a response-based phase II study (OMNIVORE).
        J Clin Oncol. 2020; 38: 4240-4248https://doi.org/10.1200/JCO.20.02295