Real-world data support the clinical effectiveness of nivolumab + ipilimumab as first-line treatment for IMDC intermediate- or poor-risk metastatic renal cell carcinoma (mRCC), investigators reported at the European Society for Medical Oncology’s 2022 Congress (ESMO 2022) in Paris, France.

The objective response rate (ORR) and median duration of response (DOR) were consistent with those observed in the CheckMate 214 clinical trial in which nivolumab + ipilimumab demonstrated superior efficacy compared with sunitinib for the first-line treatment of intermediate- or poor-risk advanced RCC.

The findings also suggest that first-line nivolumab + ipilimumab was generally well tolerated in the real-world setting, with low rates of treatment-related adverse events (TRAEs), hospitalizations, and emergency department visits.

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Using electronic medical data from The US Oncology Network, Daniel Geynisman, MD, of Fox Chase Cancer Center in Philadelphia, Pennsylvania, and his collaborators retrospectively analyzed data from 188 patients with IMDC intermediate- or poor-risk mRCC (60.1% and 39.9% of patients, respectively) treated with first-line nivolumab + ipilimumab. The patients had a median age of 63 years. The median follow-up was 20.1 months. The median overall survival (OS) was 32.5 months, the investigators reported. The 12-month OS rate was 76.6%. The median progression-free survival (PFS) was 11.1 months; the 12-month PFS rate was 49.1%.

In addition, the ORR was 43.3% and the median time to treatment response was 2.8 months. The median DOR was not reached, although 65.1% of patients had an ongoing response by month 12, according to the investigators.

Of the 82 patients who received second-line therapy, 56.1% received cabozantinib and 11.0% received pazopanib.

The most frequent TRAEs were fatigue (13.8% of patients), rash (10.1%), and diarrhea (6.9%). The treatment-related hospitalization rate was 6.4%, and the emergency department visit rate was 3.2%.

Disclosure: Bristol-Myers Squibb funded the study. Dr Geynisman reported consulting and advisory fees from biotech, pharmaceutical, and/or device companies. Please see original reference for a full list of disclosures.


Geynisman D, Chan P, Robert N, et al. Real-world (RW) outcomes in metastatic renal cell carcinoma (mRCC) patients treated with first-line (1L) nivolumab plus ipilimumab (NIVO+IPI) in the United States. Presented at: ESMO 2022, September 9-13, Paris, France. Abstract 1465P.