Abstract 1465P
Background
NIVO+IPI is a first-in-class combination immunotherapy for the treatment of IMDC intermediate- or poor-risk (I/P-risk) advanced renal cell carcinoma. In this RW study, treatment patterns, clinical outcomes, safety, sequences, and healthcare resource utilization in a United States community oncology setting were evaluated for this regimen.
Methods
A retrospective analysis utilizing electronic medical data from The US Oncology Network examined patients with an IMDC I/P-risk clear cell mRCC who initiated 1L NIVO+IPI between 01-Apr-2018 and 31-Dec-2019 with follow-up until 30-Jun-2021. Baseline demographic and clinical characteristics, treatment patterns, treatment-related adverse events (TRAEs), and healthcare resource utilization were examined descriptively. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and time to treatment response (TTR) were analyzed using Kaplan–Meier methods.
Results
188 mRCC patients treated with 1L NIVO+IPI were identified. Median age was 63 (range, 30–89) years, 39.9% were IMDC poor risk, and 19.7% had ECOG performance status score 2 or higher. Median follow-up was 20.1 (range, 0.7–38.2) months. Median OS was 32.5 months, and the 12-month OS rate was 76.6% (95% CI, 69.7-82.1%). The median PFS was 11.1 months, and the 12-month PFS rate was 49.1% (95% CI, 41.7-56.2%). The ORR was 43.3% (95% CI, 34.8–52.1), and the median TTR was 2.8 (range, 0.3–4.6) months. Among the 83 patients who received 2L therapy, 55.4% received cabozantinib, and 10.8% received pazopanib. TRAEs were reported in 90 patients. Among all 188 patients, the most frequent TRAEs were fatigue (13.8%), rash (10.1%), and diarrhea (6.9%); the treatment-related hospitalization rate was 6.4%, and the emergency room visit rate was 3.2%.
Conclusions
This RW study supports the clinical efficacy of 1L NIVO+IPI in patients with low performance status and IMDC I/P-risk mRCC. Although a high percentage of patients had poor IMDC risk, the NIVO+IPI combination was well tolerated in the RW setting, with low rates of adverse events and healthcare resource use.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Ontada, Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
P. Chan: Financial Interests, Personal, Full or part-time Employment: Ontada. N. Robert: Financial Interests, Personal, Advisory Role: Bristol Myers Squibb, Advi, Boehringer Ingelheim, New Century Health; Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb; Financial Interests, Personal, Speaker’s Bureau, Ontada: Roche; Financial Interests, Personal, Leadership Role: McKesson; Financial Interests, Personal, Stocks/Shares: McKesson, Johnson & Johnson, Moderna; Financial Interests, Personal, Stocks/Shares, Ontada: Oncolytics Biotech; Financial Interests, Personal, Full or part-time Employment: Ontada. L. Chen: Financial Interests, Personal, Full or part-time Employment: Ontada. V. Del Tejo, L.C. Rosenblatt, S. Huo: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. All other authors have declared no conflicts of interest.