(Renal Cell Carcinoma) Is Opdivo Monotherapy or Opdivo Plus Yervoy Effective?

• May 16, 2022
• 1 min read

On April 20, 2022, Dr. Michael B. Atkins and colleagues from Georgetown Lombardi Comprehensive Cancer Center published results in the Journal of Clinical Oncology from the Phase 2 clinical trial (NCT03117309) evaluating the efficacy and safety of Opdivo (nivolumab) monotherapy and Opdivo plus Yervoy (ipilimumab) in treatment-naive patients with advanced clear cell renal cell carcinoma (ccRCC).

This Phase 2 trial enrolled 123 treatment-naive patients with advanced ccRCC. Patients first received Opdivo monotherapy (Part A, up to 96 weeks); those with disease progression or stable disease at 48 weeks switched to Opdivo plus Yervoy (Part B). The primary endpoint was 1-year progression-free survival (PFS) rate in patients with PD-L1 expression of 0% and ≥20%.

Results:

Overall ORR: 34.1%. ORR by IMDC risk category: favorable-risk 57.1%, intermediate-/poor-risk 25.0%, sarcomatoid features 36.4%.

ORR by PD-L1 expression: 0% PD-L1: 26.9%; 1–20% PD-L1: 50.0%; ≥20% PD-L1: 75.0%. Median duration of response: 27.6 months. Primary endpoint 1-year PFS: 0% PD-L1: 34.6%; ≥20% PD-L1: 75.0%.

In Part A, 96 patients experienced disease progression or stable disease, of whom 35 entered Part B. Part B ORR: 11.4%. Grade 3 or higher adverse events: Opdivo monotherapy 35%; Opdivo plus Yervoy 43%.

Conclusion: Based on the Phase 2 trial results, Dr. Atkins and colleagues concluded that Opdivo monotherapy demonstrated meaningful anti-tumor activity in treatment-naive advanced ccRCC patients, with activity correlated with PD-L1 expression. The combination of Opdivo plus Yervoy showed limited anti-tumor activity in this setting.

Source: https://ascopubs.org/doi/abs/10.1200/JCO.21.02938

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