From the Guidelines
Nivolumab plus ipilimumab is the recommended immunomodulating agent for the treatment of renal cell cancer, administered through slow IV infusion, due to its significant improvement in overall survival, progression-free survival, and objective response rate compared to sunitinib, as demonstrated in the most recent and highest quality study 1.
Treatment Regimen
The typical regimen for nivolumab plus ipilimumab involves nivolumab 3 mg/kg and ipilimumab 1 mg/kg administered intravenously once every 3 weeks for four cycles, followed by nivolumab 3 mg/kg once every 2 weeks.
Efficacy
This combination has shown to improve OS probability (52% vs 39%; HR 0.66; 95% CI, 0.55 to 0.80; P < .0001) and PFS probability (33% vs 16%; HR 0.75; 95% CI, 0.62 to 0.90; P < .0015) when compared with sunitinib, as well as higher ORR (42% vs 26%; P < .0001) and complete response rates (10.1% vs 1.4%) 1.
Safety and Quality of Life
Nivolumab plus ipilimumab was associated with fewer patient-reported symptoms and better health-related quality of life (HRQoL) than sunitinib, with grade 3 or higher adverse events seen in 47.3% and 64.1% of the patients treated with Nivo plus Ipi and sunitinib, respectively 1.
Key Considerations
It is essential to note that the benefits of nivolumab plus ipilimumab were greater for patients with programmed death-ligand 1 (PD-L1) ≥ 1%, and this combination was superior to sunitinib independent of PD-L1 expression 1. Some key points to consider when administering this treatment include:
- Close monitoring of patients during administration due to potential severe side effects
- Pre-medications to help manage side effects
- Slow infusion to minimize adverse reactions
- Patient selection based on performance status, organ function, and PD-L1 expression.
From the FDA Drug Label
1.7 Advanced Renal Cell Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced RCC. • OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC • OPDIVO, as a single agent, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
The drug nivolumab (OPDIVO) is an immunomodulating agent that is administered through slow IV infusion to treat renal cell cancer, among other indications. Key points include:
- First-line treatment of adult patients with intermediate or poor risk advanced RCC in combination with ipilimumab or cabozantinib.
- Single-agent treatment of adult patients with advanced RCC who have received prior anti-angiogenic therapy 2.
From the Research
Immunomodulating Agents for Renal Cell Cancer
- The treatment of metastatic renal cell carcinoma (RCC) with high-dose interleukin-2 (HD IL-2) has resulted in durable tumor regression in a minority of patients 3.
- HD IL-2 can induce complete tumor regression in a small number of patients, and many patients have experienced extended disease-free intervals 3, 4.
- Interleukin-2 (IL-2) was historically one of the few treatments for adults with stage IV solid tumors that could produce complete responses (CRs) that were often durable for decades without further therapy 4.
Administration of Immunomodulating Agents
- HD IL-2 is typically administered through slow IV infusion 3, 4.
- The goal for IL-2 therapy is typically to administer the maximum number of doses of IL-2 without putting the patient at unacceptable risk for severe, irreversible toxicity 4.
Efficacy of Immunomodulating Agents
- Nivolumab plus ipilimumab (NIVO+IPI) has shown efficacy benefits over sunitinib in patients with intermediate/poor-risk advanced sarcomatoid renal cell carcinoma (sRCC) 5, 6.
- NIVO+IPI maintained long-term survival benefits and demonstrated durable and deep responses over sunitinib at minimum follow-up of 5 years 5.
- The efficacy of NIVO+IPI was better than sunitinib regardless of tumor PD-L1 expression, but the magnitude of OS, PFS, and ORR benefits with NIVO+IPI was greater for sRCC patients with tumor PD-L1 ≥1% 5.