(Squamous Cell Carcinoma) Is Opdivo + Yervoy Effective as First-Line Treatment?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On December 6, 2022, Robert I. Haddad and colleagues at Dana-Farber Cancer Institute published results in the Journal of Clinical Oncology from the CheckMate 651 Phase III clinical trial evaluating Opdivo (nivolumab) + Yervoy (ipilimumab) as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
The CheckMate 651 Phase III trial randomized recurrent or metastatic HNSCC patients (N=947) in a 1:1 ratio to:
- Opdivo + Yervoy group
- EXTREME regimen group: 6 treatment cycles followed by cetuximab maintenance therapy
Primary endpoint: overall survival (OS) in PD-L1-positive (CPS≥20) patients. Secondary endpoints: OS in PD-L1-positive (CPS≥1) patients, OS in all patients, objective response rate (ORR) and duration of response (DoR) in PD-L1-positive (CPS≥20) patients.
Results:
- Overall median OS (all patients): Opdivo + Yervoy group 13.9 months vs. EXTREME group 13.5 months — no significant difference.
- Median OS in PD-L1-positive patients (CPS≥20): Opdivo + Yervoy group 17.6 months vs. EXTREME group 14.6 months — no significant difference.
Secondary endpoints:
- Median OS in PD-L1-positive patients (CPS≥1): Opdivo + Yervoy group 15.7 months vs. EXTREME group 13.2 months.
- Median PFS in PD-L1-positive patients (CPS≥20): Opdivo + Yervoy group 5.4 months vs. EXTREME group 7.0 months.
- ORR in PD-L1-positive patients (CPS≥20): Opdivo + Yervoy group 34.1% vs. EXTREME group 36.0%.
- Median DoR: Opdivo + Yervoy group 32.6 months vs. EXTREME group 7.0 months.
Safety:
Grade 3–4 adverse events: Opdivo + Yervoy group 28.2% vs. EXTREME group 70.7%.
Based on the CheckMate 651 results, Robert I. Haddad and colleagues concluded: In recurrent or metastatic HNSCC patients, Opdivo + Yervoy as first-line treatment did not demonstrate significant improvements in OS compared to the EXTREME regimen in either all patients or PD-L1-positive (CPS≥20) patients. Additionally, the safety profile of Opdivo + Yervoy did not reflect a favorable response advantage.
Source: https://ascopubs.org/doi/full/10.1200/JCO.22.00332
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