(Squamous Cell Carcinoma) Is Opdivo + Yervoy Effective as First-Line Treatment?

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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