In a French phase II trial (IMMUNEBOOST-HPV) reported in the Journal of Clinical Oncology, Mirghani et al found that use of induction nivolumab prior to chemoradiation (CRT) did not meet the endpoint of ‘receipt of full treatment in due time’ (FTDT) in patients with high-risk human papillomavirus (HPV)-driven oropharyngeal cancer.
Study Details
The multicenter trial included 61 evaluable patients with HPV-positive oropharyngeal cancer with either T4 and/or N2/N3 disease or a smoking history of more than 10 pack-years. They were randomly assigned 2:1 between July 2019 and September 2021 to receive two nivolumab infusions of 200 mg 2 weeks apart followed by CRT (70 Gy with cisplatin; experimental arm, n = 41) or CRT alone (n = 20).
The primary endpoint was rate of patients receiving FTDT, defined as:
- Two nivolumab infusions on days 1 and 13 to 17
- CRT started between days 27 and 37 after the first nivolumab infusion
- No radiotherapy break ≥ 7 days
- > 95% of theoretical/prescribed RT dose
- Cisplatin dose received ≥ 200 mg/m2.
If two or fewer patients in the experimental arm failed FTDT, the strategy would be considered feasible.
Key Findings
The primary endpoint was not met, since 4 of 41 patients in the experimental arm received < 200 mg/m2 cisplatin.
The 2-year cumulative incidence of relapse was 7.3% (95% confidence interval [CI] = 1.9%–18.0%) in the experimental arm vs 15.0% (95% CI = 3.6%–34.0%) in the control group.
Grade 4 or 5 adverse events were observed only in the experimental arm, occurring in seven patients.
The investigators concluded: “Induction nivolumab before CRT did not meet the predefined feasibility threshold because of reduced cisplatin dosing after toxicity in 10% of patients. The relapse incidence was numerically lower in the experimental arm but this finding is exploratory and requires confirmation.”
Haitham Mirghani, MD, PhD, of University Paris Cité, INSERM U970, PARCC, Paris, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by the French National Cancer Institute. For full disclosures of the study authors, visit ascopubs.org.
