KEY TAKEAWAYS
- The IMvoke010 phase 3 trial aimed to investigate the efficacy and safety of atezolizumab in patients with locally advanced SCCHN post-definitive therapy.
- The primary endpoint was to determine INV-EFS.
- Researchers noticed a numerical improvement in INV-EFS with atezo in high-risk LA SCCHN patients; further investigation is ongoing.
Treatment for locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) typically involves surgery, radiation, and/or chemotherapy, with subsequent surveillance for recurrence/metastases due to poor outcomes. However, an unmet need persists in this patient population.
In this study, IMvoke010 (NCT03452137), D. J. Wong and her team aimed to investigate atezolizumab (atezo) efficacy and safety in high-risk LA SCCHN post-definitive therapy.
Researchers performed an inclusive analysis on eligible patients with LA SCCHN (Stage IVa or IVb involving the oral cavity, larynx, hypopharynx, HPV negative oropharynx, or Stage III HPV positive oropharynx [per AJCC 8th edition]) who had undergone multi-modal definitive treatment without disease progression. These patients were randomized (1:1) to receive either atezo 1200 mg or placebo.
Treatment was administered every 3 weeks for up to 1 year or until disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was investigator-assessed event-free survival (INV-EFS), with overall survival (OS) as a key secondary endpoint for efficacy, alongside safety assessments.
About 406 patients were randomized, with 203 receiving atezo and 203 receiving placebo. Of these, 156 (38.4%) underwent surgery as part of their definitive treatment. As of the clinical cutoff on September 27, 2023, the median follow-up period was 46.5 months.
The median INV-EFS was 59.5 months with atezo compared to 52.7 months with placebo (HR 0.94; 95% CI 0.70-1.26). INV-EFS outcomes were consistent across all subgroups. OS did not differ significantly between the atezo and placebo arms.
The study concluded that while atezolizumab did not meet the primary endpoint of INV-EFS in patients with LA SCCHN, a numerical improvement was observed. However, this improvement did not reach statistical significance. Atezo was generally well tolerated, and no new safety signals were identified.
The trial was sponsored by the Hoffmann-La Roche.
Source: https://www.abstractsonline.com/pp8/#!/20272/presentation/11426
Clinical Trial: https://clinicaltrials.gov/study/NCT03452137
Wong D. J., Fayette J., Teixeira M., et al. (2024). “IMvoke010: A phase III, double-blind randomized trial of atezolizumab (atezo) after definitive local therapy vs placebo in patients (pts) with high-risk locally advanced (LA) squamous cell carcinoma of the head and neck (SCCHN).” Presented at AACR 2024 (Abstract CT009).
