Abstract
Background: Treatment (tx) for LA SCCHN includes a combination of surgery, radiation and/or chemotherapy followed by monitoring for local recurrence/distant metastases as standard of care. Given poor outcomes, there remains a clear unmet need in this pt population. IMvoke010 (NCT03452137) evaluated the efficacy and safety of atezo in pts with LA SCCHN who are at high-risk for disease progression following multi-modal definitive tx.
Methods: Eligible pts 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]) with no disease progression after multi-modal definitive tx were randomized (1:1) to receive atezo 1200 mg or placebo. Tx was given every 3 weeks for 1 year or until disease progression, unacceptable toxicity or consent withdrawal. Primary endpoint: investigator-assessed event-free survival (INV-EFS). Other key endpoints: overall survival (OS, secondary for efficacy) and safety.
Results: A total of 406 pts were randomized to receive either atezo (n=203) or placebo (n=203). 156 (38.4%) pts underwent surgery as part of definitive tx. At clinical cutoff (27 September 2023), median follow-up was 46.5 months (mos). Median INV-EFS was 59.5 mos with atezo vs 52.7 mos with placebo (HR, 0.94; 95% CI, 0.70-1.26). INV-EFS results were generally consistent across all subgroups. OS showed no difference between arms for atezo vs placebo. Safety data are reported (Table).
Conclusion: This study did not meet the primary endpoint of INV-EFS, a numerical improvement in INV-EFS was observed for atezo in pts with LA SCCHN, but this was not statistically significant. Atezo was generally well tolerated, and no new safety signals were identified.
Key efficacy and safety results
| Efficacy . | Atezo (n=203)* . | Placebo (n=203) . |
|---|---|---|
| Median INV-EFS, mos | 59.5 | 52.7 |
| HR (95% CI) | 0.94 (0.70-1.26) | |
| P-value | 0.6804† | |
| Median OS, mos | NE | NE |
| HR (95% CI) | 0.96 (0.68-1.36) | |
| Safety, n (%) | ||
| Grade 3-4 AEs | 55 (27.2) | 43 (21.2) |
| TRAEs Grade 3-4 | 20 (9.9) | 12 (5.9) |
| Grade 5 AEs | 3 (1.5) | 5 (2.5) |
| SAEs | 32 (15.8) | 32 (15.8) |
| AEs leading to tx discontinuation | 18 (8.9) | 9 (4.4) |
| Efficacy . | Atezo (n=203)* . | Placebo (n=203) . |
|---|---|---|
| Median INV-EFS, mos | 59.5 | 52.7 |
| HR (95% CI) | 0.94 (0.70-1.26) | |
| P-value | 0.6804† | |
| Median OS, mos | NE | NE |
| HR (95% CI) | 0.96 (0.68-1.36) | |
| Safety, n (%) | ||
| Grade 3-4 AEs | 55 (27.2) | 43 (21.2) |
| TRAEs Grade 3-4 | 20 (9.9) | 12 (5.9) |
| Grade 5 AEs | 3 (1.5) | 5 (2.5) |
| SAEs | 32 (15.8) | 32 (15.8) |
| AEs leading to tx discontinuation | 18 (8.9) | 9 (4.4) |
CI, confidence interval; HR, hazard ratio; *safety-evaluable pts (n=202); †α boundary: 0.0427
Citation Format: Deborah J. Wong, Jérôme Fayette, Maria Teixeira, Kumar Prabhash, Ricard Mesia, Andrzej Kawecki, Arunee Dechaphunkul, José Dinis, Ye Guo, Muneyuki Masuda, Ching-Yun Hsieh, Maria Grazia Ghi, Claudia Vaz de Melo Sette, Tao Jiang, Yibing Yan, Monika Kaul, Ritika Jagtiani, Christina Matheny, Vaikunth Cuchelkar, Robert Haddad. 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) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr CT009.
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