KEY TAKEAWAYS
- CheckMate 577 Phase 3 trial aimed to assess the disease-free survival of individuals diagnosed with stage II or III esophageal or gastroesophageal junction cancer.
- The trial randomly divided patients into two groups: one group received nivolumab treatment, administered at 240 mg every 2 weeks for 16 weeks.
- The median disease-free survival for the nivolumab group was 22.4 months, whereas the placebo group had a median disease-free survival of 11.0 months.
- Adjuvant therapy with nivolumab extended disease-free survival in patients who underwent surgical resection for esophageal or gastroesophageal junction cancer.
There’s been no established adjuvant treatment for patients with a high risk of recurrence following neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer. CheckMate 577 trial was undertaken as a global, randomized, double-blind, placebo-controlled phase 3 trial to assess the efficacy of a checkpoint inhibitor as adjuvant therapy in individuals diagnosed with esophageal or gastroesophageal junction cancer. In this study, individuals diagnosed with resected (R0) stage II or III esophageal or gastroesophageal junction cancer who had undergone neoadjuvant chemoradiotherapy but still had residual pathological disease were randomly divided into two groups. The first group received nivolumab, while the second group received a placebo designed to match the nivolumab treatment. The primary outcome measure assessed in this study was disease-free survival.
The study included 794 patients, 532 patients receiving nivolumab, and 262 receiving a placebo. The median disease-free survival for the nivolumab group was 22.4 months (95% CI, 16.6 to 34.0), whereas the placebo group had a median disease-free survival of 11.0 months (95% CI, 8.3 to 14.3). The hazard ratio for disease recurrence or death was calculated to be 0.69 (96.4% CI, 0.56 to 0.86; P<0.001), indicating a significant difference between the two groups. Nivolumab demonstrated a favorable disease-free survival outcome in various prespecified subgroups. In the study, 71 out of 532 patients (13%) in the nivolumab group and 15 out of 260 patients (6%) in the placebo group experienced Grade 3 or 4 adverse events. The investigators deemed these adverse events associated with the active drug or the placebo. The trial protocol was terminated due to adverse events related to the active drug or placebo, affecting 9% of patients in the nivolumab group and 3% in the placebo group. In the cohort of individuals who underwent surgical removal of esophageal or gastroesophageal junction cancer and previously treated with neoadjuvant chemoradiotherapy, the duration of being free from disease was notably extended in patients who received adjuvant therapy with nivolumab compared to those who were administered a placebo.
Source: https://pubmed.ncbi.nlm.nih.gov/33789008/
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02743494
Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lièvre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. doi: 10.1056/NEJMoa2032125. Erratum in: N Engl J Med. 2023 Feb 16;388(7):672. PMID: 33789008.
