Nivo-adjuvant.

Top Line: Does adjuvant immunotherapy improve outcomes for patients with resected esophageal or EG junction cancer?

The Study: CheckMate 577 enrolled patients with stage II or III esophageal or EG junction cancer that had been treated with neoadjuvant chemoradiation followed by an R0 resection with residual primary and/or nodal disease (i.e. no pathologic complete response). Also, patients were enrolled regardless of PD-L1 status. Among the nearly 800 patients enrolled, >80% were men, ~70% were from western countries, >60% had stage III disease, 60% had primary esophageal tumors, 71% had adenocarcinoma, <20% had PD-L1 expression ≥ 1%, and most had residual primary disease. They were randomized to placebo or nivolumab, which was given at 240 mg q2 weeks x 16 weeks followed by 480 mg q4 weeks for up to a year total. The addition of adjuvant nivo doubled median disease-free survival from 11→ 22 months. This was a heterogeneous population, but the benefit of nivo was seen across most subgroups (including PD-L1 status). With that said, patients with esophageal primaries and those with squamous histology appeared to derive a greater benefit than those with GE junction primaries and/or adenocarcinoma. Overall survival results are maturing.

TBL: Adjuvant nivolumab doubles median disease-free survival in patients with esophageal/EG junction cancer who have completely resected residual disease after neoadjuvant chemoradiation. | Kelly, N Engl J Med 2021

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