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FDA added another on Thursday, with the PD-1 immune checkpoint inhibitor now approved as an adjuvant treatment for esophageal and gastroesophageal junction (GEJ) cancers.

Nivolumab is specifically indicated for patients with residual pathologic disease following neoadjuvant chemoradiotherapy (CRT) and complete surgical resection. This marks the first immunotherapy approval in this patient population.

Approval was based on findings from CHECKMATE-577, a phase III trial that randomized 794 patients (2:1) with residual pathologic disease following neoadjuvant CRT and completely resected tumors to either nivolumab or placebo.

"We saw a doubling in median disease-free survival [DFS] compared to placebo, which suggests that Opdivo could become a new standard of care for these patients," said Ronan J. Kelly, MD, MBA, of the Baylor Scott & White Charles A. Sammons Cancer Center in Dallas, in a from drugmaker Bristol Myers Squibb. "This is exciting news, providing renewed hope."

Median DFS improved from 11 months in the placebo arm to 22.4 months with the addition of nivolumab (HR 0.69, 95% CI 0.56-0.85, P=0.0003), and the benefit was observed regardless of PD-L1 expression or tumor histology:

• Adenocarcinoma: HR 0.75 (95% CI 0.59-0.96)
• Squamous cell carcinoma: HR 0.61 (95% CI 0.42-0.88)

"Locally advanced esophageal and [GEJ] cancers are aggressive tumor types that often require multiple approaches to address the disease, including chemotherapy, radiation and surgery," said Kelly. "Even after neoadjuvant CRT followed by surgery, there may be a high risk of recurrence for patients who do not achieve a pathologic complete response."

Common adverse events (≥20%) associated with nivolumab in CHECKMATE-577 included fatigue, diarrhea, nausea, rash, musculoskeletal pain, and cough. Treatment discontinuation and dose delays for toxicity occurred in 12% and 28% of patients, respectively. Pneumonitis was the most common (≥2%) serious toxicity seen in the trial, and there was one fatal reaction (myocardial infarction) following administration of the drug.

The recommended dosing for nivolumab in this setting is 480 mg intravenous every 4 weeks or 240 mg every 2 weeks for 1 year of treatment.

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