Long-term results for nivolumab plus chemotherapy and nivolumab plus ipilimumab in oesophageal cancer

With long-term follow-up, both nivolumab plus chemotherapy and nivolumab plus ipilimumab continued to demonstrate clinically meaningful benefits over chemotherapy alone in the first-line treatment for patients with advanced oesophageal squamous cell carcinoma (OSCC). The updated results of the phase 3 CheckMate 648 trial further confirm these 2 treatment regimens as novel first-line options in patients with advanced OSCC.

The CheckMate 648 study (NCT03143153) showed that treatment with either nivolumab plus chemotherapy or nivolumab plus resulted in superior overall survival (OS) outcomes compared with chemotherapy alone in patients with advanced OSCC [1]. The study randomised 970 patients who were previously untreated for their advanced OSCC 1:1:1 to one of the 3 treatment arms. At the ASCO GI meeting, Dr Ken Kato (National Cancer Center Hospital, Japan) presented the results after a minimum follow-up of 29 months [2].

Nivolumab plus chemotherapy continued to outperform chemotherapy alone in terms of OS (median OS 12.8 vs 10.7 months; HR 0.78; 95% CI 0.65–0.93) and progression-free survival (5.8 vs 5.6; HR 0.83; 95% CI 0.68–1.00). Corresponding results in patients with tumour cell PD-L1 expression levels ≥1% for OS (15.0 vs 9.1; HR 0.59; 95% CI 0.46–0.76) and PFS (6.8 vs 4.4; HR 0.67; 95% CI 0.51–0.89) demonstrated ongoing benefits in this subset of patients as well.

Likewise, nivolumab plus ipilimumab displayed a superior median OS compared with chemotherapy alone in all randomised patients (12.7 vs 10.7; HR 0.77; 95% CI 0.65–0.92) and in patients with PD-L1 levels ≥1% (13.1 vs 9.1; HR 0.62; 95% CI 0.48–0.80). For progression-free survival, the updated data did not show a benefit for the combination regimen over chemotherapy in all patients (2.9 vs 5.6; HR 1.26; 95% CI 1.04–1.51) or in the subset of patients with PD-L1 levels ≥1% (4.0 vs 4.4; HR 1.04; 95% CI 0.79–1.36).

According to Dr Kato, no new safety issues emerged with longer follow-up. The most common treatment related adverse events in the nivolumab plus chemotherapy arm were nausea (59%), decreased appetite (43%), and stomatitis (32%). For the nivolumab plus ipilimumab arm these were rash (17%), pruritis (13%), and hypothyroidism (13%), and for the chemotherapy alone arm, the most frequently reported safety issues were nausea (52%), decreased appetite (43%), and anaemia (22%).

The long-term follow-up results of CheckMate 648 continue to support the use of the assessed nivolumab-containing regimens in the first-line treatment of patients with advanced OSCC.

1. Doki Y, et al. N Engl J Med. 2022;386:449–462.
2. Kato K, et al. Nivolumab (NIVO) plus chemotherapy (chemo) or ipilimumab (IPI) vs chemo as first-line (1L) treatment for advanced esophageal squamous cell carcinoma (ESCC): 29-month (mo) follow-up from CheckMate 648. Abstract 290, ASCO GI 2023, 19–21 January, San Francisco, CA, USA.

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Posted on 17 March 202321 May 2024