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 . 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 .
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.
- Doki Y, et al. N Engl J Med. 2022;386:449–462.
- 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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Table of Contents: ASCO GI 2023
Letter from the Editor
ASCO GI 2023 Highlights Podcast
Oesophageal and Gastric Cancer
Zolbetuximab plus mFOLFOX6 successful in CLDN18.2-positive subgroup of gastric cancer
Regorafenib offers survival benefit for patients with pre-treated gastric cancer
Radiotherapy or not in locally advanced oesophageal or junctional cancer?
Neoadjuvant immunotherapy is safe and efficacious in a phase 2 gastric cancer trial
S-1 adjuvant chemotherapy: 4 or 8 courses in stage 2 gastric cancer?
LATG/LAPG demonstrates excellent long-term efficacy in stage 1 gastric cancer
3-year follow-up data confirms benefits of nivolumab plus chemotherapy
Long-term results for nivolumab plus chemotherapy and nivolumab plus ipilimumab in oesophageal cancer
Promising phase 2 results for HER-Vaxx in gastric cancer
Anal and Colorectal Cancer
IMbrave 151 missed primary endpoint in advanced BTC
Combination botensilimab plus balstilimab demonstrates promising activity in heavily pre-treated MSS CRC
Mutation-based selection to identify patients suitable for panitumumab treatment
Fucoidan associated with quality-of-life benefits in patients with rectal cancer receiving CCRT
ctDNA appears useful in monitoring patients with anal cancer undergoing CRT
SUNLIGHT trial meets primary endpoint in refractory metastatic CRC
Does cell-free DNA influence MRD testing in post-operative colon cancer?
OPERA: surgery may be avoided with adequate therapy in rectal cancer
Can we improve total neoadjuvant therapy for rectal cancer?
Palliative radiation therapy improves hepatic pain in HCC and liver metastasis
Improved survival following postoperative sorafenib plus TACE in HCC
Quality-of-life benefits for tislelizumab in uHCC
Stereotactic body radiation therapy beneficial for patients with locally advanced HCC
SWOG 1815, first-ever phase 3 trial in BTC, fails
Acceptable safety profile and encouraging efficacy of nanvuranlat in BTC
First-line NALIRIFOX superior to standard treatment in mPDAC
Novel approach delivers quality-of-life benefits for patients with pancreatic cancer
ESMO 2021 Highlights Podcast