Camrelizumab add-on to chemo improves survival in patients with ESCC

Adding camrelizumab to chemotherapy led to significantly improved overall survival (OS) and progression-free survival (PFS) in patients with advanced or metastatic oesophageal squamous cell carcinoma (ESCC), according to the ESCORT-1st* study.

This phase III, double-blind, placebo-controlled, multicentre trial analysed 596 patients with advanced or metastatic ESCC (median age 62.0 years, 87.8 percent male) who were recruited from 60 hospitals in China. The participants were randomized to receive either intravenous camrelizumab 200 mg (n=298) or placebo (n=298) in addition to six cycles of chemotherapy (paclitaxel 175 mg/m² and cisplatin 75 mg/m²). All treatments were administered intravenously  every 3 weeks. [JAMA 2021;326:916-925]

At a median follow-up of 10.8 months, patients who received camrelizumab plus chemotherapy had a significantly longer OS than those who received placebo plus chemotherapy (median 15.3 vs 12.0 months; hazard ratio [HR], 0.70, 95 percent confidence interval [CI], 0.56–0.88; one-sided p=0.001).

Patients in the camrelizumab group also achieved a significantly longer PFS (median 6.9 vs 5.6 months; HR, 0.56, 95 percent CI, 0.46–0.68; one-sided p<0.001) than those in the placebo group.

A higher objective response rate was observed in the camrelizumab vs the placebo group (72.1 percent vs 62.1 percent; two-sided p=0.009), with a disease control rate of 91.3 percent vs 88.9 percent (p=0.33).

Treatment-related adverse events (AEs) occurred in 99.3 percent of patients in the camrelizumab group and 97.0 percent in the placebo group.

Decreased neutrophil count (39.9 percent vs 43.4 percent) and white blood cell count (24.2 percent vs 26.6 percent) and anaemia (17.4 percent vs 13.5 percent) were the most common grade ≥3 AEs reported in the camrelizumab vs placebo groups. Serious AEs occurred more often in the camrelizumab than the placebo group (30.2 percent vs 23.2 percent).

The camrelizumab group also demonstrated a higher rate of immune-related events than the placebo group (84.6 percent vs 33.0 percent). “[This] may have been due in part to the longer treatment exposure of this group,” the researchers noted.

“[Of note,] results showed that the AE profile observed in the current trial was consistent with that previously observed with camrelizumab, paclitaxel-cisplatin, as well as that with camrelizumab plus chemotherapy in other tumour types,” said the researchers. [Lancet Oncol 2020;21:832-842; Lancet Respir Med 2021;9:305-314]

“Both primary endpoints in this study were met at the pre-planned interim analysis of OS and final analysis of PFS … The [two-drug] cytotoxic regimen in this study was chosen according to both international and local treatment guidelines, and paclitaxel-cisplatin was recommended especially for ESCC in China,” according to the researchers.

“[In conclusion,] among patients with advanced or metastatic ESCC, the addition of camrelizumab to chemotherapy [as an initial treatment strategy], compared with placebo and chemotherapy, significantly improved OS and PFS,” said the researchers.

“The study was continued and the results of long-term assessment will be reported subsequently,” they noted.

*ESCORT-1st: Study of SHR-1210 in combination with chemotherapy in advanced esophageal cancer