|The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
The programmed death-1 (PD-1) inhibitor camrelizumab combined with paclitaxel and cisplatin has the potential to become a new standard first-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC).
The current standard first-line therapy for advanced or metastatic ESCC is doublet chemotherapy, and patient prognosis remains poor. Camrelizumab, a humanized anti-PD-1 monoclonal antibody, has shown promising activity in previously treated advanced or metastatic ESCC. This immunotherapy appears to work synergistically with chemotherapy, but clinical evidence has been lacking in ESCC, said lead author Rui-hua Xu, MD, PhD of the Sun-Yat Sen University Cancer Center in China during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
“Novel drugs and strategies are needed to improve clinical outcomes in this disease,” said Dr Xu.
This immune checkpoint inhibitor is also being investigated for the treatment of hepatocellular carcinoma and Hodgkin lymphoma, among other cancers.
The randomized, double-blind, placebo-controlled, phase 3 ESCORT-1st trial (ClinicalTrials.gov Identifier: NCT03691090) evaluated the efficacy and safety of camrelizumab plus chemotherapy vs chemotherapy in 596 patients with untreated advanced or metastatic ESCC. Eligible patients were randomly assigned to receive camrelizumab 200 mg (298 patients) or placebo (297 patients), both combined with up to 6 cycles of paclitaxel 175 mg/m2 and cisplatin 75 mg/m2, given intravenously once every 3 weeks.
Tumor response was assessed every 6 weeks according to RECIST v1.1. Co-primary endpoints were overall survival (OS) and independent review committee (IRC)-assessed progression-free survival (PFS). Efficacy was assessed in all randomly assigned patients and safety was assessed in all treated patients.
After a median follow-up of 10.8 months, camrelizumab plus chemotherapy was found to have improved OS (median, 15.3 months) compared with placebo plus chemotherapy (median, 12 months). PFS per IRC was also superior with camrelizumab plus chemotherapy (median, 6.9 months) vs placebo plus chemotherapy (median, 5.6 months).
The overall response rate per investigator was 72.1% in the camrelizumab-chemotherapy group vs 62.1% in the placebo-chemotherapy group. The disease-control rate was 93.1% vs 88.9%. “Median duration of response was also superior with camrelizumab-chemotherapy (7 months) over placebo (4.6 months),” said Dr Xu.
Incidences of grade 3 or higher treatment-related adverse events were comparable between the 2 groups (63.4% camrelizumab vs 67.7% placebo). Decreased neutrophil count (39.9% vs 43.4%) was the most common. Serious treatment-related adverse events occurred in 30.2% of camrelizumab-treated patients vs 23.2% of placebo who received patients, and treatment-related deaths occurred in 3% vs 3.7% of the two treatment arms, respectively. No new safety signals were identified.
“The addition of camrelizumab to chemotherapy provided superior OS and PFS vs placebo plus chemotherapy, with a manageable safety profile,” Dr Xu concluded.
Based on the results of this trial, the researchers are submitting a new drug application to seek the approval from China National Medical Products Administration for camrelizumab plus chemotherapy in the treatment of untreated advanced or metastatic ESCC.
Disclosure: This research was supported by Jiangsu Hengrui Medicine. Please see the original reference for a full list of authors’ disclosures.
Read more of Cancer Therapy Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.
Xu R, Luo H, Lu J, et al. ESCORT-1st: A randomized, double-blind, placebo-controlled, phase 3 trial of camrelizumab plus chemotherapy versus chemotherapy in patients with untreated advanced or metastatic esophageal squamous cell carcinoma (ESCC). J Clin Oncol. 2021;39:(suppl 15; abstr 4000). doi:10.1200/JCO.2021.39.15_suppl.4000