Abstract
Immune checkpoint inhibition has transformed cancer treatment. For gastroesophageal cancer, this class of drugs have demonstrated durable responses and survival benefit in a subgroup of patients, resulting in regulatory approval. However, several recent randomized phase III studies in gastroesophageal cancer have reported negative results, blunting initial enthusiasm. Identification and validation of predictive biomarkers with appropriate patient selection for benefit from immunotherapy is an area of intense research with novel concepts rapidly emerging. In this review we describe the latest immune checkpoint inhibitor trials which have been reported in gastroesophageal cancers with a focus on predictive biomarkers. We also explore novel biomarkers being developed to improve precision oncology for immunotherapy in gastroesophageal cancers.
Highlights
Gastroesophageal cancers (GEC) are a leading cause of cancer morbidity and mortality globally
Prespecified analysis of health-related quality of life was better for nivolumab compared to chemotherapy, which is of importance given a proportion of patients continue with nivolumab for a prolonged period of time [42]
*this is the prevalence of combined positive score (CPS) ≥ 10 within this trial, which is a biomarker selected population of CPS ≥ 1. +this trial did not differentiate between CPS 0, and CPS ≥ 1, and the survival/response rates reported here is for the entire trial population
Summary
Gastroesophageal cancers (GEC) are a leading cause of cancer morbidity and mortality globally. Several anti-PD-1 and anti-PD-L1 antibodies are approved as single-agents and in combination with other drugs for the treatment of multiple tumor types including lung cancer, melanoma, renal cell carcinoma, hepatocellular carcinoma, and others [20, 21]. Several phase III trials across multiple tumor types (including GEC) have reported negative outcomes, with ICI failing to demonstrate superiority over standard-of-care (SOC) therapies [22,23,24,25,26,27,28]. These studies highlight the importance of biomarker development and appropriate patient selection for ICI. The PD-L1 CPS score was developed using the 22C3 assay as a companion diagnostic for pembrolizumab in GC and has been FDA approved [33]
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