Neoadjuvant Immunotherapy: A Promising New Standard of Care

Abstract

Neoadjuvant immunotherapy has emerged as a promising approach in the treatment of various malignancies, with preclinical studies showing improved immune responses in the preoperative setting. FDA-approved neoadjuvant-immunotherapy-based approaches include triple-negative breast cancer and early non-small cell lung cancer on the basis of improvement in pathological response and event free survival. Nevertheless, current trials have only shown benefits in a fraction of patients. It is therefore crucial to identify predictive biomarkers to improve patient selection for such approaches. This review aims to provide an overview of potential biomarkers of neoadjuvant immunotherapy in early triple-negative breast cancer, bladder cancer, melanoma, non-small cell lung cancer, colorectal cancer and gastric cancer. By the extrapolation of the metastatic setting, we explore known predictive biomarkers, i.e., PD-L1, mismatch repair deficiency and tumour mutational burden, as well as potential early-disease-specific biomarkers. We also discuss the challenges of identifying reliable biomarkers and the need for standardized protocols and guidelines for their validation and clinical implementation.

Neoadjuvant followed by adjuvant pembrolizumab in melanoma: time biases in the data analysis of the SWOG S1801 trial.

“…The phase 3 NADINA trial is investigating the role of 2 cycles of ipilimumab (80 mg) and nivolumab (240 mg) before surgery [18] . Other neoadjuvant immunotherapy strategies, like intratumoral injections, are being investigated within ongoing or completed phase 3 trials (NeoDREAM NCT03567889, PIVOTAL NCT02938299) [19] .…”

Management of stage III non-small-cell lung cancer: rays of hope

“…Recently, the results of several randomized phase II and III trials of neoadjuvant and pre-operative ICI, combined with CT for resectable NSCLC, have been presented or published [ 27 ]. The theoretical advantage of a neoadjuvant approach stands in an enhance antitumor immune response as tumor antigens and lymph nodes are still in place [ 28 , 29 ].…”

A Narrative Review of Current Knowledge on Cutaneous Melanoma

“…In the case of immune therapies, preclinical studies have shown that preoperative administration leads to increased survival. There are hypotheses suggesting that even a single dose of a PD-1 inhibitor could potentially stimulate the activity of cytotoxic lymphocytes [168]. Moreover, in the case of Pembrolizumab, randomized clinical trials have observed an increased efficiency of neoadjuvant administration.…”