Optimizing the dose and schedule of immune checkpoint inhibitors in cancer to allow global access. Correspondence from Duncan C. Gilbert and colleagues MRCCTU
. A complete response was achieved in 63% of patients, but patients receiving fewer than 6 months of treatment had a higher risk of relapse. Similarly, the CheckMate 153 phase 3b/4 study included a cohort of patients diagnosed with NSCLC who were randomized to continue or discontinue nivolumab after 1 year. Median PFS was longer with continuous treatment, and although not formally powered, median OS was also longer in the continuous arm.
Many randomized trials are evaluating dose optimization of immunotherapy drugs, broadly testing early cessation, extended interval administration or reduced doses . The multi-center DANTE trial in the UK is evaluating the overall duration of immune checkpoint inhibitors in metastatic melanoma, randomizing patients that respond after 12 months of treatment between stopping and continuation, with a primary endpoint of PFS.
Several French and US studies are using a two-armed approach to investigate extending the interval between the administration of immune checkpoint inhibitors. In the UK, the multistage REFINE basket trial includes patients with advanced-stage cancer treated with immune checkpoint inhibitors who show a response or stable disease at 3 months.
The effect of reducing doses is also being explored with the DEDICATION-1/NVALT30 trial, a Dutch non-inferiority study comparing 300 mg of pembrolizumab with the usual 400 mg every 6 weeks in patients with advanced NSCLC — an innovative example of a self-funding trial. The DELLI trial is enrolling patients in India with recurrent or relapsed solid tumors that progress after first-line systemic therapy and who are eligible for second-line treatment.
The above treatment optimization trials should be supported enthusiastically to reduce costs and, potentially, toxicity; late toxicity of immune checkpoint inhibitors is increasingly recognized and may be in part due to treatment exposure
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