Abstract
Patients with lung cancer are particularly vulnerable to complications from coronavirus disease-2019 (COVID-19). Recurrent hospital visits and hospital admission are potential risk factors for acquiring infection with its causative pathogen, severe acute respiratory syndrome coronavirus−2 (SARS-CoV-2). As immune checkpoint inhibitors (ICIs) constitute the therapeutic backbone for the vast majority of patients with advanced lung cancer in the absence of actionable driver oncogenes, there have been intense discussions within the oncology community regarding risk-benefit of delaying these treatments or use of alternative extended-interval treatment strategies to minimize the risk of viral transmission secondary to unintended nosocomial exposures. In the midst of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) granted accelerated approval for extended-interval strategy of pembrolizumab at a dose of 400 mg every 6 weeks for all already approved oncologic indications. Herein, we summarize the evidence from the in silico pharmacokinetic modeling/simulation studies supporting extended-interval dosing strategies for the ICIs used in lung cancer. We further review the evolving clinical evidence behind these approaches and predict that they will continue to be used in routine practice even long after the pandemic, particularly for patients with durable disease control.
Highlights
Immune checkpoint inhibitors (ICIs) have acquired an indisputable place in the evidencebased care of lung cancers [1]
The effect of anti-drug antibodies (ADA) on drug clearance merits further investigation, as a negative association with overall survival has been found for ipilimumab in patients with advanced melanoma [41], and conflicting results have been reported for nivolumab in the post-drug approval setting [16]
Knowledge of immune checkpoint inhibitors (ICIs) PK properties from dose-ranging studies during early drug development has proven fruitful in facilitating subsequent modeling and simulation efforts that have permitted exploration of the efficacy and safety of extended-interval dosing strategies, resulting in regulatory approval for multiple ICIs currently used in routine clinical practice
Summary
Patients with lung cancer are vulnerable to complications from coronavirus disease-2019 (COVID-19). In the midst of the COVID-19 pandemic, the U.S Food and Drug Administration (FDA) granted accelerated approval for extended-interval strategy of pembrolizumab at a dose of 400 mg every 6 weeks for all already approved oncologic indications. We summarize the evidence from the in silico pharmacokinetic modeling/simulation studies supporting extended-interval dosing strategies for the ICIs used in lung cancer. We further review the evolving clinical evidence behind these approaches and predict that they will continue to be used in routine practice even long after the pandemic, for patients with durable disease control
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