Patients and Researchers Push for Lower Doses of Expensive Cancer Immunotherapies

Northwestern economist Chuck Manski stopped a year-long nivolumab infusion for advanced melanoma after it damaged his thyroid and caused severe dryness, echoing a global trend of clinicians using lower or less frequent immunotherapy doses. Researchers and patients argue that reduced dosing of drugs such as nivolumab (Opdivo) and pembrolizumab (Keytruda) could spare patients toxicities and save the U.S. health system billions, yet pharmaceutical firms have little incentive to study cheaper regimens.

Studies from India report efficacy with doses as low as one-twelfth of the label, while European and VA pilots are evaluating half-dose or spaced-out schedules. The FDA’s Project Optimus, launched in 2021, now requires more precise dose-finding before approval, but it cannot compel post-approval trials. Major oncology groups at ASCO are launching multi-arm trials, and advocates like Kelly Shanahan push companies to disclose real-world dose-adjustment data. The debate highlights a clash between patient safety, cost containment and pharmaceutical profit motives.