A recent study conducted by researchers at Karolinska Institutet in Sweden indicates that administering lower doses of immunotherapy for malignant melanoma can enhance treatment effectiveness while minimizing side effects. The findings were published in the Journal of the National Cancer Institute, presenting a significant shift in how these therapies may be administered.
Hildur Helgadottir, a researcher at the Department of Oncology–Pathology and the study’s lead author, stated, “The results are highly interesting in oncology, as we show that a lower dose of an immunotherapy drug, in addition to causing significantly fewer side effects, actually gives better results against tumors and longer survival.” This highlights a crucial advancement in the treatment of one of the most aggressive forms of skin cancer.
Shift in Treatment Regimen
Traditionally, the approved dose of nivolumab and ipilimumab has been standardized, but Sweden has begun exploring lower doses due to the severe side effects associated with these treatments. The higher cost of ipilimumab, which contributes significantly to these adverse effects, has prompted healthcare providers to adopt a more flexible approach to dosing.
“In Sweden, we have greater freedom to choose doses for patients, while in many other countries, due to reimbursement policies, they are restricted by the doses approved by the drug authorities,” Helgadottir noted. This flexibility allows for a more tailored approach to patient care.
The study involved nearly 400 patients diagnosed with advanced, inoperable malignant melanoma, providing a solid foundation for its conclusions. The results demonstrated that the lower dose of ipilimumab led to a higher response rate among patients—49% compared to 37% for those receiving the traditional dosage. Additionally, the median progression-free survival for patients on the lower dose was nine months, significantly longer than the three months observed with the standard treatment.
Improved Outcomes and Side Effects
Overall survival rates also reflected this trend, with patients receiving the lower dosage living an average of 42 months compared to just 14 months for those on the higher dose. Notably, serious side effects were reported in only 31% of patients in the low-dose group, whereas 51% experienced severe reactions in the traditional group.
“The new immunotherapies are very valuable and effective, but at the same time they can cause serious side effects that are sometimes life-threatening or chronic,” Helgadottir remarked. The findings suggest that reducing the dosage may enable more patients to sustain treatment for extended periods, thus contributing to improved outcomes and prolonged survival rates.
While the study offers promising insights, it is important to note that it is a retrospective observational study. As such, it cannot definitively establish a causal relationship between the lower dosage and the improved patient outcomes. Researchers adjusted for various factors, including age and tumor stage, yet the observed benefits of the lower dose of ipilimumab persisted.
As the medical community continues to explore innovative treatment options, this study underscores the potential for new dosing strategies to enhance patient care in oncology. Further research will be necessary to validate these findings and potentially influence treatment protocols on a global scale.
For more detailed information, the study is titled “Evaluation of the flipped dose NIVO3+IPI1 in patients with advanced unresectable melanoma,” published in the Journal of the National Cancer Institute in 2025, DOI: 10.1093/jnci/djaf327.
