Conventional time to event endpoints, such as overall survival and progression-free interval fail to reflect quality of life when characterizing outcomes with immune checkpoint inhibitors (ICI). Treatment-free survival (TFS) represents an alternative approach, to more accurately characterize the time free of systemic therapy, providing a more patient-centric view of ICI therapy. There remains a paucity of studies evaluating TFS outcomes in advanced melanoma patients receiving immunotherapy, especially in the non-clinical trial context. Here, we present the first real-world observational analysis of TFS outcomes for patients with advanced melanoma receiving first-line ICI therapy.
Demographic, clinical and survival characteristics of patients with advanced melanoma receiving first-line ICI therapy (n=316) was collected retrospectively from a multi-center observational cohort study in Alberta, Canada. Treatment-free survival was defined as the difference in the 36-month restricted mean survival time between 2 survival endpoints, time to ICI cessation or censored at last follow up, and time to subsequent systemic anti-cancer therapy, death or censored at last follow up.
The restricted mean TFS was longer for nivolumab plus ipilimumab (mean 12.38 months, 95% CI 8.79-16.00) when compared to nivolumab (mean 8.93 months 95% CI 4.38-13.47) and pembrolizumab (mean 11.14 months, 95% CI 8.47, 13.80). During the 36 month follow up, interval patients treated with Nivolumab plus ipilimumab spent 34.4% of their time off systemic anticancer treatments, compared to the 30.9% and 24.8% of their time for the pembrolizumab and nivolumab treatment groups respectively.
TFS represents a patient-centric, informative endpoint for advanced melanoma patients treated with first-line ICI therapy. Of note, patients treated with combination nivolumab plus ipilimumab spent more time alive and free from systemic anti-cancer therapy than those treated with anti-PD-1 monotherapy alone. This information may inform therapeutic decision making, given the number of treatment choices available to clinicians and patients in this context.
The authors.
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D.Y.C. Heng: Non-Financial Interests, Personal, Advisory Role: Pfizer, Novartis, Bristol Myers Squib, Janssen, Astellas, Ipsen, Eisai, Merck; Financial Interests, Personal, Research Grant: Pfizer, Novartis, Exelixis, Bristol Myers Squibb, Ipsen. T. Cheng: Financial Interests, Personal, Research Grant: Pfizer. V. Navani: Non-Financial Interests, Personal, Advisory Role: Kyowa Kirin, Ipsos. All other authors have declared no conflicts of interest.