Abstract 69P
Background
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.
Methods
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.
Results
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.
Conclusions
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.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
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.