Outcomes of advanced melanoma patients who discontinued pembrolizumab (pembro) after complete response (CR) in the French early access program (EAP)

Characteristics and outcomes of advanced melanoma patients with complete response and elective discontinuation of first‐line anti‐programmed death‐1 monotherapy: A real‐world multicentre observational cohort study

“…Therefore, we performed an analysis of the association between the time on treatment and tumor progression, but we did not find any significant relation neither for the total duration of anti-PD1 therapy nor for the therapy duration after CR. However, it's important to mention that in the studies with the best results (24-month PFS from IT discontinuation >85%), including ours, the median duration of anti-PD1 therapy was close to 24 months (Dimitriou et al, 2021;Robert et al, 2018;Saiag et al, 2019).…”

“…This is concordant with results from KEYNOTE‐001 and KEYNOTE‐006 studies in which 24‐month PFS among patients with CR and who discontinued pembrolizumab were 89.9% and 85.4%, respectively (Robert et al, 2018, 2019). These results have been confirmed in real‐life studies on elective IT discontinuation: in a large real‐life French study Horizon, 24‐month PFS among 80 patients with CR who ceased treatment with pembrolizumab was 87% (Saiag et al, 2019) and in another cohort of 86 patient with CR who electively discontinued IT (90% anti‐PD1 monotherapy) it was 96% (Dimitriou et al, 2021). However, not all real‐world reports confirm these proportions; in a large cohort of 117 patients who electively discontinued IT, the 24‐month PFS was 80% (Jansen et al, 2019) and in two other studies, in which the majority of patients with CR discontinued IT electively, the 24‐month PFS was even below 80% (van Zeijl et al, 2022; Warner et al, 2020).…”

“…. These results have been confirmed in real-life studies on elective IT discontinuation: in a large reallife French study Horizon, 24-month PFS among 80 patients with CR who ceased treatment with pembrolizumab was 87%(Saiag et al, 2019) and in another cohort of 86 patient with CR who electively discontinued IT (90% anti-PD1 monotherapy) it was 96%(Dimitriou et al, 2021). However, not all real-world reports confirm Abbreviations: CR, complete response; PET-CT, Positron emission tomography-computed tomography.TA B L E 3 Treatment outcomes.Abbreviations: OS, overall survival; melOS, melanoma-specific OS; PFS, progression-free survival from the start of anti-PD1 treatment; PFS-TD, PFS after anti-PD1 treatment discontinuation.…”

“…First of all, these are studies with different designs and distinct populations included. The majority of the above‐mentioned studies, including the KEYNOTE‐001 trial, enrolled heterogeneous populations with up to 56% of patients treated previously with different therapy, including IT (Jansen et al, 2019; Robert et al, 2018; Saiag et al, 2019; Warner et al, 2020), and the patients included were treated with anti‐PD1 monotherapy but also with a combination of anti‐PD1 and ipilimumab (Dimitriou et al, 2021). Moreover, all these studies and KEYNOTE‐006 trial permitted inclusion of patients with mucosal melanoma (Dimitriou et al, 2021; Jansen et al, 2019; Robert et al, 2018, 2019; Saiag et al, 2019; Warner et al, 2020).…”

“…Taking into consideration the favorable prognosis of patients who achieve CR, it has been proposed that the treatment may be safely stopped in this patient subgroup. Data from several clinical trials and retrospective real-world studies seem to confirm this hypothesis with long-term progression-free survival (PFS) after treatment discontinuation in the range of 85%-96% among patients with CR (Dimitriou et al, 2021;Robert et al, 2018Robert et al, , 2019Saiag et al, 2019;Valentin et al, 2021). However, it may be difficult to draw clear conclusions from these studies, as they contain mixed populations including, for example, non-cutaneous melanoma, patients who received IT in 1st or further lines therapies and who were treated with both anti-PD1 or a combination of anti-PD1 and anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA4) antibodies.…”