§ Time on pembrolizumab § Time aaer stopping pembrolizumab § PD • Deceased è Con5nued response
29 28 27
Pa5ent/physician decision
Methods
Between sep 2014 and april 2016: 141 pa5ents recieved pembrolizumab (2 mg/kg q3wks) in an EAP at the UZ Brussel. Data with regards to treatment disposi5on and outcome were collected at baseline and during further treatment. Pa5ents discon5nuing their treatment on pembrolizumab for reasons other than progressive disease progression (PD) were iden5fied and classified as “stop due to adverse events” or “pa5ents/physicians decision in the absence of PR or AE”.
31
26 25 24 23 22 21 20 19 18 17 16 15 14 13
Table 1: Overview of subgroups.
12 11 10 9 8 7 6
AE
Pembrolizumab is a PD-‐1 blocking an5body that is approved for the treatment of advanced melanoma. While maximum dura5on of treatment in responding pa5ents was arbitrarily determined to be a maximum of 2 years in the registra5on trials, op5mal dura5on of therapy has not been determined.
5 4 3 2 1 0 0
16
32
48
64
80
96
112
128
144
Figure 2: Swimmerplot: Overview 30 pa5ents discon5nuing pembrolizumab in absence of PD.
160
Figure 1: subgroup defini5on
Figure 3: OS of the total cohort (N=141).
Figure 4: OS pts discon5nuing due to AE (N=6) vs pt/physician decision (N=24).
Table 2:Overview of AE leading to permanent pembrolizumab discon5nua5on.
Relapses Pa?ent/physcian decision: 1 relapse aaer 9 weeks with succesfull pembrolizumab reintroduc5on leading to a new CR Discon?nua?on due to AE 2 Pa5ents relapsed aaer respec5vely 16 weeks and 17 weeks with good response aaer start of BRAF + MEK inhibitor
Conclusion In this real life single centre experience, advanced melanoma pa5ents stopped pembrolizumab treatment upon decision taken by pa5ent/physician in the absence of progressive disease or adverse events. This subgroup was at low risk for short term progression (median FU 34 weeks). Addi5onal follow-‐up is needed to determine the long-‐term PFS and outcome of pa5ents who are retreated at progression. Early interrup5on of pembrolizumab treatment in the absence of PD or AE could be a viable op5on that reduces treatment intensity without sacrificing long-‐term outcome.