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. 2021 Nov 5;13(21):5550.
doi: 10.3390/cancers13215550.

Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study

Morten Fink  1 , Anders Schwartz Vittrup  1 , Lars Bastholt  2 , Inge Marie Svane  3 , Marco Donia  3 , Adam A Luczak  4 , Christina H Ruhlmann  5 , Louise Mahncke Guldbrandt  1 , Ulrich Heide Koehler  1 , Mette Lerche Winther  2 , Eva Ellebaek  3 , Charlotte Aaquist Haslund  4 , Henrik Schmidt  1
Affiliations

Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study

Morten Fink et al. Cancers (Basel). .

Abstract

Immune-related adverse events (irAEs) are very prevalent when treating patients with ipilimumab and nivolumab in combination, and 30-40% of patients discontinue the treatment for this reason. It is of high clinical relevance to investigate the consequences of discontinuing the treatment early since combination therapy with ipilimumab and nivolumab is the first line of treatment for many patients with metastatic melanoma. In this follow-up study, with real-world data from the nationwide DAMMED database, we investigated whether there was a difference in progression-free survival (PFS) and overall survival (OS) for patients who discontinued or did not discontinue treatment within the first four doses of treatment due to irAEs. In total, 448 patients were treated with ipilimumab and nivolumab. Of these, 133 patients discontinued due to irAEs in the induction phase. Using the Cox proportional hazards model, there was no significant difference in PFS when comparing the group that discontinued with the group that did not discontinue. The group that discontinued had a significantly longer OS than the group that received the full length of treatment. Therefore, we conclude that there is no significant negative impact on efficacy for patients who discontinue due to irAEs in the induction phase of combination immunotherapy for metastatic melanoma.

Keywords: DAMMED; immune-related adverse events; immunotherapy; ipilimumab; melanoma; nivolumab.

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Conflict of interest statement

Inge Marie Svane has received honoraria for consultancies and lectures from Novartis, Roche, Merck and Bristol-Myers Squibb; a restricted research grant from Novartis; and financial support for attending symposia from Bristol-Myers Squibb, Merck, Novartis, Pfizer and Roche. Marco Donia has for the past two years received honoraria for lectures from Roche, and institutional research support from Bristol Myers Squibb. Eva Ellebaek has received honoraria from BMS, Pierre Fabre, and Novartis for consultancies and lectures, and travel/conference expenses from MSD.

Figures

Figure 1
Figure 1
Patients divided into groups matching their discontinuation status and reason.
Figure 2
Figure 2
Kaplan–Meier plot showing the progression-free survival for the two groups, respectively.
Figure 3
Figure 3
Kaplan–Meier plot showing the overall survival for the two groups, respectively.
See this image and copyright information in PMC

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