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Poster Display session 3

5005 - Real-world outcomes of ipilimumab plus nivolumab for advanced melanoma in the Netherlands

Date

30 Sep 2019

Session

Poster Display session 3

Presenters

Michiel van Zeijl

Citation

Annals of Oncology (2019) 30 (suppl_5): v533-v563. 10.1093/annonc/mdz255

Authors

M.C.T. van Zeijl1, M.W.J.M. Wouters2, A.J.M. van den Eertwegh3, L.C. de Wreede4, M.J.B. Aarts5, A.C.J. van Akkooi2, F.W.P.J. Van den Berkmortel6, J.W. de Groot7, M.J. Boers-Sonderen8, J.J.M. van der Hoeven8, G.A.P. Hospers9, E. Kapiteijn10, D. Piersma11, R.S. van Rijn12, K.P.M. Suijkerbuijk13, A.J. Ten Tije14, A.A.M. Van der Veldt15, G. Vreugdenhil16, J.B.A.G. Haanen17

Author affiliations

  • 1 Medical Oncology, Leiden University Medical Center (LUMC), 2300 RC - Leiden/NL
  • 2 Surgical Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, 1066 CX - Amsterdam/NL
  • 3 Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, location VUmc, 1081 HV - Amsterdam/NL
  • 4 Biomedical Data Sciences, Leiden University Medical Center (LUMC), 2300 RC - Leiden/NL
  • 5 Medical Oncology, Maastricht UMC+, 6229HX - Maastricht/NL
  • 6 Medical Oncology, Zuyderland Medical Center - Heerlen, 6419PC - Heerlen/NL
  • 7 Medical Oncology, Isala Clinics, 8025AB - Zwolle/NL
  • 8 Medical Oncology, Radboud University Medical Centre, Nijmegen/NL
  • 9 Medical Oncology, University Hospital Groningen (UMCG), 9700 RB - Groningen/NL
  • 10 Medical Oncology, Leids Universitair Medisch Centrum (LUMC), 2333 ZA - Leiden/NL
  • 11 Medical Oncology, Medisch Spectrum Twente, 7513 ER - Enschede/NL
  • 12 Medical Oncology, Medical Center Leeuwarden, 8934AD - Leeuwarden/NL
  • 13 Medical Oncology, University Hospital Utrecht, 3508 GA - Utrecht/NL
  • 14 Medical Oncology, Amphia Ziekenhuis, 4819EV - Breda/NL
  • 15 Medical Oncology, Erasmus University Medical Center, 3015 CE - Rotterdam/NL
  • 16 Medical Oncology, Maxima Medisch Centrum, 5500 MB - Veldhoven/NL
  • 17 Medical Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, 1066 CX - Amsterdam/NL
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Resources

Abstract 5005

Background

In phase III trials, the results of ipilimumab plus nivolumab combination therapy (IPI+NIVO) are promising for metastatic melanoma (MM), despite many treatment-related grade 3-4 adverse events (AEs). Here, we report real-world outcomes of IPI+NIVO for MM.

Methods

Patients with (non-uveal) MM who received 1st-line IPI+NIVO between 2015 and 2017 were selected from the Dutch Melanoma Treatment Registry, a nation-wide population based registry. Probability of 2nd-line treatment was estimated with competing risk analysis and overall survival (OS) with Kaplan-Meier method and Cox regression analysis.

Results

In total, 2116 pts with MM were treated with systemic therapy of which 151 pts with 1st-line IPI+NIVO. Median age was 58yrs versus 64yrs for pts treated with other systemic therapy in 1st-line. Half of the pts treated with 1st-line IPI+NIVO had elevated LDH, 90% an ECOG PS of ≤ 1, 32% brain metastases (21% symptomatic), 87% stage IV-M1c and 42% had BRAF-mutated melanoma. Grade 3-4 AEs occurred in 90 pts (60%); 39 (26%) had colitis, 37 (25%) hepatitis and 22 (13%) endocrine insufficiency. No deaths due to AEs were reported. For 66 pts who stopped IPI+NIVO because of AEs, 1-yr survival probability was 76% (95%CI: 66-87) compared to 57% (95%CI: 47-69) for the remaining 85 (56%) patients treated with 1st-line IPI+NIVO. A total of 50 (33%) pts completed all 4 courses of IPI+NIVO and 44 (29%) pts received maintenance with NIVO. The 1- and 2-yr OS probabilities (95%CI) were 66% (58-74%) and 55% (46-65%). Probability of still being in 1st-line IPI+NIVO at 1- and 2-yrs was 50% (95%CI; 42-59) and 34% (95%CI; 25-45). Cumulative incidence for 2nd-line treatment and death at 1yr were respectively 24% (95%CI: 18-33) and 27% (95%CI: 20-34). Adjusted HR for ECOG PS of ≥ 2, symptomatic brain metastases, liver metastases were respectively 3.1 (95%CI; 1.2-8.3), 2.0 (95%CI; 1.0-3.8), 2.2 (95%CI; 1.2-4.2). HR for BRAF-wildtype status was 0.5 (95%CI; 0.2-0.9).

Conclusions

Half of pts receiving 1st-line IPI+NIVO for MM had elevated LDH, one third brain metastases and a majority ECOG PS ≤ 1. Nevertheless, OS is encouraging especially in pts who stopped treatment due to AEs. With appropriate patient selection in real-world, promising results can be achieved with 1st-line IPI+NIVO.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

A.J.M. van den Eertwegh: Advisory / Consultancy: BMS; Advisory / Consultancy: Merck; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy: Novartis; Advisory / Consultancy: Amgen. A.C.J. van Akkooi: Advisory / Consultancy: Amgen; Advisory / Consultancy: BMS; Advisory / Consultancy: Novartis; Advisory / Consultancy: MSD - Merck; Advisory / Consultancy: MSD - Pfizer; Advisory / Consultancy: 4SC. J.W. de Groot: Advisory / Consultancy: BMS; Advisory / Consultancy: Merck. G.A.P. Hospers: Advisory / Consultancy: BMS; Advisory / Consultancy: Merck. E. Kapiteijn: Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Roche; Advisory / Consultancy: Novartis; Advisory / Consultancy: Merck. K.P.M. Suijkerbuijk: Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Honoraria (institution), Advisory / Consultancy: Novartis; Advisory / Consultancy: Pierre Fabre; Honoraria (institution): Roche. A.A.M. Van der Veldt: Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: Roche; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Ipsen. J.B.A.G. Haanen: Advisory / Consultancy: Amgen; Advisory / Consultancy: AZ; Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy: Bayer; Advisory / Consultancy: Celsius Therapeutics; Advisory / Consultancy: GSK; Advisory / Consultancy: Roche/Genentech; Advisory / Consultancy, Research grant / Funding (institution): MSD; Advisory / Consultancy: Merck Serono; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Seattle Genetics; Advisory / Consultancy, Research grant / Funding (institution): Neon Therapeutics; Advisory / Consultancy: AIMM; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Immunocore. All other authors have declared no conflicts of interest.

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