1221PD - (Neo-)adjuvant ipilimumab + nivolumab (IPI+NIVO) in palpable stage 3 melanoma – updated relapse free survival (RFS) data from the OpACIN trial and...

Date 11 September 2017
Event ESMO 2017 Congress
Session Melanoma and other skin tumours
Topics Cancer in Adolescents
Cancer Immunology and Immunotherapy
Melanoma and other Skin Tumours
Presenter Elisa Rozeman
Citation Annals of Oncology (2017) 28 (suppl_5): v428-v448. 10.1093/annonc/mdx377
Authors E.A. Rozeman1, L. Fanchi2, A.C.J. van Akkooi3, P. Kvistborg2, J.V. Thienen1, B. Stegenga4, B. Lamon5, J.B. Haanen1, T.N.M. Schumacher2, C.U. Blank1
  • 1Medical Oncology Department, Het Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI-AVL), 1006 BE - Amsterdam/NL
  • 2Department Of Molecular Oncology And Immunology, Het Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI-AVL), 1006 BE - Amsterdam/NL
  • 3Surigical Oncology Department, Het Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI-AVL), 1006 BE - Amsterdam/NL
  • 4Immuno-oncology, Bristol-Meyers Squibb, 3502 HB - Utrecht/NL
  • 5Immuno-oncology, Bristol-Myers Squibb, 08540 - Princeton/US

Abstract

Background

The combination of IPI+NIVO induces high response rates and improved overall survival in late stage melanoma. T cell checkpoint inhibition is of greatest value at the moment of TCR triggering and therefore dependent on the amount of antigen present, indicating that adjuvant immunotherapy will work most efficiently, when initiated prior to surgery.

Methods

Two-arm Phase 1b feasibility trial consisting of 20 high risk AJCC stage 3B/C melanoma patients with palpable nodal disease receiving the combination of IPI 3mg/kg and NIVO 1mg/kg, either adjuvant four courses after surgery, or split neo-adjuvant and adjuvant.

Results

In this update 20 patients are evaluable. Neo-adjuvant application of IPI+NIVO was feasible and no surgery-associated adverse events were attributed to (neo-) adjuvant therapy. 18/20 patients had to stop earlier due to grade 3/4 toxicities. Neo-adjuvant IPI+NIVO reduced tumor load in 8/10 patients (3 pCR, 4 near pCRs [minimal remaining micro metastases], 1 pPR [

Conclusions

The combination of IPI+NIVO in the (neo-)adjuvant treatment setting for high risk stage 3 melanoma patients is promising and currently tested in an international phase 2 randomized trial comparing different combination schemes (OpACIN-neo trial, NCT02977052) with the aim of preserving efficacy, but reducing toxicity. Biomarkers identifying patients responding upon neo-adjuvant IPI+NIVO and remaining relapse-free for a long time, will help to select the patients that need to be exposed to IPI+NIVO associated toxicity.

Clinical trial identification

NCT02437279

Legal entity responsible for the study

NKI-AVL

Funding

Bristol-Myers Squib

Disclosure

P. Kvistborg: Advisory board: Neon therapeutics, Merck, Personalis. J.V. Thienen: Advisory board: MSD, Bristol-Myers Squibb. B. Stegenga, B. Lamon: Employee of Bristol-Myers Squibb. J.B. Haanen: Advisory role: Bristol-Myers Squibb, MSD, Pfizer, Roche, Novartis, Neon Therapeutics Research grants: Bristol-Myers Squibb, MSD, GSK. C.U. Blank: Advisory role: Bristol-Myers Squibb, MSD, GSK, Roche, Novartis, Lilly, Pfizer Research grants: Bristol-Myers Squibb, Novartis. All other authors have declared no conflicts of interest.