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ePoster Display

1042P - Anti-PD1 (PD1) monotherapy or in combination with ipilimumab (IPI) after BRAF/MEK inhibitors (BRAF/MEKi) in BRAF mutant metastatic melanoma (MM) patients (pts)

Date

16 Sep 2021

Session

ePoster Display

Topics

Immunotherapy

Tumour Site

Melanoma

Presenters

Ines Pires da Silva

Citation

Annals of Oncology (2021) 32 (suppl_5): S867-S905. 10.1016/annonc/annonc706

Authors

I. Pires da Silva1, D. Zakria2, T. Ahmed1, C. Trojaniello3, F. Dimitriou4, C. Allayous5, C. Gerard6, L. Zimmer7, S. Lo1, O.A. Michielin6, C. Lebbe5, J. Mangana4, P.A. Ascierto3, D. Johnson2, M. Carlino8, A.M. Menzies9, G.V. Long9

Author affiliations

  • 1 Medical Oncology, Melanoma Institute Australia, 2065 - Sydney/AU
  • 2 Medical Oncology, Vanderbilt University Medical Center, 37232 - Nashville/US
  • 3 Melanoma, Cancer Immunotherapy & Developmental Therapeutics, Istituto Nazionale Tumori - IRCCS - Fondazione Pascale, 80131 - Napoli/IT
  • 4 Department Of Dermatology, University Hospital Zurich, 8091 - Zurich/CH
  • 5 Dermatology, Hopital Saint Louis AP-HP, 75010 - Paris/FR
  • 6 Oncology, Centre Hospitalier Universitaire Vaudois - CHUV, 1011 - Lausanne/CH
  • 7 Department Of Dermatology, University Hospital Essen, 45147 - Essen/DE
  • 8 Westmead & Blacktown Hospitals, Melanoma Institute Australia, Sydney University, 2065 - Wollstonecraft/AU
  • 9 Royal North Shore And Mater Hospitals, Melanoma Institute Australia, The University of Sydney, 2060 - Sydney/AU

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Abstract 1042P

Background

Pts with V600BRAF mutant MM have numerically higher rates of progression-free survival (PFS) and overall survival (OS) with 1st line IPI+PD1 vs PD1. Whether this is also true after BRAF/MEKi therapy is yet to be determined. We aimed to: (1) determine the efficacy and safety of PD1 vs IPI+PD1 after BRAF/MEKi; and (2) identify the subgroup of pts with >3 yrs OS with PD1+/-IPI after BRAF/MEKi.

Methods

MM pts treated with BRAF/MEKi who had subsequent PD1 or IPI+PD1 at 8 melanoma centres were included. The endpoints were objective response rate (ORR), PFS, OS & safety for PD1 vs IPI+PD1. Multivariate analysis (MVA) and backward elimination technique were used to build models to predict those pts with OS > 3 yrs with PD1+/-IPI after BRAF/MEKi.

Results

Of 200 MM pts treated with BRAF/MEKi, 115 (57%) had subsequent PD1 and 85 (43%) had IPI+PD1. Differences in baseline characteristics for PD1 vs IPI+PD1 included med. age (63 vs 54 yrs), ECOG PS >= 1 (62% vs 44%), time between BRAF/MEKi and PD1+/-IPI (0.5 vs 0.1 mo), M1C/M1D stage (72% vs 94%) and brain metastases (mets) (38% vs 65%). Med. follow-up from start of IPI+/-PD1 was 37.8 mo (CI 95% 33.9 – 52.9). ORR was 36%; 34% with PD1 vs 39% with IPI+PD1 (p>0.05). PFS rate at 1 yr was 34%; 33% with PD1 vs 34% with IPI+PD1 (med PFS 3.8 vs 4.2 mo, p>0.05). OS rate at 1 yr was 55%; 53% with PD1 vs 58% with IPI+PD1 (med OS 14.4 vs 20.5 mo, p>0.05). >=G3 toxicity was higher with IPI+PD1 (31%) vs PD1 (8%) (p<0.05). On MVA, ECOG PS=0 & >=G3 toxicity were associated with higher ORR. ECOG PS=0, elective BRAF/MEKi cessation & absence of liver metastases were associated with longer PFS and OS. OS was significantly longer with IPI+PD1 vs PD1 in non-V600E mutations (80% vs 51%), but no difference in V600E mutations (53% vs 53%). PFS and OS were numerically longer with IPI+PD1 vs PD1 across all other subgroups except for OS in females & III/M1A/M1B stages. 22% of pts had OS >3 yrs with PD1+/-IPI after BRAF/MEKi; the combination of ECOG PS=0, absence of liver metastases and normal LDH identify these pts (AUC=0.82).

Conclusions

IPI+PD1 appears superior to PD1 after BRAF/MEKi in most subgroups of pts, although is more toxic. A combination of clinical factors can accurately identify pts with >3 yrs OS with PD1+/-IPI after BRAF/MEKi.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Melanoma Institute Australia.

Funding

Has not received any funding.

Disclosure

I. Pires da Silva: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Other, Travel Support: BMS; Financial Interests, Personal, Other, Travel Support: Roche. C. Allayous: Financial Interests, Personal, Other, travel support: Roche; Financial Interests, Personal, Other, travel support: BMS ; Financial Interests, Personal, Other, travel support: Amgen. L. Zimmer: Financial Interests, Personal, Other, honoraria: Roche; Financial Interests, Personal, Other, honoraria: BMS ; Financial Interests, Personal, Other, honoraria: MSD; Financial Interests, Personal, Other, honoraria: Novartis; Financial Interests, Personal, Other, honoraria: Pierre Fabre; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Advisory Board: Sunpharma; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal and Institutional, Research Grant: Novartis; Financial Interests, Personal, Other, Travel support: BMS; Financial Interests, Personal, Other, Travel support: Pierre Fabre; Financial Interests, Personal, Other, Travel support: Sanofi; Financial Interests, Personal, Other, Travel support: Amgen; Financial Interests, Personal, Other, Travel support: Novartis; Financial Interests, Personal, Other, Travel support: Sunpharma. O.A. Michielin: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: GSK; Financial Interests, Personal, Invited Speaker: Pierre-Fabre; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Pierre-Fabre; Financial Interests, Personal and Institutional, Research Grant: BMS; Financial Interests, Personal and Institutional, Research Grant: MSD; Financial Interests, Personal and Institutional, Research Grant: Amgen. C. Lebbe: Financial Interests, Personal, Research Grant: Bristol-Myers Squibb; Financial Interests, Personal, Research Grant: Roche; Financial Interests, Personal, Other, honoraria: Merck Sharp & Dohme; Financial Interests, Personal, Other, honoraria: Novartis; Financial Interests, Personal, Other, honoraria: Amgen; Financial Interests, Personal, Other, honoraria: Avantis Medical Systems; Financial Interests, Personal, Other, honoraria: Pierre Fabre; Financial Interests, Personal, Other, honoraria: Pfizer; Financial Interests, Personal, Other, honoraria: Incyte; Financial Interests, Personal, Other, honoraria: Merck Serono; Financial Interests, Personal, Other, honoraria: Sanofi. J. Mangana: Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Bristol Myers and Squibb ; Financial Interests, Personal, Advisory Board: Pierre Fabre ; Financial Interests, Personal, Other, travel support : Ultrasun; Financial Interests, Personal, Other, travel support : L’ oreal; Financial Interests, Personal, Other, travel support : Merck Sharp & Dohme; Financial Interests, Personal, Other, travel support : Bristol Myers and Squibb ; Financial Interests, Personal, Other, travel support : Pierre Fabre . P.A. Ascierto: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Roche-Genentech; Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Array; Financial Interests, Personal, Advisory Board: Merck Serono; Financial Interests, Personal, Advisory Board: Pierre-Fabre; Financial Interests, Personal, Advisory Board: Incyte; Financial Interests, Personal, Advisory Board: Medimmune; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Syndax; Financial Interests, Personal, Advisory Board: Sun Pharma; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Idera; Financial Interests, Personal, Advisory Board: Ultimovacs; Financial Interests, Personal, Advisory Board: Sandoz; Financial Interests, Personal, Advisory Board: Immunocore; Financial Interests, Personal, Advisory Board: 4SC; Financial Interests, Personal, Advisory Board: Alkermes; Financial Interests, Personal, Advisory Board: Italfarmaco; Financial Interests, Personal, Advisory Board: Nektar; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Regeneron; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Oncosec; Financial Interests, Personal, Advisory Board: Nouscom; Financial Interests, Personal, Advisory Board: Takis; Financial Interests, Personal, Advisory Board: Lunaphore; Financial Interests, Personal and Institutional, Research Grant: Bristol Myers Squibb; Financial Interests, Personal and Institutional, Research Grant: Roche-Genentech; Financial Interests, Personal and Institutional, Research Grant: Array; Financial Interests, Personal and Institutional, Research Grant: Sanofi; Financial Interests, Personal, Other, travel support : MSD. D. Johnson: Financial Interests, Personal, Advisory Board: Array Biopharma; Financial Interests, Personal, Advisory Board: Bristol-Myers Squibb; Financial Interests, Personal, Advisory Board: Catalyst Biopharma; Financial Interests, Personal, Advisory Board: Iovance; Financial Interests, Personal, Advisory Board: Jansen; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal and Institutional, Research Grant: Bristol-Myers Squibb ; Financial Interests, Personal and Institutional, Research Grant: Incyte; Financial Interests, Personal, Advisory Board: Oncosec. M. Carlino: Financial Interests, Personal, Advisory Board: Bristol-Myers Squibb; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Ideaya; Financial Interests, Personal, Advisory Board: Regeneron; Financial Interests, Personal, Advisory Board: Nektar; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Qbiotics; Financial Interests, Personal, Other, honoraria: Bristol-Myers Squibb; Financial Interests, Personal, Other, honoraria: MSD; Financial Interests, Personal, Other, honoraria: Novartis. A.M. Menzies: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Pierre-Fabre ; Financial Interests, Personal, Advisory Board: QBiotics. G.V. Long: Financial Interests, Personal, Advisory Board: Aduro Biotech Inc; Financial Interests, Personal, Advisory Board: Amgen Inc; Financial Interests, Personal, Advisory Board: Array Biopharma inc; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim International GmbH; Financial Interests, Personal, Advisory Board: Bristol-Myers Squibb; Financial Interests, Personal, Advisory Board: Highlight Therapeutics S.L; Financial Interests, Personal, Advisory Board: Merck Sharpe & Dohme; Financial Interests, Personal, Advisory Board: Novartis Pharma AG; Financial Interests, Personal, Advisory Board: QBiotics Group Limited; Financial Interests, Personal, Advisory Board: Regeneron Pharmaceuticals Inc. All other authors have declared no conflicts of interest.

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