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Poster display session

5287 - Nivolumab (NIVO) in patients (pts) with advanced (adv) chemotherapy-refractory (CT-Rx) esophagogastric (EG) cancer according to microsatellite instability (MSI) status: CheckMate 032

Date

09 Sep 2017

Session

Poster display session

Topics

Immunotherapy;  Oesophageal Cancer;  Gastric Cancer

Presenters

Patrick Ott

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

P.A. Ott1, D.T. Le2, J.W. Kim3, P.A. Ascierto4, P. Sharma5, P. Bono6, K. Peltola6, D. Jäger7, T.R..J. Evans8, F. de Braud9, I. Chau10, J.C. Bendell11, M. Tschaika12, C.T. Harbison12, H. Zhao12, E. Calvo13, Y. Janjigian14

Author affiliations

  • 1 Medical Oncology, Dana-Farber Cancer Institute, 2215 - Boston/US
  • 2 Medical Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore/US
  • 3 Medical Oncology, Yale Cancer Center, New Haven/US
  • 4 Melanoma, Cancer Immunotherapy And Innovative Therapy Unit, Istituto Nazionale Tumori IRCCS, 80131 - Naples/IT
  • 5 Genitourinary Medical Oncology, MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 6 Medical Oncology, Comprehensive Cancer Center, Helsinki University Hospital  , 00029   - Helsinki/FI
  • 7 Medical Oncology, National Center for Tumor Diseases, University Hospital Heidelberg, 69120 - Heidelberg/DE
  • 8 Medical Oncology, Beatson West of Scotland Cancer Centre, University of Glasgow, G61 1BD - Glasgow/GB
  • 9 Medical Oncology, Fondazione IRCCS Istituto Tumori Milano, University of Milan, 20133 - Milan/IT
  • 10 Department Of Medicine  , Royal Marsden Hospital  , London and Surrey/GB
  • 11 Medical Oncology, Sarah Cannon Research Institute/Tennessee Oncology, 37203 - Nashville/US
  • 12 Oncology, Bristol-Myers Squibb, Princeton/US
  • 13 Medical Oncology, START Madrid, Centro Integral Oncologico Clara Campal, Madrid/ES
  • 14 Medical Oncology, Gastrointestinal Oncology Service, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US
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Resources

Abstract 5287

Background

NIVO improved OS vs placebo in Asian pts with gastric/gastroesophageal junction cancer in the phase 3 ATTRACTION-2 study (Kang YK, et al. ASCO GI 2017 [abstract 2]). In CheckMate 032, NIVO ± ipilimumab (IPI) demonstrated ORRs of 14% (NIVO monotherapy) and 26% (NIVO 1 mg/kg + IPI 3 mg/kg) in CT-Rx EG cancer (NCT01928394; Janjigian YY, et al. ASCO 2017 [abstract 4014]). The Cancer Genome Atlas identified MSI-high (MSI-H) EG tumors as having therapeutic targets that may make them responsive to immune checkpoint inhibitors. This exploratory analysis evaluated ORR and OS by MSI status in pts with EG cancer treated with NIVO monotherapy in CheckMate 032.

Methods

Pts with adv CT-Rx EG (including gastric, esophageal, and gastroesophageal junction) cancer were treated with NIVO 3 mg/kg every 2 weeks (n = 59). MSI status was centrally assessed using a PCR-based assay. Best objective response (BOR), ORR, and DCR (BOR of CR, PR, or SD) per investigator (INV) were assessed per RECIST v1.1.

Results

MSI status was determined in 25 pts; 7 (28%) were MSI-H, and 18 (72%) were non–MSI-H. ORR per INV was 29% in MSI-H pts, 11% in non–MSI-H pts, and 9% in pts with unknown MSI (MSI-U). DCR was 71%, 28%, and 26%, respectively. Of the 7 responders, 3 were PD-L1+ (≥1% tumor expression; 1 per MSI category), 3 were PD-L1 (MSI-U, n = 2; non–MSI-H, n = 1), and 1 was not evaluable for PD-L1 assessment (MSI-H). BOR is shown in the Table. Median OS (95% CI) was 14.75 mo (1.51, NA) in MSI-H pts, 6.49 mo (2.96, 12.42) in non–MSI-H pts, and 5.03 mo (2.76, 16.16) in MSI-U pts. Safety for the full EG cohort was previously reported (Janjigian YY, et al. ASCO 2016 [abstract 4010]).

Conclusions

In this subgroup analysis, 7 pts (28%) were MSI-H, representing a biologically unique subset of EG tumors. NIVO monotherapy led to survival benefit and responses in both MSI-H and non–MSI-H pts.Table:

674P ORR and BOR per INV according to MSI status

MSI-H n = 7Non–MSI-H n = 18MSI-U n = 34
ORR, n (%) [95% CI]2 (29) [4, 71]2 (11) [1, 35]3 (9) [2, 24]
BOR, n (%)
CR1 (14)00
PR1 (14)2 (11)3 (9)
SD3 (43)3 (17)6 (18)
PD2 (29)11 (61)21 (62)
Not evaluable02 (11)4 (12)

Clinical trial identification

CA209032 Revised Protocol 06, dated 18-Nov-2015

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

Bristol-Myers Squibb

Disclosure

P.A. Ott: Grants, personal fees and non-financial support from BMS during the conduct of the study; grants/personal fees from BMS, Merck and Celldex, Amgen, Alexion, Pfizer, Cytomx, AZ/MedImmune and ArmoBiosciences outside the submitted work. P.A. Ascierto: Grants and personal fees from BMS, Roche-Genentech, MSD, Array, Novartis, Amgen,Merck Serono, and Pierre Fabre outside the submitted work P. Sharma: Consultant/Advisor for BMS, GSK, AstraZeneca, Amgen, Constellation, Jounce, Kite Pharma, Neon, Evelo, EMD Sereno, and Astellas, during the conduct of the study; Stock with Jounce, Kite Pharma, Evelo, Constellation, and Neon. Has a patent Jounce licensed P. Bono: Honoraria from Pfizer, BMS, Orion Pharma, Novartis and MSD, research grant from Novartis, outside the submitted work; Stock Ownership: Tilt Biotherapeutics K. Peltola: Personal fees from BMS, Roche, Orion Pharma, and MSD, outside the submitted work; Stock Holder: Faron Pharmaceuticals D. Jäger: Consulting/advisory role for Roche, BMS and Bayer T.R.J. Evans: Personal fees/non-financial support from BMS, Eisai, Clovis, Karus Therapeutics, Baxalta, Bayer, Celgene, GSK, Otsuka, Roche-Genentech, TC Biopharm, Immunova, Basilea, e-Therapeutics, Immunocore, Vertex, Verastem, Daiichi and Merck F. de Braud: Advisory boards and/or travel support from Amgen, Celgene, Novartis, Roche, BMS, MSD I. Chau: Advisory Board: Sanofi Oncology, Eli-Lilly, Bristol Meyers Squibb, MSD, Bayer, Roche, Five Prime Therapeutics; Research funding: Janssen-Cilag, Sanofi Oncology, Merck-Serono, Novartis; Honorarium: Taiho, Pfizer, Amgen, Eli-Lilly, Gilead Science J.C. Bendell: Payment to institution from the study sponsor for performing the study M. Tschaika, C.T. Harbison: Employee and stock holder at BMS H. Zhao: Employee of BMS E. Calvo: Personal Fees/Non-financial support: Astellas Pharma, GSK, Lilly/ImClone, Nanobiotix, Novartis, Pfizer, Roche/Genentech, PsiOxus Ther, Abbvie, Boehringer Ingelheim, BMS, Eisai, Janssen, Merck, Millenium, Nektar, OncoMed, PharmaMar, Puma Biotech, Sanofi, Spectrum Pharm. All other authors have declared no conflicts of interest.

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