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Mini oral session - Gastrointestinal tumours, non-colorectal

LBA54 - Ipilimumab or FOLFOX in combination with nivolumab and trastuzumab in previously untreated HER2 positive locally advanced or metastastic esophagogastric adenocarcinoma (EGA): Results of the randomized phase II INTEGA trial (AIO STO 0217)

Date

17 Sep 2021

Session

Mini oral session - Gastrointestinal tumours, non-colorectal

Presenters

Alexander Stein

Citation

Annals of Oncology (2021) 32 (suppl_5): S1283-S1346. 10.1016/annonc/annonc741

Authors

A. Stein1, L. Paschold2, J. Tintelnot3, E. Goekkurt1, P.C. Thuss-Patience4, S. Lorenzen5, T.J. Ettrich6, J. Riera Knorrenschild7, L. Jacobasch8, A. Kretzschmar9, S. Kubicka10, S. Al-Batran11, A. Reinacher-Schick12, D. Pink13, M. Sinn3, U. Lindig14, A. Hinke15, S. Hegewisch Becker16, M. Binder2

Author affiliations

  • 1 University Cancer Center Hamburg, Hematology-Oncology Practice Eppendorf, 20249 - Hamburg/DE
  • 2 Department Of Internal Medicine Iv, Oncology/hematology, Martin-Luther-University Halle-Wittenberg, 06120 - Halle/DE
  • 3 Department Of Oncology, Hematology And Bmt With Division Of Pneumology, UKE Universitätsklinikum Hamburg-Eppendorf KMTZ, 20246 - Hamburg/DE
  • 4 Hematology Oncology Dept., Universitätsklinik Charité, Campus Virchow Klinikum, 13353 - Berlin/DE
  • 5 Hematology And Oncology, Rechts der Isar Hospital,TUM, 81675 - Munich/DE
  • 6 Department Of Internal Medicine I, University of Ulm, 89081 - Ulm/DE
  • 7 Oncology/hematology, Universitätsklinikum Marburg, 35043 - Marburg/DE
  • 8 Oncology/heamatology Department, Gemeinschaftspraxis Haematologie - Onkologie, 01307 - Dresden/DE
  • 9 Oncology Dept., Klinikum St. Georg gGmbH, 04129 - Leipzig/DE
  • 10 Cancer Center Reutlingen, Klinikum am Steinenberg Reutlingen, 72764 - Reutlingen/DE
  • 11 Institute Of Clinical Cancer Research, Nordwest-Krankenhaus, 60488 - Frankfurt am Main/DE
  • 12 Dept. Of Hematology, Oncology And Palliative Care, Katholisches Klinikum Bochum - St. Josef-Hospital, 44791 - Bochum/DE
  • 13 Klinik Und Poliklinik Für Innere Medizin C, University Greifswald, HELIOS Klinikum Bad Saarow, 15526 - Bad Saarow/DE
  • 14 Oncology/hematology, University Hospital Jena, Friedrich-Schiller-University, 7740 - Jena/DE
  • 15 Na, CCRC - Cancer Clinical Research Consulting, 40595 - Düsseldorf/DE
  • 16 Oncology And Hematology Department, Facharztzentrum Eppendorf, 20249 - Hamburg/DE
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Resources

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Abstract LBA54

Background

In 1st line EGA, the addition of PD-1 inhibitors to chemotherapy improved outcome in selected patient populations. The INTEGA trial compared different immunotherapy regimens in 1st line HER2+ EGA.

Methods

INTEGA is a randomized exploratory phase II investigator initiated trial with two experimental arms. Patients (pts) with previously untreated (for advanced disease) HER2+ (local status - IHC3+ or 2+/ISH+) EGA were randomized to receive trastuzumab (trast) and nivolumab (nivo) (240mg or 1mg/kg with ipi) in combination with either ipilimumab (ipi) (4x 3mg/kg every 3 weeks) (arm A) or mFOLFOX6 (arm B) for up to 12 months. The 1° endpoint was to increase the 12month overall survival rate (OSR@12) from 55% (trast/chemo - ToGA regimen) to 70% in each arm.

Results

Between March 2018 and May 2020 a total of 97 pts were enrolled and 88 randomized (44 per arm) in 21 German sites. Baseline characteristics were female/male 18/70, median age 61 (range 41-80), ECOG 0/1 54/34, GEJ/stomach 66/22, prior surgery for primary tumor in 24 patients and were well balanced between groups. Central posthoc biomarker analysis (ongoing) yet showed PD-L1 CPS>1 in 55 and >5 in 41 pts and HER2 positivity in 76 pts while 8 were negative (incl. one failed ISH). The 1° endpoint of 70% OSR@12 was reached in arm B, but not in arm A (57%) (Table). Treatment related grade 3/4 AE/SAE occurred in 29/15 pts in arm B and in 20/17 pts in arm A. Liquid biopsy analyses showed strong correlation of high ctDNA load with shorter PFS/OS and emergence of truncating HER2 mutations on trast. Table: LBA54

All (n=88) CPS>1 (n=55) CPS>5 (n=41)
Arm A Arm B Arm A Arm B Arm A Arm B
ORR 32% 56% 38% 65% 29% 68%
mPFS 3.2 mo 10.7 mo 2.2 mo 11 mo 2 mo 11 mo
PFSR@12 15% 37% 15% 34% 7% 37%
mDOR 5.8 mo 9.2 mo - - - -
mOS 16.4 mo 21.8 mo 16.4 mo 21.8 mo 12.5 mo 22.4 mo
OSR@12 57% 70% 54% 70% 51% 69%

mPFS – median PFS, PFSR@12 - PFS rate at 12 months, mDOR - duration of response, OSR@12 - OS rate at 12 months, mo - months

Conclusions

Trast/nivo/FOLFOX showed increased efficacy compared to the ToGA regimen, whereas trast/nivo/ipi did not improve OS over trast/chemo. Subgroupanalyses are ongoing and will be presented.

Clinical trial identification

NCT03409848.

Editorial acknowledgement

Legal entity responsible for the study

AIO Studien gGmbH.

Funding

Bristol Myers-Squibb.

Disclosure

A. Stein: Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Personal and Institutional, Invited Speaker: BMS; Financial Interests, Personal and Institutional, Advisory Board: BMS. All other authors have declared no conflicts of interest.

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