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ePoster Display

1382P - Phase Ib/II open-label, randomised evaluation of second-line atezolizumab (atezo) + linagliptin (lina) vs ramucirumab (ram) + paclitaxel (pac) in MORPHEUS-gastric cancer

Date

16 Sep 2021

Session

ePoster Display

Presenters

Jeeyun Lee

Citation

Annals of Oncology (2021) 32 (suppl_5): S1040-S1075. 10.1016/annonc/annonc708

Authors

J. Lee1, J.A. Ajani2, H.C. Chung3, Y. Kang4, S. Iqbal5, S. Allen6, N. Al-Sakaff7, J. Decalf8, S. Li9, J. Pintoffl7, P. Sayyed7, Y. Bang10

Author affiliations

  • 1 Division Of Hem/oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR
  • 2 Department Of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, 1515 - Houston/US
  • 3 Department Of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, 03722 - Seoul/KR
  • 4 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 5 Department Of Oncology, USC Norris Comprehensive Cancer Center, Los Angeles/US
  • 6 Oncology Biomarker Development, Genentech Inc,, South San Francisco/US
  • 7 Product Development Oncology, F. Hoffmann-La Roche Ltd, Basel/CH
  • 8 Department Of Cancer Immunology, Genentech Inc,, South San Francisco/US
  • 9 Biostatistics, Roche (China) Holding Ltd, Shanghai/CN
  • 10 Internal Medicine, Seoul National University College of Medicine, 110-744 - Seoul/KR
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Abstract 1382P

Background

The MORPHEUS platform consists of multiple, global, open-label, randomised phase Ib/II trials designed to identify early efficacy signals and safety of treatment (tx) combinations across cancers. Atezo (anti–PD-L1) was tested with lina, a dipeptidyl peptidase-4 (DPP-4) inhibitor, in patients (pts) with locally advanced or metastatic gastric or gastroesophageal junction cancer (GC) within MORPHEUS-GC. Given the role of DPP-4 in the regulation of several pro-inflammatory chemokines and intratumoural T-cell recruitment, we hypothesised that adding lina to atezo could stimulate anti-tumour immune responses in GC.

Methods

Eligible GC pts who progressed on first-line platinum- or fluoropyrimidine-containing regimen received atezo (1200 mg IV every 3 weeks) with lina (5 mg orally daily). Control tx was ram + pac. Primary endpoints were confirmed objective response rate (ORR, investigator-assessed RECIST 1.1) and safety. Secondary endpoints included disease control rate (DCR; response and/or stable disease [SD] ≥ 12 weeks), duration of response (DOR), progression-free survival (PFS) and overall survival (OS).

Results

14 pts received atezo + lina and 12 ram + pac and were evaluable for efficacy and safety (data cutoff: 11 July 2019). Confirmed best overall responses were: 3 partial responses (PR; ORR 21%), 2 SD and 8 progressive disease (PD) with atezo + lina and 2 PR (ORR 17%), 8 SD and 2 PD with ram + pac. DCR was 21% with atezo + lina and 67% with ram + pac. DOR was 3.5 to 7.4+ (censored) mo and 2.9 to 3.7 mo, respectively. Median PFS was 2.0 mo (95% CI: 1.6, 4.9) with atezo + lina and 5.8 mo (95% CI: 3.7, 9.2) with ram + pac. OS data were immature. 50% of atezo + lina and 75% of ram + pac pts had a Gr 3-4 adverse event (AE), with no Gr 5 AEs in either arm. 29% and 92% of pts had dose modifications/interruptions due to AEs of any grade, respectively. 1 pt in both study arms had an AE leading to tx withdrawal. Updated data, including biomarkers and pharmacokinetics, will be presented.

Conclusions

Limited activity was seen with atezo + lina; 3 responders had long DOR. However, 8 of 14 pts had PD as best response. AEs were consistent with each agent’s known safety profile.

Clinical trial identification

NCT03281369.

Editorial acknowledgement

Medical writing assistance for this abstract was provided by Priscilla Hong PharmD, of Health Interactions, Inc.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

J. Lee: Financial Interests, Advisory Role: Oncologie; Financial Interests, Advisory Role: Seattle Genetics; Financial Interests, Research Grant: AstraZeneca; Financial Interests, Research Grant: Lilly; Financial Interests, Research Grant: Merck Sharp & Dohme. J.A. Ajani: Financial Interests, Other, Honoraria: Acrotech Biopharma; Financial Interests, Other, Honoraria: Aduro Biotech; Financial Interests, Other, Honoraria: Astellas Pharma; Financial Interests, Other, Honoraria: AstraZeneca; Financial Interests, Other, Honoraria: Bristol-Myers Squibb; Financial Interests, Other, Honoraria: DAVA Pharmaceuticals; Financial Interests, Other, Honoraria: Lilly; Financial Interests, Other, Honoraria: Zymeworks; Financial Interests, Advisory Role: American Cancer Society; Financial Interests, Advisory Role: BeiGene; Financial Interests, Advisory Role: Bristol-Myers Squibb; Financial Interests, Advisory Role: Insys Therapeutics; Financial Interests, Advisory Role: Merck; Financial Interests, Advisory Role: Vaccinogen; Financial Interests, Research Grant: Amgen; Financial Interests, Research Grant: Bristol-Myers Squibb; Financial Interests, Research Grant: Daiichi Sankyo; Financial Interests, Research Grant: Delta-Fly Pharma; Financial Interests, Research Grant: Gilead Sciences; Financial Interests, Research Grant: Lilly/ImClone; Financial Interests, Research Grant: Merck; Financial Interests, Research Grant: Novartis; Financial Interests, Research Grant: ProLynx; Financial Interests, Research Grant: Roche/Genentech; Financial Interests, Research Grant: Taiho Pharmaceutical; Financial Interests, Research Grant: Takeda; Financial Interests, Research Grant: Zymeworks; Financial Interests, Funding, Patents, Royalties, Other Intellectual Property: Genentech; Financial Interests, Funding, Patents, Royalties, Other Intellectual Property: Roche; Financial Interests, Funding, Patents, Royalties, Other Intellectual Property: BMS; Financial Interests, Funding, Patents, Royalties, Other Intellectual Property: Taiho; Financial Interests, Funding, Patents, Royalties, Other Intellectual Property: MedImmune; Financial Interests, Funding, Patents, Royalties, Other Intellectual Property: Merck; Financial Interests, Funding, Patents, Royalties, Other Intellectual Property: Amgen; Financial Interests, Funding, Patents, Royalties, Other Intellectual Property: Lilly; Financial Interests, Other, Honoraria: Merck. H.C. Chung: Financial Interests, Advisory Role: Amgen; Financial Interests, Advisory Role: Beigene; Financial Interests, Advisory Role: Bristol-Myers Squibb; Financial Interests, Advisory Role: Celltrion; Financial Interests, Advisory Role: Gloria Biosciences; Financial Interests, Advisory Role: Lilly; Financial Interests, Advisory Role: Merck Serono; Financial Interests, Advisory Role: MSD; Financial Interests, Advisory Role: Quintiles; Financial Interests, Advisory Role: Taiho Pharmaceutical; Financial Interests, Advisory Role: Zymeworks; Financial Interests, Speaker’s Bureau: Foundation medicine; Financial Interests, Speaker’s Bureau: Lilly; Financial Interests, Speaker’s Bureau: Merck Serono; Financial Interests, Research Grant: Amgen; Financial Interests, Research Grant: Beigene; Financial Interests, Research Grant: Bristol-Myers Squibb; Financial Interests, Research Grant: GlaxoSmithKline; Financial Interests, Research Grant: Lilly; Financial Interests, Research Grant: Merck Serono; Financial Interests, Research Grant: MSD; Financial Interests, Research Grant: Taiho Pharmaceutical. Y. Kang: Financial Interests, Advisory Role: ALX Oncology; Financial Interests, Advisory Role: Amgen; Financial Interests, Advisory Role: Bristol-Myers Squibb; Financial Interests, Advisory Role: DAEHWA Pharmaceutical; Financial Interests, Advisory Role: Macrogenics; Financial Interests, Advisory Role: Novartis; Financial Interests, Advisory Role: Surface Oncology; Financial Interests, Advisory Role: Zymeworks. S. Iqbal: Financial Interests, Personal, Other, Honoraria: Eisai; Financial Interests, Advisory Role: AstraZeneca; Financial Interests, Advisory Role: Beigene. S. Allen: Financial Interests, Personal, Full or part-time Employment: Genentech; Financial Interests, Personal, Stocks/Shares: Genentech/Roche. N. Al-Sakaff: Financial Interests, Personal, Full or part-time Employment: Roche; Financial Interests, Personal, Stocks/Shares: Roche; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche. J. Decalf: Financial Interests, Personal, Full or part-time Employment: Genentech. S. Li: Financial Interests, Personal, Full or part-time Employment: Roche. J. Pintoffl: Financial Interests, Personal, Full or part-time Employment: Roche. P. Sayyed: Financial Interests, Full or part-time Employment: Roche; Financial Interests, Stocks/Shares: Roche. Y. Bang: Financial Interests, Advisory Role: Astellas Pharma; Financial Interests, Advisory Role: AstraZeneca/MedImmune; Financial Interests, Advisory Role: Bayer; Financial Interests, Advisory Role: BeiGene; Financial Interests, Advisory Role: Bristol-Myers Squibb; Financial Interests, Advisory Role: Daiichi Sankyo; Financial Interests, Advisory Role: Genentech/Roche; Financial Interests, Advisory Role: Genexine; Financial Interests, Advisory Role: GlaxoSmithKline; Financial Interests, Advisory Role: Green Cross; Financial Interests, Advisory Role: Hanmi; Financial Interests, Advisory Role: Lilly; Financial Interests, Advisory Role: Merck Serono; Financial Interests, Advisory Role: MSD Oncology; Financial Interests, Advisory Role: Novartis; Financial Interests, Advisory Role: Samyang; Financial Interests, Advisory Role: Taiho Pharmaceutical; Financial Interests, Institutional, Research Grant: Astellas Pharma; Financial Interests, Institutional, Research Grant: AstraZeneca/MedImmune; Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Institutional, Research Grant: BeiGene; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: Boston Biomedical; Financial Interests, Institutional, Research Grant: Bristol-Myers Squibb; Financial Interests, Institutional, Research Grant: Chong Kun Dang Pharmaceutical; Financial Interests, Institutional, Research Grant: Curis; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Five Prime Therapeutics; Financial Interests, Institutional, Research Grant: Genentech/Roche; Financial Interests, Institutional, Research Grant: Genexine; Financial Interests, Institutional, Research Grant: GlaxoSmithKline; Financial Interests, Institutional, Research Grant: Green Cross; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Macrogenics; Financial Interests, Institutional, Research Grant: Merck Serono; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Ono Pharmaceutical; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Taiho Pharmaceutical; Financial Interests, Institutional, Research Grant: Takeda.

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