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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

2498 - MORPHEUS: a Phase Ib/II umbrella study platform evaluating the safety and efficacy of multiple cancer immunotherapy (CIT)–based combinations in different tumour types

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Topics

Immunotherapy

Tumour Site

Presenters

Ian Chau

Citation

Annals of Oncology (2018) 29 (suppl_8): viii400-viii441. 10.1093/annonc/mdy288

Authors

I. Chau1, G.M. Haag2, O.E. Rahma3, T.M. Macarulla4, S.L. McCune5, D.A. Yardley6, B.J. Solomon7, M. Johnson8, G.A. Vidal9, P. Schmid10, G. Argiles4, K. Dimick11, S. Mahrus11, H. Abdullah11, X. He11, P. Sayyed12, H. Barak11, C. Bleul12, E. Cha11, A. Drakaki13

Author affiliations

  • 1 Department Of Medicine, The Institute of Cancer Research/Royal Marsden NHS Foundation Trust, SM2 5PT - Sutton/GB
  • 2 National Center For Tumor Diseases, University Hospital Heidelberg, Heidelberg/DE
  • 3 Medical Oncology, Dana-Farber Cancer Institute, Boston/US
  • 4 Vall D'hebron Institute Of Oncology (vhio), Vall d'Hebron University Hospital (HUVH), Barcelona/ES
  • 5 Marietta Cancer Center, Northwest Georgia Oncology Centers, Marietta/US
  • 6 Sarah Cannon Research Institute, Tennessee Oncology, Nashville/US
  • 7 Medical Oncology, Peter MacCallum Cancer Center, 3002 - Melbourne/AU
  • 8 Oncology, Sarah Cannon Research Institute, Tennessee Oncology, Nashville/US
  • 9 Medical Oncology, University of Tennessee West Cancer Center, Germantown/US
  • 10 Barts Cancer Institute, Queen Mary University London, EC1M 6BQ - London/GB
  • 11 Pd Oncology, Genentech, Inc., South San Francisco/US
  • 12 Pd Oncology, F. Hoffmann-La Roche, Ltd, Basel/CH
  • 13 Medicine, UCLA Medical Center, Los Angeles/US
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Resources

Abstract 2498

Background

Significant survival benefit has been achieved with CIT across multiple tumour types, but only subsets of patients (pts) experience durable response with CIT monotherapy. Efficacious CIT combinations targeting multiple cancer immune escape mechanisms need to be identified to extend clinical benefit to more pts. The MORPHEUS platform includes multiple Phase Ib/II trials designed to identify early signals of safety and activity of CIT combinations. Using a randomised trial design, multiple CIT combination arms are compared with a single standard-of-care control arm. We present 7 tumour type–specific MORPHEUS trials, each evaluating various CIT combinations that simultaneously enhance immune-cell priming and activation, tumour infiltration and/or recognition of tumour cells for elimination.

Trial design

The MORPHEUS trials described here are global, open-label, randomised, Phase Ib/II trials enrolling pts with 1 of the following cancers: pancreatic ductal adenocarcinoma (PDAC), gastric or gastro-oesophageal junction cancers (GC/GEJ), hormone receptor-positive or triple-negative breast cancers (HR+/TNBC), non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) (Table). These trials have the flexibility to open new treatment arms with novel CIT combinations as they become available and to close arms that show minimal activity or unacceptable toxicity. Pts experiencing loss of clinical benefit or unacceptable toxicity may be eligible to switch to a different CIT combination arm. Eligibility requires measurable disease per RECIST v1.1. Further eligibility criteria will be provided. Primary endpoints are safety and investigator-assessed ORR per RECIST v1.1. Secondary endpoints include PFS, OS, DCR and DOR. Exploratory biomarkers will also be examined.Table: 1239TiP

Summary of Cancer-Type Specific MORPHEUS Trials
Cancer TypeCohortNo. of Experimental ArmsaCountries Currently Targeted for Enrolment
PDAC2L3Germany, South Korea, Spain, United States
GC and GEJ1L2Germany, South Korea, Spain, Taiwan, United Kingdom, United States
2L4
HR+ BC2L4France, South Korea, Spain, United Kingdom, United States
TNBC2L5Australia, France, Germany, South Korea, Spain, United Kingdom, United States
NSCLC1L2Australia, France, South Korea, Spain, United Kingdom, United States
2L+b5
CRC3L2Australia, France, South Korea, Spain, United Kingdom, United States
a

Not all experimental arms may be open at the same time.

b

Patients who have progressed on prior platinum chemotherapy and anti–PD-L1/PD-1 treatment given concurrently or sequentially. CIT, cancer immunotherapy; CRC, colorectal cancer; GC, gastric cancer; GEJ, gastro-oesophageal junction cancer; HR+ BC, hormone receptor–positive breast cancer; NSCLC, non-small cell lung cancer; PD-1, programmed death-1; PDAC, pancreatic ductal adenocarcinoma; PD-L1, programmed death-ligand 1; TNBC, triple-negative breast cancer.

Clinical trial identification

NCT03193190, NCT03281369, NCT03280563, NCT03424005, NCT03337698.

Legal entity responsible for the study

F. Hoffmann-La Roche AG.

Funding

F. Hoffmann-La Roche AG.

Editorial Acknowledgement

Medical writing assistance for this abstract was provided by Steffen Biechele, PhD, of Health Interactions.

Disclosure

I. Chau: Honoraria: Amgen, Gilead Sciences, Lilly, Pfizer, Taiho Pharmaceutical; Consulting or advisory role: Bayer, Bristol-Myers Squibb, Five Prime Therapeutics, Lilly, MSD Oncology, Roche/Genentech, Sanofi; Research funding: Janssen-Cilag (Inst), Lilly (Inst), Merck Serono (Inst), Sanofi (Inst); Travel, accommodations, expenses: Bristol-Myers Squibb, Lilly, Merck Serono, MSD, Sanofi. G.M. Haag: Advisory role: BMS, Taiho, Nordic, Lilly, MSD; Honoraria: Roche, Pfizer; Travel grant: Amgen, Ipsen, BMS; Research funding: Nordic, Taiho Pharmaceuticals. O.E. Rahma: Consulting or advisory role: Celgene, Alcimed, Gfk, Merck, Five Prime Therapeutics, Putnam Associates; Travel, accommodations, expenses: Merck, Clinical Care Options; Honoraria: Merck, Company: Clinical Care Options, MI Bioresearch; Research Funding: Amgen, Merck. D.A. Yardley: Speaker's bureau, Advisory boards: Genentech. B.J. Solomon: Advisory boards: AstraZeneca, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche/Genentech, Novartis; Honoraria: Bristol-Myers Squibb, AstraZeneca; Grant/research support: Pfizer; Royalty, IP Rights/Patent Holder: Veristrat (Biodesix). Consulting/advisory role (inst): Genentech/Roche, Celgene, Boehringer Ingelheim, AstraZeneca, OncoMed, BerGenBio, Lilly, EMD Serono, Kadmon, Janssen, Mirati Therapeutics, Genmab, Pfizer, AstraZeneca, Sten CentRx, Novartis, Checkpoint Therapeutics, Array BioPharma, Regeneron, Merck, Hengrui Pharmaceutical, Lycera, BeiGene, Tarveda Therapeutics, Loxo, AbbvieBoehringer Ingelheim, Guardant Health, Foundation Medicine, Daiichi Sankyo, Danofi; Research funding to institution: Mersana; Immediate family member: Contract lobbyist: Astellas Pharma, Otsuka. G.A. Vidal: Advisory board: Genentech, Eli Lily, Immunomedics; Sponsored research: PUMA and Celcuit; Speaker: PUMA, AstraZeneca, Novartis, Lilly, Pfizer. P. Schmid: Honoraria: AstraZeneca, Bayer, Boehringer, Celgene, Eisai, Novartis, Pfizer, Puma, Roche/Genentech; Research support/funding: Astellas, AstraZeneca, Medivation, Novartis, Oncogenex, Roche/Genentech (all to instituation). Spouse: Employee: Roche. K. Dimick, S. Mahrus, C. Bleul: Employee: Roche/Genentech. P. Sayyed: Employee and stock: Roche. H. Barak: Employee and stock: Roche/Genentech; Previously employed: Baxalta. E. Cha: Employee and stock: Roche/Genentech. A. Drakaki: Consulting: BMS; Research funds: Kite. All other authors have declared no conflicts of interest.

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