Evidence map›Paper›PMID 36940261›Full record

Trial reportThe oncologist2023

Atezolizumab Plus PEGPH20 Versus Chemotherapy in Advanced Pancreatic Ductal Adenocarcinoma and Gastric Cancer: MORPHEUS Phase Ib/II Umbrella Randomized Study Platform.

Andrew H Ko, Kyu-Pyo Kim, Jens T Siveke, Charles D Lopez, Jill Lacy, Eileen M O'Reilly, Teresa Macarulla, Gulam A Manji, Jeeyun Lee, Jaffer Ajani and 10 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 43 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 3 pooled it
12.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03193190 phase1 / phase2completednot on this map

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

TypeinterventionalSponsorHoffmann-La RocheRan2017 to 2025Enrolled341ConditionsPancreatic AdenocarcinomaArmsNab-Paclitaxel, Gemcitabine, Oxaliplatin, Leucovorin, Fluorouracil
NCT03281369 phase1 / phase2terminatednot on this map

A Phase Ib/II, Open-Label, Multicenter, Randomized, Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

TypeinterventionalSponsorHoffmann-La RocheRan2017 to 2025Enrolled219ConditionsGastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal CarcinomaArms5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin, Atezolizumab, Cobimetinib
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 3 syntheses or guidelines pooled it, 52 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 16 institutions in 7 countries.

Andrew H KoDivision of Hematology/Oncology, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.
Kyu-Pyo KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Jens T SivekeDepartment of Medical Oncology and Division of Solid Tumor Translational Oncology, German Cancer Consortium (DKTK/DKFZ, partner site Essen), West German Cancer Center, University Hospital Essen, Essen, Germany.
Charles D LopezDivision of Hematology Oncology, Oregon Health & Science University, Knight Cancer Institute, Portland, OR, USA.
Jill LacyDepartment of Medicine, Section of Medical Oncology, Yale School of Medicine, Yale University, New Haven, CT, USA.
Eileen M O'ReillyDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Teresa MacarullaGastrointestinal Cancer Unit, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Gulam A ManjiDivision of Hematology and Oncology, Columbia University Irving Medical Center, New York, NY, USA.
Jeeyun LeeDivision of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Jaffer AjaniDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Maria Alsina MaquedaGastrointestinal Cancer Unit, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Sun-Young RhaDepartment of Internal Medicine, Yonsei Cancer Center, Yonsei University Health System, Seoul, Republic of Korea.
Janet LauGenentech, Inc., South San Francisco, CA, USA.
Nedal Al-SakaffF. Hoffmann-La Roche, Ltd, Basel, Switzerland.
Simon AllenGenentech, Inc., South San Francisco, CA, USA.
Danny LuHoffmann-La Roche Limited, Mississauga, ON, Canada.
Colby S ShemeshGenentech, Inc., South San Francisco, CA, USA.
Xinxin GanProduct Development Safety, Roche (China) Holding Ltd, Shanghai, People's Republic of China.
Edward ChaGenentech, Inc., South San Francisco, CA, USA.
Do-Youn OhDepartment of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
Columbia University Irving Medical Center · USDeutschen Konsortium für Translationale Krebsforschung · DEMemorial Sloan Kettering Cancer Center · USOregon Health & Science University · USRoche (Canada) · CARoche (China) · CNRoche (Switzerland) · CHSeoul National University Hospital · KRSungkyunkwan University · KRThe University of Texas MD Anderson Cancer Center · USUCSF Helen Diller Family Comprehensive Cancer Center · USUniversity of Ulsan · KRVall d'Hebron Hospital Universitari · ESVall d'Hebron Institute of OncologyYale University · USYonsei University Health System · KR

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe MORPHEUS platform comprises multiple open-label, randomized, phase Ib/II trials designed to identify early efficacy and safety signals of treatment combinations across cancers. Atezolizumab (anti-programmed cell death 1 ligand 1 [PD-L1]) was evaluated in combination with PEGylated recombinant human hyaluronidase (PEGPH20).

methodsIn 2 randomized MORPHEUS trials, eligible patients with advanced, previously treated pancreatic ductal adenocarcinoma (PDAC) or gastric cancer (GC) received atezolizumab plus PEGPH20, or control treatment (mFOLFOX6 or gemcitabine plus nab-paclitaxel [MORPHEUS-PDAC]; ramucirumab plus paclitaxel [MORPHEUS-GC]). Primary endpoints were objective response rates (ORR) per RECIST 1.1 and safety.

resultsIn MORPHEUS-PDAC, ORRs with atezolizumab plus PEGPH20 (n = 66) were 6.1% (95% CI, 1.68%-14.80%) vs. 2.4% (95% CI, 0.06%-12.57%) with chemotherapy (n = 42). In the respective arms, 65.2% and 61.9% had grade 3/4 adverse events (AEs); 4.5% and 2.4% had grade 5 AEs. In MORPHEUS-GC, confirmed ORRs with atezolizumab plus PEGPH20 (n = 13) were 0% (95% CI, 0%-24.7%) vs. 16.7% (95% CI, 2.1%-48.4%) with control (n = 12). Grade 3/4 AEs occurred in 30.8% and 75.0% of patients, respectively; no grade 5 AEs occurred.

conclusionAtezolizumab plus PEGPH20 showed limited clinical activity in patients with PDAC and none in patients with GC. The safety of atezolizumab plus PEGPH20 was consistent with each agent's known safety profile. (ClinicalTrials.gov Identifier: NCT03193190 and NCT03281369).

Indexed as

AdenocarcinomaCarcinoma, Pancreatic DuctalPancreatic NeoplasmsStomach NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHumansHyaluronoglucosaminidasePaclitaxelAntibodies, Monoclonal, HumanizedatezolizumabHyaluronoglucosaminidasePaclitaxelPEGPH20basket studycombination therapygastric cancerhyaluronanimmunotherapypancreatic cancerPD-L1proof of concept

Identifiers

PMID36940261
PMCPMC10243783
OpenAlexW4327910154

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.