Journal Article

DKFZ-2023-00568

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Atezolizumab Plus PEGPH20 Versus Chemotherapy in Advanced Pancreatic Ductal Adenocarcinoma and Gastric Cancer: MORPHEUS Phase Ib/II Umbrella Randomized Study Platform.

Ko, A. H. ; Kim, K.-P. ; Siveke, J.DKFZ* ; Lopez, C. D. ; Lacy, J. ; O'Reilly, E. M. ; Macarulla, T. ; Manji, G. A. ; Lee, J. ; Ajani, J. ; Alsina Maqueda, M. ; Rha, S.-Y. ; Lau, J. ; Al-Sakaff, N. ; Allen, S. ; Lu, D. ; Shemesh, C. S. ; Gan, X. ; Cha, E. ; Oh, D.-Y.

2023
Oxford University Press Oxford

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Please use a persistent id in citations: doi:10.1093/oncolo/oyad022

Abstract: The 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).In 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.In 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.Atezolizumab 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).

Keyword(s): PD-L1 ; basket study ; combination therapy ; gastric cancer ; hyaluronan ; immunotherapy ; pancreatic cancer ; proof of concept

Note: 2023 Jun 2;28(6):553-e472

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Contributing Institute(s):

1. DKTK ED ES zentral (ED01)

Research Program(s):

1. 899 - ohne Topic (POF4-899) (POF4-899)

Appears in the scientific report 2023

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; ; Article Processing Charges ; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; DOAJ Seal ; Essential Science Indicators ; Fees ; IF >= 5 ; JCR ; PubMed Central ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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