Evidence map›Paper›PMID 33076423›Full record

ArticleCancers2020

Ramucirumab in Combination with Pembrolizumab in Treatment-Naïve Advanced Gastric or GEJ Adenocarcinoma: Safety and Antitumor Activity from the Phase 1a/b JVDF Trial.

Ian Chau, Nicolas Penel, Andres O Soriano, Hendrik-Tobias Arkenau, Jennifer Cultrera, Rafael Santana-Davila, Emiliano Calvo, Christophe Le Tourneau, Lars Zender, Johanna C Bendell and 7 more

Open access · goldAbstract read
In one paragraph

Article in Cancers, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
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  11. Article
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  15. Article
  16. Immune evasion mechanisms and therapeutic strategies in gastric cancer.World journal of gastrointestinal oncology · 2022
    Review
  17. Review
  18. Article
  19. Article
  20. Research Progress of Immunotherapy for Gastric Cancer.Technology in cancer research & treatment
    Review
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

17 authors at 9 institutions in 4 countries.

Ian ChauGastrointestinal Units, Royal Marsden Hospital, London SM2 5PT, UK.ORCID 0000-0003-0286-8703
Nicolas PenelGeneral Oncology Department, Medical Oncology Department, Oscar Lambret Cancer Center, 59020 Lille, France.
Andres O SorianoSarah Cannon Research Institute/Florida Cancer Specialists, Englewood, FL 34223, USA.
Hendrik-Tobias ArkenauSarah Cannon Research Institute United Kingdom and University College London, London W1G 6AD, UK.ORCID 0000-0002-2015-1549
Jennifer CultreraSarah Cannon Research Institute/Florida Cancer Specialists Leesburg South, Leesburg, FL 34748, USA.
Rafael Santana-DavilaDepartment of Medicine, University of Washington Medicine, Seattle Cancer Care Alliance, Seattle, WA 98109, USA.
Emiliano CalvoEarly Phase Clinical Drug Development Program, START Madrid-CIOCC, Centro Integral Oncológico Clara Campal, 28050 Madrid, Spain.ORCID 0000-0003-4921-829X
Christophe Le TourneauDepartment of Drug Development and Innovation, Institut Curie, 75005 Paris, France.ORCID 0000-0001-9772-4686
Lars ZenderDepartment of Internal Medicine VIII, University Hospital Tübingen, 72076 Tübingen, Germany.
Johanna C BendellSarah Cannon Research Institute/Tennessee Oncology, Nashville, TN 37203, USA.
Gu MiEli Lilly and Company, Indianapolis, IN 46285, USA.
Ling GaoEli Lilly and Company, Indianapolis, IN 46285, USA.
Samuel Clark McNeelyEli Lilly and Company, Indianapolis, IN 46285, USA.
Joana M OliveiraEli Lilly and Company, New York, NY 10016, USA.
David FerryEli Lilly and Company, New York, NY 10016, USA.
Roy S HerbstYale Cancer Center, New Haven, CT 06520, USA.
Charles S FuchsYale Cancer Center, New Haven, CT 06520, USA.
Eli Lilly (United States) · USSarah Cannon · USYale Cancer Center · USCentre Oscar Lambret · FRInstitut Curie · FRRoyal Marsden Hospital · GBSarah Cannon Research Institute · GBSeattle Cancer Care Alliance · USUniversity Children's Hospital Tübingen · DE

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Eli Lilly and Company N/ANCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

Ramucirumab (anti-VEGFR2) plus pembrolizumab (anti-PD1) demonstrated promising antitumor activity and tolerability among patients with previously treated advanced cancers, supporting growing evidence that combination therapies modulating the tumor microenvironment may expand the spectrum of patients who respond to checkpoint inhibitors. Here we present the results of this combination in first-line patients with metastatic G/GEJ cancer. Twenty-eight patients (≥18 years) with no prior systemic chemotherapy in the advanced/metastatic setting received ramucirumab (8 mg/kg days 1 and 8) plus pembrolizumab (200 mg day 1) every 3 weeks as part of JVDF phase 1a/b study. The primary endpoint was safety. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and overall survival (OS). Tumors were PD-L1-positive (combined positive score ≥ 1) in 19 and -negative in 6 patients. Eighteen patients experienced grade 3 treatment-related adverse events, most commonly hypertension (14%) and elevated alanine/aspartate aminotransferase (11% each), with no grade 4 or 5 reported. The ORR was 25% (PD-L1-positive, 32%; PD-L1-negative, 17%) with duration of response not reached. PFS was 5.6 months (PD-L1-positive, 8.6 months; PD-L1-negative, 4.3 months), and OS 14.6 months (PD-L1-positive, 17.3 months; PD-L1-negative, 11.3 months). Acknowledging study design limitations, ramucirumab plus pembrolizumab had encouraging durable clinical activity with no unexpected toxicities in treatment-naïve biomarker-unselected metastatic G/GEJ cancer, and improved outcomes in patients with PD-L1-positive tumors.

Indexed as

gastric/gastroesophageal junction adenocarcinomapembrolizumabphase 1bramucirumab

Identifiers

PMID33076423
PMCPMC7602637
OpenAlexW3092756800

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.