Evidence map›Paper›PMID 37268157›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2023

IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications.

M Burotto, Z Zvirbule, A Mochalova, Y Runglodvatana, L Herraez-Baranda, S N Liu, P Chan, E Shearer-Kang, X Liu, N Tosti and 3 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03735121 (A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
9.4field-weighted citation impact, top 2% 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.

NCT03735121 phase3completednot on this map

A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

TypeinterventionalSponsorHoffmann-La RocheRan2018 to 2024Enrolled438ConditionsNon-Small Cell Lung CancerArmsAtezolizumab, rHuPH20
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.

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  6. Pharmacokinetic insights into atezolizumab SC: viability of extended dosing intervals beyond the standard regimen.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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  8. Subcutaneous immunotherapy as a catalyst for decentralized, oncologist-led cancer care: a mixed-methods analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 6 countries.

M BurottoCentro de Investigación, Clínica Bradford Hill, Santiago, Chile. Electronic address: Mburotto@bradfordhill.cl.
Z ZvirbuleLatvian Oncology Center, Riga Eastern Clinical University Hospital, Riga, Latvia.
A MochalovaDepartment of Antitumor Drug Therapy, MEDSI Clinical Hospital, Moscow, Russia.
Y RunglodvatanaFaculty of Medicine, Vajira Hospital, Bangkok Metropolitan University, Bangkok, Thailand.
L Herraez-BarandaProduct Development Medical Affairs Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
S N LiuClinical Pharmacology, Genentech, Inc., South San Francisco, USA.
P ChanClinical Pharmacology, Genentech, Inc., South San Francisco, USA.
E Shearer-KangProduct Safety Development, Genentech, Inc., South San Francisco, CA, USA.
X LiuData and Statistical Sciences, Genentech, Inc., South San Francisco, CA, USA.
N TostiProduct Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
J A ZanghiBioAnalytical Sciences, Genentech, Inc., South San Francisco, CA, USA.
B LeutgebProduct Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
E FelipOncology Department, Vall d'Hebron University Hospital, Barcelona, Spain; Clinical Research Department, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Roche (Switzerland) · CHClinical Hospital No. 8 · RURiga East University Hospital · LVStatistical Research (United States) · USVajira Hospital · THVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAtezolizumab intravenous (IV) is approved for the treatment of various solid tumours. To improve treatment convenience and health care efficiencies, a coformulation of atezolizumab and recombinant human hyaluronidase PH20 was developed for subcutaneous (SC) use. Part 2 of IMscin001 (NCT03735121) was a randomised phase III, open-label, multicentre, noninferiority study comparing the drug exposure of atezolizumab SC with atezolizumab IV. PATIENTS AND

methodsEligible patients with locally advanced/metastatic non-small-cell lung cancer were randomised 2 : 1 to receive atezolizumab SC (1875 mg; n = 247) or IV (1200 mg; n = 124) every 3 weeks. The co-primary endpoints were cycle 1 observed trough serum concentration (C

resultsThe study met both of its co-primary endpoints: cycle 1 observed C

conclusionsCompared with IV, atezolizumab SC demonstrated noninferior drug exposure at cycle 1. Efficacy, safety, and immunogenicity were similar between arms and consistent with the known profile for atezolizumab IV. Similar drug exposure and clinical outcomes following SC and IV administration support the use of atezolizumab SC as an alternative to atezolizumab IV.

Indexed as

Antineoplastic AgentsCarcinoma, Non-Small-Cell LungLung NeoplasmsAdministration, IntravenousAntineoplastic Combined Chemotherapy ProtocolsHumansInfusions, IntravenousAntineoplastic Agentsatezolizumabcancer immunotherapynon-small-cell lung cancerpharmacokineticsrecombinant human hyaluronidasesubcutaneous

Identifiers

PMID37268157
OpenAlexW4379055533

What OpenQuestion holds

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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.