Evidence map›Paper›PMID 37385154›Full record

Trial reportESMO open2023

A phase Ib/II dose expansion study of subcutaneous sasanlimab in patients with locally advanced or metastatic non-small-cell lung cancer and urothelial carcinoma.

B C Cho, K Penkov, I Bondarenko, A Kurochkin, J Pikiel, H K Ahn, M E Korożan, M Osipov, S Odintsova, F Braiteh and 10 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in ESMO open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 18% 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

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
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 8 institutions in 3 countries.

B C ChoDivision of Medical Oncology, Yonsei Cancer Center, Seoul, Republic of Korea. Electronic address: cbc1971@yuhs.ac.
K PenkovPrivate Healthcare Institution Clinical Hospital "RZhD-Medicine", St Petersburg, Russian Federation.
I BondarenkoDepartment of Oncology and Medical Oncology, Dnipropetrovsk City Multiple-Discipline Clinical Hospital, Dnipro, Ukraine.
A KurochkinMunicipal Non-profit Enterprise of Sumy Regional Council, Sumy Regional Clinical Oncology Dispensary, Sumy, Ukraine.
J PikielPoradnia Onkologiczna, Szpitale Pomorskie Sp. z o.o, Gdynia, Poland.
H K AhnDivision of Medical Oncology, Gachon University Gil Medical Center, Incheon, Republic of Korea.
M E KorożanOddzial Onkologii Klinicznej, Szpital Grudziądz, Grudziądz, Poland.
M OsipovSbhi "Lrcod", Vsevolozhsky District, Leningrad Region, Russian Federation.
S OdintsovaCurrent Medical Technology, St Petersburg, Russian Federation.
F BraitehComprehensive Cancer Centers of Nevada, Las Vegas, USA.
A RibasJonsson Comprehensive Cancer Center, The University of California Los Angeles, Los Angeles, USA.
J E Grilley-OlsonDuke Cancer Institute, Duke University, Durham, USA.
I LugowskaEarly Phase Clinical Trials Unit, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
V BonatoPfizer Inc, San Diego, USA.
M A DamorePfizer Inc, San Diego, USA.
W YangPfizer Inc, San Diego, USA.
I A JacobsPfizer Inc, New York, USA.
M BowersPfizer Inc, Arnold, USA.
M LiPfizer Inc, San Francisco, USA.
M L JohnsonSarah Cannon Research Institute, Tennessee Oncology PLLC, Nashville, USA. Electronic address: mjohnson@tnonc.com.
Pfizer (United States) · USComprehensive Cancer Centers of Nevada · USDuke University · USGachon University Gil Medical Center · KRSarah Cannon · USThe Maria Sklodowska-Curie National Research Institute of Oncology · PLUniversity of California, Los Angeles · USYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSasanlimab is an antibody to the programmed cell death protein 1 receptor. We report updated data of subcutaneous sasanlimab in non-small-cell lung cancer (NSCLC) and urothelial carcinoma dose expansion cohorts from a first-in-human phase Ib/II study. PATIENTS AND

methodsPatients were ≥18 years of age with NSCLC or urothelial carcinoma, and no prior immunotherapies, who progressed on or were intolerant to systemic therapy, or for whom systemic therapy was refused or unavailable. Patients received subcutaneous sasanlimab at 300 mg every 4 weeks (q4w). Primary objectives were to evaluate safety, tolerability, and clinical efficacy by objective response rate (ORR).

resultsSixty-eight and 38 patients with NSCLC and urothelial carcinoma, respectively, received subcutaneous sasanlimab. Overall, sasanlimab was well tolerated; 13.2% of patients experienced grade ≥3 treatment-related adverse events. Confirmed ORR was 16.4% and 18.4% in the NSCLC and urothelial carcinoma cohorts, respectively. ORR was generally higher in patients with high programmed death-ligand 1 (PD-L1) expression (≥25%) and high tumor mutational burden (TMB; >75%). In the NSCLC and urothelial carcinoma cohorts, median progression-free survival (PFS) was 3.7 and 2.9 months, respectively; corresponding median overall survival (OS) was 14.7 and 10.9 months. Overall, longer median PFS and OS correlated with high PD-L1 expression and high TMB. Longer median PFS and OS were also associated with T-cell inflamed gene signature in the urothelial carcinoma cohort.

conclusionsSubcutaneous sasanlimab at 300 mg q4w was well tolerated with promising clinical efficacy observed. Phase II and III clinical trials of sasanlimab are ongoing to validate clinical benefit. Subcutaneous sasanlimab may be a potential treatment option for patients with NSCLC or urothelial carcinoma.

Indexed as

Carcinoma, Non-Small-Cell LungCarcinoma, Transitional CellLung NeoplasmsUrinary Bladder NeoplasmsAdolescentAdultB7-H1 AntigenHumansImmune Checkpoint InhibitorsB7-H1 AntigenImmune Checkpoint Inhibitorsnon-small-cell lung cancerPD-1phase Isasanlimaburothelial carcinoma

Identifiers

PMID37385154
PMCPMC10485400
OpenAlexW4382196725

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.