Evidence map›Paper›PMID 37141544›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

US Food and Drug Administration Approval Summary: Nivolumab Plus Platinum-Doublet Chemotherapy for the Neoadjuvant Treatment of Patients With Resectable Non-Small-Cell Lung Cancer.

Oladimeji Akinboro, Nicole Drezner, Anup Amatya, Jin Runyan, Jeanne Fourie-Zirkelbach, Miao Zhao, Youwei Bi, Kwadwo Korsah, Bronwyn Mixter, Shenghui Tang and 4 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
9.8field-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.

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

24 citing papers in PubMed, 38 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

14 authors at 1 institution in 1 country.

Oladimeji AkinboroCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0003-3847-1310
Nicole DreznerCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Anup AmatyaCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Jin RunyanCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Jeanne Fourie-ZirkelbachCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Miao ZhaoCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Youwei BiCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Kwadwo KorsahCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Bronwyn MixterOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0001-5277-4399
Shenghui TangCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-0437-665X
Erin LarkinsCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Richard PazdurCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-4771-9923
Julia A BeaverCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Harpreet SinghCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
United States Food and Drug Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOn March 4, 2022, the US Food and Drug Administration (FDA) approved nivolumab plus platinum-doublet chemotherapy for the neoadjuvant treatment of patients with resectable non-small-cell lung cancer (NSCLC). We discuss the FDA's review of the key data and regulatory considerations supporting this approval. PATIENTS AND

methodsThe approval was based on the results of CheckMate 816, an international, multiregional, active-controlled trial that randomly assigned 358 patients with resectable NSCLC, stage IB (≥4 cm) to IIIA (N2) per the American Joint Committee on Cancer seventh staging edition to receive either nivolumab plus platinum-doublet or platinum-doublet chemotherapy alone for three cycles before planned surgical resection. The major efficacy end point that supported this approval was event-free survival (EFS).

resultsAt the first planned interim analysis (IA), the hazard ratio (HR) for EFS was 0.63 (95% CI, 0.45 to 0.87;

conclusionThis approval, the first for any regimen for the neoadjuvant treatment of NSCLC in the United States, was supported by a statistically significant and clinically meaningful improvement in EFS with no evidence of detriment in OS or negative impact on patients' receipt and timing of surgery or surgical outcomes.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsHumansIpilimumabNeoadjuvant TherapyNivolumabPlatinumUnited StatesUnited States Food and Drug AdministrationIpilimumabNivolumabPlatinum

Identifiers

PMID37141544
PMCPMC10256356
OpenAlexW4368342513

What OpenQuestion holds

Textmetadata
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.