Evidence map›Paper›PMID 36951523›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023

FDA Approval Summary: Atezolizumab as Adjuvant Treatment following Surgical Resection and Platinum-Based Chemotherapy for Stage II to IIIA NSCLC.

Luckson N Mathieu, Erin Larkins, Arup K Sinha, Pallavi S Mishra-Kalyani, Samina Jafri, Shyam Kalavar, Soma Ghosh, Kirsten B Goldberg, Richard Pazdur, Julia A Beaver and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
–field-weighted citation impact
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

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

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Nanocarriers for cutting-edge cancer immunotherapies.Journal of translational medicine · 2025
    Review
  17. Article
  18. Article
  19. Article
  20. 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

11 authors.

Luckson N MathieuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-1750-0381
Erin LarkinsCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-7860-0546
Arup K SinhaCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-1687-1869
Pallavi S Mishra-KalyaniCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0003-2309-0179
Samina JafriCenter for Device and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0003-2258-7298
Shyam KalavarCenter for Device and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-7280-7132
Soma GhoshCenter for Device and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0003-0935-1141
Kirsten B GoldbergOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0001-8659-1240
Richard PazdurCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-4771-9923
Julia A BeaverCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-0725-2863
Harpreet SinghCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0003-1526-0916

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

On October 15, 2021, the FDA approved atezolizumab as adjuvant therapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have programmed cell death ligand 1 (PD-L1) expression on ≥1% of tumor cells (TC), as detected by an FDA-approved test. The approval was based on results from the IMpower010 trial, in which 1,005 patients with NSCLC who had completed tumor resection and cisplatin-based adjuvant chemotherapy were randomly assigned 1:1 to receive atezolizumab for 16 cycles or best supportive care. The primary endpoint of disease-free survival (DFS) as assessed by investigator was tested hierarchically in the following analysis populations: stage II-IIIA NSCLC with PD-L1 expression on ≥1% of TCs (PD-L1 ≥ 1% TC); all randomly assigned patients with stage II-IIIA NSCLC; and the intent-to-treat population comprising all randomly assigned patients. At the prespecified interim DFS analysis, IMpower010 demonstrated a statistically significant and clinically meaningful improvement in DFS in the stage II-IIIA PD-L1 ≥ 1% TC analysis population, with an HR of 0.66 (95% confidence interval, 0.50-0.88; P = 0.004) favoring the atezolizumab arm. The safety profile of atezolizumab was generally consistent with known toxicities of anti-PD-(L) antibodies. The VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.) was contemporaneously approved as a companion diagnostic device to select patients with NSCLC who are PD-L1 ≥ 1% TC for adjuvant treatment with atezolizumab. Atezolizumab is the first immune checkpoint inhibitor approved by FDA for the adjuvant treatment of NSCLC.

Indexed as

Antineoplastic AgentsCarcinoma, Non-Small-Cell LungLung NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenHumansPlatinumAntibodies, Monoclonal, HumanizedAntineoplastic AgentsatezolizumabB7-H1 AntigenPlatinum

Identifiers

PMID36951523
PMCPMC10440223

What OpenQuestion holds

Textmetadata
LicenceTDM
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.