Evidence map›Paper›PMID 33434335›Full record

Trial reportCancer2021

Olmutinib in T790M-positive non-small cell lung cancer after failure of first-line epidermal growth factor receptor-tyrosine kinase inhibitor therapy: A global, phase 2 study.

Keunchil Park, Pasi A Jӓnne, Dong-Wan Kim, Ji-Youn Han, Ming-Fang Wu, Jong-Seok Lee, Jin-Hyoung Kang, Dae Ho Lee, Byoung Chul Cho, Chong-Jen Yu and 5 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
3.8field-weighted citation impact, top 6% 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

18 citing papers in PubMed, 35 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. 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

15 authors at 13 institutions in 5 countries.

Keunchil ParkDivision of Hematology/Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.ORCID 0000-0002-4846-7449
Pasi A JӓnneLowe Center for Thoracic Oncology, The Belfer Institute for Applied Cancer Science, Dana-Farber Cancer Institute, Boston, Massachusetts.
Dong-Wan KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Ji-Youn HanNational Cancer Center, Goyang, Republic of Korea.
Ming-Fang WuChung Shan Medical University Hospital, Taichung, Taiwan.
Jong-Seok LeeDivision of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Jin-Hyoung KangDepartment of Radiation Oncology, Catholic University of Korea, Seoul St Mary's Hospital, Seoul, Republic of Korea.
Dae Ho LeeDepartment of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
Byoung Chul ChoYonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
Chong-Jen YuInternal Medicine, National Taiwan University Hospital, Taipei, Taiwan.ORCID 0000-0001-5664-9392
Yong Kek PangDivision of Respiratory Medicine, University of Malaya Medical Center, Kuala Lumpur, Malaysia.
Enriqueta FelipMedical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Hyunjin KimHanmi Pharmaceutical Company, Ltd, Seoul, Republic of Korea.
Eunhye BaekHanmi Pharmaceutical Company, Ltd, Seoul, Republic of Korea.
Young Su NohHanmi Pharmaceutical Company, Ltd, Seoul, Republic of Korea.
Hanmi Pharmaceutical (South Korea) · KRChung Shan Medical University Hospital · TWDana-Farber Cancer Institute · USNational Cancer Center · KRNational Taiwan University Hospital · TWSamsung Medical Center · KRSeoul National University Bundang Hospital · KRSeoul National University Hospital · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KRUlsan College · KRUniversity Malaya Medical Centre · MYVall d'Hebron Hospital Universitari · ESYonsei University · KR

Funding

Hanmi Pharmaceutical Co. Ltd.
6 · The paper itself

Abstract

backgroundIn this open-label, international phase 2 study, the authors assessed the efficacy and safety of olmutinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had a confirmed T790M mutation and disease progression on previous epidermal growth factor receptor-tyrosine kinase inhibitor therapy.

methodsPatients aged ≥20 years received once-daily oral olmutinib 800 mg continuously in 21-day cycles. The primary endpoint was the objective response rate (patients who had a confirmed best overall response of a complete or partial response), assessed by central review. Secondary endpoints included the disease control rate, the duration of objective response, progression-free survival, and overall survival. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03).

resultsOverall, 162 patients (median age, 63 years; women, >60%) were enrolled from 68 sites in 9 countries. At the time of database cutoff, 23.5% of enrolled patients remained on treatment. The median treatment duration was 6.5 months (range, 0.03-21.68 months). Overall, 46.3% of patients (95% CI, 38.4%-54.3%) had a confirmed objective response (all partial responses). The best overall response (the objective response rate regardless of confirmation) was 51.9% (84 patients; 95% CI, 43.9%-59.8%). The confirmed disease control rate for all patients was 86.4% (95% CI, 80.2%-91.3%). The median duration of objective response was 12.7 months (95% CI, 8.3-15.4 months). Estimated median progression-free survival was 9.4 months (95% CI, 6.9-12.3 months), and estimated median overall survival was 19.7 months (95% CI, 15.1 months to not reached). All patients experienced treatment-emergent adverse events, and 71.6% of patients had grade ≥3 treatment-emergent adverse events.

conclusionsOlmutinib has meaningful clinical activity and a manageable safety profile in patients with T790M-positive non-small cell lung cancer who received previous epidermal growth factor receptor-tyrosine kinase inhibitor therapy.

Indexed as

AdultAgedAged, 80 and overBrain NeoplasmsCarcinoma, Non-Small-Cell LungCirculating Tumor DNAConfidence IntervalsDrug Administration ScheduleErbB ReceptorsFemaleHumansLung NeoplasmsMaleMiddle AgedMutationPiperazinesCirculating Tumor DNAErbB ReceptorsolmutinibPiperazinesProtein Kinase InhibitorsPyrimidinesepidermal growth factor receptornon-small cell lung cancerolmutinibT790Mtyrosine kinase inhibitor

Identifiers

PMID33434335
PMCPMC8247868
OpenAlexW3121030351

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.