P1.13-44 Safety, PK, and Preliminary Antitumor Activity of the Oral EGFR/HER2 Exon 20 Inhibitor TAK-788 in NSCLC
Open accessIntegrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
A phase I/II study of TAK-788 in 39 patients with EGFR exon 20 insertions showed a 39% ORR at doses of 80-160 mg/day and 94% DCR.
“The results of a phase I/II study (NCT02716116) confirmed the preclinical activity in 39 patients harboring EGFR exon 20 insertions, with a 39% ORR at doses of 80–160 mg/day and 94% DCR.”
TAK-788 inhibits in vitro EGFR exon 20 insertion mutants more potently than WT EGFR.
“TAK-788 (AP32788) is a novel EGFR/HER2 that inhibits in vitro EGFR exon 20 insertion mutants more potently than WT EGFR.”
Cited by
Sorted by citations
Riudavets, M., Sullivan, I., Abdayem, P., & Planchard, D. (2021) · ESMO Open · doi:10.1016/j.esmoop.2021.100260 · Cited by 196 · see citing works
“Early results of a phase I/II first-in-human multicentre study of 34 refractory NSCLC patients with EGFR/HER2 exon 20 insertions reported objective responses in 3 out of 14 assessable patients, all of them harbouring an EGFR exon 20 insertion.(58) The recommended dose was 160 mg daily and toxicity was consistent with…”
BackgroundEmerging therapies for non-small cell lung cancer
Zhang, C., Leighl, N. B., Wu, Y.-L. L. C., & Zhong, W. (2019) · Journal of Hematology & Oncology · doi:10.1186/s13045-019-0731-8 · Cited by 153 · see citing works
“Another novel agent for EGFR exon 20 insertion, TAK-788, has also been reported in 2018 WCLC [80].”
BackgroundInfluentialEGFR exon 20 insertions in advanced non-small cell lung cancer: A new history begins
Remón, J., Hendriks, L. E. L., Cardona, A. F., & Besse, B. (2020) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2020.102105 · Cited by 127 · see citing works
Russo, A., Franchina, T., Ricciardi, G., Battaglia, A., Picciotto, M., & Adamo, V. (2019) · International Journal of Molecular Sciences · doi:10.3390/ijms20061431 · Cited by 110 · see citing works
“Four phase II expansion cohorts have been opened and are evaluating TAK-788 in different molecularly defined subgroups, including patients with EGFR exon 20 insertions, with or without CNS metastases [78].”
BackgroundAdvanced-Stage Non–Small Cell Lung Cancer: Advances in Thoracic Oncology 2018
Remón, J., Ahn, M., Girard, N., Johnson, M. L., Kim, D., Lopes, G. D. L., Jr., Pillai, R. N., Solomon, B., Villacampa, G. J., & Zhou, Q. H. (2019) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2019.03.022 · Cited by 83 · see citing works
Masood, A., Kancha, R. K., & Subramanian, J. (2019) · Seminars in Oncology · doi:10.1053/j.seminoncol.2019.08.004 · Cited by 83 · see citing works
Novel drugs targeting EGFR and HER2 exon 20 mutations in metastatic NSCLC
Baraibar, I., Mezquita, L., Bazo, I. G., & Planchard, D. (2020) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2020.102906 · Cited by 66 · see citing works
Khaddour, K., Jonna, S., Deneka, A. Y., Patel, J. D., Abazeed, M. E., Golemis, E. A., Borghaei, H., & Boumber, Y. (2021) · Cancers · doi:10.3390/cancers13133164 · Cited by 65 · see citing works
Han, H., Li, S., Chen, T., Fitzgerald, M., Liu, S., Peng, C., Tang, K. H., Cao, S., Chouitar, J., Wu, J., et al. (2021) · Cancer Research · doi:10.1158/0008-5472.can-21-1526 · Cited by 57 · see citing works
“In a phase I/II clinical trial, NSCLC patients with EGFR exon 20 insertions showed promising responses to mobocertinib with an objective response rate of 43% (13, 14).”
Self-citationAttili, I., Corvaja, C., Spitaleri, G., Signore, E. D., Aliaga, P. T., Passaro, A., & de Marinis, F. (2023) · Cancers · doi:10.3390/cancers15205079 · Cited by 53 · see citing works
“These agents showed only modest activity and severe gastrointestinal and cutaneous AEs, owing to EGFR inhibition, that hindered further development [28–30].”
BackgroundHER2-Altered Non-Small Cell Lung Cancer: Biology, Clinicopathologic Features, and Emerging Therapies
Yu, X., Ji, X., & Su, C. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.860313 · Cited by 43 · see citing works
“A phase I/II trial (NCT02716116) showed promising antitumor activities of mobocertinib in advanced NSCLC patients harboring EGFR ex20ins, with a similar safety profile compared to other EGFR-TKIs (78, 79).”
BackgroundInfluentialUpadhya, A., Yadav, K. S., & Misra, A. R. (2020) · Expert Opinion on Drug Delivery · doi:10.1080/17425247.2021.1825377 · Cited by 37 · see citing works
Ismail, A., Desai, A. P., & Boumber, Y. (2025) · Frontiers in Oncology · doi:10.3389/fonc.2025.1624124 · Cited by 31 · see citing works
Chen, J. A., & Riess, J. W. (2020) · Journal of Thoracic Disease · doi:10.21037/jtd.2019.08.32 · Cited by 20 · see citing works
“TAK-788 is a small molecular inhibitor of EGFR and HER2 with activity against EGFR exon 20 insertions (103).”
BackgroundHER2-Altered Non-Small Cell Lung Cancer: A Journey from Current Approaches to Emerging Strategies
Ferrari, G., Rio, B. D., Novello, S., & Passiglia, F. (2024) · Cancers · doi:10.3390/cancers16112018 · Cited by 19 · see citing works
“…an oral EGFR/HER2 inhibitor targeting exon 20 insertions, demonstrated antitumor activity in a phase I/II trial involving advanced NSCLC patients with EGFR exon 20 insertion, while results from an expansion cohort focusing on patients harbouring HER2 exon 20 alterations are still pending [39,40].”
BackgroundCase Report: Afatinib Treatment in a Patient With NSCLC Harboring a Rare EGFR Exon 20 Mutation
Zöchbauer‐Müller, S., Kaserer, B., Prosch, H., Cseh, A., Solca, F., Bauer, M. J., & Müllauer, L. (2021) · Frontiers in Oncology · doi:10.3389/fonc.2020.593852 · Cited by 19 · see citing works
Vathiotis, I. A., Bafaloukos, D. I., Syrigos, K. N., & Samonis, G. (2023) · Cancers · doi:10.3390/cancers15041286 · Cited by 18 · see citing works
“harboring EGFR exon 20 insertions (NCT02716116), resulting in an expansion cohort of patients with HER2 exon 20 insertions [44,45].”
BackgroundTargeting Infrequent Driver Alterations in Non-Small Cell Lung Cancer
Nokin, M., Ambrogio, C., Nadal, E., & Santamarı́a, D. (2020) · Trends in cancer · doi:10.1016/j.trecan.2020.11.005 · Cited by 19 · see citing works
Epidermal growth factor receptor exon 20 insertion variants in non-small cell lung cancer patients
Malapelle, U., Pilotto, S., Reale, M. L., Passiglia, F., Pisapia, P., Pepe, F., Belluomini, L., Galetta, D., Cortinovis, D. L., Tiseo, M., et al. (2021) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2021.103536 · Cited by 13 · see citing works
Scodes, S., & Cappuzzo, F. (2020) · Expert Review of Respiratory Medicine · doi:10.1080/17476348.2020.1746646 · Cited by 10 · see citing works
Man, X., Sun, X., Chen, C., Xiang, Y., Zhang, J., & Yang, L. (2024) · Frontiers in Oncology · doi:10.3389/fonc.2024.1367204 · Cited by 7 · see citing works
Hitting the Right Spot: Advances in the Treatment of NSCLC With Uncommon EGFR Mutations
Sabari, J. K., Heymach, J. V., & Sandy, B. (2021) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2021.0200 · Cited by 6 · see citing works
Bai, R., Chen, X., Song, W., Tian, H., & Cui, J. (2021) · Journal of Cancer Research and Clinical Oncology · doi:10.1007/s00432-021-03840-y · Cited by 7 · see citing works
Zhu, Y., Jean‐Baptiste, M., Lenderking, W. R., Bell, J. A., Revicki, D. A., Lin, H. M., Brake, R. L., & Reeve, B. B. (2022) · Cancer Medicine · doi:10.1002/cam4.5376 · Cited by 2 · see citing works
Absenger, G. (2019) · memo - Magazine of European Medical Oncology · doi:10.1007/s12254-019-0488-3 · Cited by 1 · see citing works
Ishida, M., Yamada, T., Katayama, Y., Kawachi, H., Sawada, R., Nakamura, R., Hirai, S., Matsui, Y., Morimoto, K., Onoi, K., et al. (2025) · SSRN Electronic Journal · doi:10.2139/ssrn.5126664
Ishida, M., Yamada, T., Katayama, Y., Kawachi, H., Sawada, R., Nakamura, R., Hirai, S., Matsui, Y., Morimoto, K., Onoi, K., et al. (2026) · npj Precision Oncology · doi:10.1038/s41698-026-01385-2
Innovative therapies for HER2-altered non-small cell lung cancer: A narrative review
Arrieta, O. G., Caballé‐Perez, E., Cabrera-Miranda, L. A., Cardona, A. F., Davila-Dupont, D., Velasco-Córdoba, M., & Treviño, L. A. C. (2026) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2026.105619
- Authors
- Neal, J., Doebele, R., Riely, G., Spira, A., Horn, L., Piotrowska, Z., Costa, D., Zhang, S., Bottino, D., Zhu, J., Kerstein, D., Li, S., & Jänne, P.
- Affiliations
- Stanford Medicine (US)
- University of Colorado Cancer Center (US)
- Memorial Sloan Kettering Cancer Center (US)
- Virginia Cancer Specialists (US)
- Vanderbilt University (US)
- Massachusetts General Hospital (US)
- Beth Israel Deaconess Medical Center (US)
- Takeda Oncology (United States) (US)
- Venue
- Journal of Thoracic Oncology
- Publisher
- Elsevier BV
- Published
- 2018-10
- Volume
- 13
- Issue
- 10
- Pages
- S599
- ISSN
- 1556-0864 (ISSN-L)
- OpenAlex
- W2898375329
- Cited by
- 28
- References
- 0
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 2 · 2023: 2 · 2022: 2 · 2021: 7 · 2020: 6 · 2019: 5
- FWCI
- 3.39
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Thoracic Oncology (publishedVersion)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
- Keywords
- EGFR exon 20 insertion, HER2 exon 20 insertion, tyrosine kinase inhibitors, non-small cell lung cancer, anticancer activity, pharmacokinetics, drug safety
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
