TATTON: a multi-arm, phase Ib trial of osimertinib combined with selumetinib, savolitinib, or durvalumab in EGFR-mutant lung cancer

Oxnard, G.R.; Yang, J.C.-H.; Yu, H.; Kim, S.-W.; Saka, H.; Horn, L.; Goto, K.; Ohe, Y.; Mann, H.; Thress, K.S.; Frigault, M.M.; Vishwanathan, K.; Ghiorghiu, D.; Ramalingam, S.S.; Ahn, M.-J.

doi:10.1016/j.annonc.2020.01.013

Cited by 438Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentHER2/EGFR in Cancer Research

TATTON: a multi-arm, phase Ib trial of osimertinib combined with selumetinib, savolitinib, or durvalumab in EGFR-mutant lung cancer

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Oxnard, G.R., Yang, J.C.-H., Yu, H., Kim, S.-W., Saka, H., Horn, L., Goto, K., Ohe, Y. +7 more·2020·Annals of Oncology

DOI 10.1016/j.annonc.2020.01.013

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Abstract

Background Osimertinib is a potent, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The multi-arm phase Ib TATTON study (NCT02143466) was designed to assess the safety and tolerability of osimertinib in combination with other targeted therapies: selumetinib (MEK1/2 inhibitor), savolitinib (MET-TKI), or durvalumab [anti-programmed cell death ligand 1 (anti-PD-L1) monoclonal antibody].Patients and methods Patients with advanced EGFR-mutant non-small-cell lung cancer and disease progression on a prior EGFR-TKI were enrolled and allocated to dose-escalating cohorts combining osimertinib 80 mg orally (p.o.) once a day with selumetinib (25-75 mg p.o. twice a day; continuous or intermittent), savolitinib (600-800 mg p.o. once a day), or durvalumab (3-10 mg/kg intravenous every 2 weeks).Results At data cut-off (28 February 2018), 77 patients were enrolled and received osimertinib plus selumetinib (n = 36), savolitinib (n = 18), or durvalumab (n = 23). Most common adverse events (any grade), occurring in ≥20% of patients across dose groups, were: selumetinib arm-diarrhea (75%), rash (58%), nausea (47%); savolitinib arm-nausea (67%), rash (56%), vomiting (50%); durvalumab arm-rash (48%), vomiting (43%), diarrhea (39%). Dose-limiting toxicities were reported in the selumetinib 25 mg (n = 1), 50 mg (n = 1), and 75 mg (n = 4) continuous-dose groups, savolitinib 600 mg (n = 1) and 800 mg dose groups (n = 2), and durvalumab 10 mg/kg (n = 1) dose group. The objective response rate was 42% (95% confidence interval 26% to 59%), 44% (22% to 69%), and 43% (23% to 66%) in the selumetinib, savolitinib, and durvalumab arms, respectively.Conclusion Our results demonstrate the feasibility of combining osimertinib 80 mg with selumetinib or savolitinib at identified tolerable, active doses. A combination of osimertinib with durvalumab was not feasible due to increased reporting of interstitial lung disease. Osimertinib-based combination therapies represent a compelling approach now being further investigated.Clinical trials number NCT02143466.

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In the phase 1 study TATTON, the incidence rate of interstitial lung disease in the osimertinib plus durvalumab arm was 22%, leading to termination of patient enrollment.
“Additionally, in the phase 1 study TATTON, the incidence rate of interstitial lung disease in the osimertinib (a third-generation EGFR-TKI) plus durvalumab arm was unexpectedly high (22%), leading to the termination of patient enrollment [192].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [192]

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Authors: Oxnard, G. R., Yang, J. C.-H., Yu, H., Kim, S.-W., Saka, H., Horn, L., Goto, K., Ohe, Y., Mann, H., Thress, K. S., Frigault, M. M., Vishwanathan, K., Ghiorghiu, D., Ramalingam, S. S., & Ahn, M.-J.
Affiliations: Dana-Farber Cancer Institute (US)
National Taiwan University (TW)
Memorial Sloan Kettering Cancer Center (US)
Asan Medical Center (KR)
Nagoya Medical Center (JP)
Vanderbilt University (US)
National Cancer Centre Japan (JP)
National Cancer Center Hospital (JP)
AstraZeneca (United Kingdom) (GB)
AstraZeneca (United States) (US)
Emory University (US)
Samsung Medical Center (KR)
Corresponding author: Oxnard, G.R.
ORCID: Oxnard, G.R.
Yu, H.
Kim, S.-W.
Saka, H.
Horn, L.
Goto, K.
Ohe, Y.
Mann, H.
Frigault, M.M.
Vishwanathan, K.
Ramalingam, S.S.
Ahn, M.-J.
Venue: Annals of Oncology
Publisher: Elsevier BV
Published: 2020-04
Volume: 31
Issue: 4
Pages: 507-516
ISSN: 0923-7534 (ISSN-L)
DOI: 10.1016/j.annonc.2020.01.013
OpenAlex: W3001408868
Cited by: 438
References: 38
Citations by year: 2026: 33 · 2025: 53 · 2024: 62 · 2023: 63 · 2022: 101 · 2021: 91 · 2020: 33 · 2019: 1 · 2015: 1
FWCI: 40.53
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 366 d)
Locations: Annals of Oncology (publishedVersion)
PubMed (publishedVersion)
Funders: AstraZeneca
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Keywords: osimertinib, EGFR-mutant non-small cell lung cancer, selumetinib, savolitinib, durvalumab, combination therapy, EGFR tyrosine kinase inhibitors, MEK inhibitors, MET inhibitors, PD-L1 inhibitors, dose-limiting toxicity, safety and tolerability, objective response rate, advanced lung cancer
MeSH terms: Acrylamides, Aniline Compounds, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Benzimidazoles, Carcinoma, Non-Small-Cell Lung, Humans, Indoles, Lung Neoplasms, Mutation, Pyrazines, Pyrimidines, Triazines, Protein Kinase Inhibitors, ErbB Receptors

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TATTON: a multi-arm, phase Ib trial of osimertinib combined with selumetinib, savolitinib, or durvalumab in EGFR-mutant lung cancer

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