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Safety and activity of the TGFβ receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer
Open accessAbstract
Background: We assessed the safety, efficacy, and pharmacokinetics of the transforming growth factor beta (TGFβ) receptor inhibitor galunisertib co-administered with the anti-programmed death-ligand 1 (PD-L1) antibody durvalumab in recurrent/refractory metastatic pancreatic cancer previously treated with ≤2 systemic regimens. Methods: This was a two-part, single-arm, multinational, phase Ib study. In a dose-finding phase, escalating oral doses of galunisertib were co-administered on days 1–14 with fixed-dose intravenous durvalumab 1500 mg on day 1 every 4 weeks (Q4W), followed by an expansion cohort phase. Results: The galunisertib recommended phase II dose (RP2D) when co-administered with durvalumab 1500 mg Q4W was 150 mg two times per day. No dose-limiting toxicities were recorded. Among 32 patients treated with galunisertib RP2D, 1 patient had partial response, 7 had stable disease, 15 had objective progressive disease, and 9 were not evaluable. Disease control rate was 25.0%. Median overall survival and progression-free survival were 5.72 months (95% CI: 4.01 to 8.38) and 1.87 months (95% CI: 1.58 to 3.09), respectively. Pharmacokinetic profiles for combination therapy were comparable to those published for each drug. There was no association between potential biomarkers and treatment outcomes. Conclusion: Galunisertib 150 mg two times per day co-administered with durvalumab 1500 mg Q4W was tolerable. Clinical activity was limited. Studying this combination in patients in an earlier line of treatment or selected for predictive biomarkers of TGFβ inhibition might be a more suitable approach. Trial registration number: ClinicalTrials.gov identifier: NCT02734160.
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Mariathasan, S., Turley, S. J., Nickles, D., Castiglioni, A., Yuen, K., Wang, Y., Kadel III, E. E., Koeppen, H., Astarita, J. L., Cubas, R., et al. (2018) · Nature · doi:10.1038/nature25501 · Cited by 5,400
Genomic analyses identify molecular subtypes of pancreatic cancer
Bailey, P., Chang, D. K., Nones, K., Johns, A. L., Patch, A.-M., Gingras, M.-C., Miller, D. K., Christ, A. N., Bruxner, T. J. C., Quinn, M. C., et al. (2016) · Nature · doi:10.1038/nature16965 · Cited by 3,621
Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors
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TGFβ drives immune evasion in genetically reconstituted colon cancer metastasis
Tauriello, D. V. F., Palomo-Ponce, S., Stork, D., Berenguer-Llergo, A., Badia-Ramentol, J., Iglesias, M., Sevillano, M., Ibiza, S., Cañellas, A., Hernando-Momblona, X., et al. (2018) · Nature · doi:10.1038/nature25492 · Cited by 1,851
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Re-Education of Macrophages as a Therapeutic Strategy in Cancer
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Metadata
- Authors
- Melisi, D., Oh, D.-Y., Hollebecque, A., Calvo, E., Varghese, A., Borazanci, E., Macarulla, T., Merz, V., Zecchetto, C., Zhao, Y., Gueorguieva, I., Man, M., Gandhi, L., Estrem, S. T., Benhadji, K. A., Lanasa, M. C., Avsar, E., Guba, S. C., & Garcia-Carbonero, R.
- Venue
- Journal for ImmunoTherapy of Cancer
- Publisher
- BMJ
- Published
- 2021-03
- Volume
- 9
- Issue
- 3
- Pages
- e002068
- ISSN
- 2051-1426 (ISSN-L)
- OpenAlex
- W3134477587
- Cited by
- 206
- References
- 8
- FWCI
- 10.52
- Type
- journal article
- Language
- en
- Open access
- gold
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- Melisi, D., Oh, D.-Y., Hollebecque, A., Calvo, E., Varghese, A., Borazanci, E., Macarulla, T., Merz, V., Zecchetto, C., Zhao, Y., Gueorguieva, I., Man, M., Gandhi, L., Estrem, S. T., Benhadji, K. A., Lanasa, M. C., Avsar, E., Guba, S. C., & Garcia-Carbonero, R. (2021). Safety and activity of the TGFβ receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer. Journal for ImmunoTherapy of Cancer. https://doi.org/10.1136/jitc-2020-002068
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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