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Safety and Antitumor Activity of the Multitargeted Pan-TRK, ROS1, and ALK Inhibitor Entrectinib: Combined Results from Two Phase I Trials (ALKA-372-001 and STARTRK-1)
Open accessAbstract
Entrectinib, a potent oral inhibitor of the tyrosine kinases TRKA/B/C, ROS1, and ALK, was evaluated in two phase I studies in patients with advanced or metastatic solid tumors, including patients with active central nervous system (CNS) disease. Here, we summarize the overall safety and report the antitumor activity of entrectinib in a cohort of patients with tumors harboring NTRK1/2/3, ROS1, or ALK gene fusions, naïve to prior TKI treatment targeting the specific gene, and who were treated at doses that achieved therapeutic exposures consistent with the recommended phase II dose. Entrectinib was well tolerated, with predominantly Grades 1/2 adverse events that were reversible with dose modification. Responses were observed in non–small cell lung cancer, colorectal cancer, mammary analogue secretory carcinoma, melanoma, and renal cell carcinoma, as early as 4 weeks after starting treatment and lasting as long as >2 years. Notably, a complete CNS response was achieved in a patient with SQSTM1–NTRK1-rearranged lung cancer. Significance: Gene fusions of NTRK1/2/3, ROS1, and ALK (encoding TRKA/B/C, ROS1, and ALK, respectively) lead to constitutive activation of oncogenic pathways. Entrectinib was shown to be well tolerated and active against those gene fusions in solid tumors, including in patients with primary or secondary CNS disease. Cancer Discov; 7(4); 400–9. ©2017 AACR. This article is highlighted in the In This Issue feature, p. 339
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New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
Eisenhauer, E. A., Therasse, P., Bogaerts, J., Schwartz, L. H., Sargent, D., Ford, R., Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., et al. (2009) · European Journal of Cancer · doi:10.1016/j.ejca.2008.10.026 · Cited by 29,534
First-Line Crizotinib versus Chemotherapy in ALK -Positive Lung Cancer
Solomon, B. J., Mok, T., Kim, D.-W., Wu, Y.-L., Nakagawa, K., Mekhail, T., Felip, E., Cappuzzo, F., Paolini, J., Usari, T., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1408440 · Cited by 3,190
Neurotrophins and their receptors: A convergence point for many signalling pathways
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Crizotinib in ROS1-Rearranged Non–Small-Cell Lung Cancer
Shaw, A. T., Ou, S.-H. I., Bang, Y.-J., Camidge, D. R., Solomon, B. J., Salgia, R., Riely, G. J., Varella-Garcia, M., Shapiro, G. I., Costa, D. B., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1406766 · Cited by 1,964
Self-citationCeritinib in ALK -Rearranged Non–Small-Cell Lung Cancer
Shaw, A. T., Kim, D.-W., Mehra, R., Tan, D. S. W., Felip, E., Chow, L. Q. M., Camidge, D. R., Vansteenkiste, J., Sharma, S., De Pas, T., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1311107 · Cited by 1,495
Self-citationShaw, A. T., Gandhi, L., Gadgeel, S., Riely, G. J., Cetnar, J., West, H., Camidge, D. R., Socinski, M. A., Chiappori, A., Mekhail, T., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(15)00488-x · Cited by 638
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Doebele, R. C., Drilon, A., Paz-Ares, L., Siena, S., Shaw, A. T., Farago, A. F., Blakely, C. M., Seto, T., Cho, B. C., Tosi, D., et al. (2020) · The Lancet Oncology · doi:10.1016/s1470-2045(19)30691-6 · Cited by 1,790
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Hong, D. S., DuBois, S. G., Kummar, S., Farago, A. F., Albert, C. M., Rohrberg, K. S., van Tilburg, C. M., Nagasubramanian, R., Berlin, J. D., Federman, N., et al. (2020) · The Lancet Oncology · doi:10.1016/s1470-2045(19)30856-3 · Cited by 1,028
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Metadata
- Authors
- Drilon, A., Siena, S., Ou, S.-H. I., Patel, M., Ahn, M. J., Lee, J., Bauer, T. M., Farago, A. F., Wheler, J. J., Liu, S. V., Doebele, R., Giannetta, L., Cerea, G., Marrapese, G., Schirru, M., Amatu, A., Bencardino, K., Palmeri, L., Sartore-Bianchi, A., Vanzulli, A., Cresta, S., Damian, S., Duca, M., Ardini, E., Li, G., Christiansen, J., Kowalski, K., Johnson, A. D., Patel, R., Luo, D., Chow-Maneval, E., Hornby, Z., Multani, P. S., Shaw, A. T., & De Braud, F. G.
- Venue
- Cancer Discovery
- Published
- 2017-04-01
- Volume
- 7
- Issue
- 4
- Pages
- 400-409
- ISSN
- 2159-8274 (ISSN-L)
- 2159-8290
- OpenAlex
- W2586704604
- Cited by
- 826
- References
- 6
- FWCI
- 75.33
- Type
- journal article
- Language
- en
- Open access
- bronze
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- CoChat. (2026). Citation check: Safety and Antitumor Activity of the Multitargeted Pan-TRK, ROS1, and ALK Inhibitor Entrectinib: Combined Results from Two Phase I Trials (ALKA-372-001 and STARTRK-1). https://app.cochat.ai/papers/10.1158/2159-8290.cd-16-1237
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- Drilon, A., Siena, S., Ou, S.-H. I., Patel, M., Ahn, M. J., Lee, J., Bauer, T. M., Farago, A. F., Wheler, J. J., Liu, S. V., Doebele, R., Giannetta, L., Cerea, G., Marrapese, G., Schirru, M., Amatu, A., Bencardino, K., Palmeri, L., Sartore-Bianchi, A., . . . De Braud, F. G. (2017). Safety and Antitumor Activity of the Multitargeted Pan-TRK, ROS1, and ALK Inhibitor Entrectinib: Combined Results from Two Phase I Trials (ALKA-372-001 and STARTRK-1). Cancer Discovery. https://doi.org/10.1158/2159-8290.cd-16-1237
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
