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Efficacy of Selpercatinib in RET Fusion–Positive Non–Small-Cell Lung Cancer
Open accessAbstract
BACKGROUND: fusion-positive NSCLC, the efficacy and safety of selective RET inhibition are unknown. METHODS: fusion-positive NSCLC who had previously received platinum-based chemotherapy and those who were previously untreated separately in a phase 1-2 trial of selpercatinib. The primary end point was an objective response (a complete or partial response) as determined by an independent review committee. Secondary end points included the duration of response, progression-free survival, and safety. RESULTS: fusion-positive NSCLC who had previously received at least platinum-based chemotherapy, the percentage with an objective response was 64% (95% confidence interval [CI], 54 to 73). The median duration of response was 17.5 months (95% CI, 12.0 to could not be evaluated), and 63% of the responses were ongoing at a median follow-up of 12.1 months. Among 39 previously untreated patients, the percentage with an objective response was 85% (95% CI, 70 to 94), and 90% of the responses were ongoing at 6 months. Among 11 patients with measurable central nervous system metastasis at enrollment, the percentage with an objective intracranial response was 91% (95% CI, 59 to 100). The most common adverse events of grade 3 or higher were hypertension (in 14% of the patients), an increased alanine aminotransferase level (in 12%), an increased aspartate aminotransferase level (in 10%), hyponatremia (in 6%), and lymphopenia (in 6%). A total of 12 of 531 patients (2%) discontinued selpercatinib because of a drug-related adverse event. CONCLUSIONS: fusion-positive NSCLC who had previously received platinum-based chemotherapy and those who were previously untreated. (Funded by Loxo Oncology and others; LIBRETTO-001 ClinicalTrials.gov number, NCT03157128.).
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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
Osimertinib in Untreated EGFR -Mutated Advanced Non–Small-Cell Lung Cancer
Soria, J.-C., Ohe, Y., Vansteenkiste, J., Reungwetwattana, T., Chewaskulyong, B., Lee, K. H., Dechaphunkul, A., Imamura, F., Nogami, N., Kurata, T., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1713137 · Cited by 5,508
Self-citationEfficacy of Larotrectinib in TRK Fusion–Positive Cancers in Adults and Children
Drilon, A., Laetsch, T. W., Kummar, S., DuBois, S. G., Lassen, U. N., Demetri, G. D., Nathenson, M., Doebele, R. C., Farago, A. F., Pappo, A. S., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1714448 · Cited by 2,824
Self-citationCrizotinib 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
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Thai, A. A., Solomon, B. J., Sequist, L. V., Gainor, J. F., & Heist, R. S. (2021) · The Lancet · doi:10.1016/s0140-6736(21)00312-3 · Cited by 2,576
Self-citationEttinger, D. S., Wood, D. E., Aisner, D. L., Akerley, W., Bauman, J. R., Bharat, A., Bruno, D. S., Chang, J. Y., Chirieac, L. R., D’Amico, T. A., et al. (2021) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2021.0013 · Cited by 948
Non–Small Cell Lung Cancer, Version 4.2024
Riely, G. J., Wood, D. E., Ettinger, D. S., Aisner, D. L., Akerley, W., Bauman, J. R., Bharat, A., Bruno, D. S., Chang, J. Y., Chirieac, L. R., et al. (2024) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2204.0023 · Cited by 855
Hendriks, L. E., Kerr, K. M., Menis, J., Mok, T. S., Nestle, U., Passaro, A., Peters, S., Planchard, D., Smit, E. F., Solomon, B. J., et al. (2023) · Annals of Oncology · doi:10.1016/j.annonc.2022.12.009 · Cited by 853
Self-citationPascual, J., Attard, G., Bidard, F.-C., Curigliano, G., De Mattos-Arruda, L., Diehn, M., Italiano, A., Lindberg, J., Merker, J. D., Montagut, C., et al. (2022) · Annals of Oncology · doi:10.1016/j.annonc.2022.05.520 · Cited by 783
Metadata
- Authors
- Drilon, A., Oxnard, G. R., Tan, D. S. W., Loong, H. H. F., Johnson, M., Gainor, J., McCoach, C. E., Gautschi, O., Besse, B., Cho, B. C., Peled, N., Weiss, J., Kim, Y.-J., Ohe, Y., Nishio, M., Park, K., Patel, J., Seto, T., Sakamoto, T., Rosen, E., Shah, M. H., Barlesi, F., Cassier, P. A., Bazhenova, L., De Braud, F., Garralda, E., Velcheti, V., Satouchi, M., Ohashi, K., Pennell, N. A., Reckamp, K. L., Dy, G. K., Wolf, J., Solomon, B., Falchook, G., Ebata, K., Nguyen, M., Nair, B., Zhu, E. Y., Yang, L., Huang, X., Olek, E., Rothenberg, S. M., Goto, K., & Subbiah, V.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-08-27
- Volume
- 383
- Issue
- 9
- Pages
- 813-824
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3081278682
- Cited by
- 828
- References
- 4
- FWCI
- 64.15
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Drilon, A., Oxnard, G. R., Tan, D. S. W., Loong, H. H. F., Johnson, M., Gainor, J., McCoach, C. E., Gautschi, O., Besse, B., Cho, B. C., Peled, N., Weiss, J., Kim, Y.-J., Ohe, Y., Nishio, M., Park, K., Patel, J., Seto, T., Sakamoto, T., . . . Subbiah, V. (2020). Efficacy of Selpercatinib in RET Fusion–Positive Non–Small-Cell Lung Cancer. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2005653
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