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Dabrafenib plus trametinib in patients with BRAF V600E-mutant anaplastic thyroid cancer: updated analysis from the phase II ROAR basket study
Open accessAbstract
BACKGROUND: Combined therapy with dabrafenib plus trametinib was approved in several countries for treatment of BRAF V600E-mutant anaplastic thyroid cancer (ATC) based on an earlier interim analysis of 23 response-assessable patients in the ATC cohort of the phase II Rare Oncology Agnostic Research (ROAR) basket study. We report an updated analysis describing the efficacy and safety of dabrafenib plus trametinib in the full ROAR ATC cohort of 36 patients with ∼4 years of additional study follow-up. PATIENTS AND METHODS: ROAR (NCT02034110) is an open-label, nonrandomized, phase II basket study evaluating dabrafenib plus trametinib in BRAF V600E-mutant rare cancers. The ATC cohort comprised 36 patients with unresectable or metastatic ATC who received dabrafenib 150 mg twice daily plus trametinib 2 mg once daily orally until disease progression, unacceptable toxicity, or death. The primary endpoint was investigator-assessed overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints were duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. RESULTS: At data cutoff (14 September 2020), median follow-up was 11.1 months (range, 0.9-76.6 months). The investigator-assessed ORR was 56% (95% confidence interval, 38.1% to 72.1%), including three complete responses; the 12-month DOR rate was 50%. Median PFS and OS were 6.7 and 14.5 months, respectively. The respective 12-month PFS and OS rates were 43.2% and 51.7%, and the 24-month OS rate was 31.5%. No new safety signals were identified with additional follow-up, and adverse events were consistent with the established tolerability of dabrafenib plus trametinib. CONCLUSIONS: These updated results confirm the substantial clinical benefit and manageable toxicity of dabrafenib plus trametinib in BRAF V600E-mutant ATC. Dabrafenib plus trametinib notably improved long-term survival and represents a meaningful treatment option for this rare, aggressive cancer.
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Citations
Cites
Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations
Flaherty, K. T., Infante, J. R., Daud, A., Gonzalez, R., Kefford, R. F., Sosman, J., Hamid, O., Schuchter, L., Cebon, J., Ibrahim, N., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1210093 · Cited by 2,810
Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations
Hyman, D. M., Puzanov, I., Subbiah, V., Faris, J. E., Chau, I., Blay, J.-Y., Wolf, J., Raje, N. S., Diamond, E. L., Hollebecque, A., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1502309 · Cited by 1,764 · cited 1×
“3,37 Noting the caveats of cross-trial comparison, the ORR observed with vemurafenib in a phase II basket trial of that agent in patients with ATC was 29%, 37 substantially lower than the ORR observed with the dabrafenib plus trametinib combination therapy in the current report.”
Self-citationFive-year outcomes with dabrafenib plus trametinib in metastatic melanoma
Robert, C., Grob, J. J., Stroyakovskiy, D., Karaszewska, B., Hauschild, A., Levchenko, E., Chiarion Sileni, V., Schachter, J., Garbe, C., Bondarenko, I., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1904059 · Cited by 1,389
Self-citationPlanchard, D., Smit, E. F., Groen, H. J. M., Mazieres, J., Besse, B., Helland, Å., Giannone, V., D'Amelio, A. M., Zhang, P., Mookerjee, B., et al. (2017) · The Lancet Oncology · doi:10.1016/s1470-2045(17)30679-4 · Cited by 1,360
Thyroid cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Filetti, S., Durante, C., Hartl, D., Leboulleux, S., Locati, L. D., Newbold, K., Papotti, M. G., & Berruti, A. (2019) · Annals of Oncology · doi:10.1093/annonc/mdz400 · Cited by 1,200
Biologic and Clinical Perspectives on Thyroid Cancer
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American Thyroid Association Guidelines for Management of Patients with Anaplastic Thyroid Cancer
Smallridge, R. C., Ain, K. B., Asa, S. L., Bible, K. C., Brierley, J. D., Burman, K. D., Kebebew, E., Lee, N. Y., Nikiforov, Y. E., Rosenthal, M. S., et al. (2012) · Thyroid · doi:10.1089/thy.2012.0302 · Cited by 935
Subbiah, V., Kreitman, R. J., Wainberg, Z. A., Cho, J. Y., Schellens, J. H. M., Soria, J. C., Wen, P. Y., Zielinski, C., Cabanillas, M. E., Urbanowitz, G., et al. (2018) · Journal of Clinical Oncology · doi:10.1200/jco.2017.73.6785 · Cited by 892
Self-citationEfficacy of Selpercatinib in RET -Altered Thyroid Cancers
Wirth, L. J., Sherman, E., Robinson, B., Solomon, B., Kang, H., Lorch, J., Worden, F., Brose, M., Patel, J., Leboulleux, S., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2005651 · Cited by 790
Self-citationBible, K. C., Kebebew, E., Brierley, J., Brito, J. P., Cabanillas, M. E., Clark, T. J., Di Cristofano, A., Foote, R., Giordano, T., Kasperbauer, J., et al. (2021) · Thyroid · doi:10.1089/thy.2020.0944 · Cited by 730
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Cited by
Ringel, M. D., Sosa, J. A., Baloch, Z., Bischoff, L., Bloom, G., Brent, G. A., Brock, P. L., Chou, R., Flavell, R. R., Goldner, W., et al. (2025) · Thyroid® · doi:10.1177/10507256251363120 · Cited by 710
Dabrafenib plus trametinib in BRAFV600E-mutated rare cancers: the phase 2 ROAR trial
Subbiah, V., Kreitman, R. J., Wainberg, Z. A., Gazzah, A., Lassen, U., Stein, A., Wen, P. Y., Dietrich, S., de Jonge, M. J. A., Blay, J.-Y., et al. (2023) · Nature Medicine · doi:10.1038/s41591-023-02321-8 · Cited by 343
Self-citationMolecular Pathways and Mechanisms of BRAF in Cancer Therapy
Poulikakos, P. I., Sullivan, R. J., & Yaeger, R. (2022) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-21-2138 · Cited by 145
BRAF — a tumour-agnostic drug target with lineage-specific dependencies
Hanrahan, A. J., Chen, Z., Rosen, N., & Solit, D. B. (2024) · Nature Reviews Clinical Oncology · doi:10.1038/s41571-023-00852-0 · Cited by 136
Xie, J., Liu, J., Zhao, M., Li, X., Wang, Y., Zhao, Y., Cao, H., Ji, M., Chen, M., & Hou, P. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms24043418 · Cited by 29
Metadata
- Authors
- Subbiah, V., Kreitman, R. J., Wainberg, Z. A., Cho, J. Y., Schellens, J. H. M., Soria, J. C., Wen, P. Y., Zielinski, C. C., Cabanillas, M. E., Boran, A., Ilankumaran, P., Burgess, P., Romero Salas, T., & Keam, B.
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2022-04
- Volume
- 33
- Issue
- 4
- Pages
- 406-415
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W4205515761
- Cited by
- 357
- References
- 42
- FWCI
- 42.76
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Subbiah, V., Kreitman, R. J., Wainberg, Z. A., Cho, J. Y., Schellens, J. H. M., Soria, J. C., Wen, P. Y., Zielinski, C. C., Cabanillas, M. E., Boran, A., Ilankumaran, P., Burgess, P., Romero Salas, T., & Keam, B. (2022). Dabrafenib plus trametinib in patients with BRAF V600E-mutant anaplastic thyroid cancer: updated analysis from the phase II ROAR basket study. Annals of Oncology. https://doi.org/10.1016/j.annonc.2021.12.014
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