Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations
Open accessAbstract
BACKGROUND: BRAF V600 mutations occur in various nonmelanoma cancers. We undertook a histology-independent phase 2 "basket" study of vemurafenib in BRAF V600 mutation-positive nonmelanoma cancers. METHODS: We enrolled patients in six prespecified cancer cohorts; patients with all other tumor types were enrolled in a seventh cohort. A total of 122 patients with BRAF V600 mutation-positive cancer were treated, including 27 patients with colorectal cancer who received vemurafenib and cetuximab. The primary end point was the response rate; secondary end points included progression-free and overall survival. RESULTS: In the cohort with non-small-cell lung cancer, the response rate was 42% (95% confidence interval [CI], 20 to 67) and median progression-free survival was 7.3 months (95% CI, 3.5 to 10.8). In the cohort with Erdheim-Chester disease or Langerhans'-cell histiocytosis, the response rate was 43% (95% CI, 18 to 71); the median treatment duration was 5.9 months (range, 0.6 to 18.6), and no patients had disease progression during therapy. There were anecdotal responses among patients with pleomorphic xanthoastrocytoma, anaplastic thyroid cancer, cholangiocarcinoma, salivary-duct cancer, ovarian cancer, and clear-cell sarcoma and among patients with colorectal cancer who received vemurafenib and cetuximab. Safety was similar to that in prior studies of vemurafenib for melanoma. CONCLUSIONS: BRAF V600 appears to be a targetable oncogene in some, but not all, nonmelanoma cancers. Preliminary vemurafenib activity was observed in non-small-cell lung cancer and in Erdheim-Chester disease and Langerhans'-cell histiocytosis. The histologic context is an important determinant of response in BRAF V600-mutated cancers. (Funded by F. Hoffmann-La Roche/Genentech; ClinicalTrials.gov number, NCT01524978.).
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In BRAFV600 colorectal cancer, targeting EGFR in combination with BRAF inhibition has led to an improvement in clinical efficacy.
“Indeed, in BRAFV600 colorectal cancer, targeting EGFR—the RTK thought to be the primary driver of feedback reactivation from preclinical studies—in combination with BRAF inhibition, has led to an improvement in clinical efficacy (34–39).”
From Vertical Pathway Inhibition Overcomes Adaptive Feedback Resistance to KRASG12C Inhibition (2020) · cites this paper as [39]
The Results > Efficacy section reports one response with vemurafenib plus cetuximab in BRAF V600–mutated colorectal cancer, versus none with vemurafenib alone. It does not establish an overall improvement in clinical efficacy: median progression-free and overall survival were shorter in the combination cohort, and the Discussion describes its clinical activity as modest. Page numbers were not available in our copy. (LLM, conf=0.85)
Experimental — accuracy not yet measuredBRAF inhibitors have proven ineffective as single agents due to adaptive feedback re-activation of the MAPK and other signaling pathways.
“BRAF inhibitors have proven ineffective as single agents due to adaptive feedback re-activation of the MAPK and other signaling pathways [5–13, 38].”
From Co-targeting SRC overcomes resistance to BRAF inhibitors in colorectal cancer (2025) · cites this paper as [6]
The Methods section (page unavailable) reports insufficient activity of vemurafenib alone in BRAF V600–mutated colorectal cancer and says EGFR feedback might mediate resistance. The claim overgeneralizes this finding to BRAF inhibitors as single agents: the paper reports activity in other cancers, does not establish feedback as the cause, and does not identify other reactivated pathways. (LLM, conf=0.88)
Experimental — accuracy not yet measuredBRAF inhibitor efficacy in colorectal cancer patients with BRAF V600E mutations is limited.
“BRAF inhibitor monotherapy is a promising treatment of many cancers, including melanoma and NSCLC; however, BRAF inhibitor efficacy in colorectal cancer patients with BRAF V600E mutations is limited (21).”
From Cetuximab Enhances the Efficacy of MRTX1133, a Novel KRAS<sup>G12D</sup>Inhibitor, in Colorectal Cancer Treatment (2023) · cites this paper as [21]
Single-agent BRAF-targeted therapy is largely ineffective in BRAFV600E colorectal cancer, with response rates below 5%.
“In contrast with other BRAFV600E tumors (i.e. melanoma), BRAFV600E-targeted therapy (like vemurafenib) has proven largely ineffective in CRC, with response rates <5% as single agents [5, 6].”
From Co-targeting SRC overcomes resistance to BRAF inhibitors in colorectal cancer (2025) · cites this paper as [6]
In another clinical study, CRC patients did not benefit from vemurafenib monotherapy and/or cetuximab.
“However, in another clinical study, CRC patients did not benefit from vemurafenib monotherapy and/or cetuximab [161].”
From Drug Resistance in Colorectal Cancer: From Mechanism to Clinic (2022) · cites this paper as [161]
A multicentric clinical study containing 27 colorectal cancer patients showed that vemurafenib alone or with cetuximab did not benefit colorectal cancer patients.
“However, a multicentric clinical study containing 27 CRC patients showed that vemurafenib alone or with cetuximab did not benefit CRC patients [99].”
From Resistance to anti-EGFR therapies in metastatic colorectal cancer: underlying mechanisms and reversal strategies (2021) · cites this paper as [99]
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- Authors
- 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., Gervais, R., Elez-Fernandez, M. E., Italiano, A., Hofheinz, R.-D., Hidalgo, M., Chan, E., Schuler, M., Lasserre, S. F., Makrutzki, M., Sirzen, F., Veronese, M. L., Tabernero, J., & Baselga, J.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- From Memorial Sloan Kettering Cancer Center, New York (D.M.H., E.L.D., J.B.); Vanderbilt University Medical Center, Nashville (I.P., E.C.); University of Texas M.D. Anderson Cancer Center, Houston (V.S.); Massachusetts General Hospital, Boston (J.E.F., N.S.R.); Royal Marsden Hospital, Sutton, Surrey, United Kingdom (I.C.); Centre Léon Bérard, Lyon (J.-Y.B.), Institut Gustave Roussy, Villejuif (A.H.), Centre François Baclesse, Centre Hospitalier Universitaire Côte de Nacre, Caen (R.G.), and Institut...
- F. Hoffmann-La Roche AG (CH)
- Universitat Autònoma de Barcelona (ES)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-08-20
- Volume
- 373
- Issue
- 8
- Pages
- 726-736
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4971773
- OpenAlex
- W1846586690
- Semantic Scholar
- abd7e5ae4940f84d6af08e479e67fa7e4788098c
- Cited by
- 1,764
- References
- 31
- Citations by year
- 2026: 55 · 2025: 102 · 2024: 115 · 2023: 122 · 2022: 143 · 2021: 189 · 2020: 210 · 2019: 192 · 2018: 192 · 2017: 241 · 2016: 169 · 2015: 30 · 2014: 2
- FWCI
- 91.52
- Type
- journal article
- Language
- en
- Update notices
- correction (2018-10-18)
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- Funders
- F. Hoffmann-La Roche
- National Cancer Institute (P30CA008748)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Melanoma and MAPK Pathways
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Keywords
- vemurafenib, BRAF V600 mutation, basket trials, non-small cell lung cancer, Erdheim-Chester disease, Langerhans cell histiocytosis, colorectal cancer, cetuximab, pleomorphic xanthoastrocytoma, anaplastic thyroid carcinoma, cholangiocarcinoma, ovarian cancer, clear cell sarcoma, targeted therapy
- MeSH terms
- Vemurafenib, Aged, Aged, 80 and over, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Female, Humans, Indoles, Lung Neoplasms, Male, Middle Aged, Mutation, Neoplasms, Sulfonamides, Histiocytosis, Disease-Free Survival, Proto-Oncogene Proteins B-raf
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