Clinical Trial

. 2023 May;29(5):1103-1112.

doi: 10.1038/s41591-023-02321-8. Epub 2023 Apr 14.

Dabrafenib plus trametinib in BRAFV600E-mutated rare cancers: the phase 2 ROAR trial

Vivek Subbiah¹, Robert J Kreitman², Zev A Wainberg³, Anas Gazzah⁴, Ulrik Lassen⁵, Alexander Stein⁶, Patrick Y Wen⁷, Sascha Dietrich⁸, Maja J A de Jonge⁹, Jean-Yves Blay¹⁰, Antoine Italiano¹¹, Kan Yonemori¹², Daniel C Cho¹³, Filip Y F L de Vos¹⁴, Philippe Moreau¹⁵, Elena Elez Fernandez¹⁶, Jan H M Schellens¹⁷, Christoph C Zielinski¹⁸, Suman Redhu¹⁹, Aislyn Boran²⁰, Vanessa Q Passos²⁰, Palanichamy Ilankumaran²⁰, Yung-Jue Bang²¹

Affiliations

¹ Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. vsubbiah@mdanderson.org.
² Laboratory of Molecular Biology, National Institutes of Health, Bethesda, MD, USA.
³ Department of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
⁴ Drug Development Department (DITEP), Gustave Roussy Cancer Institute, Villejuif, France.
⁵ Department of Oncology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
⁶ Department of Internal Medicine II (Oncology Center), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
⁷ Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
⁸ University of Heidelberg, Heidelberg, Germany.
⁹ Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
¹⁰ Center Leon Berard & University Claude Bernard Lyon I, Lyon, France.
¹¹ Early Phase Trials and Sarcoma Units, Institut Bergonié, Bordeaux, France; Faculty of Medicine, University of Bordeaux, Bordeaux, France.
¹² National Cancer Center Hospital, Tokyo, Japan.
¹³ New York Medical College, Valhalla, NY, USA.
¹⁴ Department of Medical Oncology, University Medical Center Utrecht, University Utrecht, Utrecht, The Netherlands.
¹⁵ Department of Hematology, CHU de Nantes, Nantes, France.
¹⁶ Department of Medical Oncology, Vall d'Hebron University Hospital (HUVH), Vall d'Hebron Institute of Oncology (VHIO), IOB-Quiron, UVic-UCC, Barcelona, Spain.
¹⁷ Netherlands Cancer Institute, Amsterdam, The Netherlands.
¹⁸ Medical University of Vienna, Vienna, Austria.
¹⁹ Global Program Biostatistics, Novartis Oncology, Cambridge, MA, USA.
²⁰ Global Drug Development, Oncology Development Unit, Novartis Services, Inc., East Hanover, NJ, USA.
²¹ Seoul National University College of Medicine, Seoul, Republic of Korea.

PMID: 37059834
PMCID: PMC10202803
DOI: 10.1038/s41591-023-02321-8

Clinical Trial

Dabrafenib plus trametinib in BRAFV600E-mutated rare cancers: the phase 2 ROAR trial

Vivek Subbiah et al. Nat Med. 2023 May.

. 2023 May;29(5):1103-1112.

doi: 10.1038/s41591-023-02321-8. Epub 2023 Apr 14.

Authors

Affiliations

¹ Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. vsubbiah@mdanderson.org.
² Laboratory of Molecular Biology, National Institutes of Health, Bethesda, MD, USA.
³ Department of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
⁴ Drug Development Department (DITEP), Gustave Roussy Cancer Institute, Villejuif, France.
⁵ Department of Oncology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
⁶ Department of Internal Medicine II (Oncology Center), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
⁷ Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
⁸ University of Heidelberg, Heidelberg, Germany.
⁹ Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
¹⁰ Center Leon Berard & University Claude Bernard Lyon I, Lyon, France.
¹¹ Early Phase Trials and Sarcoma Units, Institut Bergonié, Bordeaux, France; Faculty of Medicine, University of Bordeaux, Bordeaux, France.
¹² National Cancer Center Hospital, Tokyo, Japan.
¹³ New York Medical College, Valhalla, NY, USA.
¹⁴ Department of Medical Oncology, University Medical Center Utrecht, University Utrecht, Utrecht, The Netherlands.
¹⁵ Department of Hematology, CHU de Nantes, Nantes, France.
¹⁶ Department of Medical Oncology, Vall d'Hebron University Hospital (HUVH), Vall d'Hebron Institute of Oncology (VHIO), IOB-Quiron, UVic-UCC, Barcelona, Spain.
¹⁷ Netherlands Cancer Institute, Amsterdam, The Netherlands.
¹⁸ Medical University of Vienna, Vienna, Austria.
¹⁹ Global Program Biostatistics, Novartis Oncology, Cambridge, MA, USA.
²⁰ Global Drug Development, Oncology Development Unit, Novartis Services, Inc., East Hanover, NJ, USA.
²¹ Seoul National University College of Medicine, Seoul, Republic of Korea.

PMID: 37059834
PMCID: PMC10202803
DOI: 10.1038/s41591-023-02321-8

Abstract

BRAFV600E alterations are prevalent across multiple tumors. Here we present final efficacy and safety results of a phase 2 basket trial of dabrafenib (BRAF kinase inhibitor) plus trametinib (MEK inhibitor) in eight cohorts of patients with BRAFV600E-mutated advanced rare cancers: anaplastic thyroid carcinoma (n = 36), biliary tract cancer (n = 43), gastrointestinal stromal tumor (n = 1), adenocarcinoma of the small intestine (n = 3), low-grade glioma (n = 13), high-grade glioma (n = 45), hairy cell leukemia (n = 55) and multiple myeloma (n = 19). The primary endpoint of investigator-assessed overall response rate in these cohorts was 56%, 53%, 0%, 67%, 54%, 33%, 89% and 50%, respectively. Secondary endpoints were median duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety. Median DoR was 14.4 months, 8.9 months, not reached, 7.7 months, not reached, 31.2 months, not reached and 11.1 months, respectively. Median PFS was 6.7 months, 9.0 months, not reached, not evaluable, 9.5 months, 5.5 months, not evaluable and 6.3 months, respectively. Median OS was 14.5 months, 13.5 months, not reached, 21.8 months, not evaluable, 17.6 months, not evaluable and 33.9 months, respectively. The most frequent (≥20% of patients) treatment-related adverse events were pyrexia (40.8%), fatigue (25.7%), chills (25.7%), nausea (23.8%) and rash (20.4%). The encouraging tumor-agnostic activity of dabrafenib plus trametinib suggests that this could be a promising treatment approach for some patients with BRAFV600E-mutated advanced rare cancers. ClinicalTrials.gov registration: NCT02034110 .

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Conflict of interest statement

V.S. reports research funding from Novartis to conduct clinical trials; other grant support for clinical trials from AbbVie, Agensys, Alfasigma, Altum, Amgen, Bayer, BERG Health, Blueprint Medicines Corporation, Boston Biomedical, Boston Pharmaceuticals, Celgene Corporation, D3 Bio, Dragonfly Therapeutics, Exelixis, Fujifilm, GlaxoSmithKline, Idera Pharmaceuticals, Incyte Corporation, Inhibrx, Loxo Oncology/Eli Lilly, MedImmune, MultiVir, NanoCarrier, the National Comprehensive Cancer Network, NCI-CTEP, Novartis, PharmaMar, Pfizer, Relay Therapeutics, Roche/Genentech, Takeda, Turning Point Therapeutics, The University of Texas MD Anderson Cancer Center and Vegenics Pty. Ltd.; travel support from the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO), Helsinn Healthcare, Incyte Corporation, Novartis and PharmaMar; consultancy or advisory board participation for Helsinn Healthcare, Incyte Corporation, Loxo Oncology/Eli Lilly, MedImmune, Novartis, QED Therapeutics, Relay Therapeutics, Daiichi-Sankyo and R-Pharm US; and other relationship with Medscape. Y.J.B. is on an advisory board or has a consulting relationship with Merck Sharp & Dohme, Merck Serono, Daiichi-Sankyo, Astellas, Alexo Oncology, Samyang Biopharm, Hanmi, Daewoong and Amgen and has received institutional grants for clinical trials from Genentech/Roche, Merck Sharp & Dohme, Merck Serono, Daiichi-Sankyo, Astellas and Amgen. A.I. has received research grant from Bayer, Bristol Myers Squibb, Roche, Novartis, Chugai, Merck, AstraZeneca, Merck Sharp & Dohme and IPSEN and is an advisory board member for Bayer, Bristol Myers Squibb, Roche, Novartis, Chugai, Merck, AstraZeneca, Merck Sharp & Dohme, IPSEN and Parthenon. F.Y.F.L.V. is part of ongoing clinical research with the Foundation STOPbraintumors.org and clinical research with sponsors including Bristol Myers Squibb, Novartis and the European Organization for Research and Treatment of Cancer; and is a faculty member of the European Society of Medical Oncology for CNS tumors, President Quality of Care Commission with the Dutch Society of Medical Oncology, Member Quality Assurance Commission of the European Organization for Research and Treatment of Cancer, and Member Educational Commission of the European Association of Neuro-Oncology. J.Y.B. has received research support and honoraria from Novartis, Roche and GlaxoSmithKline. R.J.K. has received research funds and/or drug from Novartis, AstraZeneca, Pfizer, Genentech and Teva and is a co-inventor on the National Institutes of Health patent for Moxetumomab pasudotox. D.C.C. is a consultant with Pfizer, Nektar, Merck, Exelis and Pliant. P.Y.W. has received research support from Astra Zeneca/MedImmune, Beigene, Celgene, Chimerix, Eli Lilly, Genentech/Roche, Kazia, MediciNova, Merck, Novartis, Nuvation Bio, Puma, Servier, Vascular Biogenics and VBI Vaccines; is on the advisory board of AstraZeneca, Bayer, Black Diamond, Boehringer Ingelheim, Boston Pharmaceuticals, Celularity, Chimerix, Day One Bio, Genenta, GlaxoSmithKline, Karyopharm, Merck, Mundipharma, Novartis, Novocure, Nuvation Bio, Prelude Therapeutics, Sapience, Servier, Sagimet, Vascular Biogenics and VBI Vaccines; and is an editor with UpToDate (Elsevier). S.R., A.B., P.I. and V.Q.P. are employees with Novartis and hold stock of Novartis. Z.A.W. is a consultant with Novartis, Amgen, AstraZeneca, Daiichi, Bayer, Bristol Myers Squibb, Merck, Ipsen, Gilead, Incyte, Arcus, Astellas and Molecular Templates; has received grants from Bristol Myers Squibb, Arcus and Plexxikon; and is a Data Safety and Monitoring Board member with Pfizer and Daiichi. M.J.A.J. has received financial compensation for the institute for participating in the study. J.H.M.S. is an employee with Byondis BV and a share and patent holder (oral taxanes) and employee with Modra Pharmaceuticals. E.E.F. has received honoraria for advisory role, travel grants and research grants from Amgen, Bayer, F. Hoffman-La Roche, Merck Serono, Sanofi, Pierre Fabre, Merck Sharp & Dohme, Organon, Novartis and Servier; institutional honoraria (investigator contribution in clinical trials) from Amgen, Array Biopharma, AstraZeneca, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Debiopharm International F. Hoffmann-La Roche, Genentech, HalioDX SAS, Hutchison MediPharma International, Janssen-Cilag, MedImmune, Menarini, Merck Health KGAA, Merck Sharp & Dohme, Merus NV, Mirati, Novartis Farmacéutica, Pfizer, Pharma Mar, Sanofi Aventis Recherche & Développement, Servier, Taiho Pharma USA; is a volunteer member of the ASCO Annual Meeting Scientific Program Committee: Developmental Therapeutics – Immunotherapy; is a speaker of the ESMO Academy; and is a coordinator of the Sociedad Española de Oncología Médica (SEOM) and MIR Section of Residents and Young Assistants. K.Y. received fees for advisory boards with Novartis, Eisai, AstraZeneca, Chugai, Takeda, Genmab and OncXerna; research support to institution from Merck Sharp & Dohme, Daiichi-Sankyo, AstraZeneca, Taiho, Pfizer, Novartis, Takeda, Chugai, Ono, Sanofi, Seattle Genetics, Eisai, Eli Lilly, Genmab, Boeringer Ingelheim, Kyowa Hakko Kirin, Nihon Kayaku and Haihe; and honoraria for lectures from Pfizer, Eisai, AstraZeneca, Eli Lilly, Takeda, Chugai, Fuji Film Pharma, Merck Sharp & Dohme, Boeringer Ingelheim, Ono and Daiichi-Sankyo. C.C.Z. has received institutional honoraria from Novartis, Bristol Myers Squibb, Merck Sharp & Dohme, Pfizer, AstraZeneca, Roche, Merck KGA, Amgen, Servier, Eli Lilly, Takeda, Daichii-Sankyo, Celgene, Halozyme and Boehringer Ingelheim and holds a patent for IMUGENE (C.F.). P.M. has received honoraria and is on advisory boards with Janssen, Celgene, Takeda, Amgen, Sanofi, Abbvie and GlaxoSmithKline. U.L. is an advisory board member and has received honoraria from Bayer, Pfizer and Novartis and has received institutional research funding from Bristol Myers Squibb, Roche, Pfizer, Incyte, Eli Lilly and GlaxoSmithKline. All remaining authors declare no competing interests.

Figures

**Fig. 1. Waterfall plots for percentage of tumor reductions.**
Tumor reduction from baseline in patients with *BRAFV600E* mutation-positive rare cancers by investigator assessment (a) and by independent review (b). MR, minor response; NE, not evaluable; PD, progressive disease; SD, stable disease.

**Fig. 2. ORR with dabrafenib plus trametinib in cancers with *BRAFV600E* mutations.**
This figure presents data for the ROAR study (gray) and other studies in adults (blue) and the pediatric population (green). Data are presented for the COMBI-d study (NCT01584648) for melanoma, BRF113928 (NCT01336634) for NSCLC, NCT01723202 for differentiated thyroid cancer and ROAR (NCT02034110) and NCI-MATCH (NCT02465060) for the other tumor types. Pediatric data for gliomas and Langerhans cell histiocytosis are from the study NCT02124772, and those for LGGs are from the study NCT02684058. Data for colorectal cancer are from the study NCT01072175 (data on file, Novartis). The NCT01584648 study included previously untreated patients; NCT01723202 included patients who were refractory to radioactive iodine; NCT01336634 included both previously treated and treatment-naive patients; and other studies included patients who previously received standard treatment. Patient numbers are the patients who received treatment with dabrafenib plus trametinib. The ORR for GIST (n = 1) in the ROAR study was 0. Patients with melanoma, thyroid cancer, colorectal cancer and NSCLC were excluded in the NCI-MATCH study. This study included patients with BRAFV600E-positive tumors of the gastrointestinal tract (n = 11), lung (n = 5), CNS (n = 5), myeloma (n = 1), ameloblastoma of the mandible (n = 1) and gynecologic malignancies (n = 6). In the NCI-MATCH study, no CRs were observed; durable PRs were seen across a variety of tumor types, including papillary adenocarcinoma of the lung (n = 5), low-grade serous ovarian carcinoma (n = 5), mucinous-papillary serous adenocarcinoma of the peritoneum (n = 1), histiocytic sarcoma of the brain (n = 1), pleomorphic xanthoastrocytoma of the parietal lobe (n = 1) and cholangiocarcinoma (n = 4).

**Extended Data Fig. 1. Patient disposition.**
*Reasons for screen failures were not collected ASI, adenocarcinoma of small intestine; ATC, anaplastic thyroid cancer; BTC, biliary tract cancer; DP, declined to participate; EC, expansion cohort; GCT, germ cell tumor; GIST, gastrointestinal stromal tumor; G, grade; GVHD, graft versus host disease; HCL, hairy cell leukemia; HGG, high (WHO G3/G4) grade glioma; ID, investigator discretion; LF, lost to follow-up; LGG, low (WHO G1/G2) grade glioma; MM, multiple myeloma; NIC, not meeting inclusion criteria; OR, other reasons; PAC, primary analysis cohort; ST, study terminated by sponsor; WC, withdrew consent; WHO, World Health Organization.

**Extended Data Fig. 2. Duration of response by investigator and independent radiology assessment across tumor cohorts.**
Efficacy evaluable population; Primary and expansion cohorts; (A) Investigator assessment (B) Independent radiology assessment. **ATC:** Among 20 responders by investigator assessment, nine (45%) patients had disease progression and four (20%) died. Seven (35%) patients ended their follow-up and were censored. Among 19 responders by independent radiology assessment, 12 (63%) patients had disease progression and one (5%) died. Six (32%) patients ended their follow-up and were censored. **BTC:** Among 23 responders by investigator assessment, 20 (87%) patients had disease progression and 2 (9%) died. One (4%) patient was censored due to end of follow-up. Among the 20 responders by independent radiology assessment, 14 (70%) patients had disease progression and one (5%) died. Five (25%) patients were censored due to end of follow-up. **LGG:** Among nine responders by investigator assessment, two (22%) patients had disease progression. Seven (78%) patients were censored due to end of follow-up. Among eight responders by independent radiology assessment, seven (88%) patients had disease progression. One (13%) patient was censored due to end of follow-up. **HGG:** Among 15 responders by investigator assessment, nine (60%) patients had disease progression. Six (40%) patients were censored due to end of follow-up. Among 14 responders by independent radiology assessment, 12 (86%) patients had disease progression. Two (14%) patients were censored due to end of follow-up. **ASI:** Due to small numbers of responders, KM curves are not shown. Of the two responders by investigator assessment, one patient had disease progression and one was censored due to end of follow-up. Among the two responders by independent radiology assessment, both patients had disease progression. **HCL:** Among 49 responders by investigator assessment, four (8%) patients had disease progression and two (4%) patients died. Forty-three patients (88%) were censored due to end of follow-up. **MM:** Due to small numbers of responders, KM curves are not shown. Among five responders by investigator assessment, 4 (80%) patients had disease progression. One (20%) patient was censored due to end of follow-up. ASI, adenocarcinoma of small intestine; ATC, anaplastic thyroid cancer; BTC, biliary tract cancer; G, grade; HCL, hairy cell leukemia; HGG, high (WHO G3/G4) grade glioma; KM, Kaplan-Meier; LGG, low (WHO G1/G2) grade glioma; MM, multiple myeloma; WHO, World Health Organization.

**Extended Data Fig. 3. Progression free survival by investigator and independent radiology assessment across tumor cohorts.**
Efficacy evaluable population: Primary and expansion cohorts in all except low grade glioma and MM which is primary analysis cohort; (A) Investigator assessment (B) Independent radiology assessment. ATC: By investigator assessment in 36 patients, 21 (58%) patients had disease progression and six (17%) had died without disease progression. Nine (25%) patients were censored due to end of follow-up. By independent radiology review, progression of disease was observed in 26 (72%) patients and three (8%) patients died without disease progression. Seven (19%) patients were censored due to end of follow-up. BTC: By investigator assessment in 43 patients, 33 (77%) patients had disease progression and six (14%) patients had died without disease progression. Four patients were censored due to end of follow-up. By independent radiology review, progression of disease was observed in 27 (63%) patients and five (12%) patients died without disease progression. Eleven (26%) patients were censored due to end of follow-up. ASI: By investigator assessment in three patients, one patient (33%) had disease progression. Two (67%) patients were censored due to end of follow-up. By independent radiology review, progression of disease was observed in three (100%) patients. LGG: By investigator assessment in 13 patients, six (46%) patients had disease progression. Seven (54%) patients were censored due to end of follow-up. By independent radiology review, progression of disease was observed in nine (69%) patients and one (8%) patient died without disease progression. Three (23%) patients were censored due to end of follow-up. HGG: By investigator assessment in 45 patients, 38 (84%) patients had disease progression. Seven (16%) patients were censored due to end of follow-up. By independent radiology review, progression of disease was observed in 36 (80%) patients and four (9%) patients died without disease progression. Five (11%) patients were censored due to end of follow-up. HCL: By investigator assessment in 55 subjects, six (11%) patients had disease progression and three (5%) patients had died without disease progression. Forty-six (84%) patients were censored due to end of follow-up. MM: By investigator assessment in 10 patients, nine (90%) patients had disease progression. One patient was censored due to end of follow-up. ASI, adenocarcinoma of small intestine; ATC, anaplastic thyroid cancer; BTC, biliary tract cancer; G, grade; HCL, hairy cell leukemia; HGG, high (WHO G3/G4) grade glioma; LGG, low (WHO G1/G2) grade glioma; MM, multiple myeloma; WHO, World Health Organization.

**Extended Data Fig. 4. Overall survival across tumor cohorts.**
Efficacy evaluable population: Primary and expansion cohorts in all except low grade glioma and multiple myeloma which are primary analysis cohorts. ATC: Among 36 patients, 24 (67%) patients died, 12 (33%) patients were censored due to end of follow-up. BTC: Among 43 patients, 34 (79%) patients died, nine (21%) patients were censored due to end of follow-up. ASI: All three patients died during the study LGG: Among 13 patients (in the primary analysis cohort), four (31%) patients died, nine (69%) patients were censored due to end of follow-up. HGG: Among 45 patients, 28 (62%) patients died, 17 (38%) patients were censored due to end of follow-up. HCL: Among 55 patients, eight (15%) patients died, 47 (85%) patients were censored due to end of follow-up. MM: Among 10 patients, nine (90%) patients died, one patient was censored due to end of follow up. ASI, adenocarcinoma of small intestine; ATC, anaplastic thyroid cancer; BTC, biliary tract cancer; G, grade; HCL, hairy cell leukemia; HGG, high (WHO G3/G4) grade glioma; LGG, low (WHO G1/G2) grade glioma; MM, multiple myeloma; WHO, World Health Organization.

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Comment in

ROAR brings in a new histology-agnostic approval for rare cancers.
Romero D. Romero D. Nat Rev Clin Oncol. 2023 Jul;20(7):425. doi: 10.1038/s41571-023-00778-7. Nat Rev Clin Oncol. 2023. PMID: 37169890 No abstract available.

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Dabrafenib plus trametinib in BRAFV600E-mutated rare cancers: the phase 2 ROAR trial

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Dabrafenib plus trametinib in BRAFV600E-mutated rare cancers: the phase 2 ROAR trial

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