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Multicenter Study
. 2025 Jan:199:108038.
doi: 10.1016/j.lungcan.2024.108038. Epub 2024 Nov 26.

Real-world efficacy of the dabrafenib-trametinib (D-T) combination in BRAF V600E-mutated metastatic non-small cell lung cancer (NSCLC): Results from the IFCT-2004 BLaDE cohort

Aurélie Swalduz  1 , Michèle Beau-Faller  2 , David Planchard  3 , Julien Mazieres  4 , Sophie Bayle-Bleuez  5 , Didier Debieuvre  6 , Vincent Fallet  7 , Margaux Geier  8 , Alexis Cortot  9 , Sébastien Couraud  10 , Catherine Daniel  11 , Charlotte Domblides  12 , Eric Pichon  13 , Elizabeth Fabre  14 , Sébastien Larivé  15 , Ulrike Lerolle  16 , Pascale Tomasini  17 , Marie Wislez  18 , Pascale Missy  19 , Franck Morin  19 , Virginie Westeel  20 , Jean-Bernard Auliac  21
Affiliations
Multicenter Study

Real-world efficacy of the dabrafenib-trametinib (D-T) combination in BRAF V600E-mutated metastatic non-small cell lung cancer (NSCLC): Results from the IFCT-2004 BLaDE cohort

Aurélie Swalduz et al. Lung Cancer. 2025 Jan.

Abstract

Background: BRAF V600E mutations occur in 2-5 % of advanced non-small cell lung cancer (NSCLC) patients. The dabrafenib-trametinib (D-T) combination was associated with improved and durable OS in patients in phase II. This study (IFCT-2004 BLaDE study) reported the efficacy of D-T combination in a large retrospective French real-world multicenter cohort of patients with advanced BRAF V600E-mutated NSCLC.

Method: Patients with advanced BRAF V600E-mutated NSCLC diagnosed between 01.01.2016 and 31.12.2019 and treated with D-T in combination, regardless of the treatment line, were included. The primary endpoint was the 12-month OS rate (%) in patients receiving D-T as a second-line therapy or beyond.

Results: A total of 163 patients were included: 50.3 % were female, 30.2 % were never smokers, 95.1 % had adenocarcinoma, and 78.2 % had a PDL1 ≥ 1 %. The median age was 68.3 years. At D-T initiation, 80.8 % of patients had a PS of 0/1, 78.6 % had stage IV disease, and 20.9 % had brain metastasis. At the cutoff, the median follow-up was 27.4 months. The 12-month OS rate in patients receiving D + T as a second-line therapy or beyond (n = 119) was 67.4 %, with a median progression-free survival (mPFS) of 10.4 months. Among the 44 patients who received D + T as a first-line therapy, the 12-month OS rate was 67.4 %, with an mPFS of 18.2 months. D-T discontinuation for toxicity was reported in 10.3 % of patients.

Conclusions: To our knowledge, this is the largest retrospective cohort of BRAF-mutated patients reported. The findings confirmed the significant efficacy of D-T in combination with BRAF V600E-mutated metastatic NSCLC in pretreated and untreated patients. These results under real-world conditions are consistent with those of other registered studies.

Keywords: BRAF mutation; Dabrafenib-trametinib combination; Non-small-cell lung cancer; Real-world evidence; Targeted therapy.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: A. Swalduz: honoraria: AstraZeneca, Janssen, Roche, Amgen, and BMS; consulting or advisory role: AstraZeneca, Janssen, Roche, Amgen, BMS, Pfizer, and Lilly D Planchard: Consulting, advisory role or lectures: AstraZeneca, Abbvie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Merck, Novartis, Janssen, Pfizer, Roche, Pierre-fabre, Takeda, ArriVent, Mirati, Seagen; Clinical trials research as principalor coinvestigator (institutional financial interests): AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, Pfizer, Roche, Medimmun, Sanofi-Aventis, Taiho Pharma, Novocure, Daiichi Sankyo, Abbvie, Janssen, Pierre-fabre, Takeda, ArriVent, Mirati, Seagen; Travel, Accommodations, Expenses: AstraZeneca, Roche, Novartis, Pfizer. S Bayle-Beuez: Employment: Roche, Amgen;honoraria: Roche, Amgen; research funding: Roche; consulting or advisory role: Amgen. V Fallet: Consulting or advisory role: Pfizer, Jansen, AstraZeneca, BMS, Takeda, Roche; speakers’ bureau: AstraZeneca, BMS, Takeda M Geier: consulting or advisory role; Pfizer, Sanofi, Chugai, BMS. S Couraud: honoraria: Amgen, Astra Zeneca, BMS, MSD, Roche, Sanofi, Fabentech, Boehringher Ingelheim, Takeda; research funding: Amgen, Astra Zeneca, BMS, MSD, Roche, Sanofi, Chugai, Novartis, Pfizer, Sysmex, Cellgene, Takeda, Janssen; travel, accomodations, travels: Astra Zeneca, Roche, Takeda. C Domblides: Consulting or advisory role: Astra-Zeneca, Amgen, BMS, Takeda; Travel, accomodations, expenses: Amgen, Astra-Zeneca, Bristol-Myers Squibb, MSD, Pfizer, Pierre Fabre, Roche. E Pichon: honoraria: Takeda, Bristol Myers Squibb, Astra Zeneca. M Wislez: Consulting fees from BMS, MSD, Novartis, AstraZeneca, Roche, Amgen. V Westeel: Honoraria: Astra Zeneca, BMS, Amgen, Roche; consulting or advisory role: MSD, Takeda; speakers’bureua: BMS, Astra Zeneca, Roche, MSD, Pfizer, Amgen; Travel, accomodations, expenses: BMS, Astra Zeneca, Sanofi JB Auliac: Honoraria for attending scientific meetings, speaking, organizing research or consulting, from Boehringer Ingelheim, Hoffman-Roche,Takeda, BMS, MSD, Astra Zeneca, Amgen, Janssen and Pfizer. All the other authors declare that they have no conflicts of interest.

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