Updated Overall Survival Analysis From the Phase II PHAROS Study of Encorafenib Plus Binimetinib in Patients With BRAF V600E-Mutant Metastatic Non–Small Cell Lung Cancer
The phase II PHAROS study previously showed that encorafenib plus binimetinib has antitumor activity in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (mNSCLC). In PHAROS, 98 patients (59 treatment-naïve; 39 previously treated) received encorafenib 450 mg once daily and binimetinib 45 mg twice daily. We report updated results from data cutoff of March 14, 2025. The median duration of treatment with both encorafenib and binimetinib was 16.3 months in treatment-naïve and 5.5 months in previously treated patients. After median follow-up for overall survival (OS) of 52.3 months in treatment-naïve patients, mOS was 47.6 months (95% CI, 31.3 to not estimable); 4-year OS probability was 49% (95% CI, 35 to 62). After median follow-up for OS of 48.2 months in previously treated patients, mOS was 22.7 months (95% CI, 14.1 to 32.6); 4-year OS probability was 31% (95% CI, 16 to 47). In treatment-naïve and previously treated groups, 58% and 26% received ≥1 subsequent systemic anticancer treatment, respectively. Safety profile remained consistent with that in previous analyses. Although comparisons across trials should be done cautiously, to our knowledge, encorafenib plus binimetinib was associated with the longest mOS reported to date with targeted treatment in patients with treatment-naïve BRAF V600E-mutant mNSCLC.
Authors
- Rachel E. Sanborn (ORCID: https://orcid.org/0000-0003-0542-6054)
- Michael David Offin (ORCID: https://orcid.org/0000-0002-7959-3018)
- Linh Alejandro
- Egbert F. Smit (ORCID: https://orcid.org/0000-0002-7329-6995)
- Marcelo Vailati Negrao (ORCID: https://orcid.org/0000-0001-8938-6699)
- Daniel Morgensztern (ORCID: https://orcid.org/0000-0003-4349-2028)
- Myung‐Ju Ahn (ORCID: https://orcid.org/0000-0002-5740-9654)
- Jonathan Wade Goldman (ORCID: https://orcid.org/0000-0002-4925-8243)
- Ibiayi Dagogo‐Jack (ORCID: https://orcid.org/0000-0003-0781-9257)
- Melissa L. Johnson (ORCID: https://orcid.org/0000-0001-9874-1314)
- Tiziana Usari
- Bruce E. Johnson (ORCID: https://orcid.org/0000-0002-5252-3677)
- Anne S. Tsao (ORCID: https://orcid.org/0000-0003-0505-6639)
- Gregory J. Riely (ORCID: https://orcid.org/0000-0001-5357-4313)
- Keith D. Wilner (ORCID: https://orcid.org/0000-0002-2276-7865)
- N. Rifi (ORCID: https://orcid.org/0009-0004-7627-9519)
- Maen Hussein (ORCID: https://orcid.org/0000-0001-6160-6776)
- Jeffrey Clarke (ORCID: https://orcid.org/0000-0001-5647-0245)
- Suresh S. Ramalingam (ORCID: https://orcid.org/0000-0002-0757-3106)
- Enriqueta Felip (ORCID: https://orcid.org/0000-0002-7620-0098)
- Xiaosong Zhang (ORCID: https://orcid.org/0000-0002-0122-2356)
Institutions
- Hebron University (PS)
- Memorial Sloan Kettering Cancer Center (US)
- The University of Texas MD Anderson Cancer Center (US)
- Emory University (US)
- University of California, Los Angeles (US)
- Pfizer (United States) (US)
- Washington University in St. Louis (US)
- Leiden University Medical Center (NL)
- Providence Portland Medical Center (US)
- Samsung Medical Center (KR)
- Massachusetts General Hospital (US)
- Sarah Cannon (US)
- Dana-Farber Cancer Institute (US)
- Pfizer (France) (FR)
- Florida Cancer Specialists & Research Institute (US)
- Duke Medical Center (US)
- Vall d'Hebron Hospital Universitari (ES)
- Pfizer (Italy) (IT)
- Center for Cancer Research (US)
- Vall d'Hebron Institute of Oncology (ES)
- Duke Cancer Institute
- Sungkyunkwan University (KR)
Publication Details
- Journal
- Journal of Clinical Oncology
- Published
- 2025-10-19
- DOI
- https://doi.org/10.1200/jco-25-02023
- Citations
- 3
- Primary Topic
- Lung Cancer Treatments and Mutations
- Type
- article
- Field-Weighted Citation Impact
- 4.56
Funders
- Pfizer
- Memorial Sloan-Kettering Cancer Center