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Found 1 Presentation For Request "1109P"
1109P - Chinese subgroup results from an open-label, phase IIa study of dabrafenib plus trametinib in Asian patients with advanced BRAF V600-mutant melanoma (NCT02083354)
- Lili Mao (Beijing, China)
Abstract
Background
Dabrafenib plus trametinib has approved for BRAF V600–mutant unresectable or metastatic melanoma on the basis of results from the COMBI-d and COMBI-v trials. However, there is limited data of the combination in Asian populations. NCT02083354 is a single-arm, open-label, multicenter, phase IIa study in 77 Asian patients with stage III and IV
Methods
Enrolled patients were diagnosed unresectable or metastatic BRAF V600 mutant melanoma, non-treated or pretreated, but no prior treatment with BRAF or MEK inhibitors. Patients were assigned to receive dabrafenib 150 mg q12h and trametinib 2 mg once daily. Primary endpoint was the ORR by investigator assessment using RECIST v1.1. Secondary endpoints included PFS, duration of response and OS.
Results
Between March 2014 and November 2017, 61 Chinese patients enrolled in NCT02083354 trial (1 patient withdraw consent after enrollment). The ORR was 71.7%, and the complete response was observed in 4(6.7%) patients. 39(65%) patients had partial responses, and 17 (28.3%) patients had stable diseases. ORR was 86.7% in treatment naive patients (n=15). ORR of patients previously received chemotherapy (n=43) was 65.1% and that of patients previously received PD-1 inhibitor (n=7) was 85.7%. The median PFS was 9.33 month (95% CI, 7.87-10.78 and 11.2 months in ITT and treatment naive population, respectively. Median OS was 21.1 month (95%CI, 16.6-25.7) and 24 months in ITT and treatment naive population, respectively. Particularly, the ORR, PFS and OS was 88.9%, 7.47 months and 21.4 months respectively in acral melanoma (n=12), showing no statistically significance with that of non-acral patients.
Conclusions
This analysis demonstrates meaningful efficacy of dabrafenib plus trametinib in Chinese patients with advanced BRAF V600 mutant melanoma, including acral melanoma patients.
Characteristics Patients (n=60) Age (years) 48.75±12.27 Male, n (%) 24 (40%) Clinical subtype of primary site Non-CSD 24 (40.0%) CSD 15 (25.0%) Acral 12 (20.0%) unknown 9 (15.0%) Tumor stage at screening, n (%) Unresectable stage IIIc 2 (3.3%) Stage IV M1a 10 (16.7%) M1b 14 (23.3%) M1c 31 (51.7%) Unknown 3 (5%) LDH, n (%) ≤ULN 37 (61.7%) >ULN 23 (38.3%) Number of prior therapies, n (%) 0 15 (25%) 1 19 (31.7%) 2 19 (31.7%) ≥ 3 7 (11.7%) Prior immunotherapy, n (%) 9 (15%) Number of metastatic organs, n (%) 1 12 (20%) 2 13 (21.7%) ≥3 35 (58.3%)
Legal entity responsible for the study
Novartis.
Funding
Novartis.
Disclosure
All authors have declared no conflicts of interest.