necessary [0.0001:the upper limit of normal (ULN) vs. ULN) and BRAF mutation subtype (V600E vs. V600K). The major efficacy outcome was investigator-assessed progression-free survival (PFS) per RECIST v1.1 with additional efficacy outcome measures of overall survival (OS) and confirmed overall response rate (ORR). The COMBI-v study compared Tafinlar and trametinib to vemurafenib as first-line treatment therapy for patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E or V600K mutation-positive cutaneous melanoma. Patients were randomized (1:1) to receive Tafinlar 150 mg twice daily and trametinib 2 mg once daily or vemurafenib 960 mg twice daily. Randomization was stratified by lactate dehydrogenase (LDH) level (> the upper limit of normal (ULN) vs. ULN) and BRAF mutation subtype (V600E vs. V600K). The major efficacy outcome measure was overall survival. Additional efficacy outcome measures were PFS and ORR as assessed by investigator per RECIST v1.1. In the COMBI-d study, 423 patients were randomized to Tafinlar plus trametinib (n = 211) or Tafinlar plus placebo (n = 212). The median age was 56 years (range: 22 to 89 years), 53% were male, >99% were White, 72% had ECOG performance status of 0, 4% had Stage IIIC, 66% had M1c disease, 65% had a normal LDH, and 2 patients had a history of brain metastases. All patients had tumor containing BRAF V600E or V600K mutations as determined by centralized testing, 85% with BRAF V600E mutations and 15% with BRAF V600K mutations. In the COMBI-v study, 704 patients were randomized to Tafinlar plus trametinib (n = 352) or single-agent vemurafenib (n = 352). The median age was 55 years (range: 18 to 91 years), 96% were White, and 55% were male, 6% percent of patients had Stage IIIC, 61% had M1c disease, 67% had a normal LDH, 70% had ECOG performance status of 0, 89% had BRAF V600E mutation-positive melanoma, and one patient had a history of brain metastases. The COMBI-d and COMBI-v studies demonstrated statistically significant improvements in OS and PFS (see Table 11 and Figures 2 and 3). Table 11. Efficacy Results in Patients with BRAF V600E or V600K Melanoma a Endpoint COMBI-d Study COMBI-v Study Tafinlar plus Trametinib N = 211 Tafinlar plus Placebo N = 212 Tafinlar plus Trametinib N = 352 Vemurafenib N = 352 Overall Survival Number of deaths (%) 99 (47%) 123 (58%) 100 (28%) 122 (35%) Median, months (95% CI) 25.1 (19.2, NR) 18.7 (15.2, 23.1) NR (18.3, NR) 17.2 (16.4, NR) HR (95% CI) 0.71 (0.55, 0.92) 0.69 (0.53, 0.89) P value (log-rank test) 0.01 0.005 a Progression-Free Survival (PFS) b Number of events (%) 102 (48%) 109 (51%) 166 (47%) 217 (62%) Median, months (95% CI) 9.3 (7.7, 11.1) 8.8 (5.9, 10.9) 11.4 (9.9, 14.9) 7.3 (5.8, 7.8) HR (95% CI) 0.75 (0.57, 0.99) 0.56 (0.46, 0.69) P value (log-rank test) 0.035] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug 4 years Approval History FDA approved 2013 Manufacturer Novartis Pharmaceuticals Corporation Drug Class Multikinase inhibitors Related Drugs multikinase inhibitors Imbruvica , Nexavar , Jakafi , Sutent , ibrutinib , Stivarga Melanoma, Metastatic Opdivo , Keytruda , nivolumab , pembrolizumab , Yervoy , ipilimumab , Mekinist , trametinib , dabrafenib , Proleukin , dacarbazine , Zelboraf , vemurafenib , cobimetinib , Cotellic , PegIntron , Sylatron , aldesleukin , Imlygic , peginterferon alfa-2b , More... Tafinlar Rating 1 User Review 9.0 /10 1 User Review 9.0 Rate it! Tafinlar Images Tafinlar 50 mg (GS TEW 50 mg) View larger images adequately subtle
barely enough Tafinlar these days
EmoticonEmoticon