Incyte announces long-term extension data from Phase 3 TRuE-V program

Incyte announced new 104-week results from the pivotal Phase 3 TRuE-V clinical trial program evaluating Opzelura cream 1.5% in patients 12 years of age and older with nonsegmental vitiligo, a chronic autoimmune disease characterized by depigmentation of skin. These data were presented in two late-breaking oral presentations at the 2023 American Academy of Dermatology Annual Meeting, held from March 17-21 in New Orleans. The 104-week long-term extension data build on the 52-week TRuE-V1 and TRuE-V2 results previously announced and published in The New England Journal of Medicine. The LTE evaluated TRuE-V1 and TRuE-V2 study participants from Weeks 52 to 104 in two separate cohorts based on patients who achieved a complete or almost complete response by Week 52. In the cohort of patients who achieved complete or almost complete facial repigmentation, patients were randomized in a double-blind fashion to receive Opzelura twice daily or vehicle through Week 104 to evaluate time to relapse and time to maintain greater than or equal toF-VASI90 response; time to regain F-VASI75 and F-VASI90 response after relapse was also evaluated. In the cohort of patients who did not achieve complete or almost complete facial repigmentation, all patients were continued on Opzelura BID to evaluate long-term efficacy and safety. Key findings from Cohort A: Many patients who achieved a high level of facial repigmentation in TRuE-V1/TRuE-V2 were able to maintain durable response for one year after discontinuing Opzelura treatment. Approximately 29% of patients randomized to the withdrawal arm relapsed during the extension period . Among patients who relapsed in the withdrawal arm, 75% of patients regained greater than or equal toF-VASI75 once treatment with Opzelura was reinitiated and 69% of patients regained greater than or equal toF-VASI90. For those continuing Opzelura treatment, approximately 62% of patients who achieved greater than or equal toF-VASI90 at Week 52 maintained response for one year with ongoing Opzelura treatment. Opzelura was well tolerated with no serious treatment-related adverse events through Week 104. Mild or moderate treatment-related adverse events among patients in the Opzelura arm included application site dermatitis, application site rash and hyperlipidemia. Key findings from Cohort B: In patients who did not achieve near complete facial repigmentation at Week 52 and continued treatment with Opzelura, improvements in facial and total body repigmentation, as shown by greater proportions of patients reaching F-VASI75 and T-VASI50, were observed through Week 104. For patients treated with Opzelura from Day 1 in the parent studies, the percentage who achieved F-VASI75 at Week 104 more than doubled compared to Week 52, and approximately 34% attained F-VASI90 at Week 104. Additionally, T-VASI50 was achieved at Week 104 by 64% of TRuE-V1 and TRuE-V2 patients applying Opzelura since Day 1, increasing from 43% at Week 52. Opzelura was well tolerated with no serious treatment-related adverse events through Week 104. All treatment-related adverse events in the Opzelura arm were mild or moderate, the most common being application site pruritus.