お知らせ • Mar 29
Incyte Announces New Positive 54-Week Data for Povorcitinib in Hidradenitis Suppurativa
Incyte announced 54-week data evaluating the safety and efficacy of povorcitinib (INCB54707), an oral small-molecule highly-selective JAK1 inhibitor, from the pivotal Phase 3 STOP-HS clinical trial program in adult patients (=18 years) with moderate to severe hidradenitis suppurativa (HS). Phase 3 data from the STOP-HS program demonstrate povorcitinib’s substantial and durable clinical efficacy through Week 54 in patients with moderate to severe hidradenitis suppurativa (HS). Through Week 54, clinically meaningful and durable responses were observed across all groups in both STOP-HS1 and STOP-HS2, with up to 71.4% of patients achieving HiSCR50. Improvements in clinical responses across high stringent thresholds were observed, with up to 57% of participants achieving HiSCR75 and up to 29% of participants achieving HiSCR100. Povorcitinib treatment led to consistent reductions across key inflammatory lesion types, with full resolution (ANdT=0) achieved in up to 20% of patients. Additionally, clinically meaningful improvements in quality-of-life measures, including skin pain and fatigue, were observed at Week 54. The overall safety profile of povorcitinib through 54 weeks is consistent with previously reported data, and both doses were well tolerated. As previously reported, both STOP-HS1 and STOP-HS2 met the primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR50, =50% reduction from baseline in the total abscess and inflammatory nodule count [AN count] without an increase in abscess or draining tunnel count relative to baseline), versus placebo at Week 12, at both doses (45 mg and 75 mg). After Week 12, study participants entered the 42-week extension period. Participants receiving 45 mg or 75 mg of povorcitinib in the double-blind period continued to receive the same dose, while participants who received placebo were reassigned 1:1 to receive povorcitinib 45 mg or 75 mg. Through Week 54, clinically meaningful and durable responses were observed across all groups in both STOP-HS1 and STOP-HS2, with up to 71.4% of patients achieving HiSCR50. Improvements in clinical responses across high stringent thresholds were observed, with up to 57% of participants achieving HiSCR75 and up to 29% of participants achieving HiSCR100. Across both trials, povorcitinib treatment led to consistent reductions across all three key inflammatory lesion types—abscesses (A), inflammatory nodules (N) and draining tunnels (dT). Full clearance of inflammatory lesions (ANdT=0) was achieved by 16.1-20.2% of patients at Week 54. Reductions in dT counts were observed with both doses (75 mg, up to -62.0%; 45 mg, up to -57.7%), as well as reduction in inflammatory nodule counts (75 mg, up to -63.2%; 45 mg, up to -57.0%) and abscess counts (75 mg, up to -63.7%; 45 mg, up to -62.9%). Additionally, at Week 54, a high proportion of participants across both doses achieved clinically meaningful improvements in skin pain (40.5-46.8%), fatigue (49.0-58.0%) and skin condition-related (59.4-64.7%) and HS-specific (33.7-40.2%) quality of life (QoL). The overall safety profile of povorcitinib over 54 weeks was consistent with previously reported 24-week data, and both doses were well tolerated. Through Week 54, treatment-emergent adverse events (TEAEs) were similar across doses and studies, occurring in 76.2% to 83.4% of patients. The most frequent TEAEs across both studies and doses were acne, nasopharyngitis and upper respiratory tract infections with most events reported as mild or moderate. The incidence of serious TEAEs were low (3.7% to 6.4%) and similar across studies. Grade >3 TEAEs were 5.4% to 8.0%. TEAEs leading to discontinuation were low and similar between doses and studies (6.1% to 9.4%). Rates of adverse events of special interest (AESI) including herpes zoster, serious infections, opportunistic infections, malignancies and other embolic or thromboembolic events, were low. The STOP-HS clinical trial program includes two Phase 3 studies, STOP-HS1 (NCT05620823) and STOP-HS2 (NCT05620836), evaluating the efficacy and safety of povorcitinib (INCB54707) in adult patients with moderate to severe HS. Both studies include a 12-week double-blind, placebo-controlled treatment period, followed by a 42-week double-blind extension period. Eligible participants either continued treatment in the STOP-HS LTE study (NCT06212999) or concluded treatment and entered a 30-day safety follow-up period. The studies have each enrolled approximately 600 patients (age =18 years) diagnosed with moderate to severe HS for at least three months prior to the screening visit and who meet certain criteria: total AN count of =5, lesions in at least two distinct anatomical areas and a documented history of inadequate response to at least a three-month course of at least one conventional systemic therapy (oral antibiotic or biologic drug) for HS or a demonstrated intolerance or contraindication to such conventional systemic therapies. The primary endpoint for both studies is the proportion of patients who achieve HiSCR50, defined as at least a 50% reduction from baseline in the total AN count at Week 12, with no increase from baseline in abscess or draining tunnel count. Key secondary endpoints include the proportion of patients achieving at least 75% reduction in AN count with no increase from baseline in abscess or draining tunnel count (HiSCR75) at Week 12, the proportion of patients experiencing at least one flare over 12 weeks, the proportion of patients with a >3-point decrease in the Skin Pain NRS score at Week 12, among those with a baseline score of =3, and the proportion of patients achieving a 30% reduction and at least 1-unit reduction from baseline in Skin Pain NRS at Week 12, among those with a baseline score of =3. The studies also evaluate the frequency and severity of adverse events during the study. Povorcitinib (INCB54707) is an oral small-molecule JAK1 selective inhibitor currently being investigated in Phase 3 clinical trials for moderate to severe HS (STOP-HS1, STOP-HS2, STOP- HS LTE), nonsegmental vitiligo (STOP-V1, STOP-V2) and prurigo nodularis (PN; STOP-PN1, STOP-PN2), as well as a Phase 2 trial for moderate to severe asthma. The New Drug Application (NDA) and Marketing Authorization Application (MAA) for povorcitinib as a potential treatment for patients with moderate to severe HS is under review by the U.S. Food and Drug Administration and European Medicines Agency, respectively. Topline Phase 3 data for povorcitinib in vitiligo and PN are anticipated in mid-2026 and Fourth Quarter 2026, respectively.