Incyte : Povorcitinib in Vitiligo Oral Presentation (AAD)

Presented at the American Academy of Dermatology (AAD) Annual Meeting

March 17-21, 2023; New Orleans, LA

Efficacy and Safety of Povorcitinib for Extensive Vitiligo: Results From a

Double-Blinded,Placebo-Controlled,Dose-Ranging Phase 2b Study

Amit G. Pandya, MD,1,2 Khaled Ezzedine, MD, PhD,3 Thierry Passeron, MD, PhD,4,5

Nanja van Geel, MD, PhD,6 Kurt Brown, MD,7 Leandro Santos, MSc,7 Lois Erskine, PhD,7

Kofi Wagya, PhD,7 Andrew Blauvelt, MD, MBA8

1University of Texas Southwestern Medical Center, Dallas, TX, USA; 2Palo Alto Foundation Medical Group, Sunnyvale, CA, USA; 3Henri Mondor University

Hospital and Université Paris-Est Créteil Val de Marne, Paris, France; 4Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France;

5INSERM U1065, C3M, Université Côte d'Azur, Nice, France; 6Ghent University Hospital, Ghent, Belgium; 7Incyte Corporation, Wilmington, DE, USA;

8Oregon Medical Research Center; Portland, OR, USA

1

Presenting Author Disclosures

• Investigator for Aclaris Therapeutics, Immune Tolerance Network, Incyte, and Pfizer
• Consultant for AbbVie, Arcutis, Avita Medical, Chromaderm, Immune Tolerance Network, Incyte, Pfizer, TWi, Viela Bio, and Villaris
• Holds stock options for Tara Medical and Zerigo Health

2

Background

• Vitiligo is a chronic autoimmune disease that targets melanocytes, resulting in patches of skin depigmentation1
• Disease pathogenesis is largely regulated by interferon-γ activation of the JAK signaling pathway2
• Povorcitinib is an oral, small-molecule, selective JAK1 inhibitor with potential activity in the treatment of nonsegmental vitiligo
• Objective: To evaluate the efficacy and safety of povorcitinib in patients with extensive nonsegmental vitiligo in a phase 2b trial (NCT04818346)

JAK, Janus kinase.
1. Rodrigues M, et al. J Am Acad Dermatol. 2017;77(1):1-13.2. Rashighi M, Harris JE. Ann Transl Med. 2015;3(21):343.	3

Study Design (NCT04818346)

Patient population:

• Adults 18-75 years old
• Nonsegmental vitiligo
• Vitiligo-affectedBSA*:
• • Total body ≥8%
  • Face ≥0.5%
• VASI score:
• • T-VASI≥8
  • F-VASI≥0.5

Efficacy assessments:

• % change from baseline in T-VASI†
• % patients achieving T-VASI50,F-VASI50, and F-VASI75

Safety assessments:

Incidence of TEAEs

Placebo-Controlled Period

Extension Period

Follow-Up Period

(24 weeks)

(28 weeks)

(24 weeks)

Randomized

Completed

Treated

Completed

n=43

Povorcitinib 45 mg qd

33

32

Povorcitinib 45 mg qd

27

n=42

35

34

29

Povorcitinib 75 mg qd

Post-Treatment

n=43

Povorcitinib 15 mg qd

38

37

Povorcitinib 75 mg qd

30

n=43

Placebo qd

35

35

33

Week

24

36

52 56

76

Day 1

Visits every 4 weeks

Visits every 4 weeks

Primary endpoint

Interim data lock

BSA, body surface area; F-VASI, facial VASI; F-VASI50/75, ≥50%/≥75% reduction from baseline in F-VASI; qd, once daily; TEAE, treatment-emergent adverse event; T-VASI, total VASI;
T-VASI50, ≥50% reduction from baseline in T-VASI; VASI, Vitiligo Area Scoring Index.
* Total and facial BSA were locally assessed. † Week 24 assessment was the primary endpoint.	4

Patient Demographics and

Clinical Characteristics at Baseline

			Povorcitinib
	Placebo	15 mg		45 mg	75 mg		Total
Characteristic	(n=43)	(n=43)		(n=43)	(n=42)		(N=171)
Age,	51.0	45.0		51.0	52.5		50.0
median (range), y	(24-72)	(23-67)		(25-72)	(24-74)		(23-74)
Female, n (%)	24	29	21	19	93
(55.8)	(67.4)	(48.8)	(45.2)	(54.4)
Race, n (%)
White	34	32		38	28		132
(79.1)	(74.4)		(88.4)	(66.7)		(77.2)
Asian	2	4		0	7	13
(4.7)	(9.3)		(16.7)	(7.6)
Black	2	3		1	3	9
(4.7)	(7.0)		(2.3)	(7.1)	(5.3)
Hispanic, n (%)	8	6		11	7	32
(18.6)	(14.0)		(25.6)	(16.7)		(18.7)
Fitzpatrick skin type,
n (%)
I-III	28	26		35	25	114
(65.1)	(60.5)		(81.4)	(59.5)	(66.7)
IV-VI	15	17		8	17		57
(34.9)	(39.5)		(18.6)	(40.5)		(33.3)

			Povorcitinib
	Placebo	15 mg		45 mg	75 mg		Total
Characteristic	(n=43)	(n=43)		(n=43)	(n=42)		(N=171)
Baseline F-VASI,	1.5	1.3		1.3		1.1		1.3
mean (SD)	(0.8)	(0.8)		(0.8)		(0.7)		(0.8)
Baseline T-VASI,	28.3	27.1	23.6		22.7		25.5
mean (SD)	(21.5)	(20.1)	(19.8)		(14.2)		(19.1)
Duration of disease,	19.5	17.6		19.9		20.5		19.4
mean (SD), y	(14.0)	(13.0)		(15.5)		(13.7)		(14.0)
Family history of	15	9	11		14	49
vitiligo, n (%)	(34.9)	(20.9)	(25.6)		(33.3)	(28.7)
Thyroid disorders,	11	12		12		12	47
n (%)	(25.6)	(27.9)		(27.9)		(28.6)	(27.5)
Previous therapy,*
n (%)
Topical	18	24	21		25	88
corticosteroid	(41.9)	(55.8)	(48.8)		(59.5)	(51.5)
Topical calcineurin	14	13	17		20	64
inhibitor	(32.6)	(30.2)	(39.5)		(47.6)	(37.4)
Any phototherapy	20	17	13		27	77
(46.5)	(39.5)	(30.2)		(64.3)	(45.0)

* Patients could have used multiple previous lines of therapy.	5