The purpose of this study is to measure the effect of multiple doses of orally administered povorcitinib on skin PK and to characterize plasma PK parameters of povorcitinib following multiple doses of orally administered povorcitinib.in healthy participants.

Start Date12 Aug 2024

Sponsor / Collaborator

Incyte Corp.

100 Clinical Results associated with Povorcitinib

100 Translational Medicine associated with Povorcitinib

100 Patents (Medical) associated with Povorcitinib

Literatures (Medical) associated with Povorcitinib

01 Jun 2024·JDDG: Journal der Deutschen Dermatologischen Gesellschaft

Chronic Prurigo

Review

Author: Steinbrink, Kerstin ; Müller, Svenja ; Ständer, Sonja ; Zeidler, Claudia ; Thünemann, Julia

SummaryChronic prurigo (CPG) is a neuroinflammatory dermatosis characterized by prolonged pruritus lasting more than 6 weeks, pruriginous skin lesions, and repeated scratching.Patients with CPG suffer significantly from psychological distress and a marked impairment in their quality of life. The most common subtype of CPG is chronic nodular prurigo (CNPG, also called prurigo nodularis).In addition to the clinical features of CPG and the burden of disease, this CME article provides an overview of the significant advances in understanding the pathophysiology, including the associated therapeutic options for CPG. Dupilumab is the first approved therapy for moderate and severe CNPG to date from the European Medicines Agency (EMA) and the US Food & Drug Administration (FDA). It also highlights other agents currently being studied in Phase II and Phase III clinical, randomized, placebo‐controlled trials. These include biologics such as nemolizumab (anti‐IL‐31‐RA‐mAb), vixarelimab/KPL‐716 (anti‐Oncostatin‐M receptor β‐mAb), and barzolvolimab/CDX‐0159 (anti‐KIT‐mAb), as well as Janus kinase inhibitors such as povorcitinib/INCB054707 and abrocitinib, and opioid modulators such as nalbuphine.

01 Mar 2024·Journal of the American Academy of Dermatology

Efficacy and safety of the oral Janus kinase 1 inhibitor povorcitinib (INCB054707) in patients with hidradenitis suppurativa in a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study

Article

Author: Kimball, Alexa B ; Santos, Leandro L ; Bibeau, Kristen B ; Okun, Martin M ; Porter, Martina L ; Zouboulis, Christos C ; Kirby, Joslyn S ; Alavi, Afsaneh ; Wang, Annie ; Brown, Kurt ; Bechara, Falk G

BACKGROUNDJanus kinase 1 inhibition may alleviate hidradenitis suppurativa (HS)-associated inflammation and improve symptoms.OBJECTIVETo assess efficacy and safety of povorcitinib (selective oral Janus kinase 1 inhibitor) in HS.METHODSThis placebo-controlled phase 2 study randomized patients with HS 1:1:1:1 to receive povorcitinib 15, 45, or 75 mg or placebo for 16 weeks. Primary and key secondary end points were mean change from baseline in abscess and inflammatory nodule count and percentage of patients achieving HS Clinical Response at week 16.RESULTSOf 209 patients randomized (15 mg, n = 52; 45 mg, n = 52; 75 mg, n = 53; placebo, n = 52), 83.3% completed the 16-week treatment. At week 16, povorcitinib significantly reduced abscess and inflammatory nodule count from baseline (least squares mean [SE] change: 15 mg, -5.2 [0.9], P = .0277; 45 mg, -6.9 [0.9], P = .0006; 75 mg, -6.3 [0.9], P = .0021) versus placebo (-2.5 [0.9]). More povorcitinib-treated patients achieved HS Clinical Response at week 16 (15 mg, 48.1%, P = .0445; 45 mg, 44.2%, P = .0998; 75 mg, 45.3%, P = .0829) versus placebo (28.8%). A total of 60.0% and 65.4% of povorcitinib- and placebo-treated patients had adverse events.LIMITATIONSBaseline lesion counts were mildly imbalanced between groups.CONCLUSIONPovorcitinib demonstrated efficacy in HS, with no evidence of increased incidence of adverse events among doses.

01 Jan 2024·International Immunopharmacology

A systematic review of Janus kinase inhibitors and spleen tyrosine kinase inhibitors for Hidradenitis suppurativa treatment

Review

Author: Heidari, Nazila ; Ghane, Yekta ; Heidari, Amirhossein ; Goodarzi, Azadeh ; Sadeghi, Sara

BACKGROUNDS AND AIMSHidradenitis suppurativa (HS) is a challenging skin disease with an underlying inflammatory process. Substantial progress has been made in our understanding of HS over the last few years, with the advancement of novel treatment approaches. The current systematic review aims to evaluate the safety and efficacy of Janus kinase (JAK) inhibitors and spleen tyrosine kinase (Syk) inhibitors in treating HS.METHODA thorough systematic search was performed on PubMed/Medline, Web of Science, and Ovid Embase databases up to September 23th, 2023. Clinical studies published in English were included.RESULTSOur search yielded ten articles with a total of 165 patients treated with four types of JAK inhibitors (upadacitinib, povorcitinib, tofacitinib, and baricitinib) and one Syk inhibitor (fostamatinib). Upadacitinib, povorcitinib, and tofacitinib improved clinical outcomes, with a significant reduction in hidradenitis suppurativa clinical response (HiSCR) and abscess and inflammatory nodule count (AN count) during the treatment period. Also, these drugs are well tolerated in most HS patients with minimal adverse events (AEs). Moreover, baricitinib depicted an amelioration in signs and symptoms of HS in one case report. Also, fostamatinib exhibited favorable tolerability throughout a 12-week in moderate-to-severe HS patients. The remarkable clinical improvement, as assessed through HiSCR and hidradenitis suppurativa severity (IHS4), corresponded closely with serological indicators of inflammation following fostamatinib administration was achieved.CONCLUSIONJAK and Syk inhibitors are potentially efficacious in managing moderate-to-severe HS since the proinflammatory cytokines are mediated by JAK and Syk signaling pathways. However, further research with a more rigorous examination is mandatory to evaluate such medication's long-term safety and efficacy.

News (Medical) associated with Povorcitinib

22 Oct 2024

·www.prnewswire.com

JAK Inhibitors Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 50+ Companies Working in the Domain

JAK inhibitors are a class of medications that work by blocking Janus kinases (JAKs), enzymes that are involved in the signaling pathways of various cytokines and growth factors. JAK inhibitors offer a more targeted approach to treating immune-mediated diseases compared to traditional therapies like corticosteroids or conventional immunosuppressants; this specificity reduces side effects and increases efficacy and is a major driver for the demand for JAK inhibitors. LAS VEGAS, Oct. 22, 2024 /PRNewswire/ -- DelveInsight's ' JAK Inhibitors Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline JAK inhibitors in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the JAK inhibitors pipeline domain. Key Takeaways from the JAK Inhibitors Pipeline Report DelveInsight's JAK inhibitors pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline JAK inhibitors. Key JAK inhibitors companies such as Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical and others are evaluating new JAK Inhibitors drugs to improve the treatment landscape. Promising pipeline JAK inhibitors such as Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others are under different phases of JAK inhibitors clinical trials. In October 2024, Pelabresib in combination with ruxolitinib showed benefit in treating patients with JAK Inhibitor-Naïve Myelofibrosis significantly reduced splenomegaly, and improved anemia that has not been previously treated with Janus kinase inhibitors (JAKis). In September 2024, Eli Lilly and Company and EVA Pharma announced that the companies have agreed to expand access to baricitinib to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. In May 2024, Ajax Therapeutics, Inc., announced that it had received clearance for its Investigational New Drug application from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical study of AJ1–11095, a first-in-class Type II JAK2 inhibitor, for the treatment of patients with myelofibrosis. In February 2024, Novartis announced that it intends to acquire MorphoSys. The acquisition, which was unanimously approved by the boards of both Novartis and MorphoSys, is expected to close in the first half of 2024, subject to customary closing conditions. In January 2024, NS Pharma received orphan drug designation (ODD) from the European Commission (EC) for NS-229, which is being developed to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease. In December 2023, Sun Pharmaceuticals Inc. announced that it has entered a licensing agreement with Aclaris Therapeutics Inc., the company announced in a regulatory filing. Under the agreement, Aclaris granted Sun Pharma exclusive rights under certain patents for the use of deuruxolitinib, Sun Pharma's JAK inhibitor, or other isotopic forms of ruxolitinib, to treat alopecia areata (AA) or androgenetic alopecia (AGA). Request a sample and discover the recent advances in JAK inhibitors drugs @ JAK Inhibitors Pipeline Report The JAK inhibitors pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage JAK inhibitors drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the JAK inhibitors clinical trial landscape. JAK Inhibitors Overview Janus kinase (JAK) inhibitors are a class of medications designed to interfere with the activity of the Janus kinase family of enzymes, which play a crucial role in the signaling pathways of immune responses. These enzymes are key mediators in transmitting signals from cytokines and growth factors, which regulate blood cell production and immune system function. By blocking these signals, JAK inhibitors help to control the overactive immune response seen in several inflammatory and autoimmune diseases. They have shown significant efficacy in treating conditions like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, among others. The most common JAK inhibitors include tofacitinib, baricitinib, and upadacitinib, which are administered orally. Beyond their role in autoimmune diseases, JAK inhibitors are also being explored for use in treating certain cancers and myeloproliferative disorders, where abnormal JAK signaling contributes to uncontrolled cell growth. In diseases like myelofibrosis and polycythemia vera, JAK inhibitors can help reduce symptoms and improve quality of life. However, there are potential side effects associated with their use, including increased susceptibility to infections, blood clots, and cardiovascular risks, given their impact on the immune system. As research continues, the therapeutic potential of JAK inhibitors is expanding, offering new hope for patients with difficult-to-treat conditions. Find out more about JAK inhibitors drugs @ JAK Inhibitors Analysis A snapshot of the Pipeline JAK Inhibitors Drugs mentioned in the report: Learn more about the emerging JAK inhibitors @ JAK Inhibitors Clinical Trials JAK Inhibitors Therapeutics Assessment The JAK inhibitors pipeline report proffers an integral view of the emerging JAK inhibitors segmented by stage, product type, molecule type, and route of administration. Scope of the JAK Inhibitors Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Key JAK Inhibitors Companies: Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical, and others. Key JAK Inhibitors Pipeline Therapies: Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others. Dive deep into rich insights for new JAK inhibitors, visit @ JAK Inhibitors Drugs Table of Contents For further information on the JAK inhibitors pipeline therapeutics, reach out @ JAK Inhibitors Therapeutics Related Reports JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Eli Lilly and Company, Suzhou Zelgen Biopharmaceuticals Co., Ltd, Incyte Corporation, Kartos Therapeutics, Inc., Dompé Farmaceutici S.p.A, Sanofi, Kiniksa Pharmaceuticals, Ltd., Celgene, Abivax S.A., Telios Pharma, Inc., AstraZeneca, Karyopharm Therapeutics Inc, TWi Biotechnology, Inc., Geron Corporation, Ajax Therapeutics, Inc., among others. JAK Inhibitors Competitive Landscape JAK Inhibitors Competitive Landscape – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Pfizer, Sierra Oncology, Theravance Biopharma, Dizal Pharmaceutical, Aclaris Therapeutics, Celon Pharma, Incyte Corporation, AbbVie, Galapagos, among others. KRAS Inhibitors Market KRAS Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key KRAS inhibitors companies, including Novartis, Roche, Genentech, Verastem Oncology, Revolution Medicines, Cardiff Oncology, Immuneering Corporation, Jacobio Pharmaceuticals, BridgeBio Pharma, Mirati Therapeutics, Deciphera Pharmaceuticals, Elicio Therapeutics, InventisBio, Gritstone Bio, D3 Bio , among others. PD/L-1 Inhibitors Market PD/L-1 Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PD/L-1 inhibitors companies, including Merck, Laekna Therapeutics, Genentech, Tracon Pharmaceuticals Inc., Celgene, MedImmune, Hangzhou Sumgen Biotech, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1License out/inAcquisitionOrphan Drug

25 Sep 2024

·investor.incyte.com

Multiple Late-Breaking Data Presentations from Incyte’s Dermatology Portfolio will be Featured at the European Academy of Dermatology and Venereology (EADV) 2024 Congress

WILMINGTON, Del.--(BUSINESS WIRE)--Sep. 25, 2024-- Incyte (Nasdaq:INCY) today announced that key data from across its dermatology portfolio, including multiple late-breaking abstracts, will be presented at the upcoming European Academy of Dermatology and Venereology (EADV) Congress 2024 held September 25-28 in Amsterdam. “We’re excited to present five late-breaking oral presentations at this year’s congress, featuring data that could further expand treatment options for those living with immune-mediated dermatologic conditions, including vitiligo, atopic dermatitis, hidradenitis suppurativa and prurigo nodularis,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “The data highlight our ongoing efforts to evaluate the efficacy and safety of ruxolitinib cream in new patient populations, as well as deepen our understanding of povorcitinib in patients impacted by debilitating immune-mediated dermatologic conditions.” Key abstracts from Incyte-sponsored programs include: Late-breaking Oral Presentations Vitiligo Impact of Treatment Duration on Response Durability: A Post Hoc Analysis of the TRuE-V Long-Term Extension Study of Ruxolitinib Cream in Vitiligo Abstract #8077. Session: D2T01.3: Late breaking news. Presentation Time: 9:15 – 9:30 a.m. ET (3:15 – 3:30 p.m. CET), September 26, 2024 Atopic Dermatitis 52-Week Safety and Disease Control With Ruxolitinib Cream in Children Aged 2 to 11 Years With Atopic Dermatitis: Results From the Phase 3 TRuE-AD3 Study Abstract #8082. Session: D2T01.4: Late breaking news. Presentation Time: 10:00 – 10:15 a.m. ET (4:00 – 4:15 p.m. CET), September 26, 2024 Hidradenitis Suppurativa Ruxolitinib Cream for Mild-to-Moderate Hidradenitis Suppurativa: 32-Week Data From a Randomized Phase 2 Study Abstract #8071. Session: D2T01.3: Late breaking news. Presentation Time: 9:00 – 9:15 p.m. ET (3:00 – 3:15 p.m. CET), September 26, 2024 Prurigo Nodularis Efficacy and Safety of Oral Povorcitinib in Patients With Prurigo Nodularis: 40-Week Results From a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Abstract #8081. Session: D2T01.3: Late breaking news. Presentation Time: 9:30 – 9:45 a.m. ET (3:30 – 3:45 p.m. CET), September 26, 2024 Lichen Planus Efficacy and Safety of Ruxolitinib Cream in Patients With Cutaneous Lichen Planus: Results From a Phase 2, Randomized, Vehicle-Controlled Study Abstract #7974. Session: D3T01.4: Late breaking news. Presentation Time: 10:30 – 10:45 a.m. ET (4:30 – 4:45 p.m. CET), September 27, 2024 ePosters Vitiligo Efficacy and Safety of Ruxolitinib Cream for the Treatment of Vitiligo Through 2 Years in the TRuE-V Studies Poster #P2983. Characterizing Maintenance of Repigmentation in a Post Hoc Analysis of the TRuE-V Long-Term Extension Study of Ruxolitinib Cream in Vitiligo Poster #P2984. Effect of Povorcitinib on Achievement of VASI50 by Body Region in Patients With Extensive Nonsegmental Vitiligo: Post Hoc Analysis of a 52-Week Phase 2 Study Poster #P3016. Effect of Povorcitinib on Achievement of VESplus50 by Body Region in Patients With Extensive Nonsegmental Vitiligo: Post Hoc Analysis of a 52-Week Phase 2 Study Poster #P3017. Full session details and data presentation listings, please see the EADV 2024 Congress online program here: https://eadvapps.m-anage.com/eadvcongress2024/en-GB/pag/ About Opzelura® (ruxolitinib) Cream 1.5% Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States and Europe as Opzelura. Opzelura and the Opzelura logo are registered trademarks of Incyte. About Povorcitinib (INCB54707) Povorcitinib (INCB54707) is an oral small-molecule JAK1 inhibitor currently in Phase 3 clinical trials for vitiligo, hidradenitis suppurativa (HS) and prurigo nodularis. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline, the promise presented by that pipeline, whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions and Incyte’s goal of improving the lives of patients, contain predictions, estimates, and other forward-looking statements. These forward-looking statements are based on our current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and regulatory agencies outside of the United States; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended June 30, 2024. We disclaim any intent or obligation to update these forward-looking statements. View source version on businesswire.com: https://www.businesswire.com/news/home/20240925048109/en/ Media media@incyte.com Investors ir@incyte.com Source: Incyte

Phase 3Clinical ResultPhase 2Drug Approval

14 Sep 2024

·www.fiercepharma.com

ESMO: Even after unique trial win, Incyte CEO views PD-1 drug Zynyz as pipeline aide

Having an in-house PD-1 allows Incyte to test novel combinations with fewer costs and faster R&D timelines than it otherwise could, CEO Hervé Hoppenot said. Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. Yet company CEO Hervé Hoppenot views the antibody molecule not necessarily as a major revenue driver but as an aide to the company’s oncology pipeline.In a first-in-class win, Zynyz and chemotherapy slashed the risk of progression or death by 37% compared with chemo alone in patients with previously untreated, inoperable advanced squamous cell anal carcinoma (SCAC), according to results from the phase 3 POD1UM-303 trial presented at the annual European Society for Medical Oncology Congress (ESMO).Patients in the Zynyz arm went a median 9.3 months without tumor progression versus 7.4 months for the control group.Incyte plans to file Zynyz with the FDA by the end of the year in the indication, potentially making it the first PD-1 inhibitor approved for first-line anal cancer, Hoppenot said in an interview with Fierce Pharma.Anal cancer is not a large oncology market from a financial perspective, Hoppenot acknowledged. Zynyz’s target patient population in the potential use has about 10,000 new diagnoses per year across the U.S. and Europe.Even before an official FDA approval, some doctors have been using PD-1 inhibitors such as Merck & Co.’s Keytruda off label to treat anal cancer patients, Hoppenot explained. These uses aren’t always covered by insurance because of the absence of a regulatory approval. Now, Incyte hopes Zynyz can fill that niche market. The company’s original bid to get Zynyz approved as a post-chemo second-line anal cancer treatment was rejected by the FDA in 2021 because of a low tumor response rate and some patient deaths unrelated to disease progression.Besides the progression-free survival result in the POD1UM-303 trial, Zynyz has shown a preliminary trend toward improving patient survival. While the data are immature, Zynyz was linked to a 30% reduction in the risk of death, as patients who took the PD-1 agent survived a median 29.2 months versus 23 months for the control arm. Zynyz showed the advantage despite the trial allowing patients in the control arm to cross over to receive the PD-1 inhibitor after progression.Given the effect size and statistical considerations, Hoppenot said he’s confident that Zynyz will show a statistically significant overall survival benefit at the final analysis, which he said is coming “very soon” next year. The value of an in-house PD-1 drugZynyz entered the market last year with an FDA approval in Merkel cell carcinoma, another rare cancer type. In addition, Incyte announced a positive phase 3 trial, POD1UM-304, for Zynyz’s combination with chemo in first-line non-small cell lung cancer (NSCLC). But that indication faces some regulatory uncertainty given the trial’s comparator arm is chemotherapy alone, when Keytruda in combination with chemo is the current standard of care.Incyte will speak with the FDA to discuss the drug’s best path forward in first-line NSCLC, and the company is prioritizing the anal cancer filing first, Hoppenot said.Even if Zynyz eventually secures its first-line NSCLC nod, the drug’s market potential there seems limited given Keytruda’s dominance, and because the PD-1 king is nearing its patent cliff in 2028.Still, Zynyz could provide Incyte some returns in the niche indications. But, more importantly, “we believe that the optionality value of being able to develop our other pipeline products in combination with [an] approved PD-1 is very valuable,” Hoppenot said.Having an in-house PD-1 allows Incyte to test its novel agents in combinations without having to buy Keytruda, the CEO said. That translates into millions of dollars in savings and faster R&D timelines.“It’s basically giving me strategic flexibility in a way that would be very difficult if I had to do it with another product,” Hoppenot said. “So, after approval, is it going to be used with biosimilar of Keytruda? I don’t really care.” Oncology's place at IncyteGeneral oncology isn’t Incyte’s biggest business area. The company is best known for its Novartis-partnered myelofibrosis and graft-versus-host disease drug Jakafi, and that department just got bigger with the FDA approval for its Syndax-partnered CSF-1R antibody Niktimvo last month.Investors are also focused on the launch of Incyte’s Opzelura cream in autoimmune skin conditions and potential phase 3 readouts for the JAK1 inhibitor povorcitinib, which is being developed in a broad range of inflammatory diseases.In oncology beyond the bone marrow cancer myelofibrosis, Incyte in February gained full rights to CD19 antibody Monjuvi from former partner MorphoSys and in August announced a positive phase 3 readout in previously treated follicular lymphoma. At ESMO 2024, the company is also sharing for the first time early-phase data for its CDK2 inhibitor, INCB123667, in certain gynecological cancers. Still, Hoppenot argued that the three business areas are essentially equal in their importance to the company. The key is optionality, the CEO said, so that success from one of the drugs could more than compensate for the expected decline of Jakafi, which faces its own patent cliff in 2028.Incyte is interested in striking deals to access external innovations, having recently bought immunology biotech Escient Pharmaceuticals for $750 million. In oncology dealmaking, the company doesn’t have specific guardrails around tumor types but is more focused on whether the mechanism in question is unique, Hoppenot said.Being realistic about the price of a first- or best-in-class drug in late-stage development, Hoppenot said Incyte is focusing on earlier-stage assets, especially around targets where the company has done some internal research.

Phase 3Clinical ResultDrug ApprovalAcquisition

100 Deals associated with Povorcitinib

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
prurigo nodularis	Phase 3	US	Incyte Corp.	10 Oct 2024
prurigo nodularis	Phase 3	NL	Incyte Corp.	10 Oct 2024
prurigo nodularis	Phase 3	CA	Incyte Corp.	10 Oct 2024
prurigo nodularis	Phase 3	AT	Incyte Corp.	10 Oct 2024
prurigo nodularis	Phase 3	CZ	Incyte Corp.	10 Oct 2024
prurigo nodularis	Phase 3	DE	Incyte Corp.	10 Oct 2024
prurigo nodularis	Phase 3	CL	Incyte Corp.	10 Oct 2024
prurigo nodularis	Phase 3	AU	Incyte Corp.	10 Oct 2024
Hidradenitis Suppurativa	Phase 3	CN	China Medical System Holdings Ltd.	-
Nonsegmental vitiligo	Phase 3	CN	China Medical System Holdings Ltd.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05061693 (CTgov)	Phase 2	prurigo nodularis	146	placebo (Placebo)	cpbapxsjse(gxnuwoqnrn) = msrbsxwylc ephxsbxoje (shzujsvodl, sgzxevsqkk - jltskezvhi) View more	-	27 Aug 2024
				Povorcitinib (Povorcitinib 15 mg)	cpbapxsjse(gxnuwoqnrn) = ioembyvfot ephxsbxoje (shzujsvodl, evboqkcqmh - yxkkgczkld) View more
NCT04818346 (AAD2024) Manual	Phase 2	-	171	Povorcitinib (age≤40 years)	(gzyxwitxef) = uokyeqkcwf dymreaohzp (cqxsubhbls )	Positive	10 Mar 2024
				Povorcitinib (age>40 years)	(gzyxwitxef) = qpmydtqnti dymreaohzp (cqxsubhbls )
NCT05061693 (Corporate Publications) Manual	Phase 2	prurigo nodularis	146	Povorcitinib 15 mg	(nomuenukfw) = qvcrtelhep wtikextuvd (gnuwzbdhdv ) Met View more	Positive	10 Mar 2024
				Povorcitinib 45 mg	(nomuenukfw) = pynquihqkl wtikextuvd (gnuwzbdhdv ) Met View more
NCT04818346 (Corporate Publications) Manual	Phase 2	Nonsegmental vitiligo	171	povorcitinib15-to-75 mg	(prdxdmnflv) = voafiwwigt koskpztibg (fsfynbfynq ) View more	Positive	11 Oct 2023
				povorcitinib45 mg	(prdxdmnflv) = cpwxpuktoc koskpztibg (fsfynbfynq ) View more
NCT04818346 (phase 2b, EADV2023)	Phase 2	Vitiligo Fitzpatrick skin types I - III	171	Povorcitinib 15 mg	pqrlupkiwe(gsycgomdic) = ovxizlnqek rjyxfbvljf (svkhdjyuhi )	Positive	11 Oct 2023
				Povorcitinib 45 mg	pqrlupkiwe(gsycgomdic) = encxzszorp rjyxfbvljf (svkhdjyuhi )
EADV2023	Phase 2	-	209	Povorcitinib 15 mg	zqensmpiaa(bizzsulpqj) = fusqritdeh juxwtzowub (tnygkenqcp )	-	11 Oct 2023
				Povorcitinib 45 mg	zqensmpiaa(bizzsulpqj) = pwptdugixs juxwtzowub (tnygkenqcp )
NCT04818346 (phase 2b, CTgov)	Phase 2	Nonsegmental vitiligo	171	placebo+povorcitinib (Placebo)	rcltoacowt(bdkhgefcfl) = oonpjnjqmt nybojpdquo (kvtvslkmpd, fmzxmacruy - ogrxqebaoa) View more	-	05 Jul 2023
				Povorcitinib (Povorcitinib 15 mg)	rcltoacowt(bdkhgefcfl) = iyvxdcpngn nybojpdquo (kvtvslkmpd, blijcrliwh - ffnjzmdquh) View more
NCT04476043 (phase 2 dose-ranging study \| phase 2 study, CTgov)	Phase 2	Hidradenitis Suppurativa	209	INCB054707 (INCB054707 15 mg)	quzlpmcgtd(mnuuqcfisf) = miuvqcforj vgopynynrl (bsudlcvfof, covnmqtbhy - rntcelqvuk) View more	-	26 Jan 2023
				INCB054707 (INCB054707 45 mg)	quzlpmcgtd(mnuuqcfisf) = htzjmkrwkd vgopynynrl (bsudlcvfof, ksimesarbb - evjewmttab) View more
NCT04476043 (phase 2 dose-ranging study, EADV2022)	Phase 2	Hidradenitis Suppurativa	209	INCB054707 15 mg	bwosgljzqe(xgmtoilxww) = unwbyjrwug pqtaybtyti (urvqsluqco ) View more	Positive	07 Sep 2022
				INCB054707 45 mg	bwosgljzqe(xgmtoilxww) = gisfljtbzj pqtaybtyti (urvqsluqco ) View more
NCT04476043 (EADV2022)	Phase 2	Hidradenitis Suppurativa	209	INCB054707 15 mg	gxdrtbvyqq(ibnkiqmpnh) = 65.4% of placebo- and 60.0% of INCB054707-treated pts (15 mg, 59.6%; 45 mg, 60.0%; 75 mg, 60.4%) reported any TEAE mjpieobqxu (gtbpwtbpaa ) View more	-	07 Sep 2022
				INCB054707 45 mg

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