Pablo J. Cagnoni
President, Head of Research and Development at Incyte
Thank you, Herve, and good morning.
As we continue to execute on our pipeline of numerous potential first or best-in-class medicines, we remain on track to deliver more than 10 high-impact launches by 2030. In the next few slides, I will highlight a number of these programs. We continue to expand the opportunity of ruxolitinib cream with additional indications. Based on the positive Phase III data in pediatric atopic dermatitis, the supplemental NDA was recently filed. With the potential approval in 2025, we are excited with the possibility of providing an effective non-steroidal topical options for the 2 million to 3 million pediatric patients with AD in the US.
Following interactions with the FDA, we have finalized the design for the Phase III study of ruxolitinib cream in patients with mild-to-moderate hidradenitis suppurativa. The study, which will have a primary implant of high-score 75 is expected to begin in the first half of 2025 and could represent a new treatment option to the approximately 150,000 patients with mild-to-moderate HS in the US.
As a reminder, we're currently conducting a Phase III study evaluating ruxolitinib cream in patients with prurigo nodularis, a chronic skin disorder that presents its multiple firm nodules, commonly located on the extensive surfaces of the extremities and that are intensely pruritic. This pivotal study is enrolling well, and we are now on track to report results in the first half of 2025 with a potential approval as early as 2026. With no topical therapies currently approved for PN and approximately 200,000 patients diagnosed in the US, we see this as an important additional option for patients and a significant opportunity for ruxolitinib cream.
As shown on Slide 15, we're continuing to execute a broad development plan for povorcitinib, our oral small-molecule, highly selective JAK1 inhibitor. Povorcitinib is currently being evaluated in Phase III studies in hidradenitis suppurativa, vitiligo and prurigo nodularis and in randomized Phase II proof-of-concept studies in asthma and chronic spontaneous urticaria with data for both expected in 2025. Povorcitinib has already shown encouraging efficacy and safety in a randomized Phase II study involving patients with moderate to severe hidradenitis suppurativa, a highly painful inflammatory condition. As a reminder, we reported that by week 52, up to 29% of patients achieved a high score 100 response, indicating complete resolution of all symptoms.
Additionally, povorcitinib demonstrated a rapid and significant reduction in pain, offering the opportunity to transform the current standard of care for this disease. The 2 Phase III studies, STOP-HS1 and STOP-HS2, are enrolling well, thanks to the strong Phase II data and the limited effective treatment options available. We expect to have Phase III data by early 2025.
We have refined our guidance for the Phase II proof-of-concept study of povorcitinib in chronic spontaneous urticaria and now anticipate data in the first half of 2025. CSU is a mast cell-driven disease characterized by hypes and severe chronic itching. The overactivation of dermal mast cells and basophils leads to increased serum levels of Th1, Th2 and Th17-related cytokines. We know that JAK1 inhibition can modulate mast cell activation, including the granulation and cytokine production, both of which contribute to chronic spontaneous urticaria. This randomized double-blind Phase II study is being conducted in patients who are inadequately controlled or have progressed on second-generation antihistamines, which represent a potential patient population of over 300,000 patients in the US alone.
As you can see on Slide 16, our updated inflammation and immunity pipeline continues to evolve. Recently, we presented promising data from a Phase II study of ruxolitinib cream in patients with cutaneous lichen planus. At this time, we do not plan to advance ruxolitinib cream into a registrational study for the syndication and intend to publish the results of the study in the future. For lichen sclerosus, given the prioritization of other indications and programs, we are not currently planning to advance this indication into a registrational study. As a reminder, 262 and 547 are currently being evaluated in a number of indications, and we anticipate data for these studies in the first quarter of 2025.
Moving to MPNs and graft-versus-host disease on Slide 17. We highlight here a number of ongoing programs where we have the goal of developing new therapeutic options to build upon the significant impact Jakafi has had on patients. For our BET inhibitor, dose escalation is ongoing, both as monotherapy and in combination with ruxolitinib. As a reminder, we have reported reductions in spleen length and volume as well as improvements in both symptoms and hemoglobin. We plan to advance this program into Phase III development and expect to provide an update later this year. Additionally, for zilurgisertib, our ALK2 inhibitor, we plan to provide an update later this year. And for ruxolitinib XR, we plan to share the bioequivalency data in early 2025.
Moving to our oncology pipeline on Slide 18. We continue to build a robust portfolio with increased emphasis on first-in-class and our best-in-class and novel immuno-oncology programs. For tafasitamab, we shared positive top line results from the Phase III study in patients with follicular lymphoma, and we are on track to file the sNDA with the FDA this year, which could lead to a potential approval in 2025. As a reminder, the Phase III data for first-line DLBCL in combination with R-CHOP is expected in the first half of 2025. During the ESMO conference in September, we shared positive top line results for the pivotal Phase III study of retifanlimab in SCAC. Retifanlimab met the primary endpoint, demonstrating a clinically meaningful 37% reduction in the risk of progression or death with a hazard ratio of 0.63. The study showed that retifanlimab was generally well tolerated and no new safety signals were detected.
At ESMO, we also shared promising evidence of clinical activity from our potentially first-in-class small molecule CDK2 inhibitor, which demonstrated a number of complete and partial responses as well as stable disease in patients with Cyclin E1 overexpressing tumors, most notably in ovarian and endometrial cancer. We believe our CDK2 inhibitor could be a foundational therapy for patients with ovarian cancer as well as other Cyclin E1 overexpressing tumor types, and we plan to move aggressively in initiating registrational studies in 2025. We will be meeting with FDA in the coming months to discuss trial designs. As highlighted on the slide, we're considering different designs for the registrational program, and we will continue to update you on the regulatory strategy for this program in the coming months.
In closing, Slide 20 shows a summary of the considerable number of milestones across the remainder of 2024 and 2025. These milestones will continue the transformation of our pipeline with a strong focus or new molecular entities with the potential to make an indelible impact on patients.
With that, I would like to turn the call over to Christiana for the financial update.
