ruxolitinib XR / Incyte - LARVOL DELTA

Details on Incyte data presentations at ASH include: Poster Presentations (Incyte Press Release)

Clinical data • Acute Graft versus Host Disease • Anemia • Chronic Graft versus Host Disease • Essential Thrombocythemia • Follicular Lymphoma • Myelofibrosis • Myeloproliferative Neoplasm • Polycythemia Vera

The Company is on track to submit ruxolitinib extended-release (XR) bioequivalence data to the U.S. Food and Drug Administration (FDA) in the fourth quarter. (Businesswire)

P1 data • Acute Graft versus Host Disease • Myelofibrosis • Myeloproliferative Neoplasm • Polycythemia Vera

A Study to Evaluate the Bioequivalence of Ruxolitinib Extended Release (XR) Tablets With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants (clinicaltrials.gov) - P1 | N=168 | Completed | Sponsor: Incyte Corporation | Recruiting ➔ Completed

Trial completion

Incyte Reports 2024 Fourth Quarter and Year-End Financial Results, Provides 2025 Financial Guidance and Highlights 2025 R&D Milestones (Businesswire) - "Jakafi (ruxolitinib) net revenues of $773 million (+11% Y/Y) in the fourth quarter 2024 and $2.8 billion (+8% Y/Y) for the full year 2024; Jakafi net revenues guidance range of $2,925 - $2,975 million for the full year 2025....Key Recent Company Updates: A bioequivalence study of ruxolitinib extended-release (XR) has been completed. These data are anticipated to be submitted to the U.S. Food and Drug Administration (FDA) by year-end 2025 once the stability studies are complete. In December 2024, additional results from the pivotal Phase 3 inMIND trial evaluating treatment with tafasitamab (Monjuvi), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide and rituximab compared with placebo plus lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma were featured...These data have been submitted to the FDA and approval for this indication is expected in the second half of 2025."

FDA approval • P1 data • Sales • Follicular Lymphoma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Polycythemia Vera

Incyte Reports 2024 Third Quarter Financial Results and Provides Updates on Key Clinical Programs (Businesswire) - "Additional Pipeline Updates: A bioequivalence study of ruxolitinib extended-release (XR) is enrolling. The data are anticipated in the first half of 2025....Trials of ruxolitinib twice daily (BID) with BETi and zilurgisertib are ongoing. Additional data for BETi and zilurgisertib are anticipated in the fourth quarter of 2024. The Phase 1 studies evaluating mCALR and JAK2V617Fi are ongoing and enrolling patients. Initial data for both studies are anticipated in 2025."

Clinical data • P1 data • Myelofibrosis • Myeloproliferative Neoplasm

A Study to Evaluate the Bioequivalence of Ruxolitinib Extended Release (XR) Tablets With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants (clinicaltrials.gov) - P1 | N=168 | Recruiting | Sponsor: Incyte Corporation | Not yet recruiting ➔ Recruiting

Enrollment open

My Treatment Approach: Optimizing Treatment for Chronic GVHD : Episode 5: Overview of Advanced Therapies in cGVHD (OncLive) - "Dr Holtan: Both ruxolitinib and ibrutinib are approved for use in cases of cGVHD that have failed 1 or more lines of systemic therapy."

Video

A Study to Evaluate the Bioequivalence of Ruxolitinib Extended Release (XR) Tablets With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants (clinicaltrials.gov) - P1 | N=168 | Not yet recruiting | Sponsor: Incyte Corporation

New P1 trial

A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants. (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Incyte Corporation | Active, not recruiting ➔ Completed

Trial completion

Management of Chronic Graft-versus-Host Disease (cGvHD) : Episode 2: Steroid-Refractory cGvHD: Emerging Treatment Options (Targeted Oncology) - "This segment explores the management of steroid-refractory cGvHD, highlighting the data from clinical trials on agents like ibrutinib and ruxolitinib. The discussion delves into the potential benefits, risks, and optimal patient selection for these novel therapies."

Video

A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants. (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Incyte Corporation | Recruiting ➔ Active, not recruiting | N=12 ➔ 24 | Trial primary completion date: Aug 2024 ➔ Apr 2024

Enrollment change • Enrollment closed • Trial primary completion date

A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants. (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Incyte Corporation

New P1 trial

Evaluating Ruxolitinib in Steroid Refractory Chronic GvHD : Episode 7: Navigating Unmet Needs in SR/D cGvHD (Targeted Oncology) - "Dr Chao provides his insights into the ongoing complexities that clinicians face and shaping a comprehensive understanding of the areas requiring further attention and innovation in cGvHD management."

Video

FDA Issues Complete Response Letter to Ruxolitinib XR Tablets for MPNs (Targeted Oncology) - "'An extended-release would help mitigate patient's risk, and increase compliance by being a once daily medication vs a twice daily medication. The FDA issued a complete response letter, which means that they have looked at the application that considered it and are not going to approve the application. [Incyte] does have the option to resubmit, so it's not dead in the water, but at least with the data that was presented so far, they either need to generate new data, or reformulate the data that was submitted in order to get the application approved, or go a different avenue for regulatory approval,' Aaron T. Gerds, MD, MS...told Targeted Oncology....'It depends on what was in the letter, the specifics to why the application was denied, but the next steps would be to take a look at what that feedback was, and try to formulate a strategy to overcome it by providing the data that the FDA is requesting in order to approve it,' added Gerds."

Media quote

Incyte Provides Regulatory Update on Ruxolitinib Extended-Release Tablets (Businesswire) - "Incyte...announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor, for once-daily (QD) use in the treatment of certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD). The complete response letter states that the FDA cannot approve the application in its present form. The FDA acknowledged that the study submitted in the New Drug Application (NDA) met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval. Incyte intends to meet with the FDA to determine appropriate next steps."

FDA event • Acute Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Polycythemia Vera

Educated Patient MPN Summit: November 19, 2022 - Episode 3: Educated Patient MPN Summit Essential Thrombocythemia Panel: November 19, 2022 (Cure Today) - "Gerds...The first follow-up question is risk for what? So we really think about risk in two ways in essential thrombocythemia. One is the risk of thrombosis or blood clots. Dr. Tremblay laid out nicely a major complication and predictor for things to come with this disease....Well, the first thing I say is write your senator. So advocacy, I think, while it doesn't directly provide hope it, it's probably the greatest way to make an impact. Until we have reform of this system, I don't expect it to change. I think being an active participant in the process can help keep your attitude positive. It's a process, right, and we just have to go through it."

Video

Incyte Reports 2022 Third Quarter Financial Results and Provides Updates on Key Clinical Programs (Businesswire) - "Total net product revenues grew to $713 million (+20% Y/Y) as a result of strong Jakafi® (ruxolitinib) and Opzelura™ (ruxolitinib) cream net product revenues...Additionally, the Prescription Drug User Fee Act (PDUFA) target action date for once-daily (QD) ruxolitinib extended release (XR) formulation is March 23, 2023....A Phase 1/2 combination trial of axatilimab with ruxolitinib in patients with newly-diagnosed cGVHD is in preparation and is expected to initiate in the first quarter of 2023....Over 62,000 units of Opzelura were shipped in the third quarter with positive physician and patient experiences continuing to fuel uptake in AD. The launch in vitiligo is progressing well, contributing to the growth in overall demand. An increasing number of plans are adding Opzelura to formularies, helping to drive net product revenues to $38 million, a growth of 130% versus prior quarter."

Commercial • New P1/2 trial • PDUFA date • Sales • Acute Graft versus Host Disease • Atopic Dermatitis • Chronic Graft versus Host Disease • Dermatology • Graft versus Host Disease • Immunology • Vitiligo

Incyte Reports 2022 Second Quarter Financial Results and Provides Updates on Key Clinical Programs (Businesswire) - "Jakafi® (ruxolitinib) net product revenues of $598 million in Q2’22 (+13% Y/Y) driven by volume growth; raising the bottom end of full year guidance to new range of $2.36 to $2.40 billion....MPNs and GVHD – key highlights...Itacitinib in chronic graft-versus-host disease (GVHD): Incyte no longer intends to develop itacitinib, a selective JAK1 inhibitor, in treatment-naïve chronic GVHD (cGVHD). Based on efficacy data from Part 1 of the Phase 2/3 GRAVITAS-309 trial, it was determined that a pivotal trial was unlikely to be successful....axatilimab...Chronic GVHD: Pivotal Phase 2 (third-line plus therapy) (AGAVE-201)."

Discontinued • Sales • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease