On October 29, 2024 Incyte reported 2024 third quarter financial results, and provides a status update on the Company’s clinical development portfolio (Press release, Incyte, OCT 29, 2024, View Source [SID1234647507]).

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"We are on track to achieve over ten impactful launches by 2030."

"In the third quarter of 2024, we delivered significant achievements, including strong revenue growth for both Jakafi (ruxolitinib) and Opzelura (ruxolitinib) cream, and the advancement of our clinical pipeline highlighted by the submission to the FDA of the supplemental New Drug Application (sNDA) for ruxolitinib cream in pediatric atopic dermatitis and several key data readouts including CDK2i, retifanlimab, tafasitamab, povorcitinib and ruxolitinib cream, which all hold near to mid-term launch potential. Additionally, in August, the FDA approved Niktimvo (axatilimab-csfr) for patients with chronic graft-versus-host disease, after failure of two prior lines of therapy, making it the first anti-CSF-1R antibody approved to target the inflammation and fibrosis associated with chronic GVHD," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We are on track to achieve over ten impactful launches by 2030."

Key Recent Company Updates

In October, the sNDA submission for ruxolitinib cream in pediatric atopic dermatitis was filed with the FDA with approval anticipated in the second half of 2025.
In October, Opzelura was granted a Notice of Compliance by Health Canada for the topical treatment of both mild to moderate atopic dermatitis and nonsegmental vitiligo in patients 12 years of age and older.
In September, Incyte presented late-breaking Phase 3 results for retifanlimab (Zynyz) and initial data from the Phase 1 CDK2 inhibitor program at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.
Featured during the Presidential Symposium, the Phase 3 POD1UM-303/InterAACT2 trial for retifanlimab met the primary endpoint of progression free survival (PFS) and demonstrated improvement across secondary endpoints in patients with squamous cell anal carcinoma (SCAC) receiving retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel). Incyte plans to file a supplemental Biologics License Application (sBLA) for retifanlimab in SCAC by the end of 2024. A potential approval in 2025 could represent the first PD-(L)1 antibody for patients with SCAC.
Phase 1 data of INCB123667, a highly selective and potentially first-in-class CDK2 inhibitor, were presented demonstrating single-agent antitumor activity across a range of doses and regimens, notably in patients with ovarian cancer and endometrial cancer whose tumors overexpress Cyclin E1. The Phase 1 trial of INCB123667 in combination with other agents is ongoing. Incyte plans to initiate a pivotal trial in ovarian cancer in 2025.
In August, Incyte and its partner Syndax announced the U.S. Food and Drug Administration (FDA) approval of Niktimvo, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients. Niktimvo is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD. In September, Incyte and Syndax announced the New England Journal of Medicine publication of data from the pivotal AGAVE-201 trial of Niktimvo in chronic GVHD and the addition of Niktimvo to the NCCN Clinical Practice Guidelines in Oncology for the treatment of chronic GVHD.
In August, Incyte announced positive topline results from the Phase 3 clinical study evaluating tafasitamab (Monjuvi) in relapsed or refractory follicular lymphoma (FL). The pivotal Phase 3 inMIND trial met the primary endpoint of PFS by investigator assessment in FL. The trial also met key secondary endpoints. No new safety signals with tafasitamab were observed. The full dataset is anticipated to be presented at an upcoming medical meeting in 2024 and Incyte expects to file an sBLA for tafasitamab in combination with lenalidomide and rituximab in FL by the end of 2024.
Jakafi:

Net product revenues for the third quarter 2024 of $741 million (+16% Y/Y):

Net product revenues were primarily driven by patient demand, which increased 10% in the third quarter of 2024 versus the same quarter in the prior year, with growth across all indications.
Opzelura:

Net product revenues for the third quarter 2024 of $139 million (+52% Y/Y):

Net product revenues of $119 million in the third quarter of 2024 in the U.S. were primarily driven by patient demand and refills in both atopic dermatitis (AD) and vitiligo.
Net product revenues of $20 million in the third quarter of 2024 ex-U.S. were primarily driven by sales in Germany and France.
Additional Pipeline Updates

Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights

A bioequivalence study of ruxolitinib extended-release (XR) is enrolling. The data are anticipated in the first half of 2025.
A Phase 2 trial evaluating the safety and efficacy of axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD is enrolling.
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.

MPN and GVHD Programs

Indication and status

Ruxolitinib XR (QD)

(JAK1/JAK2)

Myelofibrosis, polycythemia vera and GVHD

Ruxolitinib + zilurgisertib

(JAK1/JAK2 + ALK2i)

Myelofibrosis: Phase 2

Ruxolitinib + INCB57643

(JAK1/JAK2 + BETi)

Myelofibrosis: Phase 2

Ruxolitinib + axatilimab1

(JAK1/JAK2 + anti-CSF-1R)

Chronic GVHD: Phase 2

Steroids + axatilimab1

(Steroids + anti-CSF-1R)

Chronic GVHD: Phase 3 in preparation

INCA33989

(mCALR)

Myelofibrosis, essential thrombocythemia: Phase 1

INCB160058

(JAK2V617Fi)

Myelofibrosis: Phase 1

1 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals.

Other Hematology/Oncology – key highlights

Following the announcement of the positive topline results from the Phase 3 study evaluating retifanlimab, a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1), in non-small cell lung cancer (NSCLC), Incyte anticipates sharing the full dataset at an upcoming medical meeting in the fourth quarter of 2024.
The Phase 3 study evaluating tafasitamab in first-line diffuse large B-cell lymphoma (DLBCL) is ongoing. The Phase 3 data are anticipated in the first half of 2025.
The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 are ongoing and enrolling patients. Initial data for both studies are anticipated in 2025.