Full Press Release Details
Incyte Reports 2021 First Quarter Financial
and Provides Updates on Key Clinical Programs
Conference Call and Webcast Scheduled Today at
WILMINGTON, Del. - May 4, 2021 - Incyte (Nasdaq:
INCY) today reports 2021 first quarter financial results, and provides a status update on the Company's development portfolio.
"In the first quarter, we continued to make significant progress
in our strategy to drive growth and diversification. While Jakafi (ruxolitinib) net sales were affected by typical seasonal
effects and softer patient demand growth due to the ongoing pandemic, we remain confident in our full-year outlook. We are already seeing
a return of new patient starts to pre-COVID levels and are excited for the potential launch in steroid-refractory chronic graft-versus-host
disease (GVHD) later this year. The launches of Monjuvi (tafasitamab) and Pemazyre (pemigatinib) continue
to progress with good uptake by both academic and community physicians," stated Herv Hoppenot, Chief Executive Officer,
Incyte. "We expect an exciting year ahead for Incyte with the potential for multiple approvals, including ruxolitinib cream in
atopic dermatitis, and several regulatory filings, notably parsaclisib in NHL and ruxolitinib cream in vitiligo. We are also initiating
pivotal trials across key development programs for both tafasitamab and LIMBER this year."
MPNs and GVHD - key highlights
Ruxolitinib in GVHD: The supplemental New Drug Application (sNDA)
seeking approval of ruxolitinib for the treatment of steroid-refractory chronic GVHD has been accepted for Priority Review by the U.S.
Food and Drug Administration (FDA); the Prescription Drug User Fee Act (PDUFA) date is June 22, 2021. The application for approval was
based on the successful randomized REACH3 trial comparing ruxolitinib with best available therapy (BAT).
LIMBER: Our Leadership In MPNs BEyond
Ruxolitinib (LIMBER) development program continues to progress with once daily (QD) ruxolitinib in stability testing, and multiple
ongoing and planned combination trials with ruxolitinib on track. Both monotherapy trials of INCB57643 (BET) and INCB00928 (ALK2) are
ongoing, and combination trials of both agents with ruxolitinib in patients with myelofibrosis (MF) are expected to initiate later this
year. Two Phase 3 trials of ruxolitinib in combination with parsaclisib as a first-line therapy for patients with MF (LIMBER-313) and
as a therapy for MF patients with a suboptimal response to ruxolitinib monotherapy (LIMBER-304) are ongoing.
| Indication and status | ||
| Once-a-day ruxolitinib (JAK1/JAK2) | Myelofibrosis, polycythemia vera & GVHD: clinical pharmacology studies | |
| ruxolitinib + parsaclisib (JAK1/JAK2 + PI3K ) | Myelofibrosis: Phase 3 (first-line therapy) (LIMBER-313) Myelofibrosis: Phase 3 (suboptimal responders to ruxolitinib) (LIMBER-304) | |
| ruxolitinib + INCB57643 (JAK1/JAK2 + BET) | Myelofibrosis: Phase 2 in preparation | |
| ruxolitinib + INCB00928 (JAK1/JAK2 + ALK2) | Myelofibrosis: Phase 2 in preparation | |
| itacitinib (JAK1) | Myelofibrosis: Phase 2 (low platelets) | |
| ruxolitinib + CK0804 1 (JAK1/JAK2 + CB-Tregs) | Myelofibrosis: PoC in preparation | |
| ruxolitinib (JAK1/JAK2) | Steroid-refractory chronic GVHD 2 : sNDA under Priority Review | |
| itacitinib (JAK1) | Treatment-na ve chronic GVHD: Phase 3 (GRAVITAS-309) |
Other Hematology/Oncology - key highlights
Tafasitamab: Incyte and MorphoSys strategy to evaluate
tafasitamab as a backbone therapy in multiple combinations for the treatment of various B-cell malignancies is underway. The Phase 3 inMIND
trial, evaluating tafasitamab in combination with lenalidomide plus rituximab (R2) versus R2 in patients with
follicular lymphoma and marginal zone lymphoma is ongoing. Preparations are underway for the Phase 3 frontMIND trial
evaluating tafasitamab plus lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone
(R-CHOP) compared to R-CHOP alone as a first-line treatment for patients with newly diagnosed diffuse-large B-cell lymphoma (DLBCL).
A proof-of-concept trial evaluating tafasitamab plus parsaclisib (topMIND) is expected to start later this year and a second
proof-of-concept trial with tafasitamab plus lenalidomide in addition to plamotamab is expected to start later this year or early next.
Pemigatinib: In March, Pemazyre (pemigatinib)
was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with unresectable biliary tract
cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy. Additionally, the European
Commission (EC) approved Pemazyre for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast
growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. The upcoming
launches in Europe and Japan along with the continued launch in the U.S., signifies the first internally discovered product to be globally
commercialized by Incyte. The Phase 2 tumor agnostic study of pemigatinib is ongoing and continues to enroll well.
Retifanlimab: In March, the Marketing Authorization Application
(MAA) seeking approval of retifanlimab in squamous cell carcinoma of the anal canal (SCAC) was validated by the European Medicines Agency
(EMA). This follows the Biologics License Application (BLA) acceptance by the FDA for the same indication earlier this year.
| Indication and status | ||
| pemigatinib (FGFR1/2/3) | CCA: Phase 2 (FIGHT-202), Phase 3 (FIGHT-302) 8p11 MPN: Phase 2 (FIGHT-203) Tumor agnostic: Phase 2 (FIGHT-207) | |
| tafasitamab (CD19) 1 | r/r DLBCL: Phase 2 (L-MIND); Phase 3 (B-MIND); MAA under review 1L DLBCL: Phase 1b ( firstMIND ); Phase 3 ( frontMIND ) in preparation r/r FL and r/r MZL: Phase 3 ( inMIND ) r/r B-cell malignancies: PoC ( topMIND ) with parsaclisib (PI3K ) in preparation r/r B-cell malignancies: PoC with lenalidomide and plamotamab in preparation 2 | |
| parsaclisib (PI3K ) | r/r FL: Phase 2 (CITADEL-203) r/r MZL: Phase 2 (CITADEL-204) r/r MCL: Phase 2 (CITADEL-205) r/r FL and r/r MZL: Phase 3 (CITADEL-302) in preparation 1L MCL: Phase 3 (CITADEL-310) in preparation | |
| retifanlimab (PD-1) 3 | SCAC: Phase 2 (POD1UM-202); Phase 3 (POD1UM-303); BLA and MAA under review MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204) Merkel cell carcinoma: Phase 2 (POD1UM-201) NSCLC: Phase 3 (POD1UM-304) |
CCA = cholangiocarcinoma; DLBCL = diffuse large B-cell lymphoma; SCAC
= squamous cell anal carcinoma; FL = follicular lymphoma; MZL = marginal zone lymphoma; MCL = mantle cell lymphoma
| 1) | Development of tafasitamab in collaboration with MorphoSys | |
| 2) | Clinical collaboration with MorphoSys and Xencor, Inc. to investigate the combination of tafasitamab plus lenalidomide in combination with Xencor's CD20xCD3 XmAb bispecific antibody, plamotamab. | |
| 3) | retifanlimab licensed from MacroGenics |
Inflammation and Autoimmunity (IAI) - key highlights
Ruxolitinib cream: The NDA seeking approval of ruxolitinib cream
for the treatment of atopic dermatitis (AD) has been accepted for Priority Review by the FDA and the PDUFA date has been set for
June 21, 2021. The application is supported by data from the Phase 3 TRuE-AD clinical trial program - pooled results presented last month
at the American Academy of Dermatology (AAD) virtual conference provided additional context regarding the impact of ruxolitinib cream
on itch relief as well as sleep disturbance and sleep impairment.
Also at AAD, Incyte presented 104-week data from the Phase 2
program evaluating ruxolitinib cream in patients with vitiligo. Results showed patients on ruxolitinib cream achieved continued
efficacy through 104 weeks, with a longer duration of treatment being associated with greater levels of repigmentation. Incyte also
presented additional follow-up data which demonstrated a potential for maintenance of repigmentation after discontinuation of
therapy (following two years of treatment with ruxolitinib cream). The two Phase 3 trials in the TRuE-V program are ongoing with
results expected in Q2'21.
INCB54707: In March, Incyte initiated a Phase 2 trial evaluating
INCB54707 in vitiligo. A Phase 2 trial in hidradenitis suppurativa remains ongoing.
| Indication and status | ||
| ruxolitinib cream (JAK1/JAK2) | Atopic dermatitis: NDA under Priority Review Vitiligo: Phase 3 (TRuE-V1, TRuE-V2; recruitment complete in both trials) | |
| INCB54707 (JAK1) | Hidradenitis suppurativa: Phase 2b Vitiligo: Phase 2 | |
| parsaclisib (PI3K ) | Autoimmune hemolytic anemia: Phase 2 | |
| INCB00928 (ALK2) | Fibrodysplasia ossificans progressiva: Phase 2 in preparation |
Discovery and early development - key highlights
INCB106385/INCA00186: At AACR, Incyte shared clinical and pre-clinical
data from INCB106385, our novel A2A/A2B adenosine receptor antagonist, and INCA00186, our novel CD73 monoclonal antibody-both of
which highlight our ongoing efforts targeting the adenosine pathway. Incyte also presented preclinical data for our triplet combination
with retifanlimab, highlighting one of our strategies to overcome adenosine mediated PD-1 suppression.
| Modality | Candidates | |
| Small molecules | INCB01158 (ARG) 1 , INCB81776 (AXL/MER), epacadostat (IDO1), INCB86550 (PD-L1), INCB106385 (A2A/A2B) | |
| Monoclonal antibodies 2 | INCAGN1876 (GITR), INCAGN2385 (LAG-3), INCAGN1949 (OX40), INCAGN2390 (TIM-3), INCA00186 (CD73) | |
| Bispecific antibodies | MCLA-145 (PD-L1xCD137) 3 |
| 1) | INCB01158 development in collaboration with Calithera | |
| 2) | Discovery collaboration with Agenus | |
| 3) | MCLA-145 development in collaboration with Merus |
Partnered - key highlights
Baricitinib: In April, Incyte and Lilly announced the FDA extended
the review period for the sNDA for baricitinib for the treatment of moderate to severe atopic dermatitis by three months to allow time
for additional data analyses. The PDUFA action date is now expected in early Q3.
In March, Incyte and Lilly announced positive results from
BRAVE-AA2 evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA), an
autoimmune disorder that can cause unpredictable hair loss on the scalp, face and other areas of the body. In April, positive
results from a second Phase 3 study, BRAVE-AA1, were announced, with data consistent with the findings from BRAVE-AA2. Lilly plans
to submit an sNDA to the FDA for baricitinib in AA in the second half of 2021. There are currently no FDA-approved therapies for AA,
highlighting the potential for baricitinib to address a significant unmet medical need.
| Indication and status | ||
| baricitinib (JAK1/JAK2) 1 | Atopic dermatitis: Phase 3 (BREEZE-AD); approved in EU and Japan; sNDA under review Severe alopecia areata: Phase 3 (BRAVE-AA1, BRAVE-AA2) Systemic lupus erythematosus: Phase 3 (BRAVE I, BRAVE II) | |
| capmatinib (MET) 2 | NSCLC (with MET exon 14 skipping mutations): Approved as Tabrecta in U.S. and Japan |
| 1) | Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis | |
| 2) | Worldwide rights to capmatinib licensed to Novartis |
Potential therapies for patients with COVID-19
Ruxolitinib: In March, Incyte announced results from the Phase
3 DEVENT study assessing ruxolitinib plus standard of care (SoC) versus SoC in patients on mechanical ventilation with COVID-19 associated
Acute Respiratory Disease Syndrome (ARDS). While results indicate a trend towards improvement in mortality in the overall study population,
statistical significance was not reached in the primary endpoint (mortality due to any cause through Day 29). In the U.S. study population
(91% of total study participants), however, there was a clinically and statistically significant improvement in mortality in each of the
5mg and 15mg ruxolitinib arms versus placebo.
Baricitinib: In April, Incyte and Lilly announced the primary
endpoint in the Phase 3 COV-BARRIER study evaluating baricitinib in hospitalized COVID-19 patients - difference in the proportion of participants
progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including
extracorporeal membrane oxygenation (ECMO) or death by Day 28) - was not met. There was, however, a 38% reduction in mortality by Day
28 in patients treated with baricitinib in addition to SoC. Lilly will share these data with regulatory authorities in the U.S., European
Union and other geographies to evaluate next steps.
2021 First Quarter Financial Results
measures presented in this press release for the three months ended March 31, 2021 and 2020 have been prepared by the Company in accordance
with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure.
Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte's GAAP disclosures.