DE-INCYTE
21.1.2021 22:32:11 CET | Business Wire | Press release
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.
The BLA submission is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy. The trial enrolled 94 patients, including several with well-controlled human immunodeficiency virus (HIV) infection. The study, which was recently presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, resulted in an objective response rate (ORR) of 14% for retifanlimab monotherapy as determined by independent central review (ICR) using RECIST v1.1. Responses were observed regardless of PD-L1 status, presence of liver metastases, age or HIV+ status and were durable (median 9.5 months). Treatment-related adverse events ≥Grade 3 occurred in 11.7% of patients. Immune-related adverse events ≥Grade 3 occurred in 6.4% of patients. The most common adverse reactions (incidence ≥ 20%) were fatigue and diarrhea.
“Patients with SCAC who have progressed after first-line chemotherapy treatment currently have no approved treatments available, and we are encouraged that the FDA’s acceptance of this BLA for Priority Review brings us one step closer to addressing this historically neglected, yet important, tumor,” said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. “Despite SCAC being a rare disease, its incidence is increasing and its impact is profound. We look forward to working with the FDA to potentially fill an unmet need and advance progress in SCAC for patients.”
Retifanlimab has been granted Orphan Drug Designation by the FDA for the treatment of anal cancer, along with Priority Review. The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the review period by four months as compared to Standard Review. The Prescription Drug User Fee Act (PDUFA) target action date for retifanlimab is July 25, 2021.
SCAC is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers.1 Patients with metastatic SCAC have a poor 5-year survival, and there are no FDA-approved treatments for patients who have progressed after first-line chemotherapy.2
POD1UM-303/InterAACT 2 (NCT04472429), a Phase 3 trial of retifanlimab in combination with carboplatin and paclitaxel in patients with inoperable locally recurrent or metastatic SCAC, is now open and recruiting patients.
About POD1UM-202
POD1UM-202 (NCT03597295) is an open-label, single-arm, multicenter, Phase 2 study evaluating retifanlimab in patients with squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. Retifanlimab 500 mg is administered intravenously every 4 weeks.
The primary endpoint is objective response rate (ORR) as determined by independent central review using RECIST v1.1. Secondary endpoints include additional measures of clinical benefit ‒ duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS); safety and pharmacokinetics.
For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03597295 .
About POD1UM
The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-202, POD1UM-303 and several other Phase 1, 2 and 3 studies for patients with solid tumors including squamous cell carcinoma of the anal canal (SCAC), microsatellite instability-high endometrial cancer, Merkel cell carcinoma and non-small cell lung cancer, among others.
About Retifanlimab
Retifanlimab (formerly INCMGA0012), an investigational intravenous anti-PD1 antibody, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.
Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.
In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte .
Forward Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements about whether or when the FDA may approve retifanlimab for the treatment of patients with squamous cell carcinoma of the anal canal (SCAC), the potential of retifanlimab to provide a meaningful treatment for patients with SCAC, the retifanlimab development program, and the safety and efficacy of retifanlimab in patients with SCAC, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s current expectations and 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; determinations made by the FDA; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.
_________________________
1
Ghosn M, et.al. Anal cancer treatment: current status and future perspectives. World J Gastroenterol
2015;21:2294-2302.
2
Eng C, et al. The role of systemic chemotherapy and multidisciplinary management in improving the overall survival of patients with metastatic squamous cell carcinoma of the anal canal. Oncotarget
2014;5:11133-11142.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210121005917/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
KATE Launches "KABUKE: Break Convention" Kabuki-Inspired International Campaign17.7.2026 09:00:00 CEST | Press release
Where “NO MORE RULES.” intersects with the Kabuku spirit. Inspired by Japanese aesthetics, KATE shares the value of shadow enhancing makeup and self‑expression with the world. Global cosmetics brand KATE launched “KABUKE: Break Convention,” a new international campaign drawing on elements of Kabuki, the traditional Japanese performing art. The campaign debuted on Wednesday, July 8, 2026. In this campaign, KATE’s shadow enhancing makeup—rooted in Japanese aesthetics—was paired with the Kabuki spirit inherited from traditional Kabuki theater to communicate the value of individuality and self‑expression through makeup on a global scale. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708829427/en/ KATE international campaign “KABUKE: Break Convention” key visual. Dedicated website: https://www.kate-global.net/my/special/kate_kabuki/ Since its founding, KATE has championed the slogan “NO MORE RULES.,” offering makeup that defi
Meiji Seika Pharma: Results from the Global Phase III Trial (Integral-2) of Nacubactam, a Novel β-Lactamase Inhibitor, Highlighted in The Lancet Microbe’s Coverage of ESCMID Global Congress 202617.7.2026 03:00:00 CEST | Press release
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, President and Representative Director: Toshiaki Nagasato) today announced that results from the global Phase III trial (Integral-2) of nacubactam (Development Code: OP0595), a novel β-lactamase inhibitor, were highlighted in The Lancet Microbe’s coverage of ESCMID Global Congress 2026 (held in Munich, Germany). As highlighted in The Lancet Microbe’s coverage, the key findings presented by Meiji Seika Pharma at ESCMID Global Congress 2026 are as follows: The Integral-2 study (jRCT2031230076) is a global Phase III clinical trial that enrolled patients with complicated urinary tract infections, acute uncomplicated pyelonephritis, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, or complicated intra-abdominal infections caused by carbapenem-resistant Gram-negative bacteria (excluding Acinetobacter species). The study has achieved the prespecified study objectives. For the primary endpoint of overall treatme
Yoshihiro Shimamura Joins the Marché du Film’s “Investors Circle 2026” as an Invited Investor, Backing a New Feature Film17.7.2026 03:00:00 CEST | Press release
Shimamura Yoshihiro Film Production Co., Ltd. (Head office: Osaka, Japan; Representative Director: Yoshihiro Shimamura), a company active in film production and investment, today announced that Representative Director Yoshihiro Shimamura has decided to invest in an international feature film after being invited to the “Investors Circle 2026” — a distinction that reflects his standing as one of the field’s most highly regarded producers and investors. Hosted by the Marché du Film, the business arm of the Festival de Cannes and one of the world’s largest film markets, the Investors Circle is an invitation-only summit that connects a select group of private investors with high-end feature films during early-stage financing. Held in Cannes, France, May 16-17, 2026, it brings internationally acclaimed directors and producers together with investors around a curated slate of projects in development. During the summit, Shimamura attended private pitching sessions and, after individual meeting
Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis Studies17.7.2026 00:00:00 CEST | Press release
On average, about 75% of patients with scalp psoriasis treated with zasocitinib achieved clear or almost clear skin at week 16 Approximately 70% of patients with palmoplantar disease treated with zasocitinib achieved clear or almost clear skin at week 16 Zasocitinib demonstrated statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) versus placebo Results reinforce the potential of zasocitinib to deliver rapid and durable skin clearance, including in the hardest-to-treat areas, in a convenient once-daily pill Takeda (TSE:4502/NYSE:TAK) announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy, these secondary endpoint data show that zasocitinib demonstrated consistent and high rates of skin clearance across hard-to-
Merz Completes Inaugural €450 Million Schuldschein Loan Issuance16.7.2026 23:36:00 CEST | Press release
Debut transaction more than three times oversubscribed The Merz Group has successfully completed its first-ever Schuldschein loan issuance, placing a total volume of €450 million in the debt capital market – a multiple of three relating to the launch volume. The debut transaction was significantly oversubscribed and attracted strong interest from all investor groups. The proceeds were settled and paid out today. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260716926041/en/ Dr. Almuth Steinkühler, Chief Financial Officer Merz Group The transaction comprises both fixed- and floating-rate tranches with maturities of three, five, seven, and ten years. Around 50 German and international investors participated, representing a broad range of institutions, including private banks, German federal state-owned banks, public savings banks, cooperative banks, pension funds and occupational pension institutions. With the successful plac
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom