” Section 3 POD1UM-304 trial met main endpoint of general survival (OS) and all secondary endpoints in sufferers with beforehand untreated metastatic non-small cell lung most cancers (NSCLC)
” Knowledge offered on the European Society for Medical (TASE:) Oncology (ESMO) Asia Congress 2024 assist the deliberate 2025 submitting of a supplemental Biologics License Software (sBLA) within the U.S. for retifanlimab in NSCLC
WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) at present introduced outcomes from the Section 3 POD1UM-304 trial of retifanlimab (Zynyz ®), a humanized monoclonal antibody concentrating on programmed demise receptor-1 (PD-1), together with platinum-based chemotherapy for the therapy of adults with beforehand untreated non-squamous and squamous metastatic non-small cell lung most cancers (NSCLC) not harboring a driver mutation. These information had been featured at present in a mini oral presentation on the European Society for Medical Oncology (ESMO) Asia Congress 2024, held in Singapore and nearly.
The POD1UM-304 trial outcomes present a clinically significant and statistically important enchancment over chemotherapy alone. Sufferers within the retifanlimab and chemotherapy mixture therapy group achieved a median general survival (OS) of 18.1 months in comparison with 13.4 months within the placebo and chemotherapy mixture group (Hazard Ratio [HR]: 0.75; 95% Confidence Interval [CI] (0.60, 0.93); P=0.0042).
The constructive POD1UM-304 trial outcomes present further proof of retifanlimab’s security and efficacy profile in stable tumors, mentioned Pablo J. Cagnoni, M.D., President and Head of Analysis and Improvement, Incyte (NASDAQ:). We sit up for leveraging these outcomes to advance our pipeline, notably in hard-to-treat cancers like NSCLC, and to submitting a supplemental Biologic License Software for this indication to the U.S. Meals and Drug Administration subsequent yr.
The trial additionally met secondary endpoints, together with:
- Sufferers who obtained retifanlimab together with chemotherapy had a 2-month enchancment in median progression-free survival (PFS) in comparison with the placebo and chemotherapy mixture group (7.7 vs 5.5 months; [HR: 0.64; 95% CI (0.52, 0.79); P
- Overall response rate (ORR) and duration of response (DOR) by Blinded Independent (LON:) Central Review (BICR) each showed improvement in the retifanlimab and chemotherapy combination treatment group versus the placebo and chemotherapy combination group (ORR of 52% [95% CI (47, 57) vs. 39% (95% CI 32, 46), respectively; P=0.0012]; DOR of 12.7 months [95% CI (9.4, 15.2) vs. 6.1 months and [95% CI (4.2, 8.3), respectively]).
Retifanlimab was typically well-tolerated and no new issues of safety had been recognized. The most typical treatment-emergent adversarial occasions (TEAEs), in >10% of sufferers within the retifanlimab and chemotherapy mixture therapy group, had been anemia (62.7%), decreased urge for food (22.6%) and decreased neutrophil rely (22.1%). Chemotherapy administration was not compromised by the addition of retifanlimab.
Lung most cancers is the main reason for most cancers deaths globally, with the excessive majority of circumstances being NSCLC, mentioned Shun Lu, M.D., Ph.D., Shanghai Chest Hospital. I’m inspired by the noticed security and efficacy profile of retifanlimab when added to platinum-based chemotherapy on this affected person inhabitants and imagine the constructive outcomes from the POD1UM-304 trial assist retifanlimab together with chemotherapy as an extra therapy choice for beforehand untreated metastatic NSCLC.
About Non-Small Cell Lung Most cancers
Non-small cell lung most cancers (NSCLC) is the most typical kind of lung most cancers, accounting for roughly 85% of all lung most cancers circumstances worldwide.1 It’s characterised by the uncontrolled progress of malignant cells within the lungs and is commonly identified at a complicated stage, making it a number one reason for cancer-related mortality globally.1, 2, 3
About POD1UM
The POD1UM (PD1 Medical Program in A number of Malignancies) scientific trial program for retifanlimab consists of POD1UM-304 in non-small cell lung most cancers (NSCLC) and POD1UM-303 in squamous cell anal carcinoma (SCAC), in addition to different Section 1 and a couple of research for sufferers with stable tumors, together with registration-directed trials evaluating retifanlimab as a monotherapy for sufferers with Merkel cell carcinoma and microsatellite instability-high endometrial most cancers.
About POD1UM-304
POD1UM-304 is a Section 3, international, multicenter, randomized, double-blind examine evaluating platinum-based chemotherapy with retifanlimab or placebo in sufferers with first-line, metastatic squamous or non-squamous NSCLC.
Through the examine, sufferers had been randomized to obtain retifanlimab or placebo intravenously together with pemetrexed and carboplatin/cisplatin for non-squamous NSCLC, and with paclitaxel and carboplatin for squamous NSCLC. The first endpoint is general survival (OS), and secondary endpoints embrace progression-free survival (PFS), general response fee (ORR) and period of response (DOR) as assessed by blinded unbiased central evaluate (BICR). After verified progressive illness by BICR, sufferers assigned to the placebo and chemotherapy mixture group had the choice to cross over to open-label retifanlimab monotherapy.
For extra details about the examine, please go to https://clinicaltrials.gov/examine/NCT04205812.
About Zynyz ® (retifanlimab-dlwr)
Zynyz ® (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated within the U.S. for the therapy of grownup sufferers with metastatic or recurrent regionally superior Merkel cell carcinoma (MCC). This indication is accepted below accelerated approval primarily based on tumor response fee and period of response. Continued approval for this indication could also be contingent upon verification and outline of scientific profit in confirmatory trials.
In Europe, Zynyz is accepted as a monotherapy for the first-line therapy of grownup sufferers with metastatic or recurrent regionally superior MCC not amenable to healing surgical procedure or radiation remedy.
Zynyz is marketed by Incyte within the U.S. In 2017, Incyte entered into an unique collaboration and license settlement with MacroGenics (NASDAQ:), Inc. for international rights to retifanlimab.
Zynyz is a registered trademark of Incyte.
Essential Security Info
What’s crucial data I ought to find out about ZYNYZ?
ZYNYZ is a drugs which will deal with a sure kind of pores and skin most cancers by working along with your immune system. ZYNYZ may cause your immune system to assault regular organs and tissues in any space of your physique and might have an effect on the way in which they work. These issues can typically develop into extreme or life-threatening and might result in demise. You possibly can have a couple of of those issues on the similar time. These issues could occur anytime throughout therapy and even after your therapy has ended.
Name or see your healthcare supplier instantly if you happen to develop any new or worsening indicators or signs, together with:
Lung issues: cough, shortness of breath, chest ache
Intestinal issues: diarrhea (free stools) or extra frequent bowel actions than standard; stools which are black, tarry, sticky, or have blood or mucus; extreme stomach-area (stomach) ache or tenderness
Liver issues: yellowing of your pores and skin or the whites of your eyes; extreme nausea or vomiting; ache on the correct facet of your abdomen space (stomach); darkish urine (tea coloured); bleeding or bruising extra simply than regular
Hormone gland issues: complications that won’t go away or uncommon complications; eye sensitivity to gentle; eye issues; speedy heartbeat; elevated sweating; excessive tiredness; weight achieve or weight reduction; feeling extra hungry or thirsty than standard; urinating extra usually than standard; hair loss; feeling chilly; constipation; your voice will get deeper; dizziness or fainting; modifications in temper or conduct, equivalent to decreased intercourse drive, irritability, or forgetfulness
Kidney issues: lower in your quantity of urine, blood in your urine, swelling of your ankles, lack of urge for food
Pores and skin issues: rash; itching; pores and skin blistering or peeling; painful sores or ulcers in your mouth or nostril, throat, or genital space; fever or flu-like signs; swollen lymph nodes
Issues also can occur in different organs and tissues. These usually are not all the indicators and signs of immune system issues that may occur with ZYNYZ. Name or see your healthcare supplier instantly for any new or worsening indicators or signs, which can embrace:
- chest ache, irregular heartbeat, shortness of breath, or swelling of ankles
- confusion, sleepiness, reminiscence issues, modifications in temper or conduct, stiff neck, stability issues, tingling or numbness of the arms or legs
- double imaginative and prescient, blurry imaginative and prescient, sensitivity to gentle, eye ache, modifications in eyesight
- persistent or extreme muscle ache or weak point, muscle cramps
- low purple blood cells, bruising
Infusion reactions that may typically be extreme. Indicators and signs of infusion reactions could embrace: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, really feel like passing out, fever, again or neck ache
Rejection of a transplanted organ. Your healthcare supplier ought to let you know what indicators and signs it is best to report and monitor you, relying on the kind of organ transplant that you’ve got had.
Problems, together with graft-versus-host illness, in individuals who have obtained a bone marrow (stem cell) transplant that makes use of donor stem cells (allogeneic). These issues could be critical and might result in demise. These issues could occur if you happen to underwent transplantation both earlier than or after being handled with ZYNYZ. Your healthcare supplier will monitor you for these issues.
Getting medical therapy instantly could assist hold these issues from turning into extra critical. Your healthcare supplier will verify you for these issues throughout your therapy with ZYNYZ. Your healthcare supplier could deal with you with corticosteroid or hormone substitute medicines. Your healthcare supplier can also must delay or utterly cease therapy with ZYNYZ if in case you have extreme negative effects.
Earlier than you obtain ZYNYZ, inform your healthcare supplier about all your medical situations, together with if you happen to:
- have immune system issues equivalent to Crohn’s illness, ulcerative colitis, or lupus
- have obtained an organ transplant
- have obtained or plan to obtain a stem cell transplant that makes use of donor stem cells (allogeneic)
- have obtained radiation therapy to your chest space
- have a situation that impacts your nervous system, equivalent to myasthenia gravis or Guillain-Barré syndrome
- are pregnant or plan to develop into pregnant. ZYNYZ can hurt your unborn child.
Females who’re capable of develop into pregnant:
” Your healthcare supplier ought to do a being pregnant take a look at earlier than you begin therapy with ZYNYZ.
” It’s best to use an efficient technique of contraception throughout your therapy and for 4 months after your final dose of ZYNYZ. Speak to your healthcare supplier about contraception strategies that you need to use throughout this time.
” Inform (WA:) your healthcare supplier instantly if you happen to develop into pregnant or suppose you might be pregnant throughout therapy with ZYNYZ. - are breastfeeding or plan to breastfeed. It isn’t identified if ZYNYZ passes into your breast milk. Don’t breastfeed throughout therapy and for 4 months after your final dose of ZYNYZ.
Inform your healthcare supplier about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements.
The most typical negative effects of ZYNYZ embrace tiredness, muscle and bone ache, itching, diarrhea, rash, fever, nausea.
These usually are not all of the attainable negative effects of ZYNYZ. Name your physician for medical recommendation about negative effects.
Basic details about the protected and efficient use of ZYNYZ.
Medicines are typically prescribed for functions aside from these listed in a Treatment Information. If you need extra details about ZYNYZ, speak along with your healthcare supplier. You possibly can ask your healthcare supplier for details about ZYNYZ that’s written for well being professionals.
It’s possible you’ll report negative effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may additionally report negative effects to Incyte Company at 1-855-463-3463.
Please see the complete Prescribing Info for ZYNYZ for added Essential Security Info.
About Incyte
A worldwide biopharmaceutical firm on a mission to Remedy On., Incyte follows the science to seek out options for sufferers with unmet medical wants. Via the invention, growth and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for sufferers and a robust pipeline of merchandise in Oncology and Irritation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.
For added data on Incyte, please go to Incyte.com or observe us on social media: LinkedIn, X, Instagram, Fb (NASDAQ:), YouTube.
Incyte Ahead-looking Statements
Apart from the historic data set forth herein, the issues set forth on this press launch, together with statements concerning the presentation of information from Incyte’s Section 3 POD1UM-304 trial of retifanlimab (Zynyz), the potential offered by retifanlimab, whether or not or when retifanlimab, alone or together, will likely be accepted or commercially out there to be used in people wherever on the earth exterior of the already accepted indications in particular areas, and Incyte’s aim of enhancing the lives of sufferers, include predictions, estimates, and different forward-looking statements.
These forward-looking statements are primarily based on our present expectations and are topic to dangers and uncertainties which will trigger precise outcomes to vary materially, together with unanticipated developments in and dangers associated to: unanticipated delays; additional analysis and growth and the outcomes of scientific trials presumably being unsuccessful or inadequate to satisfy relevant regulatory requirements or warrant continued growth; the power to enroll ample numbers of topics in scientific trials and the power to enroll topics in accordance with deliberate schedules; determinations made by the FDA and regulatory businesses exterior of the US; the efficacy or security of our merchandise; the acceptance of our merchandise within the market; market competitors; sudden variations within the demand for our merchandise and the merchandise of our collaboration companions; the consequences of introduced or sudden value regulation or limitations on reimbursement or protection for our merchandise; gross sales, advertising and marketing, manufacturing, and distribution necessities, together with our capability to efficiently commercialize and construct industrial infrastructure for newly accepted merchandise and any further new merchandise that develop into accepted; and different dangers detailed sometimes in our studies filed with the U.S. Securities and Change Fee, together with our annual report on Type 10-Ok and our quarterly report on Type 10-Q for the quarter ended September 30, 2024. We disclaim any intent or obligation to replace these forward-looking statements.
1 Duma N, et al. Mayo Clin Proc. 2019;94:1623-1640.
2 Yang SR, et al. Entrance Oncol. 2022;12.
3 Alexander M, et al. Lung. 2020;198:897-907.
View supply model on businesswire.com: https://www.businesswire.com/information/dwelling/20241207511994/en/
Incyte Contacts:
Media
media@incyte.com
Traders
ir@incyte.com
Supply: Incyte
