Innovent Biologics Announces U.S. FDA IND Approval for the First Global MRCT Phase 3 Study (MarsLight-11) of IBI363 (PD-1/IL-2α-bias) in Squamous Non-Small Cell Lung Cancer
Innovent Biologics (OTC:IVBIY) has received FDA clearance for a global Phase 3 clinical trial (MarsLight-11) of IBI363, their novel PD-1/IL-2α-bias bispecific antibody, in IO-resistant squamous non-small cell lung cancer (NSCLC).
The trial will enroll approximately 600 patients globally across multiple regions including the U.S., China, Canada, EU, UK, and Japan. The study will compare IBI363 3 mg/kg monotherapy against docetaxel in patients with advanced squamous NSCLC who progressed after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.
IBI363 has received Fast Track Designation from FDA and Breakthrough Therapy Designation from China's NMPA. Phase 1b/2 results presented at ASCO 2025 showed promising clinical activity in IO-resistant lung cancer, cold tumors, and microsatellite stable colorectal cancer.
Innovent Biologics (OTC:IVBIY) ha ottenuto l'autorizzazione della FDA per uno studio clinico globale di Fase 3 (MarsLight-11) su IBI363, il loro nuovo anticorpo bispecifico PD-1/IL-2α-bias, per il trattamento del carcinoma polmonare non a piccole cellule (NSCLC) squamoso resistente all’immunoterapia (IO).
Lo studio arruolerà circa 600 pazienti a livello globale in diverse aree, compresi Stati Uniti, Cina, Canada, UE, Regno Unito e Giappone. La sperimentazione confronterà IBI363 in monoterapia a 3 mg/kg con docetaxel in pazienti con NSCLC squamoso avanzato che hanno progredito dopo chemioterapia a base di platino e terapia anti-PD-1/PD-L1.
IBI363 ha ricevuto la Fast Track Designation dalla FDA e la Breakthrough Therapy Designation dalla NMPA cinese. I risultati di fase 1b/2, presentati all'ASCO 2025, hanno mostrato un’attività clinica promettente nei tumori polmonari resistenti all’IO, nei tumori “freddi” e nel carcinoma colorettale microsatellite stabile.
Innovent Biologics (OTC:IVBIY) ha obtenido la autorización de la FDA para un ensayo clínico global de Fase 3 (MarsLight-11) de IBI363, su nuevo anticuerpo bispecífico con sesgo PD-1/IL-2α, en cáncer de pulmón no microcítico (CPCNP) de tipo escamoso resistente a inmunoterapia (IO).
El ensayo inscribirá aproximadamente 600 pacientes a nivel global en varias regiones, incluidas EE. UU., China, Canadá, UE, Reino Unido y Japón. El estudio comparará IBI363 en monoterapia a 3 mg/kg frente a docetaxel en pacientes con CPCNP escamoso avanzado que progresaron tras quimioterapia basada en platino y terapia anti-PD-1/PD-L1.
IBI363 ha recibido la Fast Track Designation de la FDA y la Breakthrough Therapy Designation de la NMPA china. Los resultados de fase 1b/2 presentados en ASCO 2025 mostraron actividad clínica prometedora en cánceres pulmonares resistentes a IO, tumores “fríos” y cáncer colorrectal con estabilidad de microsatélites.
Innovent Biologics (OTC:IVBIY)는 IO(면역관문억제제) 저항성 편평(non-small cell) 폐암(NSCLC) 치료를 위한 새로운 PD-1/IL-2α 편향 비스페시픽 항체 IBI363의 글로벌 3상 임상시험(MarsLight-11)에 대해 FDA 허가를 받았습니다.
해당 임상시험은 미국, 중국, 캐나다, EU, 영국, 일본 등 여러 지역에서 전 세계 약 600명 규모로 진행될 예정입니다. 연구는 3 mg/kg 단독요법인 IBI363을 백금 기반 화학요법 및 항-PD-1/PD-L1 면역치료 후 진행한 진행성 편평 NSCLC 환자에서 도세탁셀과 비교합니다.
IBI363은 FDA로부터 Fast Track 지정을, 중국 NMPA로부터는 Breakthrough Therapy 지정을 받았습니다. ASCO 2025에서 발표된 1b/2상 결과는 IO 저항성 폐암, 콜드 종양 및 마이크로새틀라이트 안정형 대장암에서 유망한 임상 효능을 보였습니다.
Innovent Biologics (OTC:IVBIY) a obtenu l'autorisation de la FDA pour un essai clinique mondial de phase 3 (MarsLight-11) portant sur IBI363, leur nouvel anticorps bispécifique PD-1/IL-2α-bias, dans le cancer du poumon non à petites cellules (NSCLC) de type épidermoïde résistant à l'immunothérapie (IO).
L'essai recrutera environ 600 patients dans le monde dans plusieurs régions, notamment les États-Unis, la Chine, le Canada, l'UE, le Royaume-Uni et le Japon. L'étude comparera IBI363 en monothérapie à 3 mg/kg au docétaxel chez des patients atteints de NSCLC épidermoïde avancé ayant progressé après une chimiothérapie à base de platine et une immunothérapie anti-PD-1/PD-L1.
IBI363 a reçu la Fast Track Designation de la FDA et la Breakthrough Therapy Designation de la NMPA chinoise. Les résultats des phases 1b/2 présentés à l'ASCO 2025 ont montré une activité clinique prometteuse dans les cancers du poumon résistants à l'IO, les tumeurs « froides » et le cancer colorectal microsatellite-stable.
Innovent Biologics (OTC:IVBIY) hat die FDA-Zulassung für eine globale Phase-3-Studie (MarsLight-11) zu IBI363, ihrem neuen PD-1/IL-2α-bias bispezifischen Antikörper, bei immuntherapie-resistentem plattenepithelialem nicht-kleinzelligem Lungenkarzinom (NSCLC) erhalten.
Die Studie wird weltweit etwa 600 Patienten einschließen und in mehreren Regionen durchgeführt, darunter USA, China, Kanada, EU, Großbritannien und Japan. Untersucht wird IBI363 als Monotherapie (3 mg/kg) im Vergleich zu Docetaxel bei Patienten mit fortgeschrittenem plattenepithelialem NSCLC, die nach platinhaltiger Chemotherapie und Anti-PD-1/PD-L1-Immuntherapie progredient sind.
IBI363 erhielt die Fast Track Designation der FDA sowie die Breakthrough Therapy Designation der chinesischen NMPA. Die auf der ASCO 2025 vorgestellten Phase-1b/2-Daten zeigten vielversprechende klinische Aktivität bei IO-resistenten Lungenkrebsen, sogenannten kalten Tumoren und bei mikrosatellitenstabilem kolorektalem Krebs.
- FDA and NMPA granted Breakthrough/Fast Track designations indicating promising therapeutic potential
- Phase 1b/2 results showed meaningful and durable clinical activity in difficult-to-treat cancers
- Global Phase 3 trial expansion across major markets (US, China, EU, UK, Japan)
- Comprehensive development strategy including multiple Phase 1b/2 trials for various cancer types
- Trial results and market approval still pending with no guarantee of success
- Will face competition from established treatments like Keytruda in the oncology space
IBI363 as a Next-generation IO therapy Set for First Global Phase 3 Lung Cancer Trial
This IND clearance follows recent positive feedback from the
The multi-regional, randomized, controlled Phase 3 trial will enroll approximately 600 patients globally including
IBI363's Breakthrough Data Validates its Dual-immune Activation Mechanism, Stepwise Development in Multiple Tumor Types
At ASCO 2025, Phase 1b/2 results demonstrated meaningful and durable clinical activity in areas of high unmet need, including IO-resistant lung cancer, traditionally "cold tumors" such as acral and mucosal melanoma, and microsatellite stable (MSS) colorectal cancer.
These promising data position IBI363 as a potential first-in-class dual-immune activation therapy with broad applicability across difficult-to-treat cancers. Innovent is rapidly progressing IBI363 into registrational studies, with a pivotal program in melanoma already ongoing, a global Phase 3 trial in squamous NSCLC expected to start shortly, and a registration strategy in colorectal cancer in planning.
In parallel, multiple Phase 1b/2 trials are evaluating IBI363 both as monotherapy and in combinations in first-line NSCLC, first-line CRC, and additional tumor types, including platinum-resistant ovarian cancer (PROC), EGFR+ NSCLC, and neoadjuvant therapy for non-squamous NSCLC. This comprehensive development strategy is designed to maximize the value of IBI363 and expand its potential to address multiple large global oncology markets and improve patient outcomes.
Roy S. Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology and Hematology for Yale Cancer Center and Smilow Cancer Hospital, Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology at Yale School of Medicine, shared, "Lung cancer remains the most prevalent malignant tumor worldwide, with particularly high incidence and mortality rates globally. Non-small cell lung cancer constitutes the majority of these cases. Although immunotherapy has significantly improved survival outcomes for some patients, those who do not respond to such treatments and lack driver gene mutations have limited therapeutic options, underscoring the urgent need for enhanced clinical interventions.
Clinical research of the PD-1/IL-2α-biased bispecific molecule IBI363 has revealed encouraging findings. Preliminary trials have demonstrated that IBI363 not only induces tumor remission in a subset of patients but also achieves disease stability in the majority of patients, indicating durable anti-tumor activity. In comparison to traditional chemotherapy, IBI363 appears to offer potential advantages in both objective response rate (ORR) and progression-free survival (PFS), providing new hope for patients diagnosed with lung cancer."
Professor Shun Lu from the Oncology Department of Shanghai Chest Hospital, stated: "As a first-in-class PD-1/IL-2α-biased bispecific antibody fusion protein, IBI363 acts by simultaneously blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is engineered to retain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This dual mechanism targets and activates tumor-specific T cells co-expressing PD-1 and IL-2α, enabling more precise and effective stimulation of this T-cell subpopulation. IBI363 has demonstrated robust antitumor activity across multiple tumor models and has shown remarkable efficacy in IO-resistant, PD-L1 low expression, and cold tumor settings.
The promising data associated with IBI363 offers a novel treatment avenue for patients with non-small cell lung cancer who have not responded to immunotherapy. As research progresses, this innovative therapy holds the potential to bridge clinical gaps and provide the possibility of long-term survival for a greater number of patients."
Dr. Hui Zhou, Chief R&D Officer for Oncology Pipeline at Innovent Biologics, said, "Today's IND clearance marks a significant milestone as we initiate the first global Phase 3 trial of our next-generation IO therapy, IBI363 (PD-1/IL-2α-bias). If successful, this trial could bring a potentially transformative treatment to patients with squamous NSCLC worldwide, who currently have limited options after checkpoint inhibitor therapy. Concurrently, we are exploring IBI363 in a broad global clinical program and look forward to more data and continued development in the future.
This achievement also signifies a milestone for Innovent's global innovation strategy, rooted in our mission to 'empower patients worldwide with affordable, high-quality biopharmaceuticals' and our vision to 'build a global premier biopharmaceutical leader.' Having developed a highly competitive pipeline aligned with our globalization strategy, we have prioritized the global R&D of our assets, alongside expanding our international team and footprint to accelerate the development and access of innovative therapies worldwide.
In addition to IBI363, Innovent is advancing a broader pipeline for global development, including next-generation ADC programs such as bispecific and dual-payload ADCs. We believe our robust pipeline and ongoing R&D efforts will continue to expand our impact in oncology on a global scale."
About Innovent Biologics
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statement: |
（1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). |
（2）Ramucirumab (Cyramza)，Selpercatinib (Retsevmo) and Jaypirca (pirtobrutinib) were developed by Eli Lilly and Company. |
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