Seven Oral Presentations: Innovent to Present Breakthrough Clinical Data of IBI363（PD-1/IL-2α-bias）and Other Novel Drug Candidates at the 2025 ASCO Annual Meeting
Innovent Biologics will present breakthrough clinical data at the 2025 ASCO Annual Meeting from May 30 to June 3 in Chicago. The company will showcase seven oral presentations, highlighting significant developments in their oncology pipeline.
Key presentations include data for IBI363 (PD-1/IL-2α-bias) in three indications: melanoma, colorectal cancer, and non-small cell lung cancer. Additionally, IBI343 (CLDN18.2 ADC) Phase 1b data in pancreatic cancer will receive an oral presentation, building on its previous success at ESMO Asia.
The presentations will also feature results from various clinical trials, including the ORIENT-21 Phase 3 study of sintilimab plus ICE in Hodgkin lymphoma, the SPRING-01 trial in rectal cancer, and the EP-STAR trial in nasopharyngeal carcinoma. Multiple poster presentations will showcase additional data from the company's diverse oncology portfolio.
Innovent Biologics presenterà dati clinici rivoluzionari al 2025 ASCO Annual Meeting, che si terrà dal 30 maggio al 3 giugno a Chicago. L'azienda proporrà sette presentazioni orali, mettendo in luce importanti sviluppi nel suo pipeline oncologico.
Tra le presentazioni principali figurano i dati relativi a IBI363 (PD-1/IL-2α-bias) in tre indicazioni: melanoma, tumore del colon-retto e carcinoma polmonare non a piccole cellule. Inoltre, i dati di Fase 1b di IBI343 (CLDN18.2 ADC) nel tumore pancreatico saranno presentati oralmente, consolidando il successo ottenuto in precedenza a ESMO Asia.
Le presentazioni includeranno anche risultati provenienti da diversi studi clinici, tra cui lo studio di Fase 3 ORIENT-21 su sintilimab più ICE nel linfoma di Hodgkin, la sperimentazione SPRING-01 nel carcinoma rettale e la sperimentazione EP-STAR nel carcinoma nasofaringeo. Numerose presentazioni poster mostreranno ulteriori dati dal variegato portafoglio oncologico dell’azienda.
Innovent Biologics presentará datos clínicos innovadores en el 2025 ASCO Annual Meeting, que se celebrará del 30 de mayo al 3 de junio en Chicago. La compañía ofrecerá siete presentaciones orales, destacando avances significativos en su cartera oncológica.
Las presentaciones clave incluyen datos de IBI363 (PD-1/IL-2α-bias) en tres indicaciones: melanoma, cáncer colorrectal y cáncer de pulmón no microcítico. Además, los datos de fase 1b de IBI343 (CLDN18.2 ADC) en cáncer de páncreas serán presentados oralmente, reforzando su éxito previo en ESMO Asia.
Las presentaciones también mostrarán resultados de varios ensayos clínicos, incluyendo el estudio de fase 3 ORIENT-21 de sintilimab más ICE en linfoma de Hodgkin, el ensayo SPRING-01 en cáncer rectal y el ensayo EP-STAR en carcinoma nasofaríngeo. Varias presentaciones en formato póster exhibirán datos adicionales del diverso portafolio oncológico de la empresa.
Innovent Biologics가 5월 30일부터 6월 3일까지 시카고에서 열리는 2025 ASCO 연례회의에서 획기적인 임상 데이터를 발표합니다. 회사는 7건의 구두 발표를 통해 종양학 파이프라인의 중요한 발전 사항을 소개할 예정입니다.
주요 발표 내용에는 세 가지 적응증인 흑색종, 대장암, 비소세포폐암에 대한 IBI363(PD-1/IL-2α-bias) 데이터가 포함됩니다. 또한 IBI343(CLDN18.2 ADC)의 췌장암 1b상 데이터도 구두 발표로 선보이며, 이는 이전 ESMO Asia에서의 성공을 기반으로 합니다.
발표에는 호지킨 림프종에서 sintilimab과 ICE 병용의 ORIENT-21 3상 연구, 직장암 SPRING-01 임상시험, 비인두암 EP-STAR 임상시험 결과도 포함됩니다. 다수의 포스터 발표를 통해 회사의 다양한 종양학 포트폴리오에 대한 추가 데이터도 공개될 예정입니다.
Innovent Biologics présentera des données cliniques révolutionnaires lors du ASCO Annual Meeting 2025, qui se tiendra du 30 mai au 3 juin à Chicago. La société proposera sept présentations orales, mettant en avant des avancées majeures dans leur pipeline oncologique.
Les présentations clés incluent des données sur IBI363 (PD-1/IL-2α-bias) dans trois indications : mélanome, cancer colorectal et cancer du poumon non à petites cellules. De plus, les données de phase 1b de IBI343 (CLDN18.2 ADC) dans le cancer du pancréas feront l’objet d’une présentation orale, s’appuyant sur le succès précédent à ESMO Asia.
Les présentations comprendront également les résultats de plusieurs essais cliniques, notamment l’étude de phase 3 ORIENT-21 du sintilimab associé à ICE dans le lymphome de Hodgkin, l’essai SPRING-01 dans le cancer du rectum, et l’essai EP-STAR dans le carcinome nasopharyngé. De nombreuses présentations sous forme de posters mettront en lumière des données supplémentaires du portefeuille oncologique diversifié de l’entreprise.
Innovent Biologics wird bahnbrechende klinische Daten auf dem 2025 ASCO Annual Meeting vom 30. Mai bis 3. Juni in Chicago präsentieren. Das Unternehmen wird sieben mündliche Präsentationen vorstellen, die bedeutende Fortschritte in ihrer Onkologie-Pipeline hervorheben.
Zu den wichtigsten Präsentationen gehören Daten zu IBI363 (PD-1/IL-2α-bias) in drei Indikationen: Melanom, kolorektales Karzinom und nicht-kleinzelliges Lungenkarzinom. Zudem werden Phase-1b-Daten von IBI343 (CLDN18.2 ADC) beim Bauchspeicheldrüsenkrebs in einer mündlichen Präsentation vorgestellt, die auf dem bisherigen Erfolg bei ESMO Asia aufbauen.
Die Präsentationen umfassen außerdem Ergebnisse verschiedener klinischer Studien, darunter die Phase-3-Studie ORIENT-21 zu Sintilimab plus ICE bei Hodgkin-Lymphom, die SPRING-01-Studie bei Rektumkarzinom und die EP-STAR-Studie bei Nasopharynxkarzinom. Zahlreiche Posterpräsentationen zeigen zusätzliche Daten aus dem vielfältigen onkologischen Portfolio des Unternehmens.
- Multiple breakthrough clinical data presentations at major oncology conference
- Three indications for IBI363 accepted for oral presentations
- Successful Phase 1b data for IBI343 in pancreatic cancer
- Strong presence in both IO and ADC platforms
- None.
Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are delighted to announce that at 2025 ASCO Annual Meeting, the first wave of three indications under development for IBI363—melanoma, colorectal cancer(CRC), and non-small cell lung cancer (NSCLC)—have all been accepted for oral presentations, highlighting the significant attention garnered by the next-generation bispecific antibodies, in particular PD-1-based immunotherapy. Additionally, following its oral presentation at ESMO Asia last December, the Phase 1b data of IBI343 in pancreatic cancer has once again secured an oral presentation at ASCO, further solidifying its potential in this challenging therapeutic area. The maturing PoC data for these innovative candidates has strengthened our confidence in advancing them into pivotal-stage development, with the goal of unlocking their clinical value for global unmet clinical needs. As one of the few biopharmaceutical companies with both the advanced technology platforms and robust pipeline in "IO+ADC" areas, Innovent will continue to make breakthroughs in the field of cancer treatment, and is committed to providing physicians and patients with more innovative, effective and safe treatment options."
Details on the abstracts are listed below:
Oral Presentation
1. Presentation Title: Efficacy and safety results of a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, in patients with immunotherapy-treated, advanced acral and mucosal melanoma
Abstract Number: 2502
Session Type: Oral Abstract
Session Title: Developmental Therapeutics-Immunotherapy
Session Date & Time: 5/31/2025 3:00 PM-6:00 PM CDT
Presenter: Jun Guo, MD, Beijing Cancer Hospital
2. Presentation Title: Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectal cancer
Abstract Number: 104
Session Type: Oral Abstract
Session Title: Clinical Science Symposium—Turning "Cold" Tumors "Hot"
Session Date & Time: 6/1/2025 9:45 AM-11:15 AM CDT
Presenter: Zhenyu Lin, MD, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
3. Presentation Title: First-in-class PD-1/IL-2α-bias bispecific antibody, IBI363, in patients with advanced immunotherapy-treated non-small cell lung cancer (NSCLC)
Abstract Number: 8509
Session Type: Oral Abstract
Session Title: Clinical Science Symposium—Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies
Session Date & Time: 6/3/2025 9:45 AM-11:15 AM CDT
Presenter: Jianya Zhou, MD, The First Affiliated Hospital, Zhejiang University School of Medicine
4. Presentation Title: Claudin18.2 (CLDN18.2) expression and efficacy in pancreatic ductal adenocarcinoma (PDAC): results from a Phase 1 dose expansion cohort evaluating IBI343
Abstract Number: 4017
Session Type: Rapid Oral Abstract
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: 6/2/2025 11:30 AM-1:00 PM CDT
Presenter: Xianjun Yu, MD, Fudan University Shanghai Cancer Center
5. Presentation Title: Sintilimab (anti-PD-1) plus ifosfamide, carboplatin and etoposide (ICE) in second-line classical Hodgkin lymphoma (cHL): Results of a multicenter, randomized, controlled, double-blind Phase 3 study (
Abstract Number: 7007
Session Type: Oral Abstract
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Session Date & Time: 5/30/2025 2:45 PM-5:45 PM CDT
Presenter: Peng Liu,MD, Cancer Hospital, Chinese Academy of Medical Sciences
6. Presentation Title: Short-course radiotherapy followed by sintilimab and CAPOX as total neoadjuvant treatment in locally advanced rectal cancer: A prospective, randomized controlled trial (SPRING-01)
Abstract Number: 3519
Session Type: Rapid Oral Abstract
Session Title: Gastrointestinal Cancer-Colorectal and Anal
Session Date & Time: 6/1/2025 11:30 AM-1:00 PM CDT
Presenter：Changqing Jing, MD, Shandong Provincial Hospital
7. Presentation Title: Dynamic circulating tumor DNA-driven, risk-adapted systematic therapy in nasopharyngeal carcinoma: The EP-STAR trial
Abstract Number: 6010
Session Type: Oral Abstract
Session Title: Clinical Science Symposium -Biomarker-Driven Adaptive Therapy: New Horizons in Head and Neck Cancer
Session Date & Time: 6/2/2025 3:00 PM-4:30 PM CDT
Presenter: Ying Sun, MD, Sun Yat-sen University Cancer Center
Poster Presentation
1. Presentation Title: A multicenter, randomized, controlled, open-label, Phase 2 study of the PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in mucosal and acral melanoma: Trial in Progress
Abstract Number: TPS9594
Session Type: Poster
Session Title: Melanoma/Skin Cancers
Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT
Presenter: Bin Lian, MD, Peking University Cancer Hospital & Institute
2. Presentation Title: IBI354, an anti-HER2 antibody-drug conjugate, in patients with locally advanced unresectable or metastatic ovarian cancers: updated results from a Phase 1 trial
Abstract Number: 5565
Session Type: Poster
Session Title: Gynecologic Cancer
Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT
Presenter: Jin Shu, MD, Chongqing University Cancer Hospital
3. Presentation Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients with HER2-positive breast cancer (BC) and other solid tumors: Updates from a Phase 1 study
Abstract Number: 1029
Session Type: Poster
Session Title: Breast Cancer—Metastatic
Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT
Presenter: Charlotte Rose Lemech, BSc, FRACP, MBBS , Scientia Clinical Research
4. Presentation Title: Safety and efficacy of the anti-TROP2 antibody-drug conjugate (ADC) IBI130 in patients with advanced triple-negative breast cancer (TNBC) and other solid tumors: Results from the Phase 1 study
Abstract Number: 1102
Session Type: Poster
Session Title: Breast Cancer—Metastatic
Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT
Presenter: Fan Wu, MD, Fujian Cancer Hospital
5. Presentation Title: A multiregional, randomized, controlled, open-label, Phase 3 study of the anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) arcotatug tavatecan (IBI343) in gastric or gastroesophageal junction adenocarcinoma (G/GEJA): Trial in Progress
Abstract Number: TPS4201
Session Type: Poster
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT
Presenter: Lin Shen, MD, Beijing Cancer Hospital
6. Presentation Title: Phase 2 trial of transarterial chemoembolization followed by sintilimab (anti-PD-1), oxaliplatin, and S-1 combined with either trastuzumab (HER-2 positive) or apatinib (HER-2 negative) as first-line therapy for gastric cancer with liver metastases.
Abstract Number: 4050
Session Type: Poster
Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT
Presenter: Dan Sha, MD, Shandong Provincial Hospital
*Abstracts of TYVYT ®(sintilimab) are from investigator-initiated clinical trials (IIT), except one abstract, #7007.
About Innovent
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 15 products in the market. It has 3 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, Adimab, 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) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company.
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