Neoadjuvant IBI110 and Sintilimab in Combination with Chemotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)- a Phase Ib Clinical Trial

This study aims to investigate the efficacy and safety of combining sintilimab and the TP regimen with/without IBI110 for neoadjuvant chemotherapy in resectable locally advanced head and neck squamous cell carcinoma (HNSCC).

Start Date26 Jun 2024

Sponsor / Collaborator

Fudan University

NCT06078657

/ Not yet recruitingPhase 2IIT

Prospective, Single-arm Phase II Exploratory Study of the Efficacy and Safety of IBI110 Combined With Sintilimab in Advanced or Metastatic Esophageal Squamous Cell Carcinoma That Has Failed First-line Anti-PD-1 Antibody Therapy

This is a single-center, prospective, single-arm Phase II clinical study to evaluate the efficacy and safety of IBI110 in combination with Sintilimab in subjects with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have failed first-line treatment with PD-1 inhibitors combined with chemotherapy.
Patients who meet the inclusion criteria will be treated with IBI110 combined with Sintilimab until disease progression, death, toxicity intolerance, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of therapy for other reasons specified in the protocol. RECIST v1.1 was used for clinical tumor imaging evaluation every 6 weeks during treatment.

Start Date01 Oct 2023

Sponsor / Collaborator

The First Affiliated Hospital of Zhengzhou University

NCT05572463

/ WithdrawnPhase 1/2

A Randomized, Open-label, Multicenter, Multi-arm, Phase 1b/2 Platform Study to Evaluate Safety and Efficacy of Investigational Immunotherapies in Participants With Previously Treated Unresectable or Metastatic Melanoma

This is a platform study evaluating the safety and efficacy of multiple novel investigational products (IPs) that target unresectable or metastatic cutaneous melanoma in participants who have failed standard treatment.

Start Date01 Nov 2022

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

[+1]

100 Clinical Results associated with Negalstobart

100 Translational Medicine associated with Negalstobart

100 Patents (Medical) associated with Negalstobart

Literatures (Medical) associated with Negalstobart

CANCER IMMUNOLOGY IMMUNOTHERAPY

Efficacy and safety of anti-LAG-3 IBI110 in combination with sintilimab and chemotherapy for advanced squamous non-small cell lung cancer: a randomized phase II study

Article

Author: Yang, Jun ; Wang, Qianyi ; Sheng, Zengmei ; Mao, Chenyu ; Wang, Wenxiang ; Cui, Jiuwei ; Zuo, Wei ; Fang, Jian ; Zhang, Zhiye ; Zhuang, Wu ; Yang, Kunyu ; Liu, Zhe ; Long, Sixiang ; Yi, Tienan ; Zhou, Caicun ; Xiong, Anwen ; Xu, Nong ; Wang, Donglin ; Ye, Lika ; Du, Xiaobo

OBJECTIVE:

To evaluate the efficacy and safety of the anti-lymphocyte activation gene-3 (LAG-3) antibody IBI110 in combination with sintilimab and chemotherapy in patients with advanced squamous non-small cell lung cancer (sqNSCLC).

METHODS:

In this multicenter, randomized, open-label, phase II study, 153 patients with previously untreated advanced sqNSCLC were randomly assigned at a 1:1:1 ratio to one of three groups: IBI110 200 mg plus sintilimab (200 mg) and chemotherapy (n = 51), IBI110 600 mg plus sintilimab and chemotherapy (n = 51), or sintilimab plus chemotherapy (standard-of-care, SOC, n = 51). The primary endpoints included the objective response rate (ORR), progression-free survival (PFS) and safety. LAG-3 expression in tumor tissue was detected by immunohistochemistry (IHC) to explore its correlation with treatment efficacy.

RESULTS:

While no statistically significant differences in ORR, PFS, or overall survival (OS) were observed across the three arms in the overall population, promising efficacy signals emerged in the LAG-3 expression ≥ 2% subgroup. In this subset, compared with the SOC regimen, the IBI110 200 mg regimen significantly improved the duration of response (DOR: 13.73 vs. 6.51 months, P = 0.037) and PFS (P = 0.0485). The safety results indicated that the IBI110 200 mg combination was manageable, with a higher incidence of grade ≥ 3 treatment-related adverse events (56.86% vs. 29.41%) primarily consisting of controllable hematological toxicities.

CONCLUSION:

The high-LAG-3 subgroup demonstrated enhanced efficacy following the addition of IBI110 to sintilimab and chemotherapy, despite the absence of improvement in the overall population with advanced sqNSCLC, supporting further investigations in biomarker-defined patients.

TRIAL REGISTRATION:

The current study has been registered with ClinicalTrial.gov (Identifier: NCT04085185).

Journal of Hematology & Oncology

Dual inhibition of LAG-3 and PD-1 with IBI110 and sintilimab in advanced solid tumors: the first-in-human phase Ia/Ib study

Article

Author: Chen, Yuling ; Wu, Zhihai ; Ni, Haiqing ; Xu, Nong ; Wang, Wenxiang ; Mao, Chenyu ; Zhao, Li ; Liu, Ying ; Zhou, Caicun ; Qian, Jiong ; Zhang, Tao ; Xiong, Anwen ; Lu, Jia ; Long, Sixiang

BACKGROUND:

Co-inhibition of immune checkpoints lymphocyte-activation gene 3 (LAG-3) and PD-1 is believed to enhance cancer immunotherapy through synergistic effects. Herein, we evaluate the safety and efficacy of IBI110 (anti-LAG-3 antibody) with sintilimab (an anti-PD-1 antibody) in Chinese patients with advanced solid tumors.

METHODS:

In this open-label phase I study, phase Ia dose escalation of IBI110 monotherapy and phase Ib combination dose escalation of IBI110 plus sintilimab were conducted in patients with advanced solid tumors. Additionally, phase Ib combination dose expansion of IBI110 plus sintilimab and chemotherapy was conducted in previously untreated, advanced squamous non-small cell lung cancer (sqNSCLC) and HER-2 negative gastric cancer (GC). In phase Ia dose escalation, patients received IBI110 monotherapy at 0.01/0.1/0.3/1/3/10/20 mg/kg Q3W. In phase Ib dose escalation, patients received IBI110 at 0.3/0.7/1.5/3/5/8/10 mg/kg Q3W plus sintilimab 200 mg Q3W. In phase Ib combination dose expansion, patients received IBI110 at recommended phase 2 dose (RP2D) plus sintilimab 200 mg Q3W and chemotherapy. The primary endpoints were safety, tolerability and efficacy including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS) assessed by RECIST v1.1 and overall survival (OS). The secondary endpoints included pharmacokinetics, pharmacodynamics and immunogenicity.

RESULTS:

In phase Ia dose escalation (n = 28), treatment-related adverse events (TRAEs) occurred in 67.9% patients and grade ≥ 3 TRAEs occurred in 21.4% patients. In phase Ib combination dose escalation (n = 45), TRAEs occurred in 75.6% patients and grade ≥ 3 TRAEs occurred in 22.2% patients. No dose-limiting toxicity (DLT) was observed. The most common TRAE was anemia (17.9%, including 3.6% ≥ G3) in phase Ia dose escalation of IBI110 monotherapy (n = 28), aspartate aminotransferase increased (28.9%, all G1-G2) in phase Ib dose escalation of IBI110 plus sintilimab (n = 45), anemia (70.0%, all G1-G2) in phase Ib dose expansion in sqNSCLC (n = 20), and neutrophil count decreased (64.7%, including 17.6%≥ G3) in phase Ib dose expansion in GC (n = 17). The RP2D of IBI110 was determined at 200 mg (3 mg/kg) Q3W. ORR in phase Ia/Ib dose escalation was 3.6% with IBI110 monotherapy and 14% with IBI110 plus sintilimab. In phase Ib combination dose expansion of IBI110 plus sintilimab and chemotherapy, unconfirmed and confirmed ORR in sqNSCLC (n = 20) was 80.0% (95% CI, 56.3-94.3) and 75.0% (95% CI, 50.9-91.3), respectively and in GC (n = 17) was 88.2% (95% CI, 63.6-98.5) and 70.6% (95% CI, 44.0-89.7), respectively.

CONCLUSIONS:

IBI110 monotherapy and in combination with sintilimab were well-tolerated in Chinese patients with advanced solid tumors. Encouraging efficacy of IBI110 in combination with sintilimab and chemotherapies was observed in sqNSCLC and GC.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT04085185.

News (Medical) associated with Negalstobart

23 Aug 2023

·www.prnewswire.com

Innovent Announces 2023 Interim Results and Business Updates

Remarkable achievements with accelerated growth and improved efficiency to underpin sustainable growth ROCKVILLE, M.D. and SUZHOU, China, Aug. 23, 2023 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, announces its 2023 interim results and major company business updates. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "Today is our 12th anniversary since we incorporated Innovent in 2011. Since last year, we have clearly outlined two strategic goals for the second decade of our business operation, which are to achieve sustainable growth and global innovation. During the first half of 2023, we have made remarkable achievements that solidify our ability to establish a sustainable business foundation as Innovent is growing stronger and healthier. We achieved strong revenue performance and improved operational efficiency that underline our sustainable business model; we continued to develop a more diversified pipeline portfolio and enhanced R&D strategy that ensures sustainable growth; and we improved financial margins and maintained high resilience that help us manage risks and enjoy sustainability in the long run. These significant progresses reinforce our confidence and commitment to our strategic goals, through further expansion of commercial portfolio, improvement of operational efficiency, and innovation through advanced R&D platform for the global market. We will uphold the vision of 'to become a global premier biopharmaceutical company' and create sustainable value for patients, employees, shareholders and the society." Solidified business operations with strong revenue performance and improved financials S trong revenue growth: Total revenue RMB2 , 701 .5 million in the first half of 2023, an increase of 20.6% compared with the first half of 2022; product sales revenue RMB2,457.5 million in the first half of 2023, an increase of 20 .4% compared with the same period of prior year, with particularly stronger growth since Q2, mainly driven by fast ramp-up of product sales volume as we fully leveraged the clinical value of our novel medicines with broad NRDL coverage and a diversified oncology portfolio. Enhanced operational efficiency under a sustainable business model: We further improved the productivity and efficiency of our commercial operations. The agile organization benefits from a scientific and systematic resource allocation system that enables more mature and fast responses to the changing environment. The selling and marketing expenses was 54.5% of total product revenue in the first half of 2023, representing a decrease of 12.2% compared to 66.7% in the first half of 2022. Core financial margins improvements: Loss Before Interest, Taxes, Depreciation and Amortization ("LBITDA") decreased remarkably by 74.2% to RMB267.4 million from RMB1,035.7 million in the same period of 2022, brought by our strong revenue growth and core financials improvement attributable to the enhanced operational efficiency under a sustainable business model. Expansion of commercial portfolio into ten approved products, including: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, PEMAZYRE®, Olverembatinib, CYRAMZA®, Retsevmo®, FUCASO® (new product, for the treatment of RRMM) and SINTBILO® (new product, for the treatment of hypercholesterolemia and mixed dyslipidemia). NRDL coverage further expanded, benefiting broader patient groups: two additional indications (1L GC and 1L ESCC) of TYVYT® (sintilimab injection), olverembatinib for the first listing, and multiple additional indications of BYVASDA® (bevacizumab injection), HALPRYZA® (rituximab injection), and SULINNO® (adalimumab injection) were included in the updated NRDL. The updated NRDL has taken effect on March 1st, 2023. Broad coverage in commercial channels and networks with an experienced and professional sales and marketing team: expansive coverage of over 5,000 hospitals and a well-structured commercial team of nearly 3,000 talents. The Company is also strategically establishing commercial presence in certain non-oncology therapeutic areas in light of the first approved drug SINTBILO® in cardiovascular area and accelerated development for multiple high value late-stage candidates, aimed for a more diversified and long-term growth. Broad pipeline across therapeutic areas to deliver differentiated innovation and growth potential We have built a strong pipeline with over 30 innovative drug candidates, among which 10 products are approved, 8 assets are in NDA review or pivotal registrational clinical trials, and approximately 20 assets in early Phase 1/2 clinical studies. Oncology: leverage extensive portfolio and navigate novel modalities and therapies to strengthen our foundation Pioneered the development of three drug candidates for treatment of lung cancer: IBI344 (ROS1): Ongoing pivotal Phase 2 for ROS1 positive NSCLC IBI351 (KRASG12C): Ongoing pivotal Phase 2 for KRASG12C mutated NSCLC IBI126 (CEACAM5 ADC): Ongoing Phase 3 for CEACAM5 highly expressed NSCLC Received preliminary positive data for multiple innovative molecules with global potential ： Bispecific antibodies with global innovation: IBI363 (PD-1/IL-2) and IBI389 (CLDN18.2/CD3) with preliminary positive clinical signals observed, IBI334 (EGFR/B7H3) is planned to enter first-in-human study shortly Monoclonal antibodies in PoC exploration: IBI110 (LAG3) , IBI939(TIGIT), IBI310 (CTLA-4) Deeply invested in ADC proprietary platform as a new wave of global innovation: IBI343 (CLDN18.2 ADC) : Phase 1 multi-regional clinical trial ongoing in Australia and China. IBI343 has potential best-in-class profiles with differentiated design for potential wide therapeutic window and high potency. More than 10 differentiated ADC projects in IND-enabling stage. Cardiovascular and metabolism (CVM) : first product approved and prioritized clinical development of multiple best-in-class assets based on robust data readout SINTBILO® (tafolecimab injection): the first domestic self-developed anti-PCSK9 monoclonal antibody, approved for the treatment of hypercholesteremia and mixed dyslipidemia Mazdutide (GLP-1R/GCGR): potential best-in-class GLP-1 dual agonist. Phase 3 registrational studies of mazdutide 6mg in obesity and type 2 diabetes are ongoing. The Phase 2 clinical study of mazdutide higher-dose 9mg met the 24-week primary endpoint, showing bariatric surgery-equivalent 15.4% weight loss efficacy for moderate to severe obesity and a consistently favorable safety profile. IBI128 (XOI): potential best-in-class XOI for the treatment of hyperuricemia in gout patients, with overall superior efficacy and good safety profile. Autoimmune: select novel targets to treat unmet needs in various autoimmune diseases IBI112 (IL-23p19) : potential long-lasting efficacy advantage and convenient extended dosing intervals for psoriasis. The Phase 3 registrational clinical study is ongoing. IBI353 (PDE4): the multi-regional Phase 2b clinical study (led by UNION) of IBI353 in psoriasis reached positive topline results. IBI355 (CD40L) and IBI356 (OX40L): innovative autoimmune molecules will enter first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases. Ophthalmology: accelerate two Phase III trials for two important assets IBI302 (VEGF/C) : Phase 3 study ready to start in the second half of 2023 for the treatment of nAMD, based on the observed longer durability and potential effect in anti-macular atrophy in Phase 2 studies. IBI311 (IGF-1R): quickly advanced into Phase 3 registrational study, eyeing on urgent unmet need in the treatment of TED in China. IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) are in the Phase 1 stage. The potential differentiation versus existing therapy brought by their innovative mechanisms and molecule designs as bispecific antibodies will be explored. Global innovation continues as core long-term strategy Innovent Academy as the innovation powerhouse continues to advance science to deliver differentiated molecules in oncology and non-oncology areas: In the first half of 2023, Innovent Academy has successfully delivered four high quality novel molecules into IND enabling stage. Further investment in our ADC platform and antibody platform, as preliminary differentiated efficacy and safety signals are observed for the FIC and BIC molecules generated from the platforms. A significant portion of preclinical programs lies in key non-oncology areas, including CVM, ophthalmology and autoimmune diseases, as another important growth pillar of global innovation as oncology counterparts. P roduct development platform utilizes scientific and efficient approaches to scout opportunities for innovative pipeline in early-stage MRCT clinical development Exploring the early-to-mid stage pipeline with global potential in ongoing PoC studies, with several molecules in the oncology and ophthalmology fields. Further explore the early clinical development of novel molecules with global potential, such as PD-1/IL-2, CLDN18.2 ADC in Phase 1 multi-regional clinical trials with preliminary differentiated clinical data observed 140,000L GMP certified production capacity which is currently one of the largest stainless steel bioreactor production capacity in China, adhering to high-standard quality compliance to GMP and providing cost advantage further strengthen our market competitiveness. Compliance and governance continued strengthening in active support to social responsibilities In active support to the sustainable development goals (SDGs) of the United Nations, we continued to adhere to the people-oriented principle, operate with integrity, take high quality as the cornerstone, follow green ecological guidance, drive development with innovation, effectively protect the rights and interests of all stakeholders, and proactively fulfill our social responsibilities. We also paid more attention to governance upgrade compliance operation, operational efficiency improvement, high-quality innovation, diversification and empowerment of employees and low-carbon development, and strived to promote inclusive healthcare, enabling more patients to have equal access to affordable, high-quality and innovative medicines. Financial Highlights for the First Half of Year 2023 Total revenue was RMB2,701.5 million, an increase of 20.6% compared to the same period of prior year. LBITDA for the reporting period was RMB267.4 million, a notably decrease of 74.2% or RMB 768.3 million from RMB1,035.7 million for the same period of prior year. Loss for the reporting period was RMB190.4 million, a notably decrease of 82.5% or RMB 894.9 million from RMB 1,085.3 million for the same period of prior year. *The remarkably decrease was mainly due to our strong revenue growth and core financials improvement attributable to the enhanced operational efficiency under a sustainable business model. *The Loss for the reporting period was mainly due to continuous investment in R&D to support our long-term strategic goal of global innovation. R&D expenses was RMB826.3 million; cash and short-term financial assets was RMB8,526.5 million, or approximately USD1.2 billion, which enables us to focus on the long-term sustainable development. About Innovent "Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. Innovent has 10 products in the market. These include: TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules), FUCASO® (Equecabtagene Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). In addition, one assets are under NMPA NDA review, seven assets are in Phase III or pivotal clinical trials, and 17 more molecules are in clinical studies. Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. Disclaimer: Innovent does not recommend any off-label usage. Note: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, olverembatinib, FUCASO® and SINTBILO® are not approved products in the United States. TYVYT® (sintilimab injection, Innovent) BYVASDA® (bevacizumab injection, Innovent) HALPRYZA® (rituximab injection, Innovent) SULINNO® (adalimumab injection, Innovent) Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan. CYRAMZA® (ramucirumab injection, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Retsevmo® (selpercatinib capsules, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics

Phase 1Clinical ResultFinancial StatementPhase 3Phase 2

05 Jun 2023

·pipelinereview.com

Innovent Presents Phase 1b Clinical Data of IBI110 (Anti-LAG-3 Monoclonal Antibody) at the 2023 ASCO Annual Meeting

ROCKVILLE, MD, USA and SUZHOU, China I June 4, 2023 I Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, announced that Phase 1b clinical data of IBI110 (anti-LAG-3 monoclonal antibody) in the first-line treatment of gastric cancer and first-line treatment of hepatocellular carcinoma are presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (ClinicalTrials.gov, NCT04085185). Efficacy and safety of IBI110 in combination with sintilimab in first-line advanced HER2-negative gastric cancer or gastroesophageal junction cancer: results from a Phase 1b study Abstract #: 2576 In this Phase 1b study, the efficacy and safety of IBI110 in combination with sintilimab and chemotherapy as first-line therapy for advanced GC was evaluated. Professor Nong Xu, The First Affiliated Hospital, School of Medicine, Zhejiang University, stated: "Gastric cancer is the second most common malignancy in China [1] . Most patients with GC are already locally advanced or metastatic when they were first diagnosed, and the 5-year survival rate is relatively low for those patients [2] . In recent years, immunotherapy has shown certain efficacy in advanced gastric cancer, but there is still room for improvement in clinical practice. In 2022, FDA and EMA approved the dual blocking therapy of PD-1 and LAG-3 for advanced melanoma, but no studies have reported clinical benefits of the combined therapy in patients with gastric cancer. In this study, based on the current standard treatment of sintilimab and chemotherapy, combination with IBI110 showed robust antitumor activity in untreated gastric cancer patients, and clinical benefits were observed both in tumor shrinkage and PFS, with manageable safety profile, which gave us more confidence to carry out follow-up studies." Efficacy and safety of IBI110 (anti-LAG-3 mAb) in combination with sintilimab (anti-PD-1 mAb) in advanced hepatocellular carcinoma (HCC): results from a Phase 1b study Abstract #: 2577 IBI110 is an IgG4κ recombinant human anti-LAG-3 monoclonal antibody developed by Innovent Biologics. The Phase 1b study aims to evaluate the efficacy and safety of IBI110 in combination with sintilimab and lenvatinib as first-line therapy for advanced HCC. Professor Baocai Xing, Peking University Cancer Hospital & Institute, stated: "Immune-checkpoint inhibitors combined with anti-angiogenic agents has been approved as the first-line treatment for advanced HCC, but many patients develop disease progression within half a year of treatment, where exists an unmet clinical need [3] . In this study, IBI110 combined with sintilimab and lenvatinib showed robust antitumor activity in untreated advanced HCC patients, with a median PFS of 9.9 months, and no new safety signals were observed. This study is also the first clinical trial reporting preliminary efficacy and safety data of LAG-3 targeting therapy in first line treatment of patients with advanced HCC, suggesting the potential of further exploration in this indication." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2023 ASCO Meeting. IBI110 in combination with sintilimab demonstrated encouraging efficacy and safety data in the first-line treatment of GC and HCC. We will continue to provide updates on the clinical data for IBI110. As immunotherapy moves into the next era, we are actively advancing the development of next-generation immune checkpoint inhibitors, which we hope will benefit patients in need soon." About IBI110 IBI110 is an IgG4κ recombinant human anti-LAG-3 monoclonal antibody independently developed by Innovent Biologics. Based on the mechanism of action and preclinical data of IBI110, it is assumed that IBI110 can inhibit the immune checkpoint signaling to achieve anti-tumor effect, which may further improve the efficacy of immunotherapy, overcome the primary drug resistance, and overcome the drug resistance after anti-PD-1 /PD-L1 monoclonal antibody treatment [4] . Based on the urgent clinical needs, Innovent has carried out clinical studies to explore the efficacy and safety of IBI110 in various advanced tumors. About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT® (sintilimab injection), BYVASDA®(bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA®(rituximab biosimilar injection), Pemazyre®(pemigatinib oral inhibitor), olverembatinib (BCR ABL TKI), Cyramza® (ramucirumab) and Retsevmo®(selpercatinib). An additional 3 assets are under NMPA NDA review, 6 assets are in Phase 3 or pivotal clinical trials, and 18 more molecules are in clinical studies. Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com . and www.linkedin.com/company/innovent-biologics/ . Disclaimer: Innovent does not recommend any off-label usage. Note: TYVYT® (sintilimab injection) is not an approved product in the United States. BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States. TYVYT® (sintilimab injection, Innovent) BYVASDA® (bevacizumab biosimilar injection, Innovent) HALPRYZA® (rituximab biosimilar injection, Innovent) SULINNO® (adalimumab biosimilar injection, Innovent) Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan. CYRAMZA® (ramucirumab, Eli Lilly). CYRAMZA® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Retsevmo®(selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Reference [1] The Global Cancer Observatory - March, 2021. https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf [2] China Guideline for the screening, early detection and early treatment of gastric cancer (2022, Beijing), Chin J Oncol, July 2022, Vol.44, No.7 [3] Finn R S, Qin S, Ikeda M, et al. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020;382(20):1894-1905. [4] J Thorac Oncol. 2017 May;12(5):814-823. 2. jco.2022.40.16_suppl.e2114 SOURCE: Innovent Biologics

Phase 1ImmunotherapyClinical ResultASCODrug Approval

05 Jun 2023

·www.prnewswire.com

Innovent Presents Phase 1b Clinical Data of IBI110 (Anti-LAG-3 Monoclonal Antibody) at the 2023 ASCO Annual Meeting

ROCKVILLE, Md. and SUZHOU, China, June 4, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, announced that Phase 1b clinical data of IBI110 (anti-LAG-3 monoclonal antibody) in the first-line treatment of gastric cancer and first-line treatment of hepatocellular carcinoma are presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (ClinicalTrials.gov, NCT04085185). Efficacy and safety of IBI110 in combination with sintilimab in first-line advanced HER2-negative gastric cancer or gastroesophageal junction cancer: results from a Phase 1b study Abstract #: 2576 In this Phase 1b study, the efficacy and safety of IBI110 in combination with sintilimab and chemotherapy as first-line therapy for advanced GC was evaluated. 17 untreated advanced GC patients received 200 mg IBI110 combined with sintilimab and chemotherapy (XELOX). As of the data cutoff date (Mar 22, 2023), median follow-up time was 15.8 (95% CI, 13.4 -16.6) months, 15 patients achieved PR, the ORR was 88.2%; the median DoR was 10.6 (95% CI, 2.5-14.4) months; the median PFS was 12.9 (95% CI, 3.8-15.8) months; the median OS was not mature yet. As for safety, treatment related adverse events (TRAEs) ≥ grade 3 occurred in 11 patients, the most common TRAEs ≥ grade 3 were platelet count decreased (23.5%) and neutrophil count decreased (17.6%). 3 patients experienced irAE≥ grade 3. There were no treatment-related deaths. Professor Nong Xu, The First Affiliated Hospital, School of Medicine, Zhejiang University, stated: "Gastric cancer is the second most common malignancy in China[1]. Most patients with GC are already locally advanced or metastatic when they were first diagnosed, and the 5-year survival rate is relatively low for those patients[2]. In recent years, immunotherapy has shown certain efficacy in advanced gastric cancer, but there is still room for improvement in clinical practice. In 2022, FDA and EMA approved the dual blocking therapy of PD-1 and LAG-3 for advanced melanoma, but no studies have reported clinical benefits of the combined therapy in patients with gastric cancer. In this study, based on the current standard treatment of sintilimab and chemotherapy, combination with IBI110 showed robust antitumor activity in untreated gastric cancer patients, and clinical benefits were observed both in tumor shrinkage and PFS, with manageable safety profile, which gave us more confidence to carry out follow-up studies." Efficacy and safety of IBI110 (anti-LAG-3 mAb) in combination with sintilimab (anti-PD-1 mAb) in advanced hepatocellular carcinoma (HCC): results from a Phase 1b study Abstract #: 2577 IBI110 is an IgG4κ recombinant human anti-LAG-3 monoclonal antibody developed by Innovent Biologics. The Phase 1b study aims to evaluate the efficacy and safety of IBI110 in combination with sintilimab and lenvatinib as first-line therapy for advanced HCC. 28 treatment-naïve advanced HCC patients received IBI110 (200 mg, Q3W) combined with sintilimab and lenvatinib and 27 of them received at least 1 post-baseline tumor assessment. As of the data cutoff date (Mar 22, 2023), median follow-up time was 12.2 (95% CI, 11.0 -12.6) months, the objective response rate (ORR) and disease control rate (DCR) was 29.6% and 85.2%, respectively; the median progression free survival (PFS) was 9.9 (95% CI, 5.7-NC) months; the PFS data was still immature and follow-up will be continued; the median overall survival (OS) was not reached. In terms of safety, 16 patients experienced ≥ grade 3 TRAEs, the most common ≥ grade 3 TRAEs were hypertension (25%) and platelet count decreased (7.1%). Professor Baocai Xing, Peking University Cancer Hospital & Institute, stated: "Immune-checkpoint inhibitors combined with anti-angiogenic agents has been approved as the first-line treatment for advanced HCC, but many patients develop disease progression within half a year of treatment, where exists an unmet clinical need[3]. In this study, IBI110 combined with sintilimab and lenvatinib showed robust antitumor activity in untreated advanced HCC patients, with a median PFS of 9.9 months, and no new safety signals were observed. This study is also the first clinical trial reporting preliminary efficacy and safety data of LAG-3 targeting therapy in first line treatment of patients with advanced HCC, suggesting the potential of further exploration in this indication." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2023 ASCO Meeting. IBI110 in combination with sintilimab demonstrated encouraging efficacy and safety data in the first-line treatment of GC and HCC. We will continue to provide updates on the clinical data for IBI110. As immunotherapy moves into the next era, we are actively advancing the development of next-generation immune checkpoint inhibitors, which we hope will benefit patients in need soon." About IBI110 IBI110 is an IgG4κ recombinant human anti-LAG-3 monoclonal antibody independently developed by Innovent Biologics. Based on the mechanism of action and preclinical data of IBI110, it is assumed that IBI110 can inhibit the immune checkpoint signaling to achieve anti-tumor effect, which may further improve the efficacy of immunotherapy, overcome the primary drug resistance, and overcome the drug resistance after anti-PD-1 /PD-L1 monoclonal antibody treatment[4]. Based on the urgent clinical needs, Innovent has carried out clinical studies to explore the efficacy and safety of IBI110 in various advanced tumors. About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT® (sintilimab injection), BYVASDA®(bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA®(rituximab biosimilar injection), Pemazyre®(pemigatinib oral inhibitor), olverembatinib (BCR ABL TKI), Cyramza® (ramucirumab) and Retsevmo®(selpercatinib). An additional 3 assets are under NMPA NDA review, 6 assets are in Phase 3 or pivotal clinical trials, and 18 more molecules are in clinical studies. Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: . and . Disclaimer: Innovent does not recommend any off-label usage. Note: TYVYT® (sintilimab injection) is not an approved product in the United States. BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States. TYVYT® (sintilimab injection, Innovent) BYVASDA® (bevacizumab biosimilar injection, Innovent) HALPRYZA® (rituximab biosimilar injection, Innovent) SULINNO® (adalimumab biosimilar injection, Innovent) Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan. CYRAMZA® (ramucirumab, Eli Lilly). CYRAMZA® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Retsevmo®(selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. Reference [1] The Global Cancer Observatory - March, 2021. [2] China Guideline for the screening, early detection and early treatment of gastric cancer (2022, Beijing), Chin J Oncol, July 2022, Vol.44, No.7 [3] Finn R S, Qin S, Ikeda M, et al. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020;382(20):1894-1905. [4] J Thorac Oncol. 2017 May;12(5):814-823. 2. jco.2022.40.16_suppl.e2114 SOURCE Innovent Biologics

Clinical ResultPhase 1ImmunotherapyASCO

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Esophageal Squamous Cell Carcinoma	Phase 2	China	The First Affiliated Hospital of Zhengzhou University	01 Oct 2023
Melanoma, Cutaneous Malignant	Phase 2	United States	Innovent Biologics (Suzhou) Co. Ltd.	01 Nov 2022
Melanoma, Cutaneous Malignant	Phase 2	Australia	Innovent Biologics (Suzhou) Co. Ltd.	01 Nov 2022
Melanoma, Cutaneous Malignant	Phase 2	France	Innovent Biologics (Suzhou) Co. Ltd.	01 Nov 2022
Melanoma, Cutaneous Malignant	Phase 2	Germany	Innovent Biologics (Suzhou) Co. Ltd.	01 Nov 2022
Melanoma, Cutaneous Malignant	Phase 2	Spain	Innovent Biologics (Suzhou) Co. Ltd.	01 Nov 2022
Melanoma, Cutaneous Malignant	Phase 2	Switzerland	Innovent Biologics (Suzhou) Co. Ltd.	01 Nov 2022
Melanoma, Cutaneous Malignant	Phase 2	United Kingdom	Innovent Biologics (Suzhou) Co. Ltd.	01 Nov 2022
Unresectable Melanoma	Phase 2	United States	Innovent Biologics (Suzhou) Co. Ltd.	01 Nov 2022
Unresectable Melanoma	Phase 2	Australia	Innovent Biologics (Suzhou) Co. Ltd.	01 Nov 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04085185 (Pubmed \| Cancer Immunol Immunother)	Phase 2	Squamous non-small cell lung cancer First line LAG-3 expression	153	IBI110 200 mg plus sintilimab and chemotherapy	qwonqpxcun(nvattsdoyd): P-Value = 0.0485 View more	Positive	27 Jan 2026
NCT04085185 (Pubmed \| Cancer Immunol Immunother)	Phase 2		153	sintilimab plus chemotherapy	qwonqpxcun(nvattsdoyd): P-Value = 0.0485 View more	Positive	27 Jan 2026
IBI110 (ASCO2025)	Phase 2	Alveolar Soft Part Sarcoma LAG-3 density	28	IBI110 (anti-LAG-3 antibody) + sintilimab (anti-PD-1 antibody)	xbppybkrjg(rraunwdjoh) = dihdwgjqvb vybkvpjyjt (qzjdzhvwdn )	Positive	30 May 2025
IBI110 (ASCO2025)	Phase 2	Alveolar Soft Part Sarcoma LAG-3 density	28	IBI110 (Cohort A (ICI-naïve))	xbppybkrjg(rraunwdjoh) = hguentpnho vybkvpjyjt (qzjdzhvwdn )	Positive	30 May 2025
NCT06494943 (Neoadjuvant IBI110 and sintilimab in combination with chemotherapy in resectable locally advanced head and neck squamous cell carcinoma, ASCO2025)	Phase 1	Locally Advanced Head and Neck Squamous Cell Carcinoma Neoadjuvant p16+	12	Sintilimab, IBI110, paclitaxel, and cisplatin	wodgdanrhv(vudlsdvekd) = sejjfvyoch uzxbnqpppd (vhjnukztmr ) View more	Positive	30 May 2025
NCT04085185 (IBI110 and sintilimab in advanced solid tumors, Pubmed \| J Hematol Oncol)	Phase 1	Advanced Malignant Solid Neoplasm	-	IBI110 monotherapy	dgsbdrbfkb(lyrciyqtpo) = jdlputvyaa ogdyvsypqx (msnhglovtn )	Positive	31 Dec 2024
	Phase 1	Advanced Malignant Solid Neoplasm	-	IBI110 plus sintilimab	dgsbdrbfkb(lyrciyqtpo) = xpymuryaak ogdyvsypqx (msnhglovtn )	Positive	31 Dec 2024
NCT04085185 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	Gastrooesophageal junction cancer \| HER2 negative Gastric Cancer First line HER2 Negative	17	Sintilimab+IBI110	rldlqntukg(dpzjjbsmbt) = daaofeegrh klrfretzdb (mgdhqfilng, 3.8 - 15.8) View more	Positive	26 May 2023
NCT04085185 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	Advanced Hepatocellular Carcinoma First line	28	Sintilimab+lenvatinib+IBI110	xqnumrhdnj(wywamnpflz) = tvnuqigjky qqqxxxqttj (atwgdawiec ) View more	Positive	26 May 2023
NCT04085185 (ESMO_IO2022) Manual	Phase 1	Squamous non-small cell lung cancer First line	20	IBI110+sintilimab+chemotherapy	owdttcpfje(gdkuefxnyi) = neutrophil count decreased (35.0%), and white blood cell count decreased (20.0%) ckpcvoedmv (frsfoniikt )	Positive	08 Dec 2022
NCT04085185 (ASCO2022) Manual	Phase 1	Gastrooesophageal junction cancer \| HER2 negative Gastric Cancer First line HER2 Negative	18	oxaliplatin+capecitabine+IBI110+sintilimab	qcvocbncnx(fyaniayhqn) = bahikdlago kjdwkenyml (vxifytxqbp ) View more	Positive	02 Jun 2022
NCT04085185 (ASCO2022) Manual	Phase 1	Advanced Lung Non-Small Cell Squamous Carcinoma First line	20	Paclitaxel+Carboplatin+IBI 110+Sintilimab	szerrhstfv(uvgwtktmpf) = neutrophil count decreased (30%), and white blood cell count decreased (20%) grtfotbmaa (akrjewwdcu ) View more	Positive	02 Jun 2022
NCT04085185 (ASCO2022) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	43	IBI110 (Phase Ia)	fjpiwwfnvj(inkagkvwop) = xfvmwjczap ffhfcnfxfy (dhdqlpfpap ) View more	Positive	02 Jun 2022
NCT04085185 (ASCO2022) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	43	IBI110+sintilimab (Phase Ib)	fjpiwwfnvj(inkagkvwop) = oongcuazeg ffhfcnfxfy (dhdqlpfpap ) View more	Positive	02 Jun 2022

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