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Last update 07 Apr 2025

Ramucirumab

Last update 07 Apr 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Ramucirumab (Genetical Recombination), Ramucirumab (genetical recombination) (JAN), Ramucirumab (USAN)

+ [11]

Target

VEGFR2

Action

antagonists

Mechanism

VEGFR2 antagonists(Vascular endothelial growth factor receptor 2 antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [3]

Active Indication

Unresectable Hepatocellular CarcinomaAdvanced gastric carcinomaMetastatic Gastric Carcinoma+ [41]

Inactive Indication

Advanced Esophageal Squamous Cell CarcinomaAdvanced Gastric AdenocarcinomaAdvanced Hepatocellular Carcinoma+ [37]

Originator Organization

Dyax Corp.

Active Organization

Eli Lilly & Co.

Merck Sharp & Dohme Corp.Eli Lilly Nederland BV

+ [4]

Inactive Organization

Basilea Pharmaceutica AG

Innovent Biologics (Suzhou) Co. Ltd.

Celgene Corp.

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (21 Apr 2014),

Gastroesophageal junction adenocarcinomaStomach Cancer

RegulationFast Track (United States), Orphan Drug (United States)

Structure/Sequence

Sequence Code 9107105H

Source: *****

Sequence Code 9583823L

Source: *****

233

Clinical Trials associated with Ramucirumab

NCT06675136

/ Not yet recruitingPhase 1IIT

Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases

This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.

Start Date17 Oct 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06616584

/ Not yet recruitingPhase 2/3IIT

A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.

Start Date11 Jul 2025

Sponsor / Collaborator

SWOG

[+2]

NCT06771622

/ RecruitingPhase 1/2

Phase Ib/IIa, Open-label, Multicenter, Dose Escalation, and Dose Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of HCB101 in Combination With Multiple Agents in Subjects With Advanced Solid Tumors

This is a non-randomized, open-label, dose-escalation, and dose-expansion Phase Ib/IIa study to evaluate the safety, tolerability, PK profile, and preliminary efficacy of HCB101 in combination therapies in subjects with advanced solid tumors. The trial consists of four cohorts, each including a part I of the dose-escalation phase (Phase Ib) and a part II of the dose-expansion phase (Phase IIa).

Start Date13 Mar 2025

Sponsor / Collaborator

HanchorBio inc

100 Clinical Results associated with Ramucirumab

100 Translational Medicine associated with Ramucirumab

100 Patents (Medical) associated with Ramucirumab

1,395

Literatures (Medical) associated with Ramucirumab

01 Dec 2025·Journal of Gastrointestinal Cancer

Network Meta-analysis of Randomized Controlled Trials in Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer: Comparisons Involving Ramucirumab

Review

Author: Taipale, Kaisa ; Paine, Abby ; Gupta, Palvi ; D'yachkova, Yulia ; Liepa, Astra M ; Earley-Valovic, Veronika ; Goel, Rajat

PURPOSE:

With relatively few direct comparisons among treatment options for previously treated advanced gastric cancer or gastroesophageal junction (GEJ) cancer, network meta-analysis (NMA) may inform evidence-based decision-making. Ramucirumab plus paclitaxel (RAM + PTX) is a preferred regimen in guideline recommendations. NMA of key outcomes may further characterize the relative clinical value of RAM + PTX.

METHODS:

A systematic literature review of randomized controlled trials of adult patients with previously treated advanced gastric/GEJ cancer informed a NMA which compared overall survival, progression-free survival, and discontinuations due to adverse events. Comparisons were reported relative to placebo/best supportive care (BSC) when possible, otherwise relative to RAM + PTX.

RESULTS:

The base-case NMA focused on second-line treatment only, from 19 of 28 studies identified. For overall survival, seven of 16 regimens were favorable relative to placebo/BSC, with RAM + PTX as the most favorable. For progression-free survival, five of 14 regimens were unfavorable relative to RAM + PTX. For discontinuations due to adverse events, two of 13 regimens were similar to placebo/BSC: ramucirumab monotherapy and fluorouracil; relative to RAM-PTX, all regimens were similar except ramucirumab monotherapy which was favorable and irinotecan + cisplatin which was unfavorable.

CONCLUSION:

This NMA of trials of previously treated gastric/GEJ cancer suggests that RAM + PTX has one of the more favorable clinical profiles.

01 Mar 2025·Clinical Colorectal Cancer

Efficacy and Safety of KH903 Plus FOLFIRI as a Second-Line Treatment in Unresectable Recurrent or Metastatic Colorectal Cancer: A Randomized Phase 2 Study

Article

Author: Lin, Rongbo ; Xu, Jiangming ; Qian, Xiaoping ; Cheng, Ying ; Ba, Y I ; Li, Jian ; Yin, Xianli ; Shen, Lin ; Shen, Yali ; Xu, Nong ; Wang, Jufeng ; Zhang, Yanqiao ; Ke, Xiao ; Zhou, Jianfeng ; Ying, Jieer ; Wu, Rong

BACKGROUND:

Patients with recurrent or metastatic advanced colorectal cancer (mCRC) often face the clinical dilemma as this unresectable disease is continuously progressing and endangering the patients' lives. In the current study, we explored the clinical feasibility of KH903 in combination with FOLFIRI chemotherapy as a new clinical indication for mCRC.

METHODS:

Patients (N = 122) were randomized 1:1 to 4mg/kg q1w KH903 or 5mg/kg q2w KH903, and both groups of patients were treated with the fixed regimen of FOLFIRI (every 2 weeks) along with the KH903 therapy. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were Overall Survival (OS), objective response rate (ORR), and disease control rate (DCR).

RESULTS:

As of December 30, 2020, median (m)PFS was 5.68 months (95% CI, 4.67-7.13) with 4mg/kg q1w versus 5.19 months (95% CI, 4.04, 5.78) with 5mg/kg q2w (HR, 0.76; 95% CI, 0.50-1.16),and mOS was 13.14 months (95% CI, 10.61-19.52) versus 16.03 months (95% CI, 10.28- NE), respectively (HR, 1.11; 95% CI, 0.65-1.89), The ORR was 15.9% and 11.9% for both groups, respectively, and The DCR for both groups was 85.7% and 83.1%, respectively. Grade 3 or higher treatment-related adverse event rates for both groups were 68.3% vs.52.5%, respectively.

CONCLUSIONS:

KH903 in combination with FORFIRI in second-line treatment of patients with mCRC showed prolonged mPFS and mOS, comparing to the similar agents (Avastin®, ZALTRAP®, Cyramza®) and no new safety signals were observed.

01 Mar 2025·INTERNAL MEDICINE

Successful Treatment with Ramucirumab Plus Erlotinib following Osimertinib-induced Interstitial Lung Disease

Article

Author: Nagano, Tatusya ; Yamamoto, Masatsugu ; Katsurada, Naoko ; Fujimoto, Shodai ; Hazama, Daisuke ; Tachihara, Motoko

Epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) are key drugs for patients with EGFR mutation-positive non-small cell lung cancer, and osimertinib is the standard treatment. Although drug-induced interstitial lung disease (ILD) is a remarkable adverse event of EGFR-TKIs, evidence regarding the continuation and re-challenge of EGFR-TKIs after drug-induced severe ILD is lacking. This is the first report of successful switching to ramucirumab plus erlotinib after osimertinib-induced severe ILD in an 81-year-old woman with stage IV lung adenocarcinoma harboring the EGFR L858R mutation in exon 21. These findings suggest that ramucirumab plus erlotinib may be a viable treatment option for osimertinib-induced severe ILD.

222

News (Medical) associated with Ramucirumab

31 Mar 2025

·www.prnewswire.com

Innovent Receives NMPA Breakthrough Therapy Designation for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Melanoma

SAN FRANCISCO and SUZHOU, China, March 30, 2025 /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, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, as monotherapy for the treatment of unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. Recently, Innovent initiated and dosed the first patient for IBI363 in its first pivotal study to evaluate the efficacy and safety of IBI363 monotherapy versus pembrolizumab (Keytruda®) monotherapy in patients with unresectable, locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. Furthermore, IBI363 has received two fast track designations (FTD) from the U.S. Food and Drug Administration (FDA), for the treatment of squamous non-small cell lung cancer and melanoma, respectively. IBI363 has demonstrated outstanding efficacy signals in immunotherapy (IO)-naïve melanoma patients across two earlier clinical trials (Phase 1a/1b study NCT05460767 and Phase 2 study NCT06081920), which enrolled a total of 26 patients with advanced acral or mucosal melanoma: The overall objective response rate (ORR) was 61.5%, and the disease control rate (DCR) was 84.6%—significantly higher than current domestic immunotherapy standards. Prolonged follow-up revealed sustained tumor responses and long-term benefits, suggesting the potential superiority of IBI363 over existing standard therapies. Dr. Hui Zhou, Senior Vice President of Innovent, said, "As Innovent's first-in-class next-generation IO therapy, IBI363 simultaneously and selectively inhibits the PD-1/PD-L1 pathway and activates the IL-2 pathway. IBI363 has recently received multiple FTD and BTD designations, signifying regulatory recognition of its clinical value in addressing unmet medical needs. Non-cutaneous melanoma subtypes like mucosal melanoma—which are more prevalent in China—are particularly resistant to immunotherapy with limited clinical benefits[i]. We aim to validate IBI363's potential in its first pivotal trial, through a head-to-head comparison with pembrolizumab, as a superior treatment option for melanoma patients over the current standard-of-care. We are also accelerating the global development of IBI363 across multiple tumor types, with the goal of extending the benefits of China's innovation to patients worldwide." NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of investigational drugs for serious diseases or conditions when preliminary clinical evidence indicates substantial improvement over current therapies. BTD qualifies a drug candidate for accelerated review by the CDE and provides the sponsor with timely advice and communication to expedite the approval process, helping to address the unmet clinical needs of patients more swiftly. About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) IBI363 is a first-in-class drug candidate independently developed by Innovent Biologics. It is a PD-1/IL-2 bispecific antibody fusion protein designed to enhance efficiency while minimizing toxicity. The IL-2 arm of IBI363 has been engineered to optimize therapeutic effects with reduced side effects, while the PD-1 binding arm enables PD-1 blockade and selective IL-2 delivery. By simultaneously inhibiting the PD-1/PD-L1 pathway and activating the IL-2 pathway, IBI363 facilitates more precise and efficient targeting and activation of tumor specific T cells. Preclinical studies have shown that IBI363 exhibits strong anti-tumor activity across multiple tumor-bearing pharmacological models, including those resistant to PD-1 inhibitors and metastatic models. Additionally, it has demonstrated a favorable safety profile in preclinical models. Clinical trials of IBI363 are currently underway in China, the United States, and Australia to evaluate its safety, tolerability and preliminary efficacy in subjects with advanced malignancies. The first pivotal study of IBI363 has been initiated, for the treatment of IO-naive mucosal or acral melanoma. Furthermore, IBI363 has received two fast track designations (FTD) from the U.S. FDA, for the treatment of melanoma and squamous NSCLC, respectively. IBI363 has also received breakthrough therapy designation from the NMPA of China for the treatment of melanoma. About Melanoma Melanoma is a malignant tumor that develops from melanocytes. Although melanoma accounts for only 3% of all types of skin cancer, it has the highest mortality rate of all types and is the most likely to metastasize. In China, the incidence and mortality rate of melanoma continue to rise. Melanoma is classified into three main subtypes: cutaneous, acral and mucosal. The characteristics of melanoma in Chinese patients differs greatly from those seen in European and American Caucasian populations in terms of pathogenesis, biological behavior, histological morphology, treatment response and prognosis[i]. For advanced cutaneous and acral melanomas, patients with the BRAF V600 mutation typically receive BRAF inhibitor combined with MEK inhibitors as the preferred molecular targeted therapy. For those without the BRAF V600 mutation, chemotherapy combined with anti-angiogenic drugs can be is a first-line treatment option. Notably, pembrolizumab has been approved as the first-line treatment indication for advanced melanoma in September 2024 in China, although clinical benefits are limited. For second-line treatment, therapies not previously used in first-line settings are recommended. Patients who have not received PD-1 monoclonal antibody in the first-line setting may be treated with PD-1 inhibitors as a second-line option. For advanced mucosal melanoma -which are more prevalent in China-are particularly resistant to immunotherapy with limited clinical benefits, in urgent need of new treatment options. 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 , 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 Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. 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. References: [i] CSCO黑色素瘤诊疗指南（2023年版） SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Fast TrackClinical ResultImmunotherapyPhase 2Breakthrough Therapy

27 Mar 2025

·www.prnewswire.com

Innovent to Present Preclinical Data of Multiple Novel Molecules at the 2025 AACR Annual Meeting

SAN FRANCISCO and SUZHOU, China, March 26, 2025 /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, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that preclinical data on multiple novel bispecific antibodies as well as antibody-drug-conjugates (ADCs) from its oncology pipeline will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. The AACR Annual Meeting will take place from April 25 to April 30, 2025, in Chicago, Illinois. Late-Breaking Research: Immunology 2 Topic: Preclinical Data of IAR037, A Novel CD40/PD-L1 Bispecific Antibody for the Treatment of Advanced Solid Tumors Resistant to Immune Checkpoint Inhibitors Abstract Number: LB139 Presentation Time ：Monday Apr 28, 2025 9:00 AM - 12:00 PM Location: Poster Section 52 Late-Breaking Research: Clinical Research 1 Topic: Preclinical characterization of IBI3010, a FRα targeting biparatopic antibody-drug conjugate (ADC), for the treatment of FRα expressing tumors Abstract Number: LB222 Presentation Time ：Monday Apr 28, 2025 2:00 PM - 5:00 PM Location: Poster Section 53 Poster Session: Experimental and Molecular Therapeutics - New and Emerging Cancer Drug Targets Topic: IBI3019, a first-in-class EGFR/CDH17/CD16A tri-specific antibody, demonstrated potent efficacy against CRC and an excellent safety profile in preclinical studies Abstract Number: 4249 Presentation Time: Tuesday Apr 29, 2025 9:00 AM - 12:00 PM Location: Poster Section 17 Poster Board Number: 6 Poster Session: Experimental and Molecular Therapeutics - Therapeutic Approaches to Attack the Tumor Microenvironment Topic: IBI3026, a first-in-class anti-PD-1/IL-12 fusion protein, demonstrates the potential to be a new immuno-oncology therapy by releasing the break in immune response and strongly activating T and NK cells in the tumor microenvironment Abstract Number: 3118 Presentation Time: Monday Apr 28, 2025 2:00 PM - 5:00 PM Location: Poster Section 24 Poster Board Number: 2 Poster Session: Experimental and Molecular Therapeutics - Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies Topic: IBI3014, a TROP2xPD-L1 bi-specific ADC integrating ADC killing with checkpoint blockade within one molecule, exhibits promising efficacy and safety in preclinical models Abstract Number: 344 Presentation Time: Sunday Apr 27, 2025 2:00 PM - 5:00 PM Location: Poster Section 16 Poster Board Number: 11 Poster Session: Experimental and Molecular Therapeutics - Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies Topic: Trop2 and B7H4 bi-specific ADC with improved efficacy and safety for gynecologic cancers Abstract Number: 345 Presentation Time: Sunday Apr 27, 2025 2:00 PM - 5:00 PM Location: Poster Section 16 Poster Board Number: 12 Poster Session: Immunology - T Cell Engagers Topic: A 2+1 format MUC16 targeting T cell engager induces MUC16-dependent T cell activity and superior anti-tumor efficacy Abstract Number: 3510 Presentation Time: Monday Apr 28, 2025 2:00 PM - 5:00 PM Location: Poster Section 38 Poster Board Number: 18 Poster Session: Immunology - Modulation of Tumor Microenvironment: Modulation of Lymphocyte Influx Topic: A PD1-IFNα fusion protein, composed of an attenuated IFNα fused to a clinically validated PD1 mAb, induced PD1-dependent IFNα signaling and demonstrated superior anti-tumor efficacy Abstract Number: 4881 Presentation Time: Tuesday Apr 29, 2025 9:00 AM - 12:00 PM Location: Poster Section 40 Poster Board Number: 9 Poster Session: Experimental and Molecular Therapeutics - Novel Antitumor Agents 3 Topic: Olverembatinib* (HQP1351) in combination with lisaftoclax (APG-2575) overcomes venetoclax resistance in preclinical models of acute myeloid leukemia (AML) Abstract Number: 5652 Presentation Time: Tuesday Apr 29, 2025 2:00 PM – 5:00 PM Poster Session: Experimental and Molecular Therapeutics - Novel Antitumor Agents 3 Topic: Effects of olverembatinib* (HQP1351) in combination with BCL-2 inhibitor lisaftoclax (APG-2575) in T-cell acute lymphoblastic leukemia (T ALL) Abstract Number: 5648 Presentation Time: Tuesday Apr 29, 2025 2:00 PM – 5:00 PM * In July 2021, Innovent and Ascentage Pharma (6855.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China. Dr. Kaijie He, Vice President of Innovent, stated: "With the expansion and enhancement of Innovent Academy's technology platforms, our global R&D efforts are taking shape and accelerating global competitiveness, enabling the efficient generation of novel molecules with global potential. We are proud to showcase a batch of preclinical research findings at this year's AACR Annual Meeting, including multiple globally first-in-class bispecific antibodies, multi-specific antibodies, and antibody-drug conjugates (ADCs). These breakthroughs not only demonstrate our growing scientific capabilities but also reaffirm our commitment to delivering transformative therapeutic options for patients worldwide. Moving forward, we remain focused on innovation—optimizing precision targets and exploring novel mechanisms—to provide revolutionary solutions for some of the world's most challenging diseases and enable more patients to benefit from the rapid advancements in cutting-edge science." 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, 3 assets in Phase III or pivotal clinical trials and 16 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 , 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. Forward-looking statement 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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company 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 materialise or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AACRADCImmunotherapy

24 Mar 2025

·www.prnewswire.com

Innovent Dosed First Participant in Phase 3 Clinical Study of IBI354 (Novel HER2 ADC) for Platinum-resistant Ovarian Cancer

SAN FRANCISCO and SUZHOU, China, March 23, 2025 /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, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed with IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate, HER2 ADC) in a randomized, controlled, multicenter Phase 3 clinical trial (HeriCare-Ovarian01), for platinum-resistant ovarian cancer (PROC) with HER2 expression. HeriCare-Ovarian01 is the first Phase 3 clinical trial (NCT06834672) in China to investigate PROC with HER2 expression (IHC 1+, 2+ or 3+). The study will evaluate the safety and efficacy of IBI354, compared with investigator's choice of chemotherapy for PROC with HER2 expression. The primary endpoints are progression-free survival (PFS) and overall survival (OS). Previously, in a multicenter Phase 1/2 study in participants with advanced solid tumors, a total of 87 participants with platinum-resistant ovarian cancer were enrolled and were treated with 6-12 mg/kg doses of IBI354. 67 (77.0%) participants had previously received at least 3 anti-tumor regimens. As of July 24, 2024, the overall objective response rate (ORR) was 40.2% and the disease control rate (DCR) was 81.6%. Among them, ORR reached 52.5% and DCR reached 90.0% in 40 ovarian cancer participants treated with 12mg/kg Q3W ORR reached 55.6% and DCR reached 88.9% in 27 subjects with HER2 IHC 1+ (12mg/kg Q3W dose group). The median follow-up time of 12mg/kg Q3W dose group was 6.5 months as of the cut-off date, and progression-free survival (PFS) and duration of response (DoR) were not mature. The data was presented at the ESMO conference. In the phase 1/2 clinical study (n=368), IBI354 demonstrated an excellent safety profile. No DLT was occurred up to 18mg/kg dose group. The overall incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 21.5%, the incidence of TRAEs leading to dose interruption was 12.2%, the incidence of TRAEs leading to dose reduction was 2.4%, the overall incidence of TRAEs leading to discontinuation was 1.6%, and no TRAE leading to death reported. The most common TRAEs are nausea, white blood cell count decreased, and anemia. The incidence of interstitial lung disease was only 1.6%, all were grade 1. The Principal Investigator of the HeriCare-Ovarian01 study, Prof. Qi Zhou from Chongqing University Cancer Hospital, stated, "Prolonging PFS and OS of PROC is an urgent unmet medical need. Ovarian cancer is characterized by a pattern of frequent recurrence, which ultimately leads to platinum resistance. Non-platinum monotherapy chemotherapy remains the primary treatment option at this stage, but its limited efficacy is a major contributor to the high mortality rate associated with ovarian cancer. As a fully-validated target, HER2-targeted therapy has proven effective in breast and gastric cancers. IBI354, as a innovative conjugate of anti-HER2 monoclonal antibody and camptothecin derivative, has shown good anti-tumor activity in PROC with HER2 expression in the previous study. Especially in the population with low HER2 expression (IHC 1+), the efficacy of IBI354 is comparable to that in the population with higher HER2 expression. At the same time, IBI354 has an excellent safety profile, showing a very low risk of common or concerned toxicities of other antibody-drug conjugates (ADCs), such as interstitial lung disease, fatigue, diarrhea, hair loss, eye toxicity, etc. I look forward to positive results from the HeriCare-Ovarian01 study. It is hoped that IBI354 may provide survival benefits to the PROC patients with varying levels of HER2 expression." The Principal Collaborating Investigator of the study from Zhejiang Cancer Hospital, Prof. Tao Zhu, stated: "We are pleased to complete the first patient enrollment for the HeriCare-Ovarian01 study at our site. Although ovarian cancer ranks third among gynecologic malignancies in incidence, behind cervical and endometrial cancers, its mortality rate exceeds the combined total of the latter two, making it the deadliest gynecologic cancer and a severe threat to women's health. As an anti-HER2 ADC, preliminary findings from IBI354 have demonstrated encouraging objective response rates (ORR) and disease control rates (DCR) in PROC. Furthermore, IBI354 exhibits a superior clinical safety profile and treatment tolerability compared to other ADCs. Current clinical data suggest promising development prospects for IBI354 in PROC. We are hopeful that IBI354 will achieve success in the HeriCare-Ovarian01 study, offering new therapeutic options for this patient population." Dr. Zhou Hui, Senior Vice President of Innovent, stated, "I'm pleased that the Phase III clinical study of IBI354 in HER2-expressing PROC has completed the first participant dosing. I look forward to positive results for IBI354 to provide a better treatment option for patients with HER2-expressing PROC. ADC is one of the core technology areas of Innovent's strategic layout. We combine the world's leading antibody engineering and multiple sets of differentiated linker-payload technologies to create a highly competitive and innovative TOPO1i ADC technology platform SoloTx®. IBI354 has demonstrated excellent safety and efficacy data in the previous study, which fully proves the value and the development strength of Innovent ADC platform. We will deeply layout the ADC and immunotherapy areas, focusing on the next generation of innovation, committed to bring better benefits to cancer patients." About Ovarian Cancer OC is one of the leading causes of death among gynecological cancers. According to the International Agency for Research on Cancer, there will be about 324,000 new cases of ovarian cancer worldwide in 2022, and about 206,000 deaths[1]. About 61,000 new cases and 33,000 deaths were reported in China[2]. A higher mortality/morbidity ratio suggests a shorter survival time. Platinum-containing chemotherapy is the first choice for systemic treatment of advanced ovarian cancer. About 70% of patients with platinum-sensitive ovarian cancer will relapse after receiving platinum-containing chemotherapy and eventually develop platinum resistance[3]. There is a lack of effective treatment for platinum-resistant cancer patients. The existing evidence is non-platinum-single drug chemotherapy with or without anti-angiogenic therapy, with ORR only about 4-13.2% and median overall survival (OS) only about 10.9-14 months[4-8]. There is a urgent unmet medical need for PROC, and it is recommended that these patients participate in clinical trials in Chinese and foreign guidelines.It has been reported that about 38% of ovarian cancer patients have HER2 expression[9]. There are currently no anti-HER2 treatments approved for HER2-overexpressed ovarian cancer in China. About IBI354 IBI354 is an innovative HER2-targeted antibody–drug conjugate developed using Innovent's proprietary novel topoisomerase inhibitor platform. Based on this platform, Innovent is promoting clinical trial studies multiple self-developed ADC molecules, which have shown promising safety and efficacy signals. With a drug-to-antibody ratio (DAR) of 8, IBI354 delivers a high payload of effective drugs to tumors. The highly hydrophilic linker design contributes to its excellent biophysical and pharmacokinetic (PK) properties, while the hydrophobic payload enhances its bystander effect, targeting adjacent antigen-low or negative tumor cells. IBI354 exhibits extremely low exposure of free toxin in circulation and has an ideal safety profile based on pre-clinical and clinical studies. IBI354 has demonstrated remarkable anti-tumor activity in various tumor-bearing mice models, particularly in those resistant to HER2-targeted therapies and in metastatic tumors. Starting from the urgent clinical needs, in addition to the phase III study (HeriCare-Ovarian01) already initiated in PROC, Innovent will develop IBI354 in multiple solid tumor indications. 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 , 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. Disclaimer: Innovent does not recommend any off-label usage. 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. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Phase 1Clinical ResultADCPhase 2

100 Deals associated with Ramucirumab

External Link

KEGG	Wiki	ATC	Drug Bank
D09371	Ramucirumab	L01XC21	DB05578

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Unresectable Hepatocellular Carcinoma	Japan	Eli Lilly & Co.	20 Jun 2016
Advanced gastric carcinoma	Australia	Eli Lilly Australia Pty Ltd.	23 Jul 2015
Metastatic Gastric Carcinoma	Australia	Eli Lilly Australia Pty Ltd.	23 Jul 2015
Colorectal Cancer	European Union	Eli Lilly Nederland BV	19 Dec 2014
Colorectal Cancer	Iceland	Eli Lilly Nederland BV	19 Dec 2014
Colorectal Cancer	Liechtenstein	Eli Lilly Nederland BV	19 Dec 2014
Colorectal Cancer	Norway	Eli Lilly Nederland BV	19 Dec 2014
Hepatocellular Carcinoma	European Union	Eli Lilly Nederland BV	19 Dec 2014
Hepatocellular Carcinoma	Iceland	Eli Lilly Nederland BV	19 Dec 2014
Hepatocellular Carcinoma	Liechtenstein	Eli Lilly Nederland BV	19 Dec 2014
Hepatocellular Carcinoma	Norway	Eli Lilly Nederland BV	19 Dec 2014
Malignant neoplasm of gastro-oesophageal junction	European Union	Eli Lilly Nederland BV	19 Dec 2014
Malignant neoplasm of gastro-oesophageal junction	Iceland	Eli Lilly Nederland BV	19 Dec 2014
Malignant neoplasm of gastro-oesophageal junction	Liechtenstein	Eli Lilly Nederland BV	19 Dec 2014
Malignant neoplasm of gastro-oesophageal junction	Norway	Eli Lilly Nederland BV	19 Dec 2014
Metastatic Colorectal Carcinoma	European Union	Eli Lilly Nederland BV	19 Dec 2014
Metastatic Colorectal Carcinoma	Iceland	Eli Lilly Nederland BV	19 Dec 2014
Metastatic Colorectal Carcinoma	Liechtenstein	Eli Lilly Nederland BV	19 Dec 2014
Metastatic Colorectal Carcinoma	Norway	Eli Lilly Nederland BV	19 Dec 2014
Non-Small Cell Lung Cancer	European Union	Eli Lilly Nederland BV	19 Dec 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Non-Small Cell Lung Cancer	Phase 3	United States	Merck Sharp & Dohme Corp.	14 Mar 2023
Recurrent Non-Small Cell Lung Cancer	Phase 3	United States	Eli Lilly & Co.	14 Mar 2023
Advanced Gastric Adenocarcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	10 Mar 2021
Advanced Hepatocellular Carcinoma	Phase 3	China	Eli Lilly & Co.	13 Jun 2017
Advanced Hepatocellular Carcinoma	Phase 3	China	Lilly Asia Shanghai Representative Office	13 Jun 2017
Advanced Hepatocellular Carcinoma	Phase 3	Hong Kong	Eli Lilly & Co.	13 Jun 2017
Advanced Hepatocellular Carcinoma	Phase 3	Hong Kong	Lilly Asia Shanghai Representative Office	13 Jun 2017
Advanced Hepatocellular Carcinoma	Phase 3	Taiwan Province	Lilly Asia Shanghai Representative Office	13 Jun 2017
Advanced Hepatocellular Carcinoma	Phase 3	Taiwan Province	Eli Lilly & Co.	13 Jun 2017
Adenocarcinoma	Phase 3	China	Eli Lilly & Co.	02 Mar 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05002127 (ASPEN-06, ASCO_GI2025) Manual	Phase 2/3	HER2 Positive Gastroesophageal Adenocarcinoma \| HER2-positive gastric cancer HER2+	127	EvorpaceptEvorpacept (ALX148) + Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	czhjnbcxqd(eggcelmrci) = jkxbwzjkvr bcsugzlkkq (analhjolih ) View more	Positive	23 Jan 2025
				Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	czhjnbcxqd(eggcelmrci) = gnzgthulye bcsugzlkkq (analhjolih ) View more
NCT02795858 (Pubmed \| Oncologist) Manual	Phase 2	Advanced Neuroendocrine Neoplasm	43	Ramucirumab + somatostatin analog therapy	nghrfggsar(cypcnvvfmg) = etidndtsez whreegcrtp (gpiccvjpya, 9.0 - 25.6) View more	Positive	17 Jan 2025
NCT02581215 (HCRN GI14-198, CTgov)	Phase 2	Pancreatic Cancer	84	mFOLFIRINOX+Ramucirumab (Arm A: Experimental Arm)	kczqvklism = yjvlxnkxuf gtkjmswbyy (ajgrgsqywn, oqqgkwoupq - ymjxsloaqm) View more	-	01 Jan 2025
				mFOLFIRINOX (Arm B: Placebo Arm)	kczqvklism = gbcrhosdok gtkjmswbyy (ajgrgsqywn, fncyboognu - hzsqxwrxov) View more
ESMO_ASIA2024 Manual	Not Applicable	Metastatic Colorectal Carcinoma Second line	95	FOLFIRI+Bevacizumab	toqrblfdqv(nseuplpqjx) = mcrzakzxgy fidxvxhrhf (safsicsudb ) View more	Positive	07 Dec 2024
				FOLFIRI+Ramucirumab	toqrblfdqv(nseuplpqjx) = ljwpittjil fidxvxhrhf (safsicsudb ) View more
REAL-SPEED (ESMO_ASIA2024)	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR L858R mutation	168	Ramucirumab plus Erlotinib (RAM+ERL)	raljcqmydc(kqzlmdtwfn) = notable ceoptgmgsf (hmsqxqrhck ) View more	Positive	07 Dec 2024
NCT05071053 (CARMEN-GC01, CTgov)	Phase 2	Adenocarcinoma \| stomach adenocarcinoma \| Gastrooesophageal junction cancer ... View more	35	Ravtansine+Tusamitamab+Ramucirumab	rfwkbklyhk = kqkjhzrdcg dgusmpnxyp (jduzbcptux, emhtjexfhf - aazfziehzj) View more	-	05 Dec 2024
NCT02934464 (ARMANI, Pubmed) Manual	Phase 3	HER2 negative Gastric Cancer \| HER2 negative Gastroesophageal Junction Adenocarcinoma Maintenance HER2 Negative	280	paclitaxel + ramucirumab	ntxfccqckv(fafsxdypoh) = ndjbnynota frnbjrmbnj (txwhhsanxd, 5.9 - 7.8) View more	Positive	15 Nov 2024
				FOLFOX or CAPOX	ntxfccqckv(fafsxdypoh) = gswkmhlgft frnbjrmbnj (txwhhsanxd, 2.8 - 4.2) View more
NCT03909334 (RAMOSE \| HCRN LUN-18-335, Pubmed \| J Clin Oncol) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	139	Osimertinib Ramucirumabrumab	wxmakvanel(hhtyhdhjxg) = pgngpvpewq heffuokjmu (mbunlzasvy ) View more	Positive	08 Oct 2024
				Osimertinib	wxmakvanel(hhtyhdhjxg) = zzwnrvokxv heffuokjmu (mbunlzasvy ) View more
JPRN-jRCTs041180166 (WJOG9216G (RECAST), ESMO2024) Manual	Phase 2	Metastatic Colorectal Carcinoma First line	122	FOLFOXIRI pluRAMAM	getrgtoetc(rwzeqleusc) = rkcklifymc glhcpdcyfi (gksnbeoddg, 26.8 - 36.5)	Negative	14 Sep 2024
				8 cycles of FOLFOXIRI plus RAM followed by 5-FU/l-leucovorin plus RAM	getrgtoetc(rwzeqleusc) = sryztgegke glhcpdcyfi (gksnbeoddg, 21.9 - 31.2)
ESMO2024 Manual	Not Applicable	Non-Small Cell Lung Cancer Third line \| Second line	173	Docetaxel with Nintedanib (D+N)	cdkdjcvxce(lorswwvuse) = qypntptbib tkakpjqltq (uckrlrkqoe ) View more	Negative	14 Sep 2024
				Docetaxel with Ramucirumab (D+R)	cdkdjcvxce(lorswwvuse) = qcoxkingrb tkakpjqltq (uckrlrkqoe ) View more

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