EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER3 antagonists(Receptor tyrosine-protein kinase erbB-3 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersMouth and Tooth Diseases+ [7]

Active Indication

Fallopian Tube CarcinomaPlatinum-Resistant Epithelial Ovarian CarcinomaPlatinum-Resistant Fallopian Tube Carcinoma+ [61]

Inactive Indication-

Originator Organization

Systimmune, Inc.

Sichuan Baili Pharmaceuticals Co.,Ltd

Active Organization

Bristol Myers Squibb Co.

Sichuan Biokin Pharmaceutical Co., Ltd.Baili Bio Chengdu Pharmaceutical Co. Ltd.

+ [3]

Inactive Organization-

License Organization

Sichuan Biokin Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

Shanghai Maibang Biotechnology Co. Ltd.

Drug Highest PhasePhase 3

First Approval Date-

RegulationBreakthrough Therapy (United States), Breakthrough Therapy (China)

Structure/Sequence

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Sequence Code 43254

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Sequence Code 10172664

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Clinical Trials associated with Izalontamab Brengitecan

NCT07100080

/ Not yet recruitingPhase 2/3

IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy

A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy

Start Date15 Oct 2025

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT06994195

/ RecruitingPhase 3

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer

This trial is a registered, phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with platinum-resistant recurrent epithelial ovarian cancer.

Start Date04 Aug 2025

Sponsor / Collaborator

Sichuan Baili Pharmaceuticals Co.,Ltd

[+1]

NCT06962787

/ RecruitingPhase 2

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1+ Axitinib Without or With Pembrolizumab (BL-B01D1+ Axitinib ± Pembrolizumab) in Patients With Locally Advanced or Metastatic Renal Cancer

This Phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 + axitinib without or with pembrolizumab (BL-B01D1 + axitinib ± pembrolizumab) in patients with locally advanced or metastatic renal cancer.

Start Date28 Jul 2025

Sponsor / Collaborator

Sichuan Baili Pharmaceuticals Co.,Ltd

[+1]

100 Clinical Results associated with Izalontamab Brengitecan

100 Translational Medicine associated with Izalontamab Brengitecan

100 Patents (Medical) associated with Izalontamab Brengitecan

Literatures (Medical) associated with Izalontamab Brengitecan

01 Jul 2024·CANCER TREATMENT REVIEWS

A systematic review of antibody-drug conjugates and bispecific antibodies in head and neck squamous cell carcinoma and nasopharyngeal carcinoma: Charting the course of future therapies

Review

Author: Jiménez-Labaig, Pablo ; Braña, Irene ; Hernando-Calvo, Alberto ; Harrington, Kevin J ; Rullan, Antonio ; Bhide, Shreerang ; O'Leary, Ben ; Llop, Sandra

INTRODUCTION:

There is a need to improve the outcomes of patients with head and neck squamous cell carcinoma (HNSCC) and nasopharyngeal carcinoma (NPC), especially in recurrent unresectable and metastatic (R/M) setting. Antibody-drug conjugates (ADC) and bispecific antibodies (BsAb) may deliver promising results.

METHODS:

We conducted a systematic literature review to identify ADC and BsAb clinical trials, involving patients with HNSCC and NPC, from database creation to December 2023. We reported trial characteristics, overall response rate (ORR), overall survival (OS), and grade ≥ 3 treatment-related adverse events (trAEs).

RESULTS:

23 trials (65 % phase I) were found, involving 540 R/M patients (355 [20trials] HNSCC and 185 [5trials] NPC). There were 13 ADC (n = 343) and 10 BsAb (n = 197) trials. 96 % patients were refractory to standard of care treatments. ORR ranged from 0 to 100 %, with the highest ORR for GEN1042 plus chemoimmunotherapy. ORRs for monotherapies were 47 % for ADC, and 0-37 % for BsAb. MRG003 reached in HNSCC 43 % and NPC 47 %. BL-B01D1 54 % in NPC. Longest median OS was seen with MRG003 and KN046. Grade ≥ 3 trAEs were 28-60 % in ADC trials, and 3-33 % BsAb. Grade ≥ 3 myelosuppressive trAEs were typically seen in 8 ADC trials, while 4 BsAb showed infusion-related reactions (IRR). Four treatment-related deaths were reported (1 pneumonitis), all ADC trials.

CONCLUSION:

ADC and BsAb antibodies show promise in R/M HNSCC and NPC. Results are premature by small sample sizes and lack of control arm. ADC mainly caused myelosuppression and a pneumonitis case, and BsAb IRR. Further research is warranted in this setting.

01 Jul 2024·LANCET ONCOLOGY

BL-B01D1, a first-in-class EGFR–HER3 bispecific antibody–drug conjugate, in patients with locally advanced or metastatic solid tumours: a first-in-human, open-label, multicentre, phase 1 study

Article

Author: Chen, Likun ; Yang, Jun ; Guo, Ye ; Chen, Gang ; Zhou, Ningning ; Zhu, Yi ; Zhou, Huaqiang ; Yang, Kunyu ; Zhou, Ting ; Zhang, Li ; Fu, Zhenming ; Xiao, Sa ; Huang, Yan ; Zhao, Shen ; Zhao, Hongyun ; Liu, Qianwen ; Li, Yongsheng ; Fang, Wenfeng ; Zhang, Yaxiong ; Han, Yaqian ; Ma, Yuxiang ; Zhu, Hai ; Zhao, Yuanyuan ; Yang, Yunpeng ; Xue, Jinhui

BACKGROUND:

Antibody-drug conjugates have promising clinical activity in the treatment of solid tumours. BL-B01D1 is a first-in-class EGFR-HER3 bispecific antibody-drug conjugate. We aimed to assess the safety and preliminary antitumour activity of BL-B01D1 in patients with locally advanced or metastatic solid tumours.

METHODS:

This first-in-human, open-label, multicentre, dose-escalation and dose-expansion phase 1 trial was conducted in seven hospitals in China, enrolling patients aged 18-75 years (dose escalation; phase 1a) or older than 18 years (dose expansion; phase 1b), with a life expectancy of at least 3 months, an Eastern Cooperative Oncology Group performance status of 0-1, and histologically or cytologically confirmed locally advanced or metastatic solid tumours that had progressed on current standard treatment. In the phase 1a i3+3 design, patients received intravenous BL-B01D1 at three different schedules: 0·27 mg/kg, 1·5 mg/kg, and 3·0 mg/kg weekly; 2·5 mg/kg, 3·0 mg/kg, and 3·5 mg/kg on days 1 and 8 of each cycle every 3 weeks; or 5·0 mg/kg and 6·0 mg/kg on day 1 of each cycle every 3 weeks. The primary objectives of phase 1a were to identify the safety, maximum tolerated dose, and dose-limiting toxicity. In phase 1b, patients were treated in two schedules: 2·5 and 3·0 mg/kg on days 1 and 8 every 3 weeks, or 4·5, 5·0, and 6·0 mg/kg on day 1 every 3 weeks. The primary objectives of phase 1b were to assess the safety and recommended phase 2 dose of BL-B01D1, and objective response rate was a key secondary endpoint. Safety was analysed in all patients with safety records who received at least one dose of BL-B01D1. Antitumour activity was assessed in the activity analysis set which included all patients who received at least one dose of BL-B01D1 every 3 weeks. This trial is registered with China Drug Trials, CTR20212923, and ClinicalTrials.gov, NCT05194982, and recruitment is ongoing.

FINDINGS:

Between Dec 8, 2021, and March 13, 2023, 195 patients (133 [65%] men and 62 [32%] women; 25 in phase 1a and 170 in phase 1b) were consecutively enrolled, including 113 with non-small-cell lung cancer, 42 with nasopharyngeal carcinomas, 13 with small-cell lung cancer, 25 with head and neck squamous cell carcinoma, one with thymic squamous cell carcinoma, and one with submandibular lymphoepithelioma-like carcinoma. In phase 1a, four dose-limiting toxicities were observed (two at 3·0 mg/kg weekly and two at 3·5 mg/kg on days 1 and 8 every 3 weeks; all were febrile neutropenia), thus the maximum tolerated dose was reached at 3·0 mg/kg on days 1 and 8 every 3 weeks and 6·0 mg/kg on day 1 every 3 weeks. Grade 3 or worse treatment-related adverse events occurred in 139 (71%) of 195 patients; the most common of which were neutropenia (91 [47%]), anaemia (76 [39%]), leukopenia (76 [39%]), and thrombocytopenia (63 [32%]). 52 (27%) patients had a dose reduction and five (3%) patients discontinued treatment due to treatment-related adverse events. One patient was reported as having interstitial lung disease. Treatment-related deaths occurred in three (2%) patients (one due to pneumonia, one due to septic shock, and one due to myelosuppression). In 174 patients evaluated for activity, median follow-up was 6·9 months (IQR 4·5-8·9) and 60 (34%; 95% CI 27-42) patients had an objective response.

INTERPRETATION:

Our results suggest that BL-B01D1 has preliminary antitumour activity in extensively and heavily treated advanced solid tumours with an acceptable safety profile. Based on the safety and antitumour activity data from both phase 1a and 1b, 2·5 mg/kg on days 1 and 8 every 3 weeks was selected as the recommended phase 2 dose in Chinese patients.

FUNDING:

Sichuan Baili Pharmaceutical.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

Cancer Discovery

Bispecific ADC “Really Strong” against ESCC

Author: Leslie, Mitch

A phase I study of the bispecific antibody–drug conjugate BL-B01D1 shows encouraging safety and effectiveness. The drug, which targets EGFR and HER3, triggered side effects in most patients, but at the higher of two doses tested, it spurred tumor responses in almost 40% of patients.

News (Medical) associated with Izalontamab Brengitecan

18 Aug 2025

·www.prnewswire.com

Izalontamab Brengitecan (EGFRxHER3 ADC) Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

First Breakthrough Therapy Designation in the U.S. for SystImmune and Bristol Myers Squibb's Izalontamab brengitecan (Iza-bren) based on data from the BL-B01D1-101 (CN), BL-B01D1-203 (CN), and BL-B01D1-LUNG-101 (U.S.,/EU) studies REDMOND, Wash. and PRINCETON, N.J., Aug. 18, 2025 /PRNewswire/ -- SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy. Iza-bren is a potential first-in-class bispecific antibody-drug conjugate (ADC) which targets both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3) with a topoisomerase 1 inhibitor payload. Iza-bren is being developed by Biokin in China and jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of China. The granting of BTD underscores the strength of these data and highlights the potential of iza-bren to address the significant clinical unmet need patients face after EGFR TKI and platinum-based chemotherapy treatment. While EGFR TKIs have shown clinical efficacy in the frontline setting, most patients eventually see their cancer progress after about 18 months. Subsequent treatment options often contain platinum-based chemotherapy, which are of limited efficacy and come with significant toxicities. Breakthrough Therapy Designation from the US FDA is intended to expedite the development and review of drugs that may demonstrate significant benefit over current standards of care. The FDA's decision was based on efficacy and safety data from three ongoing clinical trials: BL-B01D1-101 and BL-B01D1-203, conducted in China by Sichuan Biokin Pharmaceutical Co., Ltd., and the global BL-B01D1-LUNG-101 study conducted by SystImmune across the United States, Europe and Japan. Across these trials, iza-bren demonstrated evidence to suggest improved efficacy with a manageable safety profile in patients with EGFR-mutant NSCLC who had progressed after third-generation EGFR TKIs and platinum-based chemotherapy. "The FDA's granting of Breakthrough Therapy Designation underscores the potential of iza-bren to meaningfully improve clinical outcomes for patients with previously treated epidermal growth factor receptor mutation NSCLC," said Dr. Jonathan Cheng, Chief Medical Officer of SystImmune. "The data we have generated to date suggest that iza-bren could address a critical unmet need in patient care, and we look forward to working closely with the FDA to conduct the relevant clinical studies and seek regulatory approval." About EGFRmt NSCLC Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer cases, which remains the leading cause of cancer-related death worldwide. Among patients with NSCLC, 10% to 15% in Western populations and up to 50% in Asian populations harbor activating EGFR mutations. These tumors, most commonly of non-squamous histology, initially respond to EGFR TKIs such as osimertinib. However, resistance is nearly universal, often occurring after about 18 months, and treatment options beyond TKIs and platinum-based chemotherapy provide limited clinical benefit with significant toxicities, highlighting the critical need for new, effective therapies. About iza-bren SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3 targets that are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren's dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren's therapeutic payload is released causing genotoxic stress that leads to cancer cell death. About SystImmune SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram. SystImmune Forward-Looking Statements Any research and development information provided by SystImmune is intended for general information purposes only. Such information is not intended to provide complete medical information. We do not offer patient-specific treatment advice and if you have medical conditions, please see your medical doctor or healthcare provider. This press release may contain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which reflects the expectations regarding the company's goals, strategies, results of operations, performance, business prospects, and opportunities, including but not limited to the ability to gain Investigational New Drug status for the resulting new product and the ability to develop a successful formulation. Terms such as "anticipates," "believes," "expects," "estimates," "could," "intends," "may," "plans," "potential," "projects," "will," "would" and other similar expressions, or the negative of these terms, are generally indicative of forward-looking statements. While SystImmune, Inc. believes that expectations expressed in the forward-looking statements are based on the company's reasonable assumptions and beliefs in light of the information available to the company at the time such statements are made, it cannot give assurance that such forward-looking statements will prove to have been correct. Such forward-looking statements are not fact and are subject to uncertainties and other factors that could cause actual results to differ materially from such statements. We undertake no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. For additional information about the company, please visit . Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products described herein and the collaboration with SystImmune. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the expected benefits of, and opportunities related to, the collaboration with SystImmune may not be realized by Bristol Myers Squibb or may take longer to realize than anticipated, that the therapeutic potential of Iza-bren (BL-B01D1) may change, that Bristol Myers Squibb may fail to discover and develop any commercially successful product candidates through the collaboration with SystImmune, that such product candidates may not receive regulatory approval for the indications described in this release and, if approved, whether such product candidates will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. SOURCE SystImmune, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inBreakthrough TherapyPriority ReviewADC

10 Jul 2025

·www.fiercepharma.com

Fierce Pharma Asia—Approvals for Innovent, Dizal; BMS partner's bispecific ADC readout

Regulatory approvals for Innovent Biologics and Dizal, and a positive phase 3 readout for Biokin's Bristol Myers Squibb-partnered bispecific ADC made our news this week. In the past two weeks, China approved a first-in-class weight loss drug that Innovent Biologics licensed from Eli Lilly, Dizal won an FDA approval for a challenger to Johnson & Johnson's Rybrevant, while Biokin said a China phase 3 trial of its Bristol Myers Squibb-partnered bispecific antibody-drug conjugate has met a primary endpoint. And more.1. With China approval, Lilly and Innovent's mazdutide breaks into new class for GLP-1 obesity drugsChina has approved Innovent Biologics’ mazdutide as the world’s first dual GLP-1/glucagon receptor agonist for chronic weight management. Innovent obtained Chinese rights to the drug from Eli Lilly in 2019. In a Chinese phase 3 trial in patients who were overweight or obese, mazdutide 6mg achieved 14.8% average weight loss at 48 weeks, compared with just 0.5% for placebo.2. Dizal to challenge J&J with FDA approval for lung cancer drug ZegfrovyAstraZeneca spinout Dizal Pharmaceuticals won an FDA accelerated approval for sunvozertinib for previously treated EGFR ex 20-mutated non-small cell lung cancer. To be marketed as Zegfrovy, the oral drug will compete with Johnson & Johnson’s infused Rybrevant, which recently moved into the first-line setting as part of a chemotherapy combination.3. Biokin, having landed BMS deal, posts ph. 3 cancer win for bispecific ADCA phase 3 trial of Biokin’s bispecific antibody-drug conjugate, iza-bren, has hit at least one primary endpoint. The Chinese phase 3 is testing the EGFRxHER3 ADC in pre-treated nasopharyngeal carcinoma with objective response rate and overall survival as the primary endpoints. Bristol Myers Squibb owns ex-China rights to the drug after paying $800 million upfront.4. Roche’s Chugai inks $250M Gero deal to access age-related disease targetsIn a deal potentially worth $250 million, Roche’s Chugai Pharmaceutical is tapping Gero’s AI-based platform to develop antibodies against age-related diseases. Singapore-based Gero will identify therapeutic targets, while Chugai will utilize its antibody engineering technologies. The Japanese company will hold worldwide rights to drugs born from the collaboration.5. Alphabet's Calico stitches $596M deal for Mabwell's anti-aging assetIn another pact around age-related diseases, Alphabet’s Calico Life Sciences is licensing Mabwell Bioscience’s investigational IL-11-directed therapeutics. The deal includes $25 million upfront and up to $571 million in biobucks. It covers 9MW3811, which is in phase 1 trials across China and Australia, as the Chinese biotech highlights the drug’s potential in idiopathic pulmonary fibrosis. 6. Torrent Pharma shells out $1.4B to take over controlling stake in India's JB Pharma from KKRTorrent Pharma has obtained a 46.39% stake in India’s J.B. Chemicals and Pharmaceuticals from private equity firm KKR for 119 billion rupees ($1.4 billion). Torrent can further purchase another 25% of J.B.’s shares from public shareholders. J.B.’s offerings include some hypertension and eye disease brands and CDMO services.7. Taiho’s DMD asset fails to improve functional motor test results in phase 3 trialTaiho Pharmaceutical’s Duchenne muscular dystrophy candidate pizuglanstat failed to better placebo in a phase 3 study. In ambulatory patients, the oral drug failed to show a significant difference in time to rise from the floor after one year of treatment. Another cohort, conducted in non-ambulatory patients, has also been discontinued.8. Shionogi puts more than $600M on the table for Swiss biotech's antibiotic programShionogi is paying about $6.3 million upfront and up to $604 million in milestones for a preclinical antibiotic asset from BioVersys. The candidate, coded BV500, belongs to the antibiotic class of ansamycin and is being developed for nontuberculous mycobacterial infections.Other News of Note: 9. China approves 4 new drugs, including a global first-in-class medicine10. Cell therapy biotech shares first clinical data for in vivo CAR-T that attracted $1B AstraZeneca acquisition11. Novo keeps China manufacturing investments rolling with $112M for new quality testing lab in Tianjin12. Pressuring Merck's Gardasil, China's home-made 9-valent HPV vaccine priced at 60% discount13. Southwest Airlines sues dozens of generic drugmakers for alleged price-fixing scheme14. Biotech VC raises $200M to focus on Japan’s ‘untapped source’ of innovation15. Pfizer, Astellas boost case for Xtandi in early-stage prostate cancer with combo survival win16. Fujifilm Biotechnologies takes lessons from Denmark as debut of massive NC cell culture facility looms17. Fosun's Henlius pens $202M pact for regional rights to HanchorBio's phase 2 CD47 blocker18. US lawmakers refresh scrutiny over GenScript's ties to China (Reuters)19. Takeda survey finds colon cancer patients feel unheard by HCPs, want more info on diagnosis, treatment20. CStone out-licenses PD-L1 inhibitor’s certain European rights to Gentili (release)

Drug ApprovalPhase 3Phase 2Clinical ResultPhase 1

02 Jul 2025

·endpoints.news

Bristol Myers' China partner touts Phase 3 success for EGFRxHER3 bispecific ADC

Bristol Myers Squibb’s foray into cancer antibody-drug conjugates and bispecifics appears to be bearing fruit. Chinese startup Biokin, which partnered with Bristol Myers through its subsidiary SystImmune in 2023, said that an EGFRxHER3 bispecific ADC called izalontamab brengitecan (iza-bren) hit at least one primary endpoint in an interim Phase 3 readout. Specific data were not disclosed. Wednesday’s announcement represents a boon for Bristol Myers, which has the rights to the drug outside of China. The company is playing catch-up in the bispecific and ADC spaces with companies like AstraZeneca and Merck. AstraZeneca has its own franchise drug Enhertu (HER2-targeting ADC) and the recently approved Datroway (TROP2-targeting ADC). Merck, meanwhile, paid $4 billion upfront to Daiichi Sankyo (which is also partnered with AstraZeneca) for three different ADCs in 2023. Though iza-bren is mechanistically different from those compounds by going after two cancer targets, the drug still commanded a hefty deal. Bristol Myers paid $800 million upfront to Biokin for ex-China rights to the program, and could be on the hook for another $7.6 billion in potential biobucks. In iza-bren’s Phase 3 study, researchers enrolled patients with a form of head and neck cancer known as recurrent or metastatic nasopharyngeal carcinoma. Iza-bren is being tested against physician’s choice of chemo. The trial is measuring overall response rate and overall survival as co-primary endpoints, according to its clinicaltrials.gov page , but Biokin did not specify which endpoint was the one that succeeded. The lead indication for iza-bren is previously untreated triple negative breast cancer for patients who cannot receive anti-PD(L)1 inhibitors. A Phase 2/3 study is expected to start this month.

Phase 3ADCDrug Approval

100 Deals associated with Izalontamab Brengitecan

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Urothelial Carcinoma	Phase 3	United States	Bristol Myers Squibb Co.	22 Oct 2025
Advanced Urothelial Carcinoma	Phase 3	China	Bristol Myers Squibb Co.	22 Oct 2025
Advanced Urothelial Carcinoma	Phase 3	Japan	Bristol Myers Squibb Co.	22 Oct 2025
Advanced Urothelial Carcinoma	Phase 3	Argentina	Bristol Myers Squibb Co.	22 Oct 2025
Advanced Urothelial Carcinoma	Phase 3	Australia	Bristol Myers Squibb Co.	22 Oct 2025
Advanced Urothelial Carcinoma	Phase 3	Austria	Bristol Myers Squibb Co.	22 Oct 2025
Advanced Urothelial Carcinoma	Phase 3	Belgium	Bristol Myers Squibb Co.	22 Oct 2025
Advanced Urothelial Carcinoma	Phase 3	Brazil	Bristol Myers Squibb Co.	22 Oct 2025
Advanced Urothelial Carcinoma	Phase 3	Canada	Bristol Myers Squibb Co.	22 Oct 2025
Advanced Urothelial Carcinoma	Phase 3	France	Bristol Myers Squibb Co.	22 Oct 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Phase 3	Nasopharyngeal Carcinoma	-	伦康依隆妥单抗	croyghwkzs(qgeuwzsrde) = 伦康依隆妥单抗（Iza-bren，BL-B01D1）用于治疗鼻咽癌III期临床试验的期中分析达到主要终点 bmawjukgno (zdracigkvx ) Met	Positive	16 Jul 2025
NCT05262491 (Pubmed) Manual	Phase 1	Metastatic Esophageal Squamous Cell Carcinoma	82	BL-B01D1 2.0 mg/kg	jfzdmoqoqg(vofjsremiw) = established at 2.5 mg kg-1 D1D8 Q3W iahdtuefvl (asbnmygbmj ) View more	Positive	10 Jul 2025
NCT05262491 (Pubmed) Manual	Phase 1	Metastatic Esophageal Squamous Cell Carcinoma	82	BL-B01D1 2.5 mg/kg		Positive	10 Jul 2025
NCT05194982 (ASCO2025) Manual	Phase 1	Non-Small Cell Lung Cancer EGFR exon 20 insertions \| non-classical EGFR mutations \| mutations in HER2 ... View more	73	iza-bren (BL-B01D1) (Total)	txayiqzrmq(ttmtmnzwoe) = sbfjevzvts nhufddznit (svyghkdvgn ) View more	Positive	30 May 2025
NCT05194982 (ASCO2025) Manual	Phase 1		73	iza-breniza-bren (BL-B01D1) (EGFR mut exon20ins/non-classical)	txayiqzrmq(ttmtmnzwoe) = qpkknnkvye nhufddznit (svyghkdvgn ) View more	Positive	30 May 2025
NCT05194982 (ASCO2025) Manual	Phase 1	Small Cell Lung Cancer	58	Iza-bren	ltxzcjynyh(dhukrjiado) = habagoviiu usdztpigxf (uhafgrkolz ) View more	Positive	30 May 2025
NCT05194982 (ASCO2025) Manual	Phase 1	Small Cell Lung Cancer	58	Iza-bren 2.5 mg/kg (only 1 prior line of PD(L)-1 and PBC combination treatmen)	ltxzcjynyh(dhukrjiado) = bcxikqgrxd usdztpigxf (uhafgrkolz ) View more	Positive	30 May 2025
NCT05470348 (Phase I study of iza-bren (BL-B01D1), ESMO_BC2025)	Phase 1	Locally advanced breast cancer HER2-negative	121	iza-bren 2.5 mg/kg	pfezrsacti(arwadiaolv) = 44.6% elnlrkdwwv (ndhasxdszg ) View more	Positive	16 May 2025
NCT05262491 (ESMO2024) Manual	Phase 1	Esophageal Squamous Cell Carcinoma	83	BL-B01D1 2.0 mg/kg	qcyhdmvgiw(jqdnsbbugt) = The incidence of ≥ G3 TRAEs at 2.5 mg/kg was 53%, and the most common ≥G3 TRAEs were anemia (25%), leukopenia (18%), thrombocytopenia (18%), neutropenia (15%), lymphocyte count decreased (15%) wanaexevqy (jdkfikfcuf ) View more	Positive	16 Sep 2024
NCT05262491 (ESMO2024) Manual	Phase 1	Esophageal Squamous Cell Carcinoma	83	BL-B01D1 2.5 mg/kg		Positive	16 Sep 2024
NCT05262491 (BL-B01D1, ESMO2024) Manual	Phase 1	Biliary Tract Neoplasms	39	BL-B01D1 2.5 mg/kg	fykaagjhte(qwiupkazkt) = kvdhmlrqge eeblxehyag (leenzdehak ) View more	Positive	16 Sep 2024
NCT05785039 (BL-B01D1, ESMO2024)	Phase 1/2	Metastatic urothelial carcinoma	32	BL-B01D1 2.2 mg/kg	vvouagusre(cwddgvzkrv) = 22%/0% at 2.2mg/kg jneodgunxj (ypwnkycezy ) View more	Positive	13 Sep 2024
CTR20212923 \| NCT05194982 (Pubmed) Manual	Phase 1	Solid tumor	195	BL-B01D1 0.27 mg/kg	bagpccmoky(shnhbpkaza) = tjkwuwvqwo woijiktrdi (jqyraeckjd ) View more	Positive	01 Jul 2024
NCT05470348 (PRNewswire) Manual	Phase 1	Breast Cancer ER Negative \| HER2 Negative \| PR Negative \| ... View more	127	BL-B01D1	tdhsvwfddr(yvkhiuwupl) = vdtosontjy dcxyofkohz (hoptlweqsg ) View more	Positive	05 Dec 2023

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