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+ [62]

Inactive Indication-

Originator Organization

Systimmune, Inc.

Sichuan Baili Pharmaceuticals Co.,Ltd

Active Organization

Sichuan Baili Pharmaceuticals Co.,Ltd

Bristol Myers Squibb Co.Baili Bio Chengdu Pharmaceutical Co. Ltd.

+ [2]

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), Priority Review (China), 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.

NCT06926868

/ RecruitingPhase 2/3

A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable,or Metastatic Triple-negative Breast Cancer (TNBC)or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

Start Date11 Sep 2025

Sponsor / Collaborator

Bristol Myers Squibb Co.

[+1]

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]

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 Oct 2025·LANCET

Izalontamab brengitecan, an EGFR and HER3 bispecific antibody–drug conjugate, versus chemotherapy in heavily pretreated recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 study in China

Article

Author: Deng, Bin ; Xiao, Sa ; Qin, Xintian ; Qu, Shenhong ; Zhu, Hai ; Han, Yaqian ; Chen, Xiaozhong ; Qin, Yan ; Guo, Ye ; Chen, Shaoqing ; Chen, Lusi ; Fu, Zhichao ; Lei, Feng ; Huang, Jianli ; Wang, Junxian ; Li, Bihui ; Yang, Kunyu ; Wei, Yan ; Liu, Zhigang ; Hong, Jinsheng ; Qu, Song ; Zhu, Yi ; Yang, Yunpeng ; Zhang, Peng ; Zhang, Li ; Zhou, Huaqiang ; Tang, Linquan ; Li, Jingao ; Ji, Dongmei ; Lin, Daren ; Yang, Lei ; Shu, Xiaolei ; Chen, Dongping ; Qiu, Sufang

BACKGROUND:

People with recurrent or metastatic nasopharyngeal carcinoma that progressed after chemotherapy and programmed cell death protein 1 (PD-1) and its ligand (PD-L1) inhibitors have few treatment options and a poor prognosis. We therefore aimed to investigate the efficacy and safety of the bispecific antibody-drug conjugate izalontamab brengitecan (iza-bren) in heavily pretreated individuals with recurrent or metastatic nasopharyngeal carcinoma.

METHODS:

This multicentre, randomised, open-label, phase 3 study was conducted at 55 hospitals in China. Eligible participants were aged 18-75 years with histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that had progressed after at least two lines of systemic chemotherapy including at least one platinum-containing regimen and PD-1 or PD-L1 inhibitors. Participants were randomly assigned (1:1) to receive either iza-bren at 2·5 mg/kg intravenously on days 1 and 8 of each 3-week cycle or chemotherapy. Random assignment was done through an interactive web-based response system, stratified by baseline Eastern Cooperative Oncology Group performance status (0 vs 1), liver metastases, and previous lines of platinum-based chemotherapy (one line vs two or more lines), with a variable block size. The dual primary efficacy endpoints were objective response rate (ORR) assessed by masked independent central review as per Response Evaluation Criteria in Solid Tumours version 1.1 criteria, and overall survival. Progression-free survival, duration of response, and safety were the secondary endpoints. This report is the first planned interim analysis. This trial is registered with ClinicalTrials.gov (NCT06118333) and is ongoing.

FINDINGS:

From Dec 4, 2023, to Feb 21, 2025, 522 patients were screened, of whom 386 were enrolled and randomly assigned to receive either iza-bren (n=191) or chemotherapy (n=195). At a median follow-up of 7·66 months for the iza-bren group and 7·10 months for the chemotherapy group, the ORR by masked independent central review was 54·6% (95% CI 45·2-63·8%) with iza-bren and 27·0% (19·1-36·0%) with chemotherapy (difference 27·9%, 95% CI 15·5-39·4%; p<0·0001). Overall survival data were not mature at data cutoff. Grade 3 or higher treatment-related adverse events occurred in 80% of patients receiving iza-bren and 62% of those receiving chemotherapy. The most common grade 3 or higher treatment-related adverse events in the iza-bren group were haematological, including anaemia (50% vs 10%), decreased white blood cell count (43% vs 44%), decreased platelet count (43% vs 7%), and decreased neutrophil count (38% vs 41%). Non-haematological treatment-related adverse events in the iza-bren group were mostly grade 1 or 2. Serious treatment-related adverse events occurred in 43% of patients receiving iza-bren and 27% of those receiving chemotherapy. Four (2%) treatment-related deaths occurred in the iza-bren group.

INTERPRETATION:

Iza-bren significantly improved the ORR compared with chemotherapy in individuals with heavily pretreated recurrent or metastatic nasopharyngeal carcinoma, with a manageable safety profile. These findings suggest iza-bren might represent a new therapeutic standard for this population. Further analysis will help to fully understand the benefit of this new therapy.

FUNDING:

Baili-Bio (Chengdu) Pharmaceutical.

01 Oct 2025·NATURE MEDICINE

A bispecific antibody–drug conjugate targeting EGFR and HER3 in metastatic esophageal squamous cell carcinoma: a phase 1b trial

Article

Author: Lu, Zhihao ; Zhu, Yi ; Li, Jian ; Liu, Chang ; Ge, Sai ; Liu, Dan ; Qi, Changsong ; Xiao, Sa ; Wang, Zhenghang ; Zhou, Jun ; Lu, Ming ; Sun, Meili ; Zhang, Miao ; Gao, Shegan ; Ji, Yinghua ; Zhu, Ji ; Shen, Lin ; Zhu, Hai ; Zhang, Panpan ; Wang, Yakun ; Ma, Xuelei ; Yuan, Jiajia ; Zhong, Diansheng ; Peng, Zhi ; Cao, Yanshuo ; Gong, Jifang ; Zhang, Xiaotian ; Xue, Ran

Research on patients with advanced esophageal squamous cell carcinoma (ESCC) who have progressed on immunotherapy remains limited. BL-B01D1 is a first-in-class antibody-drug conjugate consisting of an EGFR-HER3 bispecific antibody bound to a topoisomerase I inhibitor (Ed-04) payload via a cleavable linker. Here, we present safety and efficacy data from a phase 1 study of BL-B01D1, in 82 patients previously treated for ESCC. The primary endpoint was the recommended phase 2 dose. Administered doses were 2.0 (n = 22) and 2.5 (n = 60) mg kg^-1 D1D8 infusion every 3 weeks (Q3W). The confirmed objective response rate (cORR) was 29.3% (24 of 82) in all patients and 32.9% (24 of 73) among evaluable patients. For patients dosed at 2.5 mg kg^-1, cORR was 39.6% (21 of 53) and disease control rate was 79.2% (42 of 53). In the 2.0 mg kg^-1 group, cORR was 15.0% (3 of 20), and the disease control rate was 50.0% (10 of 20). The phase 2 dose was established at 2.5 mg kg^-1 D1D8 Q3W. The incidence of G3 treatment-related adverse events at 2.5 mg kg^-1 was 63.3%; most common adverse events were anemia (28.3%), leukopenia and thrombocytopenia (18.3%, each), and neutropenia (16.7%). Two cases of ≥G3 interstitial lung disease were observed. Overall, BL-B01D1 demonstrated promising efficacy and manageable safety in patients with metastatic ESCC. A further phase 3 clinical trial has already been initiated. ClinicalTrials.gov registration: NCT05262491 .

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.

News (Medical) associated with Izalontamab Brengitecan

22 Oct 2025

·www.prnewswire.com

Largest Milestone Payment Secured: Biokin, a Rising Chinese Pharmaceutical MNC

BEIJING, Oct. 22, 2025 /PRNewswire/ -- In October 2025, a partnership between Biokin—a rising star in China's innovative pharmaceutical sector—and global pharmaceutical leader BMS triggered a $250 million milestone payment. This is believed to be the largest antibody-drug conjugate (ADC) milestone payment among hundreds of out-licensing deals involving Chinese innovative drugs. Notably, the overall transaction had previously set a record for the total value of a single-drug asset license in China. Continue Reading iza-bren, a potential first-in-class ADC comprised of an EGFR x HER3 bispecific antibody conjugated In recent years, China's dynamic pharmaceutical ecosystem has rapidly emerged as one of the world's leading sources of novel drug molecules. Such collaborations, however, often come with uncertainties in both China and the U.S. Following the $800 million upfront payment received in early 2024, Biokin's partnership with BMS has advanced smoothly once again. This progress has prompted skeptics to recognize iza-bren's blockbuster potential. The momentum behind the collaboration stems from the continued validation of iza-bren's efficacy. At the 2025 World Congress on Lung Cancer (WCLC), after Dr. Fang Wenfeng presented domestic clinical data, a physician from the prestigious MD Anderson Cancer Center in the U.S. approached him, expressing hope the drug would launch in the U.S. as soon as possible. Such a conversation would have been unimaginable in the past. Despite remarkable progress of China's biopharmaceutical industry over the past decade, nearly all first-in-class new drugs still originate from Western countries. While China has accelerated efforts to bring in overseas innovations, it has also strongly supported domestic pharmaceutical companies and clinical systems in pursuing innovation. Dr. Fang works at the renowned Sun Yat-sen University Cancer Center (SYSUCC), where his team has conducted clinical research on iza-bren for several years. In a study of 50 patients with locally advanced or metastatic EGFR-mutated NSCLC—who had received first-line treatment with other drugs but no chemotherapy—iza-bren controlled tumor progression for over a year, nearly doubling the duration achieved by the current global standard of care. More positive data about iza-bren emerged at the 2025 European Society for Medical Oncology (ESMO) Congress in mid-October. For the first time, results from the pivotal Phase III registration trial of this global first-in-class EGFR×HER3 bispecific ADC were reported: the drug achieved a twofold improvement in key efficacy endpoints in third-line or above treatment for nasopharyngeal carcinoma (NPC). The full study results were published in The Lancet, a leading international medical journal. More than 40 clinical studies of iza-bren are currently underway worldwide, including 10 Phase III registration trials in China and 3 key registration studies overseas. Regulators in China and the U.S. have designated some of these studies as "Breakthrough Therapies" to expedite development. The drug is expected to launch first in China in 2026—three years earlier than its planned U.S. launch—marking a milestone moment for China's innovative pharmaceutical sector. Growing industry consensus on iza-bren's blockbuster potential began at the 2023 ASCO Annual Meeting. At the time, Professor Zhang Li from SYSUCC first reported promising efficacy signals of the drug's Phase I trial. Iza-bren's unique bispecific ADC technology and its ability to target two high-value antigens (EGFR and HER3) have endowed it with strong efficacy and broad applicability. This has attracted multinational pharma giants facing looming patent cliffs and eager to expand their ADC portfolios. BMS reached a global co-development and commercialization agreement with Biokin, the developer of iza-bren, at a potential total value of up to $8.4 billion. Biokin distinguishes itself among China's biotech companies with its unconventional approach. It transitioned from a generic drug manufacturer, and its founder, Zhu Yi, holds no medical degrees from Europe or the U.S., nor has he worked at multinational pharmaceutical companies. Over a decade ago—when the Chinese government first began mapping out the blueprint for its innovative drug ecosystem—Zhu made a firm decision to go all-in on innovative drug R&D. In 2014, amid a global downturn in drug development, he established a lean scientific team in Seattle, U.S., marking the start of his drug R&D journey. Zhu fully leveraged the strengths of both the Chinese and U.S. biopharmaceutical ecosystems: in the U.S., he accessed resources that support early-stage innovation; in China, the efficient regulatory system, large pool of engineers, and abundant patient resources enabled the rapid translation of innovative ideas into reality. Zhu negotiated distinctive terms with BMS: beyond the substantial financial offer, he secured overseas R&D and commercialization rights. He firmly believes the latter is essential for Biokin to truly join the ranks of global pharmaceutical companies. The establishment and progress of this ambitious collaboration model have empowered Biokin to send a strong message for China's biotech industry: to become a multinational company within five years. Beyond iza-bren, Biokin also announced clinical trial results for T-bren, its second ADC drug in Phase III, at the ESMO Congress. Targeting common cancers such as lung, gastric, and breast cancer, T-bren also showed strong signals of becoming a best-in-class drug. Additionally, China's CDE recently approved Biokin's first antibody-radionuclide conjugate (ARC) drug to enter clinical trials. Biokin's story has captured the market's attention. On China's mainland stock exchanges, its market value has surged 15-fold in just over two years. Now, Hong Kong's capital market is embracing the company. Amid the hesitation of onlookers, Biokin may well emerge as a global leader in biopharmaceuticals. SOURCE Biokin WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultADCPhase 1License out/in

22 Oct 2025

·www.biospace.com

ADC, Bispecifics and Kinase Blockers Steal the Spotlight at ESMO 2025 in Berlin

The Spree River, Berlin, Germany iStock, TomasSereda Pfizer, Merck, AstraZeneca and Bristol Myers Squibb were among the many biopharmas showing off novel cancer modalities at ESMO, with antibody-drug conjugates, bispecific antibodies and kinase inhibitors demonstrating encouraging efficacy and safety for various cancers. The 2025 congress of the European Society for Medical Oncology came to a close on Tuesday, wrapping up five days of cutting-edge cancer research that pushed the boundaries of the field. Here, BioSpace rounds up the impactful and cutting-edge presentations at ESMO, the ones most likely to push forward patients’ clinical care and the broader biopharma industry. ADC Arena Heats Up Pfizer and Merck made waves in the antibody-drug conjugate sector, joining together to combine the former’s ADC Padcev with the latter’s mega-blockbuster PD-1 inhibitor Keytruda. Interim data from the Phase III EV-303/KEYNOTE-905 trial showed that the combo regimen reduced by 60% the risk of tumor recurrence, progression or death in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin treatment. Padcev plus Keytruda also led to a 50% improvement overall survival versus surgery alone, an effect that was statistically significant. Analysts at Guggenheim Partners wrote in a Tuesday note that these findings point to the “potential to change standard-of-care treatment for cisplatin-ineligible MIBC patients” and are likely to “provide [a] tailwind” for Padcev. Aside from its Padcev partnership, Merck showed work from its ADC alliance with China’s Sichuan Kelun-Biotech, which has the companies working on the anti-TROP2 ADC sacituzumab tirumotecan, being tested for EGFR-mutated non-small cell lung cancer (NSCLC). Results from a Phase III trial, conducted in China , demonstrated a significant 51% reduction in the risk of death or disease progression. Overall survival (OS) outcomes were likewise significant, with the ADC suppressing the likelihood of death by 40% versus pemetrexed plus platinum-based chemotherapy. Also in the TROP2 game is AstraZeneca with its Daiichi Sankyo–partnered ADC Datroway. At ESMO, the companies showed that Datroway resulted in a significant 43% progression-free survival (PFS) improvement in patients with locally recurrent or metastatic triple-negative breast cancer. The partners also presented data for the HER2-targetig ADC Enhertu. In patients with HER2-positive early breast cancer with residual invasive disease, the therapy resulted in a 53% decrease in the likelihood of death or recurrent invasive disease, as compared with Roche’s Kadcyla. Disease-free survival in these patients likewise improved by 53% after Enhertu treatment. Likewise presenting data at ESMO are Bristol Myers Squibb and SystImmune, which are advancing iza-bren, a bispecific ADC targeting both the EGFR and HER3 proteins. Phase I data pointed to “ promising antitumor activity ,” the companies said, with a confirmed response rate of 55% and a median PFS of 5.4 months. As for safety, common side effects were blood-related, including neutropenia, though most were generally manageable and “rarely” necessitated dose reductions. BMS and SystImmune are testing iza-bren for advanced solid tumors, including metastatic or unresectable NSCLC. Bispecifics on the Rise One of the most highly anticipated presentations at ESMO was for Akeso and Summit Therapeutics’ PD-1/VEGF bispecific antibody ivonescimab, which the partners are testing for advanced NSCLC. In the Phase III HARMONi-6 study, patients treated with ivonescimab plus chemotherapy saw a 40% PFS advantage versus those who were treated with BeOne’s PD-1 inhibitor Tevimbra plus chemotherapy. The companies did not release OS data, but analysts at Truist Securities were nevertheless encouraged by the ESMO presentation. The PFS readout, the analysts wrote, “leaves no room for doubts at this juncture, in our view,” for the benefit of ivonescimab as a frontline NSCLC treatment option. Summit, which is in charge of ivonescimab in the U.S., is planning a regulatory filing for the asset by year-end, management said in its Q3 call earlier this week. The company is specifically eyeing an approval for second-line EGFR-mutated NSCLC. Cutting off the Cascade Kinase blockers gained their own head of steam at ESMO. These are drugs that block signaling cascades that otherwise culminate in a tumor’s growth and proliferation. One such asset is zongertinib, developed by Boehringer Ingelheim for HER2-mutant advanced NSCLC. In the Phase Ib Beamion LUNG-1 study, zongertinib resulted in a 77% objective response rate and 96% disease control rate. Of note, 8% of responders showed no detectable signs of cancer in the body after treatment, while 69% reached partial treatment response. While data were not yet mature at the time, Boehringer reported an “encouraging” 79% PFS rate at six months. Going up against Boehringer is Bayer, which is developing its own tyrosine kinase inhibitor sevabertinib, likewise for HER2-mutated NSCLC. Bayer released results from a Phase I/II study, showing that in those who had been previously treated but not with a HER2-targeted agent, objective response rate reached 64% , which lasted for a median of 9.2 months. Meanwhile, in patients who had been exposed to an anti-HER2 ADC, response rate was 38% and lasted for 8.5 months. Bayer also tested sevabertinib in treatment-naive patients, of whom 71% responded to the agent, with a median duration of 11 months. There was action at ESMO for kinase inhibitors beyond NSCLC. Exelixis, for instance, tested its drug zanzalintinib for metastatic colorectal cancer (mCRC), touting a median overall survival of 10.9 months versus 9.4 months in comparators treated with Bayer’s Stivarga. OS estimates for zanzalintinib at 12 and 24 months were 46% and 20%, respectively. Analysts were effusive about these results, with William Blair saying in a Monday note that zanzalintinib set “a new survival bar in the third-line or later mCRC setting.” Exelixis is taking the drug to the FDA with these data and anticipates a filing within the year.

Clinical ResultADCPhase 3Phase 1

21 Oct 2025

·endpoints.news

'Decade of the ADCs' continues as AstraZeneca, Kelun and Merck take the stage at ESMO

Two years ago at the European Society for Medical Oncology’s annual meeting, a prominent oncologist predicted that the 2020s would be the “decade of the ADCs.” There were several high-value ADC-focused deals in 2023 ahead of that meeting, a trend that continued through the rest of 2023 and into 2024. While dealmaking has since slowed, the hype around ADCs has not. They’re still expected to become the backbone of care for many cancers in place of traditional chemotherapy, thanks to their ability to deliver cytotoxic payloads in a more targeted way. And they’re still a hot topic at this year’s meeting in Berlin. We’ve rounded up the most impactful ADC data presented at ESMO this year: AstraZeneca and Daiichi’s Enhertu took center stage at a presidential symposium on Saturday, when the companies shared topline data from the DESTINY-Breast11 trial. The study evaluated the drug, which is the best-selling ADC out of the 17 approved globally, in the potentially “curative” neoadjuvant setting of early breast cancer. In the same session, the companies reported results from a second Phase 3 study called DESTINY-Breast05, which enrolled a slightly more advanced group of early breast cancer patients. They had residual invasive disease after surgery and neoadjuvant treatment, and were at a high risk of disease recurrence. Enhertu cut the risk of recurrence or death in these patients by 53% compared with Roche’s Kadcyla, the standard of care. The readouts “underscore the potential of Enhertu to become a foundational treatment in early-stage breast cancer,” AstraZeneca head of oncology R&D Susan Galbraith said in a release. But Enhertu has competition in China for one of its current indications: previously treated unresectable or metastatic HER2+ breast cancer. Sichuan Kelun-Biotech’s HER2-targeting ADC trastuzumab botidotin clinched an approval in that setting just days ago. That decision was based on data from Kelun’s Phase 3 study, which were presented on Monday. More than 75% of patients who received the China drug saw their tumors shrink compared with 53% of those given Kadcyla. Trastuzumab botidotin also achieved a median progression-free survival of 11.1 months versus 4.4 months for Kadcyla. Meanwhile, Merck said its Kelun-partnered TROP-2-directed ADC called sacituzumab tirumotecan, also known as sac-TMT, reduced the risk of death in a Phase 3 trial in certain previously treated non-small cell lung cancer patients. The study , also conducted in China, enrolled patients with EGFR-mutated NSCLC who had failed on treatment with an EGFR tyrosine kinase inhibitor and platinum-based chemotherapy. At a median follow-up of 18.9 months, Sac-TMT achieved an 8.3-month median progression-free survival compared to 4.3 months for patients who received chemotherapy. Median overall survival was not reached in the sac-TMT arm at a pre-specified interim analysis, versus 17.4 months in the chemotherapy arm. Merck struck a deal with Kelun for exclusive rights to develop, manufacture and commercialize sac-TMT outside of Greater China. Bispecific approaches were also hot at the confab, including an EGFRxHER3-targeting ADC developed by Bristol Myers Squibb and SystImmune. The companies on Friday shared the first data from a global Phase 1 trial of iza-bren. The 2.5 mg/kg dose produced confirmed responses in 11 out of 20 patients with previously treated EGFR-mutated non-small cell lung cancer. Separate from its work with Daiichi , AstraZeneca has seven in-house ADC assets, including one directed at FRα. In 56 platinum-resistant ovarian cancer (PROC) patients with high FRα expression enrolled in a first-in-human trial, AZD5335 achieved response rates of about 61% among patients who took one of three dose levels. The overall response rate in patients with low FRα expression at those dose levels was almost 48%, according to a congress abstract. Elsewhere in the FRα pipeline , Genmab’s rinatabart sesutecan is already in Phase 3 development. The company previously reported the drug hit a 50% ORR in heavily pretreated advanced endometrial cancer patients enrolled in a Phase 1/2 study. On Saturday, it was revealed that more than 60% of responders maintained their responses for about a year. Eli Lilly’s contender with the same target , known as LY4170156, also had new early-stage data to share. The drug achieved ORRs ranging from 33% to 61% depending on the dose. Lilly’s Phase 1 study was in patients with PROC, according to a congress abstract. Tubulis is also trying to treat PROC with an ADC , albeit with a different target. The biotech’s NaPi2b-directed candidate, TUB-040, attained a 50% confirmed ORR in a first-in-human study. Last week, the company bagged $361 million in a Series C raise, becoming the latest ADC company to pull in big bucks in recent years. Nicole DeFeudis contributed reporting.

Clinical ResultPhase 1Phase 3ADCLicense out/in

100 Deals associated with Izalontamab Brengitecan

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
ER-low Breast cancer	Phase 3	United States	Baili Bio Chengdu Pharmaceutical Co. Ltd.	04 Nov 2025
ER-low Breast cancer	Phase 3	China	Baili Bio Chengdu Pharmaceutical Co. Ltd.	04 Nov 2025
ER-low Breast cancer	Phase 3	Japan	Baili Bio Chengdu Pharmaceutical Co. Ltd.	04 Nov 2025
ER-low Breast cancer	Phase 3	Argentina	Baili Bio Chengdu Pharmaceutical Co. Ltd.	04 Nov 2025
ER-low Breast cancer	Phase 3	Australia	Baili Bio Chengdu Pharmaceutical Co. Ltd.	04 Nov 2025
ER-low Breast cancer	Phase 3	Austria	Baili Bio Chengdu Pharmaceutical Co. Ltd.	04 Nov 2025
ER-low Breast cancer	Phase 3	Brazil	Baili Bio Chengdu Pharmaceutical Co. Ltd.	04 Nov 2025
ER-low Breast cancer	Phase 3	Canada	Baili Bio Chengdu Pharmaceutical Co. Ltd.	04 Nov 2025
ER-low Breast cancer	Phase 3	Chile	Baili Bio Chengdu Pharmaceutical Co. Ltd.	04 Nov 2025
ER-low Breast cancer	Phase 3	Colombia	Baili Bio Chengdu Pharmaceutical Co. Ltd.	04 Nov 2025

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06118333 (BL-B01D1-303, ESMO2025)	Phase 3	Nasopharyngeal Carcinoma	386	Iza-bren 2.5 mg/kgIza-bren 2.5 mg/kg	qebldrxpjk \| bibvadhhgv(vrfzpqordh) = dqblvlimgb rkeurxpmzx (sqfrmsmbjd ) View more	Positive	17 Oct 2025
				TPC (capecitabine, gemcitabine, docetaxel)capecitabinebgemcitabinexdocetaxel	qebldrxpjk \| bibvadhhgv(vrfzpqordh) = bdnrpldwdc rkeurxpmzx (sqfrmsmbjd ) View more
NCT05983432 (BL-B01D1-LUNG-101 \| US-Lung-101 study, ESMO 12025 \| ESMO 22025 \| Company_Website) Manual	Phase 1	Solid tumor \| Non-Small Cell Lung Cancer	113	Iza-bren (all doses)	wpnhmjbawb(scepvypstd) = uafcrgpvpi xgqjpecrpn (vboqrxzyuv ) View more	Positive	13 Oct 2025
				Iza-bren (1.5 mg/kg D1D8 Q3W)	wpnhmjbawb(scepvypstd) = lytxzcgama xgqjpecrpn (vboqrxzyuv ) View more
NCT05990803 \| NCT05803018 (ESMO 12025 \| ESMO 22025) Manual	Phase 1/2	Recurrent ovarian cancer	96	iza-bren	lbrtcxrzek(yrpyjritkv) = wqvesevwgx zgezgbfvek (cjidknvsub ) View more	Positive	13 Oct 2025
				iza-bren (2.0 mg/kg Q3W)	lbrtcxrzek(yrpyjritkv) = vasiidkgts zgezgbfvek (cjidknvsub ) View more
NCT05785039 (BL-B01D1-201, Pubmed \| J Clin Oncol) Manual	Phase 2	Metastatic urothelial carcinoma	41	BL-B01D1 2.2 mg/kg	frsdrhcznh(ifxykpjjzt) = cawxjsuaxo pcgbxmqdal (iethevuhxi, 27.2 - 62.1) View more	Positive	08 Oct 2025
				BL-B01D1 2.5 mg/kg	-
NCT06118333 (Pubmed \| Lancet)	Phase 3	Nasopharyngeal Carcinoma	386	Izalontamab brengitecan	mpjoqrzzzs(uqsqrqjuwb) = pvaocazsxi zvyljykacw (hmqoiqzmof ) View more	Positive	01 Oct 2025
				Chemotherapy	cdvhcbqshc(wqsfrljdmb) = byjccjfaok gmwyalkxcb (oemixjrwog, 19.1 - 36.0) View more
NEWS Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR Mutation	40	iza-bren 2.5mg/kg +奥希替尼	qkfjgvhezb(ycexuqgrkf) = zrlpkflmht dgitvxwkja (wlogvdpdhr ) View more	Positive	11 Sep 2025
WCLC2025 Manual	Phase 1/2	EGFR-mutated non-small Cell Lung Cancer Second line \| Third line EGFR Mutation	172	Iza-Bren (BL-B01D1)	qqufscpiwu(grfsufyixh) = qkfacmiprj uimczjczhf (weqivymwvg, 5.5 - 9.6) View more	Positive	09 Sep 2025
				Iza-Bren (BL-B01D1) (2.5 mg/kg D1D8 Q3W)	qqufscpiwu(grfsufyixh) = dfhvxciouj uimczjczhf (weqivymwvg, 5.5 - 9.7) View more
NCT05880706 (WCLC2025) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR Mutation (Sensitizing)	154	iza-bren + osimertinib	qytvpfgdjb(ygudjnxdrq) = gqmcjpnjnr tnyhmbtomi (wtskhjrgly ) View more	Positive	08 Sep 2025
				iza-bren + osimertinib (2.2 mg/kg (D1D8 Q3W))	qytvpfgdjb(ygudjnxdrq) = muizachxmr tnyhmbtomi (wtskhjrgly ) View more
NEWS Manual	Phase 3	Nasopharyngeal Carcinoma	-	伦康依隆妥单抗	edgytqdqiz(wpphzmljmh) = 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 mtjbqnzpcm (lcffvjqlnv ) Met	Positive	16 Jul 2025
NCT05262491 (Pubmed) Manual	Phase 1	Metastatic Esophageal Squamous Cell Carcinoma	82	BL-B01D1 2.0 mg/kg	apozpmodex(wymtcjezax) = established at 2.5 mg kg-1 D1D8 Q3W givheqxsze (pthzlnsjnp ) View more	Positive	10 Jul 2025
				BL-B01D1 2.5 mg/kg

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