izalontamab brengitecan (BL-B01D1) / Biokin Pharma, BMS - LARVOL DELTA

Phase II study of iza-bren (BL-B01D1) in combination with serplulimab in patients with small cell lung cancer (SCLC) (ELCC 2026) - P2 | "In stage II, treatment-naive pts were treated with iza-bren at 2.5 or 2.75 mg/kg D1D8 Q3W plus serplulimab or plus serplulimab and anlotinib. Legal entity responsible for the study Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. Funding Baili-Bio (Chengdu) Pharmaceutical Co., Ltd."

Clinical • Combination therapy • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

At European Lung Cancer Congress 2026, new data from the phase II BL-B01D1-204-01 study provide promising evidence for a novel approach combining a bispecific antibody-drug conjugate with immunotherapy in extensive-stage small cell lung cancer. (OncoDaily) - "The overall response rate reached 88.3%, with a confirmed response rate of 77.9%, indicating that a substantial proportion of patients experienced meaningful tumor shrinkage. Disease control was achieved in 94.8% of patients, reflecting broad clinical benefit...Median progression-free survival was 8.2 months, which compares favorably with historical outcomes in extensive-stage small cell lung cancer...In addition, early survival signals were encouraging, with a 12-month overall survival rate of 80.8% in the overall cohort, highlighting the potential impact of this approach in extensive-stage small cell lung cancer."

P2 data • Small Cell Lung Cancer

Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic breast cancer (BC) (ESMO-BC 2025) - P1 | "In heavily pre-treated locally advanced or metastatic HER2- BC, iza-bren has demonstrated encouraging efficacy with a manageable safety profile, including in pts with HER2 zero expression."

Clinical • Metastases • P1 data • Breast Cancer • Oncology • Solid Tumor • HER-2

Recent highlights and breakthroughs in immunotherapy for head and neck cancers. (PubMed, Curr Opin Oncol) - "Recent advances highlight a rapid surge in positive immunotherapy trials across different head and neck cancer entities, with clinical benefit observed both when immune checkpoint inhibitors are moved earlier in the disease course and when they are combined with agents targeting resistance mechanisms or enabling more precise drug delivery to tumors."

IO biomarker • Journal • Head and Neck Cancer • Nasopharyngeal Carcinoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • BRAF

Preclinical efficacy and safety of CS5007, an EGFR×HER3 dual-targeting antibody-drug conjugate with a topoisomerase 1 inhibitor payload (AACR 2026) - "It also showed superior in vitro cytotoxicity over a bispecific control ADC (BL-B01D1 analog) and monospecific EGFR- or HER3-targeting ADCs in various tumor cell lines, including an osimertinib-resistant NSCLC model. With demonstrated enhanced signaling inhibition, superior efficacy across multiple solid tumor models, and a favorable safety margin in preclinical studies, CS5007 is planned for an IND submission in early 2026 to support clinical development in advanced solid tumors."

ADC • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase I global study of Iza-Bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with metastatic or unresectable non-small cell lung cancer (NSCLC) and other solid tumors (ESMO 2025) - "# Non-evaluable: pts who discontinued or died without post-baseline tumor assessment Conclusions Iza-bren has demonstrated encouraging efficacy with an acceptable safety profile in multiple tumor types, including NSCLC and BC in this first report of a global population, consistent with the strong efficacy previously reported in Chinese pts. A global registrational study of first line TNBC is ongoing, while studies in other tumor types are planned."

Clinical • Metastases • P1 data • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • CSF3

JS212, a novel bispecific ADC targeting EGFR and HER3, demonstrates superior and broad antitumor activity in preclinical evaluation (AACR 2026) - "JS212 also had better antitumor activity than BL-B01D1 in an osimertinib-resistant HCC827 model. Additionally, JS212 induced near complete regression in either BL-B01D1 or patritumab-deruxtecan resistant SW620 model... JS212 is a promising EGFR and HER3 dual targeting ADC that shows superior and broad-spectrum antitumor activities and a favorable safety and pharmacokinetic profiles in preclinical evaluation, supporting its first-in-human studies. Its phase I clinical trial is ongoing, and results will be reported elsewhere."

ADC • Bispecific • First-in-human • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • ERBB3

Phase I/II Study of Iza-Bren (BL-B01D1) as Monotherapy in Patients With Locally Advanced or Metastatic EGFR Mutated NSCLC (IASLC-WCLC 2025) - P3 | "Conclusions : In previously treated EGFRmt NSCLC pts, iza-bren demonstrated promising efficacy with a manageable safety profile. Phase 3 registrational study of iza-bren as monotherapy in EGFRmt NSCLC after progression on a third generation TKI is ongoing in China (NCT06382116)."

Clinical • Metastases • Monotherapy • P1/2 data • Alopecia • Anemia • Dental Disorders • Immunology • Interstitial Lung Disease • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Stomatitis • Thrombocytopenia • EGFR

SystImmune, Inc. to Present New iza-bren (izalontamab brengitecan) Data in Extensive Stage Small Cell Lung Cancer at ELCC 2026 (PRNewswire) - "The safety and efficacy results of iza-bren in combination with serplulimab in treatment-naive patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) will be presented at ELCC. The data highlight the continued progress of iza-bren clinical development in China..."

P2 data • Small Cell Lung Cancer

Tri-specific ADC platform offers potential therapeutic advantage over bi-specific ADC (AACR 2026) - "in vivo efficacy was tested in murine xenograft models representing diverse target antigen profiles, in comparison with benchmarks Izalonatamab brengitecan (BL-B01D1, EGFR/HER3 bispecific ADC) and an Amivantamab (EGFR/c-MET bispecific mAb )-derived ADC...In conclusion, tri-specific ADCs offer a robust advantage in vitro and in vivo over EGFR/HER3 or c-MET bispecifics by enabling enhanced tumor cell binding, improved internalization, and more effective delivery of cytotoxic agents. This strategy holds promise for broader clinical application in tumors with varied receptor expressions and may address resistance in heterogeneous cancers."

ADC • Bispecific • IO biomarker • Trispecific • Oncology • CD276 • EGFR • ERBB3 • HER-2 • MET • PD-L1

Antibodies to watch in 2026. (PubMed, MAbs) - "In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab...Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by..."

Journal • Review • Oncology

Efficacy and Safety of BL-B01D1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma: A Phase II Clinical Trial. (PubMed, J Clin Oncol) - "BL-B01D1 showed promising preliminary efficacy and a favorable safety profile at 2.2 mg/kg in patients with la/mUC who had progressed after systemic therapy. These results suggest that BL-B01D1 could be a promising new agent for patients with la/mUC with few treatment options."

Journal • P2 data • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • Urothelial Cancer

Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic small cell lung cancer (SCLC). (ASCO 2025) - P1, P3 | "In SCLC pts, iza-bren has demonstrated an encouraging efficacy with a manageable safety profile. Notably, the high confirmed response rate of 75% in pts with limited prior treatment underscores its potential as a novel therapeutic option for SCLC, a disease with limited therapeutic advancements over decades. The phase III study of iza-bren in SCLC pts who received 1 prior line of PD(L)-1 and PBC combination treatment is ongoing (NCT06500026)."

Clinical • Metastases • P1 data • Anemia • Dental Disorders • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Leukopenia • Lung Cancer • Neutropenia • Oncology • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • Stomatitis • Thrombocytopenia

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. (PubMed, Lancet) - P3 | "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."

Journal • P3 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Trial in progress: A phase 2/3 trial of iza-bren (BMS986507/BL-B01D1), an EGFRxHER3 antibody-drug conjugate, vs standard-of-care chemotherapy in patients with previously untreated, locally advanced, recurrent inoperable, or metastatic triple negative breast cancer ineligible for anti-PD-(L)1 treatment (IZABRIGHT-Breast01) (SABCS 2025) - P2/3 | " IZABRIGHT-Breast01 (NCT06926868) is an open-label, randomized phase 2/3 trial evaluating the efficacy and safety of iza-bren vs chemotherapy of investigator's choice (paclitaxel, nab-paclitaxel, capecitabine, or carboplatin plus gemcitabine) in patients with previously untreated, locally advanced, recurrent inoperable or metastatic TNBC or estrogen receptor (ER)-low, HER2-negative BC who are ineligible for approved anti-programmed death-1/programmed death ligand 1 (PD-[L]1)-based treatment combinations or endocrine therapy-based treatments, respectively. The key secondary endpoint is overall survival. Other secondary endpoints include investigator-assessed PFS, objective response, disease control rate, duration of response, time to response, time to subsequent treatment, PFS after next line of treatment, safety, and health-related quality of life."

Clinical • Metastases • P2/3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • BRCA2 • ER • HER-2 • PGR

CA244-0010: IZABRIGHT-Lung01: Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy (clinicaltrialsregister.eu) - P2/3 | N=193 | Not yet recruiting | Sponsor: Bristol-Myers Squibb Services Unlimited Company

New P2/3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CA2440012: Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy (clinicaltrialsregister.eu) - P2/3 | N=198 | Recruiting | Sponsor: Bristol-Myers Squibb Services Unlimited Company

New P2/3 trial • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Phase II Study of Iza-Bren (BL-B01D1) Combo With Osimertinib in EGFR Mutated Locally Advanced or Metastatic NSCLC Patients (IASLC-WCLC 2025) - "No new safety signals were observed. Conclusions : iza-bren in combination with Osi has demonstrated promising activity with a manageable safety profile in first-line EGFRmt NSCLC pts."

Clinical • Metastases • P2 data • Alopecia • Anemia • Dental Disorders • Immunology • Interstitial Lung Disease • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Stomatitis • Thrombocytopenia • EGFR

Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with driver genomic alterations (GA) outside of classic EGFR mutations. (ASCO 2025) - P1 | "In NSCLC pts with these GAs, iza-bren showed promising activity with a manageable safety profile, supporting further evaluation of iza-bren in these populations. Note: [1] Including pts w/o post-baseline scan."

Clinical • Metastases • P1 data • Alopecia • Anemia • Dental Disorders • Immunology • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis • Thrombocytopenia • ALK • BRAF • HER-2 • KRAS • NTRK • ROS1 • SMARCA4

IZABRIGHT-Bladder01: A randomized, open-label, phase 2/3 trial of izalontamab brengitecan (iza-bren; BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), vs platinum-based chemotherapy (PBC) for patients (pts) with advanced urothelial cancer (aUC) and disease progression on or after immunotherapy. (ASCO-GU 2026) - P2/3 | "This global, randomized, open-label, phase 2/3 trial evaluates the efficacy and safety of iza-bren vs PBC (gemcitabine + cisplatin or carboplatin) in pts with aUC who progressed on or after anti–PD-(L)1-based therapy. Further HRQoL is exploratory. Enrollment is ongoing (ClinicalTrials.gov: NCT07106762)."

Clinical • Metastases • P2/3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Izalontamab Brengitecan in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations Outside of Classical EGFR Mutations: A Phase Ib Study. (PubMed, J Clin Oncol) - "iza-bren demonstrated encouraging antitumor activity and a manageable safety profile in pretreated NSCLC patients with diverse GAs outside of classical EGFR mutations, especially in EGFR exon20ins/nonclassical and HER2 mutations."

Journal • P1 data • Dental Disorders • Interstitial Lung Disease • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Stomatitis • Thrombocytopenia • ALK • BRAF • EGFR • HER-2 • KRAS • MET • NTRK • ROS1

SystImmune and Bristol Myers Squibb Highlight Positive Phase III Interim Topline Results for izalontamab brengitecan (Iza-bren) in Previously Treated Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (Bristol-Myers Squibb Press Release) - "In the pre-specified interim analysis, topline results showed that iza-bren demonstrated statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) compared to chemotherapy of physician’s choice, meeting both dual primary endpoints...This Phase III study represents the third Phase III trial in which iza-bren has achieved its primary endpoint(s)....These data will be presented at an upcoming medical meeting."

P3 data: top line • Triple Negative Breast Cancer

Recent advances in bispecific antibody-drug conjugates for breast cancer therapy. (PubMed, Cancer Chemother Pharmacol) - "BsADCs are a transformative therapeutic modality for breast cancer. Their ability to enhance tumor selectivity, overcome heterogeneity, and target resistant pathways positions them as key players in the future oncology landscape, with ongoing trials poised to define their clinical role."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD63 • EGFR • ERBB3 • HER-2

Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of BL-B01D1 for Injection in Patients with Locally Advanced or Metastatic Solid Tumors (ChiCTR) - P1 | N=500 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sichuan Baili Pharmaceutical Co., Ltd.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • BRAF • EGFR • HER-2 • KRAS • MET • NTRK • RET • ROS1

BL-B01D1-204-11: A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=206 ➔ 96

Enrollment change • Cervical Cancer • Endometrial Cancer • Oncology • Solid Tumor • PD-L1