izalontamab (SI-B001) / Sichuan Biokin Pharmaceutical - LARVOL DELTA

Phase II study of izalontamab (SI-B001) in combination with paclitaxel or docetaxel in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). (ASCO 2026) - P2 | "Izalontamab in combination with paclitaxel showed encouraging antitumor activity and a manageable safety profile in patients with R/M HNSCC who were previously treated with anti-PD-(L)1 therapy."

Clinical • Combination therapy • Metastases • P2 data • Head and Neck Cancer • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR • ERBB3

SI-B001 plus chemotherapy in patients with locally advanced or metastatic EGFR/ALK wild-type non-small cell lung cancer: A phase II, multicenter, open-label study. (ASCO 2023) - P2 | "SI-B001 plus docetaxel demonstrated antitumor activity in locally advanced or metastatic NSCLC EGFR/ALK wild-type pts who failed on prior first-line anti-PD-1/L1 antibody plus PBC, especially without AGA. The toxicity of SI-B001 + docetaxel was manageable. These findings support the continued investigation of SI-B001 and docetaxel as a treatment option in NSCLC."

Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

Izalontamab brengitecan (iza-bren) versus chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC): A multicenter, randomized, open-label, phase III study. (ASCO 2026) - P3 | " Pts with recurrent or metastatic ESCC who had progressed after first-line treatment with a PD-1/PD-L1 inhibitor plus platinum-based chemotherapy were randomized (1:1) to receive iza-bren (2.5 mg/kg at D1D8 Q3W) or physician's choice of chemotherapy (irinotecan, paclitaxel, or docetaxel Q3W). The study met both dual primary endpoints at prespecified interim analysis. Iza-bren demonstrated statistically significant and clinically meaningful improvements in OS and PFS compared with chemotherapy in pts with recurrent or metastatic ESCC who had progressed after first line PD-1/PD-L1 inhibitor plus platinum-based chemotherapy. The safety profile was manageable."

Clinical • Metastases • P3 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

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

Izalontamab brengitecan (iza-bren) versus physician's choice of chemotherapy in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC): A randomized phase III study. (ASCO 2026) - P3 | "Patients were randomized 1:1 to receive iza-bren (2.5 mg/kg D1D8 Q3W) or treatment of physician's choice (TPC) (eribulin, capecitabine, gemcitabine, or vinorelbine). This pre-planned interim analysis met both dual-primary endpoints of PFS by BICR and OS. Iza-bren demonstrated a statistically significant and clinically meaningful improvement in both PFS and OS compared with chemotherapy, with a manageable safety profile in heavily pre-treated TNBC patients, supporting iza-bren as a new standard of care in this population."

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Izalontamab (SI-B001), a novel EGFRxHER3 bispecific antibody in patients with Locally Advanced or Metastatic Epithelial Tumor: Results from first-in-human phase I/Ib study. (PubMed, Clin Cancer Res) - "Izalontamab was well tolerated and demonstrated preliminary antitumor activity in patients with locally advanced or metastatic epithelial tumors, supporting it as a promising therapeutic candidate for combination therapies, with a phase 3 study currently underway."

Journal • P1 data • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study of SI-B001+SI-B003 Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=70 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=130 ➔ 70

Enrollment change • Enrollment closed • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of SI-B001+SI-B003 Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=95 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=160 ➔ 95

Enrollment change • Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Clinical Study of SI-B001 in Combination With Paclitaxel/Docetaxel in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov) - P2 | N=45 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy (clinicaltrials.gov) - P2/3 | N=470 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

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

A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - P3 | N=540 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P3 trial • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - P3 | N=384 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Initiation date: May 2025 ➔ Aug 2025

Platinum resistant • Trial initiation date • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy (clinicaltrials.gov) - P2/3 | N=470 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02) (clinicaltrials.gov) - P3 | N=850 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

Monotherapy • New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

MODULE 1: Evolving Role of Antibody-Drug Conjugates (ADCs) in the Management of Metastatic Triple-Negative Breast Cancer (mTNBC) (ASCO 2026) - "Supported by This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Daiichi Sankyo Inc. Scientific rationale for investigating TROP2-directed ADCs for previously untreated mTNBC Key efficacy and safety data from the Phase III ASCENT-04/KEYNOTE-D19 and ASCENT-03 trials evaluating sacituzumab govitecan in combination with pembrolizumab and as monotherapy for patients with previously untreated PD-L1-positive and PD-L1-negative mTNBC, respectively Published data from the Phase III TROPION-Breast02 study of first-line datopotamab deruxtecan (Dato-DXd) versus chemotherapy for patients with advanced TNBC for whom immunotherapy was not an option Recent FDA approval of Dato-DXd for patients with previously untreated mTNBC who are not candidates for PD-1/PD-L1 inhibitor therapy; current clinical utility of this strategy and potential role of sacituzumab govitecan in the up-front setting Updated data with trastuzumab deruxtecan (T-DXd) in the..."

ADC • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

MODULE 4: Emerging Role of Bispecific Antibody-Based Approaches in the Treatment of EGFR-Mutated NSCLC (ASCO 2026) - "Supported by This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, and Johnson & Johnson. Available data with and current role, if any, of immune checkpoint inhibitors in therapy for patients with NSCLC and EGFR mutations Mechanism of antitumor activity of the PD-1 x VEGF bispecific antibody ivonescimab; rationale for its investigation in pretreated EGFR-mutant NSCLC Design, eligibility criteria and efficacy and safety findings from the Phase III HARMONi trial evaluating ivonescimab in combination with carboplatin and pemetrexed for patients with EGFR-mutated NSCLC after disease progression on a third-generation TKI Recent acceptance of a biologics license application for ivonescimab/chemotherapy for pretreated EGFR-mutated NSCLC; potential role in clinical practice Structural components and mechanism of action of the first-in-class bispecific antibody-drug conjugate izalontamab brengitecan (iza-bren) Available..."

Bispecific • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • PD-1

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01) (clinicaltrials.gov) - P2/3 | N=500 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: May 2031 ➔ Nov 2030 | Trial primary completion date: Sep 2028 ➔ Dec 2028

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

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=207 | Recruiting | Sponsor: Bristol-Myers Squibb Services Unlimited Company

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

A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cance (clinicaltrials.gov) - P3 | N=562 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

EGFR- and HER3-targeted bispecific antibody-drug conjugate demonstrates anti-tumor activity in metastatic castration-resistant prostate cancer. (PubMed, J Clin Invest) - "Izalontamab brengitecan (Iza-bren; BL-B01D1) is a bispecific ADC targeting EGFR and HER3 that has demonstrated activity in other malignancies. Importantly, tumor tissue obtained at progression after BL-B01D1 treatment confirmed ABCG2 upregulation, validating a clinically relevant resistance mechanism. These findings support BL-B01D1 as a promising therapeutic strategy in mCRPC and nominate ABCG2 as a rational target for overcoming resistance."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ABCG2 • EGFR • ERBB3

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

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