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

Invited Discussant – Asian perspectives on Iza-Bren (BL-B01D1), an EGFR×HER3 bispecific antibody-drug conjugate, versus physician's choice of chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma: A randomized, open-label, multicenter, phase III, pivotal study (BL-B01D1-303) (ESMO Asia 2025) - No abstract available

Clinical • Metastases • P3 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Iza-Bren (BL-B01D1), an EGFR×HER3 bispecific antibody-drug conjugate, versus physician's choice of chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma: A randomized, open-label, multicenter, phase III, pivotal study (BL-B01D1-303) (ESMO Asia 2025) - No abstract available

Clinical • Metastases • 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

BL-B01D1-204-13: A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer (clinicaltrials.gov) - P2 | N=260 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=120 ➔ 260

Enrollment change • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

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=206 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Endometrial Cancer • Oncology • Solid Tumor

BL-B01D1-305: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P3 | N=497 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

BL-B01D1-307: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - P3 | N=418 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

BL-B01D1-301: A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=432 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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=596 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Izalontamab brengitecan: Data readout from P1 LUNG-101 trial (NCT05983432) for 1L NSCLC and advanced solid tumors in H2 2025 (Bristol-Myers Squibb) - Q3 2025 Results

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase I/IIa, open-label, dose-finding study of the safety, pharmacokinetics, and preliminary efficacy of iza-bren (BL-B01D1) combinations in patients with advanced solid tumors (ESMO 2025) - P1/2 | "Primary objectives are to determine the safety and RDE for iza-bren + osimertinib (group A) and iza-bren + pembrolizumab (group B). Legal entity responsible for the study Bristol Myers Squibb. Funding Bristol Myers Squibb & SystImmune."

Clinical • IO biomarker • Metastases • P1/2 data • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Phase II Study of iza-bren (BL-B01D1) in Combination with Serplulimab in Patients with Small Cell Lung Cancer (SCLC) [WITHDRAWN] (ESMO 2025) - No abstract available

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

SystImmune Announces iza-bren Meets One of the Dual Primary Endpoints in the BL-B01D1-303 Trial in Recurrent or Metastatic NPC Patients with Results Presented as a Late-Breaking Oral Presentation at ESMO (PRNewswire) - "Iza-bren has shown a BICR-assessed ORR of 54.6% vs. 27.0% (Odds Ratio 3.3; 95% confidence interval 1.9-5.8; p<0.0001). Median duration of response (DoR) was 8.5 months for iza-bren versus 4.8 months for physician's choice of chemotherapy (Hazard ratio 0.43; 95% CI 0.22 to 0.83). Furthermore, median progression-free survival (PFS) was 8.38 months with iza-bren compared to 4.34 months for chemotherapy (hazard ratio of 0.44; 95% confidence interval 0.32-0.62)."

Late-breaking abstract • P3 data • Nasopharyngeal Carcinoma

SystImmune, Inc., a clinical-stage biotechnology company, today announced the treatment of the first patient in the IZABRIGHT-Breast01 study (NCT06926868), a global Ph2/3 registrational study of izalontamab brengitecan (iza-bren) in previously untreated triple negative breast cancer ineligible for anti-PD(L)1 drugs. (PRNewswire) - "This milestone triggered a one-time payment of $250 million by Bristol Myers Squibb...pursuant to the 2023 collaboration and exclusive license agreement between SystImmune and Bristol Myers Squibb. SystImmune is further eligible to receive up to an additional $250 million in contingent near-term payments and additional payments of up to $7.1 billion contingent upon the achievement of certain development, regulatory and sales performance milestones."

Commercial • Trial status • Triple Negative Breast Cancer

Iza-Bren (BL-B01D1), an EGFR×HER3 bispecific antibody-drug conjugate, versus physician's choice of chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma: A randomized, open-label, multicenter, phase III, pivotal study (BL-B01D1-303) (ESMO 2025) - P3 | "Methods Eligible R/M-NPC patients who had progressed after ≥2 prior lines of chemotherapy (including ≥1 line of platinum-based chemotherapy) and PD-(L)1 inhibitors were randomized (1:1) to received either iza-bren 2.5 mg/kg on day 1 and 8 every 3 weeks or TPC (capecitabine, gemcitabine, docetaxel). Conclusions Iza-bren improved ORR and PFS compared with chemotherapy in heavily pretreated patients with R/M-NPC, with a manageable safety profile. These findings suggest iza-bren may represent a new therapeutic standard for this population."

Clinical • Late-breaking abstract • Metastases • P3 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • EGFR • ERBB3

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

Iza-bren shows promise in recurrent or metastatic nasopharyngeal carcinoma. (PubMed, Nat Rev Clin Oncol) - No abstract available

Journal • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Phase Ib/II study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with recurrent metastatic ovarian cancer (OC) (ESMO 2025) - P1/2, P2 | "No ILD and no new safety signals were identified. Conclusions In pts with heavily pre-treated OC, iza-bren demonstrated promising efficacy with a manageable safety profile, supporting further development in OC pts."

Clinical • Metastases • P1/2 data • Oncology • Ovarian Cancer • Solid Tumor

SystImmune, Inc. and Bristol Myers Squibb Announce First Global Phase I Results of Iza-bren, an EGFR x HER3 Bispecific Antibody-Drug Conjugate, in Patients with Advanced Solid Tumors at ESMO 2025 (PRNewswire) - "In the study, 107 patients with advanced solid tumors were treated, including non-small cell lung cancer (NSCLC) patients with and without EGFR mutations....For patients receiving 2.5 mg/kg (Days 1 and 8 every 3 weeks), 55% (11 of 20) showed a confirmed response, with a median progression-free survival of 5.4 months. Confirmed responses were also seen in both the subgroup with EGFR-mutated NSCLC (3 of 10 patients) and those without the mutation (3 of 4 patients)."

P1 data • Non Small Cell Lung Cancer

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 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

Bristol Myers Squibb…announced the presentation of data across its oncology portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress 2025 to be held from October 17-21 in Berlin, Germany. (Businesswire) - "Data from more than 50 company-sponsored studies, investigator-sponsored studies, and collaborations showcase results spanning more than 10 cancer types."

Clinical data • dMMR • MSI-H • Colorectal Cancer • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Urothelial Cancer

BL-B01D1-303: A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P3 | N=386 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2027 ➔ Nov 2026

Trial completion date • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • PD-L1

BL-B01D1-303: A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P3 | N=386 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Nov 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • PD-L1