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

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 | "Secondary objectives are to assess the pharmacokinetic profile and preliminary efficacy of iza-bren + osimertinib (group A) and iza-bren + pembrolizumab (group B). Enrollment is ongoing."

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

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

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

Phase II Study of iza-bren (BL-B01D1) in Combination with Serplulimab in Patients with Small Cell Lung Cancer (SCLC) [WITHDRAWN] (ESMO 2025) - No abstract available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

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, 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

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

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

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

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

BL-B01D1-201: A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors (clinicaltrials.gov) - P2 | N=76 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Solid Tumor

A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov) - P2 | N=376 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors (clinicaltrials.gov) - P2 | N=52 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

BL-B01D1-101: A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov) - P1 | N=570 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Solid Tumor

BL-B01D1-103: A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Gastrointestinal Cancer • Solid Tumor • Triple Negative Breast Cancer • TACSTD2

BL-B01D1-SI-B003-201-03: A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors (clinicaltrials.gov) - P2 | N=186 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Oct 2025 ➔ Dec 2027 | Trial primary completion date: Oct 2025 ➔ Dec 2026

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

BL-B01D1-SI-B003-201-02: A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Nov 2025 ➔ Dec 2027 | Trial primary completion date: Nov 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

BL-B01D1-102: A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors (clinicaltrials.gov) - P1 | N=4 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=26 ➔ 4

Enrollment change • Enrollment closed • Genito-urinary Cancer • Solid Tumor • Urethral Cancer

BL-B01D1-202: A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies (clinicaltrials.gov) - P1/2 | N=38 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Endometrial Cancer • Gynecologic Cancers • Oncology • Solid Tumor

BL-B01D1-104: A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov) - P2 | N=121 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Nov 2025 ➔ Dec 2027 | Trial primary completion date: Nov 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies (clinicaltrials.gov) - P2 | N=130 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Nov 2025 ➔ Dec 2027 | Trial primary completion date: Nov 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD