alcestobart (LBL-007) / Leads Biolabs, BeiGene - LARVOL DELTA

BGB-LC-202: Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=121 | Completed | Sponsor: BeiGene | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Jan 2025 | Trial primary completion date: Dec 2026 ➔ Jan 2025

Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Anti-LAG-3 antibody LBL-007 plus anti-PD-1 antibody toripalimab in advanced nasopharyngeal carcinoma and other solid tumors: an open-label, multicenter, phase Ib/II trial. (PubMed, J Hematol Oncol) - "LBL-007 plus toripalimab exhibited a manageable safety profile in patients with advanced solid tumors and demonstrated promising antitumor activity in NPC, especially in immunotherapy-naive patients. These findings warrant further validation in future studies."

IO biomarker • Journal • P1/2 data • Cardiovascular • Fatigue • Heart Failure • Hematological Disorders • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • PD-L1

BGB-900-102: Study of BGB-A425 and LBL-007 in Combination With Tislelizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=114 | Completed | Sponsor: BeiGene | Active, not recruiting ➔ Completed

Trial completion • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

BGB-LC-201: A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=400 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Mar 2025 ➔ Jul 2025

Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

BGB-900-102: Study of BGB-A425 and LBL-007 in Combination With Tislelizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=114 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting | N=358 ➔ 114

Enrollment change • Enrollment closed • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

Liberty-201: A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=113 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting | N=226 ➔ 113 | Trial completion date: Apr 2028 ➔ Apr 2026 | Trial primary completion date: Apr 2028 ➔ Apr 2026

Enrollment change • Enrollment closed • Mismatch repair • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • PD-L1

Phase Ib/II Clinical Study of LBL-007 in Treatment of Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Trial completion date: Mar 2025 ➔ Aug 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

BGB-HNSCC-201: Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

BGB-LC-202: Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=121 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

LBL-007-CN-004: A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors (clinicaltrials.gov) - P1/2 | N=490 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Oct 2024 ➔ Oct 2025

Combination therapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Phase Ib/II study of the anti-LAG-3 antibody LBL-007 combined with the anti-PD-1 antibody tislelizumab ± chemotherapy in patients with advanced nasopharyngeal carcinoma and other malignancies (CSCO 2024) - "Study group: [Organizing Committee]"

Clinical • Metastases • P1/2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

BGB-900-102: Study of BGB-A425 and LBL-007 in Combination with Tislelizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=358 | Recruiting | Sponsor: BeiGene | Trial completion date: Dec 2027 ➔ Apr 2025 | Trial primary completion date: Mar 2026 ➔ Apr 2025

Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

Two studies were presented at the CSCO conference! Weilizhibo's innovative drug clinical research has made another major achievement [Google translation] (bydrug.pharmcube.com) - P1b/2 | N=490 | NCT05516914 | Sponsor: Nanjing Leads Biolabs Co.,Ltd | "The LBL-007 Phase Ib/II clinical study (NCT05516914) was led by Professor Zhang Li from the Cancer Center of Sun Yat-sen University and conducted in 10 centers across the country. It aims to evaluate the safety and efficacy of LBL-007 combined with anti-PD-1 antibody tislelizumab ± chemotherapy in the treatment of advanced solid tumors (Phase Ib study) and advanced nasopharyngeal carcinoma patients who have not received previous treatment (Phase II study). The research data released this time showed....Phase II included 42 patients with previously untreated recurrent or metastatic nasopharyngeal carcinoma, who received LBL-007 combined with tislelizumab and GC chemotherapy. Among the 41 patients with evaluable efficacy, the ORR was 90.2%, the disease control rate (DCR) was 100%, and the 3-month progression-free survival rate was 97.6%."

P1/2 data • Nasopharyngeal Carcinoma • Solid Tumor

A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Trial completion date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Aug 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

Phase Ib/II Clinical Study of LBL-007 in Treatment of Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Trial completion date: Dec 2024 ➔ Mar 2025 | Trial primary completion date: Jul 2024 ➔ Dec 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

BeiGene Enters Next Phase of Global Growth with Announcement of Second Quarter 2024 Financial Results and Corporate Updates (Businesswire) - "BGB-16673 (BTK CDAC): Anticipating first subject enrolled in Phase 3 program in fourth quarter of 2024 or first quarter of 2025....Multiple randomized tislelizumab lung cancer combination cohorts with BGB-A445 (anti-OX40), LBL-007 (anti-LAG3) and BGB-15025 (HPK1 inhibitor) expected to read out in 2024....Pan-KRAS, MTA-cooperative PRMT5 inhibitors and EGFR CDAC targeted protein degrader on track to enter the clinic in the second half of 2024."

Clinical data • New P3 trial • New trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

BGB-A317-290-LTE1: Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (clinicaltrials.gov) - P3 | N=300 | Enrolling by invitation | Sponsor: BeiGene | Trial completion date: Aug 2024 ➔ Dec 2026 | Trial primary completion date: Aug 2024 ➔ Dec 2026

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Anti-LAG-3 antibody LBL-007 in combination with anti-PD-1 antibody tislelizumab with or without chemotherapy in patients with advanced nasopharyngeal cancer and other malignant tumors: A phase Ib/II dose escalation/expansion study. (ASCO 2024) - P1/2 | " In phase Ⅰb, patients with relapsed and refractory advanced solid tumor received LBL-007 (300 or 600 mg) plus tislelizumab (200 mg) (both i.v. Q3W), and in phase Ⅱ, patients with previously untreated recurrent or metastatic NPC patients received LBL-007 (600 mg) plus tislelizumab (200 mg) in combination with GC chemotherapy [gemcitabine (1000 mg/m 2 ) and cisplatin (80mg/m 2 )] (i.v. LBL-007/tislelizumab combination is well-tolerated in patients with advanced malignant tumors. LBL-007/tislelizumab/GC combination showed manageable, no new safety concerns and encouraging antitumor activity in previously untreated and advanced NPC patients. The encouraging efficacy and safety profile may support a pivotal study with LBL-007 in combination with tislelizumab and GC chemotherapy for NPC development in 1L setting."

Clinical • Combination therapy • Metastases • P1/2 data • Anemia • Cachexia • Endocrine Disorders • Head and Neck Cancer • Hematological Disorders • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BGB-A317-LBL-007-202: A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=118 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Squamous Cell Carcinoma

Leads Biolabs is Proud to Announce its Participation in the 2024 ASCO Annual Meeting with One Oral Presentation and Two Posters. (PRNewswire) - "These presentations will include one oral presentation, two posters, and one online publication, showcasing advancements in various cancer indications such as nasopharyngeal cancer (NPC), extrapulmonary neuroendocrine carcinoma (EP-NEC), hepatocellular carcinoma (HCC), and renal cell carcinoma (RCC)....According to the results in the oral presentation, LBL-024 demonstrated good safety profile and very promising antitumor effects in patients with advanced malignant tumors....This phase Ⅰb/Ⅱ study indicates that the combination of LBL-007 and tislelizumab is well-tolerated in patients with advanced malignant tumors....In a Phase 1 clinical study, LBL-015 has demonstrated a good safety profile and encouraging preliminary efficacy signals in patients with advanced solid tumors....The data from the Phase 1 study indicate that LBL-019 is well tolerable and has demonstrated preliminary efficacy in patients with advanced malignant tumors."

P1 data • P1/2 data • Hepatocellular Cancer • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Renal Cell Carcinoma • Solid Tumor

BeiGene Reports First Quarter 2024 Financial Results and Business Updates (Businesswire) - "Gastrointestinal Cancers: Multiple tislelizumab combination cohorts with LBL-007 (anti-LAG3) and BGB-A445 (anti-OX40) reading out in 2024; Plan to submit a BLA with the NMPA for zanidatamab for the treatment of second-line biliary tract cancer; and CEA-ADC and FGFR2b-ADC on track to enter the clinic in the second half of 2024."

New trial • Non-US regulatory • P2 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

BeiGene Reports First Quarter 2024 Financial Results and Business Updates (Businesswire) - "Enrolled last subject in a Phase 3 clinical trial for ociperlimab (anti-TIGIT) for first-line PD-L1 high NSCLC; Multiple tislelizumab lung cancer combination cohorts with BGB-A445 (anti-OX40), LBL-007 (anti-LAG3) and BGB-15025 (HPK1 inhibitor) expected to read out in 2024; and Pan-KRAS and MTA-cooperative PRMT5 inhibitors and EGFR CDAC on track to enter the clinic in the second half of 2024."

Clinical data • New trial • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BGB-LC-201 (NCT05635708): A phase 2, open-label, multi-arm study of tislelizumab (TIS; anti-PD-1) in combination with investigational agents +/- chemotherapy as first-line treatment for patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) (AACR 2024) - P2 | "This phase 2 study will determine whether adding investigational agents BGB-A445 (OX40 agonistic monoclonal antibody [mAb]), LBL-007 (anti-lymphocyte activation gene-3 mAb), or BGB-15025 (hematopoietic progenitor kinase 1 [HPK1] inhibitor) improves the therapeutic benefit of TIS (anti-PD-1 mAb) +/- chemo in patients with locally advanced, unresectable, or metastatic NSCLC. The umbrella design allows for the use of multiple investigational drugs, administered alone or in combination, in patients with untreated locally advanced, unresectable, or metastatic NSCLC without actionable driver mutations. Exploratory endpoints include overall survival, time to response, and relevant biomarker associations with response or resistance to study treatments. Enrollment is ongoing at 66 sites in China, Asia-Pacific, the United States, and the European Union."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Liberty-201: Maintenance fluoropyrimidine and bevacizumab with or without anti-lymphocyte activation gene-3 (LAG-3) antibody LBL-007 plus anti-programmed cell death protein-1 (PD-1) antibody tislelizumab (TIS) for patients (pts) with metastatic or unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer (CRC) (AACR 2024) - P1/2 | "Secondary endpoints include overall survival, PFS2, overall response rate, duration of response, safety, pharmacokinetics, and immunogenicity. Exploratory endpoints include potential biomarkers (including but not limited to PD-L1 and LAG-3)."

Clinical • IO biomarker • Metastases • Mismatch repair • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI • PD-L1