tislelizumab subcutaneous (BGB-A317 SC) / BeOne Medicines - LARVOL DELTA

Subcutaneously Administered Tislelizumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer: Pharmacokinetics and Safety Results from the BGB-A317-103 Phase I Study. (PubMed, Clin Cancer Res) - "Subcutaneous tislelizumab demonstrated high bioavailability after thigh and abdomen injections. Safety and efficacy were consistent with previous tislelizumab plus chemotherapy studies, warranting further investigation of subcutaneous tislelizumab."

Journal • P1 data • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BGB-A317-103: Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in First-Line Treatment of Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=62 | Completed | Sponsor: BeiGene | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Model-Informed Development of a Subcutaneous Formulation of Tislelizumab: Phase 1 Pharmacokinetics in Patients With Cancer. (PubMed, Clin Transl Sci) - P1 | "This study evaluated the pharmacokinetics, bioavailability, and injection-site performance of subcutaneous tislelizumab and used population pharmacokinetic (PopPK) modeling and simulations to support phase 3 dose selection. Tislelizumab 300 mg Q3W subcutaneous thigh administration is predicted to provide exposure comparable to intravenous 200 mg Q3W, supporting its selection for phase 3 evaluation. Trial registration: ClinicalTrials.gov identifier: NCT06091943."

Clinical • Journal • P1 data • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BGB-A317-316: A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=351 | Recruiting | Sponsor: BeOne Medicines

Trial initiation date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

BGB-A317-316: A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=351 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=351 | Not yet recruiting | Sponsor: BeiGene

New P3 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A New Treatment Option for Advanced Gastric Cancer? (NEJM Journal Watch) - "The addition of the anti–PD-1 agent tislelizumab to first-line chemotherapy improved survival in patients with advanced gastric cancer and PDL-1 scores ≥5%. Adding immune checkpoint inhibitors to first-line chemotherapy for patients with metastatic gastric cancer improves response, progression-free survival (PFS) and overall survival (OS). The benefit is limited to patients testing positive for a combined score for PDL-1."

Clinical