garivulimab (BGB-A333) / BeOne Medicines - LARVOL DELTA

Phase 1/2 Study Investigating Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Anti-PD-L1 Monoclonal Antibody BGB-A333 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors (ESMO 2018) - P1/2, P1a/1b; "The primary endpoint of the phase 2 study is overall response rate. A total of 156 patients are estimated to be enrolled; as of 11 April 2018, 9 patients have been enrolled."

Clinical • Combination therapy • P1/2 data • PK/PD data • Bladder Cancer • Non Small Cell Lung Cancer

A Phase 1/2 study of the PD-L1 inhibitor, BGB-A333, alone and in combination with the PD-1 inhibitor, tislelizumab, in patients with advanced solid tumours (Br J Cancer, Nature) - P1/2 | N=39 | NCT03379259 | Sponsor: BeiGene | "This open-label, non-randomised study investigated the safety and anti-tumour activity of BGB-A333, a PD-L1 inhibitor, alone and in combination with tislelizumab in patients with advanced solid tumours with progression during/after standard therapy....Overall, 39 patients across Phase 1a (N = 15), 1b (N = 12) and 2 (N = 12) were enroled. In Phase 1a, an RP2D of 1350 mg was determined. In Phase 1a and 1b/2, serious treatment-emergent adverse events (TEAEs) were reported in five and eight patients, respectively. Two patients experienced TEAEs that led to death. In Phase 2, the ORR was 41.7% (n = 5/12; 95% confidence interval: 15.17%, 72.33%)."

P1/2 data • Oncology • Solid Tumor

A Phase 1/2 study of the PD-L1 inhibitor, BGB-A333, alone and in combination with the PD-1 inhibitor, tislelizumab, in patients with advanced solid tumours (Br J Cancer, Nature) - P1/2 | N=39 | NCT03379259 | Sponsor: BeiGene | "This open-label, non-randomised study investigated the safety and anti-tumour activity of BGB-A333, a PD-L1 inhibitor, alone and in combination with tislelizumab in patients with advanced solid tumours with progression during/after standard therapy....Overall, 39 patients across Phase 1a (N = 15), 1b (N = 12) and 2 (N = 12) were enroled. In Phase 1a, an RP2D of 1350 mg was determined. In Phase 1a and 1b/2, serious treatment-emergent adverse events (TEAEs) were reported in five and eight patients, respectively. Two patients experienced TEAEs that led to death. In Phase 2, the ORR was 41.7% (n = 5/12; 95% confidence interval: 15.17%, 72.33%)."

P1/2 data • Oncology • Solid Tumor

A Phase 1/2 study of the PD-L1 inhibitor, BGB-A333, alone and in combination with the PD-1 inhibitor, tislelizumab, in patients with advanced solid tumours. (PubMed, Br J Cancer) - P1/2 | "TEAEs reported with BGB-A333 were consistent with other PD-L1 inhibitors. Encouraging preliminary anti-tumour activity was observed with BGB-A333 in combination with tislelizumab."

Combination therapy • Journal • Metastases • P1/2 data • Oncology • Solid Tumor

[VIRTUAL] Preliminary safety and efficacy data of BGB-A333, an anti-PD-L1 monoclonal antibody, alone and in combination with tislelizumab in patients with advanced solid tumors (AACR-II 2020) - P1/2 | "BGB-A333, alone or in combination with tislelizumab, was generally well tolerated and demonstrated antitumor activity in patients with advanced solid tumors. Based on these data, expansion cohorts have been initiated."

Clinical • Combination therapy • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma

Phase 1/2 study investigating safety, tolerability, pharmacokinetics, and preliminary antitumor activity of anti-PD-L1 monoclonal antibody bgb-A333 alone and in combination with anti-PD-1 monoclonal antibody tislelizumab in patients with advanced solid tumors. (ASCO 2018) - P1/2,P1a/1b; "Phase 2B (combination dose expansion) will enroll patients with specific tumor types, which will be chosen based on data from phase 2A and other studies. The primary endpoint of the phase 2 study is overall response rate."

Clinical • Combination therapy • P1/2 data • PK/PD data • Bladder Cancer • Non Small Cell Lung Cancer

[VIRTUAL] BGB-A333, an anti-PD-L1 monoclonal antibody, in combination with tislelizumab in patients with urothelial carcinoma (ESMO 2020) - P1/2 | "Funding: BeiGene, Ltd. Clinical trial identification: NCT03379259."

Clinical • Combination therapy • Oncology • Solid Tumor • Urothelial Cancer

Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=39; Terminated; Sponsor: BeiGene; N=156 ➔ 39; Trial completion date: Dec 2020 ➔ Sep 2020; Active, not recruiting ➔ Terminated; Study Was Terminated Early

Clinical • Combination therapy • Enrollment change • Trial completion date • Trial termination • Oncology • Solid Tumor

"Catching up with #ESMO20: $BGNE presentation on BGB-A333 (anti-PD-L1) combo with tislelizumab (anti-PD-1) sounds intriguing." (@JacobPlieth)

Oncology

BeiGene Announces Data on Tislelizumab and Pamiparib to Be Presented at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress (GlobeNewswire) - "BeiGene, Ltd…announced that clinical and nonclinical data on its anti-PD-1 antibody tislelizumab and its investigational PARP inhibitor pamiparib will be presented in two mini oral presentations and five posters at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress, taking place on September 18-22, 2020."

Clinical data • P1/2 data • P2 data • Preclinical • Genito-urinary Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Urothelial Cancer

BeiGene announces clinical and preclinical data to be presented at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II (GlobeNewswire) - "BeiGene, Ltd…announced that clinical data on its investigational anti-PD-L1 antibody BGB-A333 and preclinical data on three early-stage drug candidates will be presented at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II, taking place on June 22-24, 2020."

P1/2 data • Preclinical • Oncology • Solid Tumor

Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=156; Active, not recruiting; Sponsor: BeiGene; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed

Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=156; Recruiting; Sponsor: BeiGene; Trial completion date: May 2020 ➔ Dec 2020; Trial primary completion date: Jan 2020 ➔ Aug 2020

Clinical • Combination therapy • Trial completion date • Trial primary completion date