BeiGene enrols first patients in two Phase III tislelizumab trials

18th December 2018 (Last Updated December 18th, 2018 00:00)

BeiGene has enrolled the first patients in two of its global Phase III clinical trials to evaluate tislelizumab for the treatment of patients with gastric cancer and esophageal cancer.

BeiGene enrols first patients in two Phase III tislelizumab trials
Esophageal candidiasis stained by periodic acid-Schiff procedure. Credit: KGH.

BeiGene has enrolled the first patients in two of its global Phase III clinical trials to evaluate tislelizumab for the treatment of patients with gastric cancer and esophageal cancer.

Tislelizumab is currently under development as a humanised IgG4 anti–PD-1 monoclonal antibody specifically developed to reduce binding to FcγR on macrophages.

Both Phase III trials are designed to investigate tislelizumab in combination with chemotherapy as potential first-line treatments in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

It will also evaluate the response in patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

The trials feature randomised, double-blind, placebo-controlled designs.

"Available data have shown promise for anti-PD-1 antibodies in patients with advanced gastric or gastroesophageal adenocarcinoma"

BeiGene Immuno-Oncology chief medical officer Amy Peterson said: “Available data have shown promise for anti-PD-1 antibodies in patients with advanced gastric or gastroesophageal adenocarcinoma and in patients with advanced esophageal carcinoma.

“Gastric and esophageal cancers are among the most common malignancies in Asia and collectively are responsible for over 800,000 deaths annually in China alone.”

The trial will enrol 720 patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Patients will be treated with either 200mg of tislelizumab or placebo combined with platinum- and fluoropyrimidine-based chemotherapy intravenously once every three weeks.

Co-primary objectives of the trial include progression-free survival (PFS) and overall survival (OS), while its secondary objectives are overall response rate (ORR), duration of response (DOR). quality of life (QoL), safety and tolerability.

The esophageal cancer trial intends to recruit 480 patients with unresectable, locally advanced recurrent, or metastatic ESCC.

The recruited patients are expected to receive either 200mg of tislelizumab or placebo in combination with platinum- and fluoropyrimidine-based chemotherapy, intravenously once every three weeks.

Co-primary objectives of the trial comprise PFS and OS, while secondary objectives include ORR, DOR, and QoL, as well as safety and tolerability.