Biopharmaceutical company BeiGene has presented data on its two investigational drug candidates, anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib.
The clinical data was presented at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain.
During the multi-centre, open-label Phase II trial, tislelizumab’s safety, tolerability and efficacy was evaluated in patients in China and South Korea.
Tislelizumab is a humanised IgG4 anti–PD-1 monoclonal antibody to reduce binding to FcγR on macrophages.
Patients who participated in the trial were suffering with PD-L1+ locally advanced or metastatic urothelial carcinoma (UC) previously treated with >1 platinum-containing therapy.
An independent review committee (IRC) assessed the primary endpoint of objective response rate (ORR) and confirmed it to be 23.1% of the 104 patients.
BeiGene Immuno-Oncology chief medical officer Yong Ben said: “We are excited to present the pivotal data for tislelizumab in the second indication in China, urothelial carcinoma, and look forward to continued regulatory discussions on our supplemental new drug application (sNDA) which is under priority review by the National Medical Products Administration (NMPA).”
Pamiparib in combination with low-dose temozolomide was evaluated in an open-label, multi-centre Phase Ib dose-escalation/expansion trial in patients with locally advanced or metastatic solid tumours.
The drug is an investigational inhibitor of PARP1 and PARP2.
The trial evaluated the combination’s safety, tolerability, maximum tolerated dose (MTD), and preliminary antitumor activity. It was shown to be generally well-tolerated.
Yong Ben added: “We also presented additional clinical data on pamiparib monotherapy and its combination with low-dose temozolomide and we are looking forward to Phase III and pivotal Phase II data of pamiparib trials in China next year. We are hopeful that these treatments will provide meaningful benefit to patients battling these and other forms of cancer.”