BeiGene’s Tislelizumab Granted Priority Review in China for Urothelial Carcinoma

July 23, 2019

Impact: Moderate

• BeiGene has announced that the China NMPA (National Medical Products Administration) has granted Priority Review status to the sNDA for tislelizumab (anti-PD-1; Fc-engineered) for patients with previously treated locally-advanced or metastatic urothelial carcinoma (UC).
• The filing is supported by data from a pivotal Phase 2 study in 113 PD-L1+ Chinese and South Korean patients with previously treated locally or metastatic UC.

• • In 104 evaluable patients, the ORR was 23.1% (CR rate: 7.7%).
  • Full study results are anticipated to be presented at an upcoming medical conference.

inThought Analysis

This tislelizumab announcement follows the May 30^th 2019 sNDA acceptance by NMPA and gives additional momentum to BeiGene’s efforts to develop the PD-1 antibody in China. This update follows tislelizumab’s initial filing in China, for R/R classical Hodgkin’s lymphoma (cHL; currently also under priority review) and is the asset’s first filing for a solid tumor indication.

The Chinese PD-1 axis inhibitor market is quickly heating up, with three antibodies from Chinese companies now approved, along with Opdivo (NSCLC) and Keytruda (melanoma, NSCLC). Jiangsu Hengrui’s camrelizumab was approved in May for cHL, joining Innovent/Lilly’s Tyvyt (sintilimab; cHL) and Junshi’s Tuoyi (toripalimab; melanoma).

In addition to its PD-1 efforts, BeiGene is also awaiting an NMPA decision on its BTK inhibitor, zanubrutinib, in mantle cell lymphoma and CLL, and has also filed an sNDA to expand its Abraxane marketing into pancreatic cancer. Favorable decisions on these applications have set up the possibility of a transformational second half of 2019 for BeiGene, which also recently regained full global commercialization rights to tislelizumab and a $150M termination payment as a result of the Bristol/Celgene merger.

Source: BeiGene press release