How Beigene’s PD-1 just can’t crack the west

It was way back in January 2021 that Novartis paid Beigene $650m for ex-China rights to tislelizumab, but over two years later it still can’t get the anti-PD-1 MAb approved in any of its territories. Most notably these include the US and EU, two regions where today’s second-quarter financial update from the Swiss firm brought further disappointments. In the US liver cancer has been abandoned, with Novartis citing portfolio prioritisation, joining nasopharyngeal cancer and metastatic NSCLC as indications where tislelizumab filings would no longer be pursued. A protracted delay to the one US submission that has been made, in oesophageal squamous cell carcinoma, continues, with the companies most recently promising a decision in 2023. In the EU, meanwhile, four initial approvals remain outstanding, despite having been accepted for review by the EMA 15 months ago. It is a different story in China, where Beigene retains rights, and where tislelizumab is approved in 10 indications and awaiting registration in another two. The relationship between Novartis and Beigene has separately come under strain after the Swiss firm last week decided not to opt in to develop the anti-Tigit MAb ociperlimab.Selected indications for tislelizumabSettingStudyEUUSChina1st-line hepatocellular carcinomaRationale-301–Filing plan abandoned Jul 2023Filing accepted Dec 20222nd-line oesophageal sq cell carcinomaRationale-302Filing accepted Apr 2022July 12 Pdufa date missed owing to Covid travel delays in China; decision now expected "in 2023"Approved Apr 20222nd-line NSCLCRationale-303Filing accepted Apr 2022Filing plan abandoned Jul 2022Approved Jan 20221st-line non-sq NSCLCRationale-304Filing accepted Apr 2022 (NB China study)Filing plan abandoned Oct 2022Approved Jun 20211st-line PD-L1 +ve gastric/GEJ adenoRationale-305–Filing planned 2023Approved Feb 20231st-line oesophageal sq cell carcinomaRationale-306–Filing planned 2023Filing accepted Aug 20221st-line sq NSCLCRationale-307Filing accepted Apr 2022 (NB China study)Filing plan abandoned Oct 2022Approved Jan 20211st-line nasopharyngeal cancerRationale-309–Filing plan abandoned Oct 2022Approved Jun 20221st-line SCLCRationale-312–Earlier US filing due 2024 (NB China study)–3rd-line classical Hodgkin's lymphomaRationale-203––Approved Dec 20192nd-line PD-L1+ve urothelial carcinomaRationale-204––Approved Apr 20202nd-line liver cancerRationale-208––Approved Jun 20212nd-line MSI-H/dMMR solid tumoursRationale-209––Approved Mar 2022