BeOne joins the subcutaneous crowd

Having revealed at a recent R&D day that it was working on a subcutaneous formulation of its anti-PD-1 drug Tevimbra, BeOne Medicines has moved to take this into pivotal development. A global phase 3 trial is set to begin in September, according to a just published clinicaltrials.gov listing, and compare chemo combos of SC versus IV Tevimbra in 351 patients with first-line gastric or gastroesophageal junction cancer. BeOne, which until recently was known as BeiGene, told ApexOnco that SC delivery was achieved by developing a high-concentration formulation of tislelizumab that can be administered via a prefilled syringe without requiring co-formulation with hyaluronidase; this work took place in house, and didn't rely on know-how that had been licensed in. Such considerations are important given that SC forms of Tecentriq and Opdivo use hyaluronidase technology licensed from Halozyme, while SC Keytruda uses a similar approach from Alteogen, and there is dispute over the precise scope of the IP involved. BeOne also confirmed that, like Roche, Bristol Myers Squibb and Merck & Co, it wants its phase 3 trial to support the SC formulation's use across all indications in which IV Tevimbra is currently approved.

Subcutaneously delivered anti-PD-(L)1 MAbs

Source: OncologyPipeline.