RE:Novartis returns anti-PD1 to Chinese based company BeiGene September 19, 2023 - The news marks the end of a second immuno-oncology partnership between the two companies after they parted ways on BeiGene’s anti-TIGIT candidate ociperlimab about two months ago. In a statement to Fierce Pharma, Novartis said a changing PD-1 inhibitor landscape led to the decision to terminate the tislelizumab agreement.
[Tislelizumab (BGB-A317) is a humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.] [ ONCYs Bracelet-1 study demonstrted that a non-silenced Fc receptor site on PD-1 checkpoint inhibitor like avelumab (Bavencio) for example, resulted in significantly reduced efficacy of that PD-1 checkpoint inhibitor. avelumab has a native Fc region that retains FcγR binding capability as does tislelizumab] -- https://pubmed.ncbi.nlm.nih.gov/34484871/
“This decision will provide Novartis with greater flexibility for development of its unique, potentially transformational pipeline assets, notably in markets where there are already approved PD-1 therapies in desired indications that can support development of our novel IO combination programs.”
Tislelizumab has had a rough patch since Novartis signed on. In early 2022, the FDA rejected Eli Lilly and Innovent Biologics’ PD-1 inhibitor Tyvyt (sintilimab) in NSCLC over China-only data and an inferior comparator arm. It marked a change of course as the FDA’s oncology department had previously welcomed data from China to support regulatory reviews.
This turn of events forced Novartis to rethink its regulatory plans given tislelizumab also has multiple China-only or predominantly China trials. Last summer, Novartis disclosed that it wouldn’t seek a monotherapy filing for tislelizumab monotherapy in newly diagnosed NSCLC in the U.S. after receiving feedback from the FDA.
https://www.fiercepharma.com/pharma/after-tigit-divorce-novartis-returns-tislelizumab-beigene-pd-1-gains-first-european-nod