Adagene and Roche have announced a clinical trial collaboration for assessing the triple combination of ADG126 with atezolizumab and bevacizumab in first-line treatment of advanced hepatocellular carcinoma (HCC; liver cancer).
The collaboration will evaluate Adagene’s ADG126 along with Roche’s atezolizumab and bevacizumab and leverage the latter’s MORPHEUS-LIVER platform for quick combination development.
As part of this partnership, Roche will be responsible for sponsoring and carrying out a randomised phase Ib/II multi-national trial.
In this trial, ADG126’s safety, efficacy and pharmacokinetics in combination with bevacizumab and atezolizumab, versus atezolizumab and bevacizumab alone will be evaluated in 60 patients initially.
To support the clinical trial, Adagene and Roche will supply their respective anti-cancer agent(s).
Adagene will retain development and commercialisation rights to ADG126 across the world.
Adagene co-founder and CEO Peter Luo said: “We are excited to initiate this collaboration with Roche and explore the potential of ADG126 as a key component of a triplet combination for treating first-line liver cancer, along with an established standard-of-care doublet pioneered by Roche.
“Given the longstanding safety challenges of combining multiple therapies in this cancer type, we are very excited to bring forth a potential anti-CTLA-4 treatment with an unprecedented safety profile in an immunotherapy-based triplet combination as a promising strategy to treat liver cancer patients, where two first-line therapies have already received FDA approval.”
The trial expands the global clinical development programme of Adagene for ADG126 into a new setting and tumour type as a potential component of first-line combination therapy for HCC.
The Phase Ib/II ongoing trial results have demonstrated a differentiated safety profile for the therapy at doses up to 20mg/kg with repeat dosing as a single agent and up to 10mg/kg when given along with anti-PD-1 therapy.
During this month, Roche reported positive findings from the Phase III COMMODORE 3 clinical trial, in which its antibody crovalimab achieved disease control in paroxysmal nocturnal haemoglobinuria (PNH) patients.