Roche and Bavarian Nordic have unveiled plans to assess the former’s anti-PD-L1 antibody Tecentriq in combination with the latter’s cancer vaccine candidate CV301 in bladder cancer.
The Phase II trial, which will be carried out by Bavarian Nordic and has been pencilled in to start later this year, is designed to evaluate the two-drug combination and compare results the effect of Tecentriq (atezolizumab) alone.
The study will involve patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, a patient population for which Tecentriq holds accelerated approval in the US.
CV301 is designed to generate a T cell response to both CEA and MUC1, two tumour antigens that are highly over expressed in bladder cancers. The trial will evaluate the hypothesis that combining a checkpoint inhibitor with a cancer vaccine such as CV301 could be synergistic by enhancing the immune response seen in this patient population to date.
Under the terms of the agreement, Roche has committed to supplying Tecentriq to Bavarian Nordic during the Phase II trial, and both companies will share the data.
Bavarian Nordic is also collaborating with Bristol-Myers Squibb testing CV301 in combination with Opdivo (nivolumab) in lung cancer.