Bavarian Nordic initiates trial of CV301 in combination with nivolumab in patients with lung cancer

Study is exploring potential benefits of combining a cancer vaccine and PD-1 checkpoint inhibitor.

The trial will begin with a Phase I safety component, enrolling up to 40 patients; the Phase II portion of the study will enroll 120 patients who will be randomized to receive either nivolumab (monotherapy) or a combination of CV301 and nivolumab. The study will enroll patients from up to 20 clinical sites throughout the US.

The rationale for this combination approach is for the vaccine to generate a tumour specific T cell response and allow the checkpoint inhibitor to maintain that immune effect by preventing the tumour from turning that response off.

While the primary endpoint of the study is overall survival, numerous secondary endpoints including response rate, progression free survival and duration of response will be evaluated and offer the potential for an early efficacy signal, prior to an overall survival endpoint.

"We are pleased to announce the initiation of this study, which marks the entry for Bavarian Nordic into lung cancer. While CV301 has shown the ability to generate immune responses to tumour-associated antigens in a variety of cancers, this study is the first seeking proof-of-concept for a promising combination approach and we look forward to the results as well as to advance CV301 as combination therapy in additional indications over the next years," said Paul Chaplin, President & CEO of Bavarian Nordic.