Nykode Therapeutics ASA announced positive final results from the Phase 2 VB-C-02 trial. The trial investigates the use of Nykode's therapeutic cancer vaccine candidate VB10.16 in combination with Roche's cancer immunotherapy Tecentriq® (atezolizumab) in patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer. The trial enrolled 52 patients, of which 48% had PD-L1+ tumors, who were treated for up to one year and followed for an additional 12 months.

As previously announced the company is planning an ambitious development strategy to take VB10.16 further in advanced cervical cancer and into head and neck cancer. The data announced supports the next steps which focus on PD-L1+ patients with up to one prior line of systemic therapy. The results showed a median overall survival of more than 25 months (median has not yet been reached) and a median progression free survival of 6.3 months in PD-L1+ patients.

The median overall survival for the overall population, which also includes patients with PD-L1- tumors, was 16.9 months, while the median progression free survival was 4.1 months. With overall response rate (ORR) of 29% in PD-L1+ patients (19% in overall population) and disease control rate (DCR) of 75% in PD- L1+ (60% in overall population) the final analysis confirms the previously reported positive response rates from the interim analysis. The duration of response in the overall population was 17.1 months.

In PD-L1+ patients with one prior line of systemic treatment ORR was 40% and DCR 80% with a median progression free survival of 16.9 months and median overall survival more than 25 months (not reached). VB10.16 in combination with atezolizumab was well-tolerated and has a safety profile comparable to checkpoint inhibitor monotherapy reported in literature.