“These new positive data presented at the ESMO conference, describe an important opportunity for nadunolimab in future clinical trials with potential to address a big unmet medical need” said Göran Forsberg, CEO of Cantargia.

The immunotherapy pembrolizumab, targeting PD1, is one of the most important cancer treatments with sales around US$ 25 B 2023. New data from two clinical trials in 55 patients highlight a unique opportunity using nadunolimab in patients after they have progressed on checkpoint inhibitors like pembrolizumab. A summary of the results based on the abstract submission in May 2024 was reported Sep 9, 2024, and updated results are described below.

The first trial, CANFOUR, investigated nadunolimab in combination with platinum doublet chemotherapy in 40 first- or second-line non-small cell lung cancer (NSCLC) patients. Stronger efficacy was seen in 2L pts (n=17) compared to 1L pts (n=23) (ORR 71% vs 44%; OS 15.7 vs 11.5 months). Biopsy analyses showed that the 2L pts had a higher number of IL1RAP-positive immune cells, CD163+ macrophages, CD56+ NK cells and CD8+ T cells in the tumor at baseline. Efficacy results were most pronounced in second line non-squamous pts (n=11; ORR 91%, OS 26.7 months; PFS 10.4 months) including two complete responders. The data suggest that nadunolimab may mediate its anti-tumor activity by blocking tumor promoting cells within the TME. The safety results of the combination have been presented previously and show an acceptable side effect profile.

The second trial, CIRIFOUR, investigated nadunolimab combination therapy with pembrolizumab in 15 heavily pretreated patients who had previously progressed on pembrolizumab or nivolumab monotherapy or combination treatments. Nine patients had head and neck cancer, 5 NSCLC and 1 melanoma. In this trial, the median survival was 19.7 months and the disease control rate was 60%. Similar to the CANFOUR data, the strongest benefits were observed in the group of patients with a specific profile of immune and immunosuppressive cells in the tumor microenvironment. The combination therapy was well tolerated.

The two posters are presented at the ESMO Congress 2024 in Barcelona on Saturday, September 14th by Dr Luis Paz-Ares, Hospital Universitario 12 de Octubre, Madrid, Spain and Dr Roger Cohen, University of Pennsylvania, Philadelphia, PA, US, respectively. The poster can be viewed on Cantargia’s webpage https://cantargia.com.