The immunotherapy pembrolizumab 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 pembrolizumab treatment.

“The new data, from two separate clinical trials, show a long median survival in nadunolimab treated patients after previous therapy using pembrolizumab. These patients have a tumor microenvironment containing immune suppressive cells that can be targeted with nadunolimab” said Göran Forsberg, CEO of Cantargia. “These findings clearly support additional studies as the vast number of patients who progress on immunotherapy have limited treatment options”.

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=18 in total; n=17 post-pembrolizumab) compared to 1L pts (n=22) (ORR 72% vs 41%; PFS 7.6 mo vs 6.7 mo, p = 0.038; OS 15.7 mo vs 11.5 mo). Biopsy analyses showed that 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=12; ORR 92%, OS 28.9 mo; PFS 13.0 mo) 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 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 will be 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 results above are based on the abstracts submitted May 2024 and updated data will be presented at the conference. In parallel to the presentations, the poster can will be published on Cantargia’s webpage www.cantargia.com. The abstracts are now available at the conference website www.esmo.org/meeting-calendar/esmo-congress-2024/programme.