Cantargia reported updated interim results for non-small cell lung cancer (NSCLC) patients treated with nadunolimab (CAN04) in combination with gemcitabine and cisplatin, showing efficacy well above historical controls. With 30 patients evaluable, overall response rate (ORR) was 53%, disease control rate 83%, median progression-free survival (PFS) 6.8 months and median overall survival (OS) 13.7 months. The strongest efficacy benefits were seen in patients with non-squamous NSCLC, particularly those treated previously with a checkpoint inhibitor.

The safety profile was acceptable and in line with earlier data. The results will be presented at the ASCO 2022 Annual Meeting on 6 June 2022. In total, 33 NSCLC patients were included in the phase IIa part of the CANFOUR trial, of which 30 received treatment with 1, 2.5 or 5 mg/kg of the company's IL1RAP-binding antibody, nadunolimab, in combination with gemcitabine and cisplatin.

Efficacy analyses across all 30 patients treated with the combination showed an ORR of 53%, which is well above historical data of 22-28% for chemotherapy only. Additionally, disease control rate was 83%, median PFS was 6.8 months and median OS was 13.7 months. PFS and OS were stronger than historical data which show a median PFS and OS of 5.1 months and 10.3 months, respectively2.

The last patient in the trial started treatment in September 2021. At data cut-off in April 2022, seven patients were still being treated, with one patient on therapy for over 30 months. The safety profile of the combination was acceptable and readily managed.

Rates of neutropenia and febrile neutropenia were more frequent primarily during the first cycle compared to historical data for chemotherapy alone2, but could be reduced by the granulocyte growth factor, G-CSF: only 33% of patients treated prophylactically with G-CSF developed grade 3-4 neutropenia, a level similar to chemotherapy alone, compared to 71% without prophylactic G-CSF. Thrombocytopenia and grade 1-2 infusion-related reactions following the first infusion were also more common compared to chemotherapy only. The infusion-related reactions could be efficiently managed by standard measures.