The company has reported positive results from the ongoing CANFOUR trial investigating nadunolimab (CAN04) in combination with gemcitabine/nab-paclitaxel (Abraxane) for first line treatment of patients with advanced pancreatic cancer (PDAC).
The efficacy analysis included 33 patients. Overall, the efficacy compares favorably to historical control data. Median iPFS was 7.8 months and other notable findings include five patients with durable benefit beyond initial progression (pseudoprogression), and an additional nine patients with confirmed partial response with a median duration of response of 6.8 months.
An ongoing retrospective central review of CT scans revealed one confirmed complete responder and otherwise similar efficacy data. Currently, the median survival is 12.6 months with 58% of patients still alive. The side effects were manageable with neutropenia and febrile neutropenia higher than expected from the chemotherapy alone, while chemotherapy-related neuropathy and fatigue were less common. Neutropenia can be managed by prophylactic use of growth factor therapy and dose modifications.
In CANFOUR, 36 patients with advanced PDAC were included in the first line setting at either 5 or 7.5 mg/kg of CAN04 weekly. Three of these patients withdrew consent after occurrence of infusion-related reaction during the first administration and did not receive chemotherapy. Subsequently, the efficacy analysis was performed in the 33 remaining patients. The last patient in the trial started therapy in October 2020 and seven patients are still being treated.
“The positive results support previous findings that CAN04 may enhance the efficacy of various chemotherapies.”
“The positive results support previous findings that CAN04 may enhance the efficacy of various chemotherapies. We are therefore very pleased with the outcome of this trial and are preparing next development steps of CAN04 to meet the high medical need in pancreatic cancer,” says Göran Forsberg, CEO at Cantargia.
An extension phase
The CANFOUR trial in PDAC is currently recruiting up to 40 additional patients in an extension phase. The purpose with this is to generate additional data on lower doses, to strengthen the clinical data set prior to trials, including results on CAN04 pharmacokinetics, and pharmacodynamics of the combination therapy. In the parallel combination arm of CANFOUR in NSCLC, recruitment is in the final stage with results expected to be presented during Q3, 2021.
Photo of Göran Forsberg: Cantargia