The phase 1/2a trial reported favorable efficacy data in the first-line setting when compared with existing historical results for treating advanced pancreatic cancer.
Positive efficacy results were recently announced regarding nadunolimab (CAN04) plus gemcitabine/nab-paclitaxel to treat patients with advanced pancreatic ductal adenocarinoma (PDAC), according to an announcement from Cantargia AB, the company responsible for the research.
The ongoing, open-label, phase 1/2a CANFOUR trial (NCT03267316) enrolled 36 patients with advanced PDAC, reporting the early efficacy data for the combination treatment in the first-line setting, which compares favorably to the existing historical control data.
“These data are intriguing and indicate that addition of CAN04 to standard chemotherapy generates beneficial long-term effects for patients with advanced pancreatic cancer,” coordinating investigator of the trial, Professor Ahmad Awada at Institute Jules Bordet, Brussels, Belgium, said in a press release. “Antitumor effects in the form of pseudoprogression-like events, as well as decrease in serious side effects such as neuropathy and fatigue are unique features in this trial.”
Of the 33 patients who were available for efficacy analysis, the median progression-free survival per iRECIST was 7.8 months, with a median overall survival of 12.6 months. At the analysis, 58% of patients were still alive. More, 5 of those patients benefitted from treatment continuation after initial progressive disease, with either shrinking or stable tumor size.
An additional 9 patients experienced a confirmed partial response with a median duration of response of 6.8 months. Antitumor activity of the combination was confirmed via retrospective central review of CT scans, showing 8 confirmed responses.
The safety profile included some adverse effects, although the effects were manageable and in line with previously reported safety data from nadunolimab and chemotherapy. The analysis found grade 3/4 neutropenia (67%) and grade 3 febrile neutropenia (17%) were more prevalent than the historical data suggest, while grade 3/4 neuropathy (0%) and grade 3 fatigue (6%) were less common.
“The positive results support previous findings that CAN04 may enhance the efficacy of various chemotherapies,” Göran Forsberg, CEO, at Cantargia, said in a press release. “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.”
Currently, the CANFOUR trial has recruited up to an additional 40 patients as a part of its extension phase to generate further data on lower dosing, the pharmacodynamics of the combination, and to strengthen the clinical data set prior to pivotal trials.
Cantargia reports positive results in ongoing phase IIa clinical trial in pancreatic cancer using nadunolimab and chemotherapy. News release. Cantargia AB. Published May 19, 2021. Accessed May 27, 2021. https://bit.ly/3fOq3r0