The novel drug, CAN-2409, may lead to improved survival outcomes in patients with non-metastatic pancreatic cancer, compared with standard-of-care.
Treatment with the investigational adenovirus CAN-2409 and prodrug Valtrex (valacyclovir) has been associated with improved survival when compared to standard-of-care presurgical chemoradiation in patients with non-metastatic pancreatic cancer, according to a news release from biopharmaceutical company Candel Therapeutics, the manufacturer of CAN-2409.
Interim results from a phase 2 clinical trial of 13 patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) were announced by Candel.
The results showed that, as of the March 29, 2024 data cut-off, the estimated median overall survival (OS; the time a patient lives following treatment, regardless of their disease status) was 28.8 months among patients treated with CAN-2409, Valtrex and chemoradiation followed by resection. Patients in the control group who underwent chemoradiation before surgery had a median OS of 12.5 months.
The 24-month survival rate was 71.4% in the CAN-2409 group after chemoradiation and before surgery, compared to 16.7% of patients in the control group, while the 36-month survival rates were 47.6% and 16.7%, respectively.
Borderline resectable pancreatic cancer, as defined on the website of the Division of General Surgery of the University of California San Francisco, “has grown into a major blood vessel or nearby tissue or organs. It may be possible to remove the tumor, but there is a high risk that all of the cancer cells will not be removed with surgery.”
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Of the seven patients treated with CAN-2409, four were still alive by the time of the data cut-off and two had survived more than 50 months from enrollment. One of the six patients in the control group was still alive by the data cut-off of 50.6 months. The addition of CAN-2409 to the standard of care, Candel noted, was “generally well tolerated, with no dose-limiting toxicities, including no cases of pancreatitis.”
CAN-2409, according to Candel’s news release, is “designed to deliver the herpes simplex virus thymidine kinase [HSV-tk] gene to a patient’s specific tumor and induce an individualized, systemic immune response against the disease.”
“Given frequent recurrence and short survival with [standard of care] chemotherapy for non-metastatic PDAC, effective new treatment options are urgently needed,” said Dr. Garrett Nichols, chief medical officer of Candel, in the company’s news release. “We are very encouraged by the improved survival associated with CAN-2409, which has been shown to be durable after prolonged follow-up based on the updated data shown in this randomized clinical trial. CAN-2409 was generally well tolerated without significant additional local or systemic toxicity when added to [standard of care] chemoradiation.”
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Previous data from the study were presented at the 2023 Society for Immunotherapy Annual Meeting, which served as the basis for the Food and Drug Administration granting a Fast Track Designation to the combination of CAN-2409 and Valtrex for patients with PDAC.
The Fast Track Designation, the FDA explained on its website, is part of a process that is intended to “facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.”
CAN-2409, Candel reported, is currently being evaluated in the treatment of non-small cell lung cancer and localized, non-metastatic prostate cancer as well as borderline resectable PDAC in clinical trials, with the combination of CAN-2409 and Valtrex also having been granted Fast Track Designation for the treatment of patients with stage 3/4 non-small cell lung cancer who are resistant to first-line PD-L1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy.
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