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CAN-2409 resulted in disease-free survival improvements for patients with high-risk, localized prostate cancer.
Patients with high-risk localized prostate cancer showed beneficial responses when treated with CAN-2409.
Among patients with localized prostate cancer, the viral immunotherapy CAN-2409 has elicited promising responses in a phase 3 clinical trial.
The trial, according to a news release from biopharmaceutical company Candel Therapeutics, Inc., has met its primary end point among patients with intermediate-to-high-risk, localized prostate cancer, with its demonstration of what the company described as a statistically significant improvement in disease-free survival (DFS) for patients who received CAN-2409 and the prodrug valacyclovir plus standard of care radiation therapy versus standard of care radiation therapy alone.
In the 496 patients who received CAN-2409 plus radiation therapy versus the 249 patients who received radiation therapy alone, there was a 14.5% relative improvement in DFS observed at 54 months, and patients treated with CAN-2409 had a 30% lower risk of disease progression or death.
Primary end point: a main result measured at the end of a study to see if treatment worked.
Disease-free survival (DFS): The time after treatment that a patient lives without signs and symptoms of cancer.
Pathological complete response (PCR): The absence of cancer cells in tissue samples that are removed during surgery or biopsy after treatment, according to the National Cancer Institute.
“The improvement observed in disease-free survival in this phase 3 clinical trial is clinically meaningful. We have not seen significant advances in this indication in decades. CAN-2409 has demonstrated the potential to significantly improve long-term outcomes without adding substantial toxicity to standard of care radiation,” said Dr. Glen Gejerman, Co-Director of Urologic Oncology at Hackensack Meridian Health, and one of the principal investigators of the study, in the news release. “If approved, this approach has the potential to transform the treatment paradigm in prostate cancer, offering patients with localized disease an effective treatment option that may reduce the risk of disease recurrence.”
Additionally, patients treated with CAN-2409 had a 40% lower chance of prostate cancer recurrence or death related to prostate cancer, and CAN-2409 was associated with 80.4% pathological complete responses (pCRs) in two-year post-treatment biopsies, versus 63.6% in the standard of care cohort.
The safety profile of CAN-2409 was found to be overall consistent with that seen in prior studies, with the most common side effects related to CAN-2409 being flu-like symptoms, fever and chills which were mild to moderate in severity.
“We are thrilled to report the phase 3 results for CAN-2409 in intermediate-to-high risk, localized prostate cancer,” said Dr. Paul Peter Tak, President and Chief Executive Officer of Candel, in the news release. “This study validates previous observations of CAN-2409 activity seen in difficult-to-treat solid tumors, often resistant to immunotherapy, and confirms our previous observation of synergies with radiation therapy in models of prostate cancer. Importantly, this study was conducted under a Special Protocol Assessment (SPA) agreed with the U.S. Food and Drug Administration (FDA), on key aspects of study design, meaning that safety and efficacy data generated from the study could be sufficient for the company to seek regulatory approval for CAN-2409 in this indication. We look forward to working with the FDA, as a next step, to seek approval to bring CAN-2409 to patients in the U.S. and advance our broad viral immunotherapy pipeline across other large oncology indications of high unmet need.”
Furthermore, Candel announced in the news release that a phase 2 clinical trial of patients with low-to-intermediate risk localized prostate cancer undergoing active surveillance demonstrated what the company described as a numerical improvement in the time to radical treatment and the percentage of patients achieving prostate cancer-free biopsies at one-year post-treatment, but these differences were not statistically significant.
Candel, according to the news release, plans to present data from both studies at upcoming medical conferences.
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