Candel Therapeutics has announced positive results from a mid-stage trial of its viral immunotherapy candidate in non-metastatic pancreatic cancer.
The ongoing phase 2 trial has been evaluating the candidate CAN-2409 plus valacyclovir together with standard of care (SoC) chemo-radiation followed by resection in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC).
Interim results demonstrated an estimated survival rate of 71.4% at months 24 and 36 months in patients who received the CAN-2409 regimen prior to surgery, compared to 16.7% in those receiving SoC chemo-radiation alone.
Five out of seven patients who received CAN-2409 were still alive at the time of the data cut-off, with two patients surviving more than 45 months from enrolment, while only one patient randomised to control SoC chemotherapy remained alive at the data cut-off.
A “consistent and robust activation of immune response” was also observed after dosing with CAN-2409, the company said, and that the candidate was associated with a “favourable tolerability profile”.
Garrett Nichols, Candel’s chief medical officer, said: “Given frequent recurrence and short survival with SoC chemotherapy for non-metastatic PDAC, effective new treatment options are urgently needed.
“We are encouraged by the improved survival associated with CAN-2409 for the treatment of borderline resectable PDAC, demonstrated for the first time in a randomised clinical trial.”
Pancreatic cancer is associated with a poor prognosis and remains one of the leading causes of cancer-related mortality worldwide, accounting for approximately 3.3% of all new cancer cases.
Surgical resection offers the only chance of cure and the addition of adjuvant chemotherapy has been shown to only slightly improve survival rates, Candel said, adding that immunotherapy with PD-1 antibodies with or without CTLA-4 antibodies has been “uniformly unsuccessful” in PDAC patients.
“The failure of immunotherapy to improve outcomes in pancreatic cancer is attributed to the highly immunosuppressive tumour microenvironment, which is largely devoid of immune cells,” explained Paul Peter Tak, president and chief executive officer of Candel.
“The immunological changes induced by CAN-2409, as observed in the pancreatic tissue after dosing, suggest that CAN-2409 treatment can convert the immune desert microenvironment and enable the generation of an effective anti-tumoural response and improve survival,” he added.