Author: Walter Alexander
A personalized cancer vaccine proved possible to manufacture and was well tolerated in an early phase I clinical trial, researchers said. The vaccine, known as PGV-001, was given to 13 patients with solid tumors or multiple myeloma who had a high risk of recurrence after surgery or stem cell transplant.
At last follow-up, four patients were still alive without evidence of disease and had not received subsequent therapy, four were alive and receiving therapy, three had died, and two could not be contacted for follow-up.
Thomas Marron, MD, of Mount Sinai in New York presented these results at the American Association for Cancer Research Annual Meeting recently.
“While cancer immunotherapy has revolutionized the treatment of cancer, we know that the majority of patients fail to achieve significant clinical response,” Marron said during his presentation. Personalized vaccines may help prime an improved immune response, he said.
With this in mind, Marron and colleagues developed PGV-001, a vaccine consisting of customized peptides – a kind of amino acid — given to patients along with initial treatment.
Feasibility and safety
Vaccines were given to 13 patients. Six had head and neck cancer, three had multiple myeloma – a cancer of the white blood cells — two had lung cancer, one had breast cancer, and one had bladder cancer.
Eleven patients received all 10 intended doses, and two patients received at least eight doses.
“The vaccine was well tolerated, with only half of patients experiencing mild, grade 1 adverse events,” Marron said.
Four patients developed reactions at the injection site and one person Transient injection site reactions occurred in four patients, and one patient developed a low-grade fever.
After an exam after an average of 880 days, four patients had no evidence of cancer and had not received more therapy. This includes one patient with stage III lung cancer, one with stage IV positive breast cancer, one with stage II bladder cancer, and one with multiple myeloma.
Four patients were alive and receiving other kinds of therapy. Three patients have died, two of whom saw their cancers return.
“Our results demonstrate that the OpenVax pipeline is a viable approach to generate a safe, personalized cancer vaccine, which could potentially be used to treat a range of tumor types,” Bhardwaj said.