A new clinical trial will reexamine the lung cancer vaccine tecemotide, formerly known as Stimuvax. Tecemotide stimulates the patient’s immune system to attack tumor cells. Although the drug previously failed in the START clinical trial, drugmakers reported that later analyses showed that tecemotide increased survival in the subset of patients who had been treated with chemoradiotherapy (simultaneous chemotherapy and radiation therapy, or CRT) before tecemotide. Like START, the new trial, START2, will enroll patients with locally advanced, stage III non-small cell lung cancer (NSCLC) that cannot be removed with surgery. However, START2 will exclusively focus on patients who have previously received CRT.
New results from an ongoing clinical trial suggest that an experimental vaccine may not keep melanomas from coming back after all. The vaccine targets tumors that express a gene called MAGE-A3, which is active in 65% of melanomas that have begun to spread. However, researchers will continue the phase III trial because even though this treatment does not work on melanomas broadly, it could still control a tumor subtype with a particular mutation. The results of the continued study are expected in 2015. In addition, the MAGE-A3 vaccine is being tested against non-small cell lung cancer in another phase III trial, and initial findings are expected in 2014.
While an immune system booster called IL-12p70 helps people fight cancer, this protein is toxic when injected into people systemically. Now, a new study shows how to boost levels of this protein in melanomas safely. The researchers developed a vaccine that includes immune system cells from the bodies of people with melanoma. These cells then stimulate production of the immune system booster IL-12p70 in tumors. In a phase I clinical trial, the vaccine increased IL-12p70 levels in six of seven people with melanoma, and one of them was in complete remission more than 4 years. This trial is currently accepting new participants.
A new clinical trial is underway for an immune system booster that makes an experimental vaccine against melanomas work better. The experimental vaccine is gp100, a protein made by melanoma cells, and the immune system booster is a heat shock protein. The latter got its name because it protects other proteins from heat and other forms of stress, but heat shock proteins also stimulate the immune response. The phase I trial of this combination vaccine will include 12 to 20 people with melanomas that have spread, and is currently recruiting participants.
Like many cancers, melanomas look like healthy cells to our immune system. But melanomas have unique protein fragments (peptides) on their cell surfaces that make them stand out from normal cells. A new study suggests that our immune systems can be redirected to target these cancer-specific peptides — and so melanomas. In an ongoing phase I clinical trial, the researchers found that an anti-melanoma vaccine shrank tumors in both of the people with melanomas that had spread. One of these people now has no evidence of melanoma.
A phase II clinical trial of a vaccine aimed at treating non-small cell lung cancer (NSCLC) has yielded promising findings. Tergenpumatucel-L (HyperAcute-Lung immunotherapy, or HAL) consists of genetically modified NSCLC cells that provoke a strong, targeted attack from the immune system. The treatment thus trains the patient’s immune system to attack NSCLC cells. Eight out of 28 patients with advanced NSCLC who received HAL experienced stable disease without further cancer growth. The average survival time for study participants was 11.3 months, which is longer than expected for their disease status, and one patient survived more than 50.0 months. Patients whose cancer progressed after HAL treatment were given chemotherapy. Over half of showed some degree of effectiveness, suggesting that HAL treatment may increase responsiveness to chemotherapy.
CureVac, a German biopharmaceutical company, announced the start of a phase IIb clinical trial of its vaccine, CV9104, for castration-resistant prostate cancer (CRPC). The vaccine works by prompting the body’s own immune system to attack prostate cancer cells. The trial will enroll up to 200 patients across eight European countries who have never received chemotherapy for CRPC. For more information on the clinical trial click here.
Results of a clinical trial that evaluated the prostate cancer vaccine Provenge have come under scrutiny. Questions arise regarding the reported 4-month survival benefit that ultimately led to FDA approval. Disputers suggest that a flaw in methods led to the survival benefit, but that the vaccine may actually cause harm.