New cancer vaccine extends progression-free survival in patients with advanced lung cancer

October 21, 2011

A phase 2 trial, published Online First in The Lancet Oncology, has shown that combining standard platinum-based chemotherapy with the new cancer vaccine TG4010 enhances the effect of chemotherapy and slows down the progression of advanced non-small-cell-lung cancer (NSCLC), the most common type of lung cancer, compared with chemotherapy alone.

NSCLC accounts for about 80% of lung cancer cases and is the leading cause of cancer death worldwide. Nearly half of NSCLC patients are diagnosed with advanced disease and chemotherapy is currently their only treatment option.

In advanced lung cancer and several other cancers the MUC1 protein is altered and produced in excess by tumour cells. Around 60% of NSCLCs overexpress MUC1. TG4010 is a novel therapeutic vaccine designed to stimulate an immune response against MUC1 and activate the body's own immune system to attack and destroy cancer cells.

In this study, Elisabeth Quoix from Université de Strasbourg, Strasbourg, France and colleagues enrolled 148 patients with advanced NSCLC whose tumours expressed MUC1 but had not received prior chemotherapy treatment from 23 centres across France, Poland, Germany, and Hungary. Patients were assigned to either TG4014 in combination with cisplatin and gemcitabine (74 patients; combination group) or chemotherapy alone (74 patients; control group).

At 6 months, 43% of patients in the combination group were progression free compared with 35% in the control group. Additionally, tumour response was substantially higher in patients receiving the combination treatment compared with chemotherapy alone.

Interestingly, the researchers also found that treatment with the combination regimen was particularly beneficial to a subgroup of patients with a normal number of triple-positive CD16+CD56+CD69+ lymphocytes (activated natural killer cells that can stifle or intensify immune responses) at the start of the study.

For the first time, this suggests that the level of CD16+CD56+CD69+ lymphocytes in the blood before treatment could be a predictor of the efficacy and safety of the TG4010vaccine and serve as a biomarker to help identify patients likely to benefit from immunotherapy.

The TG4010 vaccine was generally well tolerated. The most common adverse events were anaemia, neutropenia (low white blood cell count), and thrombocytopenia (abnormally low number of blood platelets), and both groups experienced a similar number of these complications. However, fever, abdominal pain, and injection site pain were more frequent in the combination group. At least one serious adverse event was experienced by 52% of patients receiving combination treatment compared with 47% of patients having chemotherapy alone.

The authors conclude: "These observations point to the importance of patients' biological status as a predictor for success of therapeutic vaccination, and suggest that analysis of biological parameters should be part of the clinical developments in cancer immunology."
-end-
Professor Elisabeth Quoix, Université de Strasbourg, Strasbourg, France. Via Mrs Ledermann (PA to Prof Quoix) T) +33 3 69 55 06 44 E) Elisabeth.quoix@chru-strasbourg.fr

Lancet

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