An experimental vaccine, called TG4010, given together with chemotherapy resulted in significantly more progression free survival in patients with advanced lung cancer compared to those on chemotherapy alone, researchers from the Université de Strasbourg in Strasbourg, France, reported in the journal The Lancet Oncology. Lung cancer is the leading cause of cancer worldwide with non-small-cell-lung cancer (NSCLC) accounting for about 80% of lung cancer cases. Almost half of NSCLC patients are diagnosed when the disease is at an advanced stage and chemotherapy is currently their only treatment option.

According to a publication Online First in The Lancet Oncology, a phase 2 trial revealed that compared with chemotherapy alone 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).

In advanced lung cancer and numerous other cancers tumor cells alter the MUC1 protein and produce these cells in excess. For example, approximately 60% of MUC1 is over expressed in NSCLCs. TG4010, a unique vaccine therapy, has been developed to stimulate immune response against MUC1 and activate the body’s natural immune system to attack and destroy cancer cells.

For the phase 2 trial Elisabeth Quoix and team examined 148 patients from 23 centers across France, Germany, Poland and Hungary with advanced NSCLC, whose tumors expressed MUC1 but who had not received prior chemotherapy (chemotherapy naïve patients).

Researchers divided the patients into two groups:

  • The combination group – patients received TG4014 in combination with cisplatin and gemcitabine
  • The control group patients received only chemotherapy

The researchers reported that six months after therapy began:

  • 43% of patients in the combination group were progression free
  • 35% in the control group

The scientists also reported that tumor response was considerably higher in the combination group compared with those who only received chemotherapy.

Remarkably, researchers also discovered at the start of the study that the combination therapy proved particularly beneficial to a subgroup of patients with a normal number of triple-positive CD16+CD56+CD69+ lymphocytes, which are activated natural killer cells that can suppress or intensify immune responses.

The findings suggest, for the first time, that CD16+CD56+CD69+ lymphocytes levels in the blood prior to treatment could predict the efficacy and safety of the TG4010 vaccine and serve as a biomarker to help identify those patients who are likely to benefit from immunotherapy.

Overall, the TG4010 vaccine was generally well tolerated. Both groups experienced similar numbers of adverse events, such as anemia, thrombocytopenia (abnormally low number of blood platelets), and neutropenia (low white blood cell count) although more patients in the combination group reported fever, abdominal pain, and injection site pain. 52% of patients in the combination group compared with 47% of patients in the control group.

In a final statement 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.”

Written by Petra Rattue