Vaccine may enhance NSCLC treatment
A total of 148 patients with advanced (stage IIIB [wet] or IV) NSCLC were enrolled in the phase 2B study, which was conducted across 23 facilities in France, Germany, Hungary, and Poland. The MUC1 protein was overexpressed in all cases; the TG4010 vaccine is designed to stimulate an immune response against the protein and activate an immune system response to destroy the cancer cells.
The 74 members of the combination group received TG4010 plus cisplatin (75 mg/m2 on day 1) and gemcitabine (1,250 mg/m2 on days 1 and 8), repeated every 3 weeks for up to six cycles. The 74 people in the control group received the same chemotherapy with no vaccination.
At the 6-month mark, progression-free survival was 43.2% in the combination group and 35.1% for the controls. In addition, tumor response was substantially higher in the combination patients.
Although the vaccine was generally well tolerated, fever and abdominal pain were more common among the vaccinated patients, as was injection-site pain. Rates of the most common adverse events of anemia, neutropenia, and thrombocytopenia were similar in both groups; for example, neutropenia was seen in 33 (45.2%) of the TG4010 recipients vs 31 (43.1%) of the chemotherapy-only patients. About half (52%) of the combination group members experienced at least one serious adverse event, compared with 47% of the others.
Professor Elisabeth Quoix of the Université de Strasbourg in Strasbourg, France, and co-investigators noted in The Lancet Oncology that a phase 2B-3 trial was launched to confirm their results.