Study details
In the LICC trial, tecemotide and placebo yielded a respective median recurrence-free survival of 6.1 months and 11.4 months (P = .1754) and a respective overall survival of 62.8 months and not reached (P = .2141), Dr. Schimanski reported at the symposium, sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology. The 3-year overall survival rate was 69.1% with tecemotide and 79.1% with placebo.
That survival “was astonishing for us,” Dr. Schimanski said. “We think – but we cannot prove it – that has resulted from careful staging due to the retrospective radiological review and the initial staging, and a very tight surveillance program.”
Findings were similar regardless of whether patients had low, medium, or high tumor MUC1 expression; therefore, “we have to conclude that the target is not really validated.”
Patients in the tecemotide arm had higher rates of any-grade nausea, fatigue, diarrhea, and viral upper respiratory tract infections, at least some of which was likely attributable to the single dose of cyclophosphamide, according to Dr. Schimanski. They also had higher (but still low) rates of grade 3 or 4 back pain, anemia, ileus, cholestatic jaundice, and increased blood uric acid levels (2.5% for each). There was a single death in that arm from Merkel cell carcinoma that was deemed potentially related to the vaccine.
Dr. Schimanski disclosed that an immediate family member is employed by Merck and that he receives research funding from Merck KGaA (institutional). The trial was funded by Merck KGaA.
SOURCE: Schimanski CC et al. GI Cancers Symposium, Abstract 480.