Vaccine for Lung Cancer Dropped From Development

[RandyW]

A vaccine product that had shown a survival benefit in an early trial in patients with non–small-cell lung cancer (NSCLC) has now been dropped from further development. The product, tecemotide (L-BLP25, Stimuvax, Merck Serono) is a liposomal-based vaccine targeting a mucin protein found on the surface of epithelial cells in the respiratory system, which is abnormally glycosylated when cells turn cancerous.

An earlier phase 2b study conducted in 171 patients with stage 3b and 4 NSCLC showed a survival benefit. An updated survival analysis showed a median overall survival (OS) of 17.2 months in patients receiving tecemotide plus best supportive care (BSC), compared with 13.0 months in patients receiving BSC alone; the 3-year survival rate was 31%, compared with 17%, respectively ( J Cancer Res Clin Oncol. 2011;137:1337-42).

These early, promising results led the company to embark on a series of larger phase 3 trials, beginning with the START study, which involved 1513 patients.

Although the START study failed to meet its primary endpoint of improving OS, there was a significant survival advantage seen in a subgroup of patients who were also treated with chemotherapy and radiation. In this subgroup of patients (n = 806), the median OS in patients receiving tecemotide was 30.8 months vs 20.6 months in patients on placebo (hazard ratio, 0.78; P = .016).

This finding was judged to be promising enough to explore further, and in April 2014, the company announced that it was launching 2 further phase 3 studies, START 2 (n = 1000) and INSPIRE (n = 420).

Now, however, clinical development of tecemotide has been halted.

"While the data from the exploratory subgroup analysis in the START trial generated a reasonable hypothesis to warrant additional study, the results of the recent trial in Japanese patients decreased the probability of current studies to reach their goals," explained Luciano Rossetti, MD, global head of research and development at Merck Serono.

The latest set of results come from a Japanese study known as EMR 63325-009, conducted in patients with stage III unresectable, locally advanced NSCLC who had received concurrent or sequential chemoradiotherapy. The product had no impact on the OS primary endpoint, nor on any of the secondary endpoints (progression-free survival, time to progression, and time to treatment failure).

"Therefore, we have decided to discontinue the development of tecemotide as a monotherapy in NSCLC in order to refocus our efforts on other promising candidates in our pipeline, like our anti- PD-L1 antibody MSB0010718C," Dr. Rossetti commented in a statement.