Merck KGaA has announced that its biopharmaceutical division will discontinue the clinical development program of tecemotide (L-BLP25) as a monotherapy in Stage III non-small cell lung cancer (NSCLC).
Tecemotide is an investigational MUC1 antigen-specific cancer immunotherapy that can boost a patient’s immune system to identify and destroy tumor cells that express the cell-surface glycoprotein MUC1, a protein involved in tumor growth and survival, which is found in NSCLC cells.
This experimental drug was being investigated in several Phase III clinical trials for the treatment of unresectable, locally advanced Stage III NSCLC.
One of these trials, the START2 study, began earlier this year as an outcome of the initial START study, which did not meet its primary endpoint.
START2 was a Phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy, safety and tolerability of tecemotide in patients suffering from unresectable, locally advanced (Stage IIIA or IIIB) NSCLC who have had a response or stable disease after at least two cycles of platinum-based concurrent chemoradiotherapy (CRT), a combination of chemotherapy and radiotherapy. The trial had a primary endpoint of overall survival and secondary endpoints of time to symptom progression, progression-free survival and time to progression.
Another ongoing study was INSPIRE, a Phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of tecemotide in NSCLC patients with the same disease criteria as the START2 trial.
“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. 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. We remain committed to developing new treatment options for patients with difficult-to-treat cancers”, Luciano Rossetti, Global Head of Research & Development at the biopharmaceutical division said in a PR Newswire press release.
The results Dr. Rossetti mentioned came from the EMR 63325-009 study, a Phase I/II study in Japanese patients with Stage III unresectable, locally advanced NSCLC who had received concurrent or sequential CRT, with a minimum of two cycles of platinum-based chemotherapy and radiation dose ≥50 Gy.
The majority of the patients included in this study received concurrent CRT, with results showing no difference in overall survival, progression-free survival, time to progression and time to treatment failure between treatment groups.
Base on this outcome, Merck KGaA’s biopharmaceutical division recommended the cessation of this study, followed by the discontinuation of all other clinical trials with tecemotide in NSCLC patients.
However, patients on active treatment can be individually assessed by their physician to continue tecemotide therapy. Furthermore, this experimental drug will continue to be supplied for ongoing investigator-sponsored trials in other indications.