Merck KGaA to initiate new Phase III trial of cancer immunotherapy tecemotide despite earlier failure
Merck KGaA said Wednesday that it will continue clinical development of the MUC1 antigen-specific cancer immunotherapy tecemotide, previously known as Stimuvax, in patients with non-small-cell lung cancer (NSCLC) despite a previous Phase III trial missing its main goal. Annalisa Jenkins, head of Global Drug Development and Medical at Merck’s Serono unit, remarked that previous results «delivered important insights that we believe justify further investigation in a new Phase III programme.»
In 2012, Merck reported that in the Phase III START trial, tecemotide failed to meet its main goal of significantly improving overall survival in patients with unresectable, locally advanced stage IIIA or IIIB NSCLC who had a response or stable disease after at least two cycles of platinum-based chemoradiotherapy (CRT) delivered concurrently or sequentially. The company said Wednesday that an exploratory analysis of a predefined subgroup in the study showed that patients who received tecemotide after concurrent CRT had median overall survival of 30.8 months versus 20.6 months for those given placebo.
The new trial, called START2, will enrol about 1000 patients with 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 CRT. Merck noted that concurrent CRT is the current standard of care for these patients. The study, which will be conducted under a special protocol assessment with the FDA, has a main goal of overall survival.
Merck licensed rights to tecemotide from Oncothyreon in 2007, and is co-developing the immunotherapy with Ono Pharmaceutical in Japan. A Phase III trial called INSPIRE is also under way and is currently enrolling 420 patients with unresectable, locally advanced stage III NSCLC in China, Hong Kong, Korea, Singapore and Taiwan.