Merck KGaA pipeline hit

pharmafile | December 21, 2012 | News story | Research and Development, Sales and Marketing Cancer, Merck KGaA, NSCLC, pipeline 

Merck KGaA’s pipeline has been dented by the ‘disappointing’ late-stage failure of Stimuvax in a programme with non-small cell lung cancer (NSCLC) patients.

The Phase III START(a) trial of Stimuvax (L-BLP25) did not meet its primary endpoint of demonstrating a statistically significant improvement in overall survival.

The German manufacturer was understandably keen to claw back as many positives from the data as possible, saying that ‘notable treatment effects’ were seen in some patient subgroups which ‘warrant further investigation’.

The company is not saying what these subgroups are but promises further analyses in the coming weeks, adding that the START study results will be presented at a future international scientific meeting.

Licenced from Oncothyreon in 2007, Stimuvax is an investigational MUC1 antigen-specific cancer immunotherapy designed to stimulate the body’s immune system to identify and target cells expressing the cell surface glycoprotein MUC1.

Around 80% of all lung cancers are NSCLC, with roughly 60% of this group over-expressing MUC1. The range of current treatments – which include AstraZeneca’s Iressa and Roche’s Tarceva and Avastin – is relatively limited. 

“We believe that the START study will offer important scientific insights to the potential for immunotherapies in the treatment of this devastating disease,” said Annalisa Jenkins, head of global drug development and medical for Merck Serono.

“We intend to discuss these data with scientific community and regulatory authorities to gain their advice on potential next steps,” she added.

START was a randomized, multi-centre, double-blind, placebo-controlled trial looking at the efficacy, safety and tolerability of Stimuvax in 1,500 patients with unresectable stage III NSCLC who had achieved response or stable disease after chemoradiotherapy.

The programme, which includes studies in the Asia-Pacific region, will continue – pending discussion with relevant regulatory agencies, Merck says.

Trials of Stimuvax in NSCLC had been put on ice in March 2010 – although resumed a few months later – after one patient in Phase II trials for multiple myeloma developed the potentially fatal brain swelling encephalitis.

Adam Hill

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