Merck Serono won’t give up on cancer vaccine
pharmafile | September 26, 2013 | News story | Sales and Marketing | Merck, Merck Serono, Stimuvax
Merck Serono’s once failed lung cancer vaccine treatment Stimuvax has been given a second chance as the German firm begins new late-stage trials.
Stimuvax, which has been renamed tecemotide, will be tested on patients with locally advanced Stage III non-small cell lung cancer (NSCLC) which cannot be surgically removed.
The previous START trial, which also included patients that had been given chemotherapy and radiotherapy separately, failed to provide evidence of improved survival.
The drug was licensed from US biotech firm Oncothyreon and is to be tested on around 1,000 patients in the new study, which is named START2. But this falls short of the 1,200 participants in the original START trial – the firm did not say why it was using fewer patients.
Dr Annalisa Jenkins, head of global drug development and medical for the Merck Serono division, said: “The START data delivered important insights that we believe justify further investigation in a new Phase III programme. NSCLC is a devastating disease, and we are pleased to be able to continue supporting innovation in this important emerging field of immuno-oncology.”
Tecemotide is an investigational MUC1 antigen-specific cancer immunotherapy designed to stimulate the body’s immune system to identify and target cancer cells expressing the cell-surface glycoprotein MUC1.
MUC1 is expressed in many cancers, including NSCLC, and has multiple roles in tumour growth and survival.
If approved it would be the only lung cancer vaccine available on the market, although there are already treatments for other cancers using the body’s immune system, including Dendreon’s prostate cancer vaccine Provenge and Bristol Myers Squibb’s melanoma treatment Yervoy.
NSCLC is one of the most deadly cancers in the world and despite having a number of treatments on the market – including AstraZeneca’s Iressa, Roche’s Avastin and Tarceva as well as Boehringer’s new Gilotrif, survival rates for the disease remain low.
New start for Merck KGaA?
Merck Serono, the pharmaceuticals unit of Merck KGaA, has only seen the colorectal cancer drug Erbitux approved since 2003 with another new treatment not expected to be on the market until at least 2016.
Erbitux has also been approved for head and neck cancer but failed to help patients with stomach tumours and was rejected for use in lung cancer in Europe, curbing its growth potential.
The failure of Stimuvax was a further blow for the firm which has taken a number of hits in the past two years, including the failure of a potential multiple sclerosis pill cladribine that was touted as a future blockbuster.
The company currently relies heavily on revenue from its ageing MS treatment Rebif, and hoped that cladribine could shore up sales when its patent lapses. But Merck KGaA lost out to Novartis’ Gilenya, the world’s first oral MS treatment to remain on the market.
These failures led to Merck KGaA to make some tough decisions, including making swingeing cuts and re-organising its top tier. The re-emergence of trials for Stimuvax will be a welcome reprieve, but analysts still expect tough times ahead for the firm.
Ben Adams
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