Merck suffers brain cancer reverse
pharmafile | February 26, 2013 | News story | Sales and Marketing | Merck, cilengitide
Merck’s oncology programme has suffered a setback as a Phase III trial of its investigational integrin inhibitor cilengitide failed in patients with newly-diagnosed glioblastoma (GBM).
The drug did not meet its primary endpoint of significantly increasing overall survival when added to the current standard chemoradiotherapy regimen (temozolomide and radiotherapy).
Each year around 240,000 people worldwide are diagnosed with GBM, the most common and aggressive type of glioma, which is in turn a prevalent type of malignant primary brain tumour.
The CENTRIC trial, run with the European Organisation for Research and Treatment of Cancer (EORTC), included patients with newly-diagnosed GBM and methylated O(6)-methylguanine-DNA methyltransferase (MGMT) gene promoter status.
Annalisa Jenkins, head of global drug development and medical for Merck Serono, admitted the findings from more than 500 patients in 23 countries were ‘disappointing’.
It is unwelcome news particularly because cilengitide is the first in this new class of targeted anticancer therapies to have reached Phase III.
The drug is thought to work by targeting integrins involved in tumour cell growth and which are over or aberrantly-expressed in many cancers.
“These results illustrate how challenging this disease remains, and that thorough clinical investigations like in this study are crucial before adopting new treatment strategies,” said Professor Roger Stupp, lead investigator and head of neuro-oncology at the University of Lausanne Medical Center.
Detailed results will be presented at this year’s American Society of Clinical Oncology (ASCO) meeting and Jenkins said that data sets would be analysed over the next few months.
“We will also evaluate the results of the currently ongoing Phase II CORE trial, which included only patients with an unmethylated MGMT gene promoter status,” she added.
There is also another Phase I/II trial of the drug ongoing in non-small cell lung cancer (NSCLC).
Despite the difficulties, pharma certainly has its eye on GBM: in a Phase III trial last year, Roche’s Avastin helped people with newly-diagnosed GBM live longer without their disease worsening.
And Actelion’s dual endothelin receptor antagonist Macitentan is also being investigated in in patients with recurring GBM.
Adam Hill
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