Companion Dx to Merck Serono's brain cancer drug could be out by 2013
This article was originally published in Scrip
MDxHealth's PredictMDx for Glioblastoma could be launched alongside Merck Serono's investigational brain cancer drug cilengitide in as little as 18 months, after the companies expanded their existing collaboration.
Merck has now agreed to support development and regulatory activities for the test; after approval, the firms are planning a co-ordinated launch with cilengitide. Financial details were not disclosed.
The drug is currently in a 500-patient Phase III trial called CENTRIC; Nomura Code analyst Michael King believes that both cilengitide and MDxHealth's companion diagnostic could reach the market at the end of 2013 or early 2014.
"The previous agreement was more of a feasibility deal – seeing if the test worked with the Merck compound," a spokesperson for MDxHealth told Scrip's sister publication Clinica. "Because of the results they've achieved, the companies have entered into a full commercialisation and development agreement."
Mr King described the news as "an important step for MDxHealth in commercialising its technology as a companion diagnostic". "However, we believe that the immediate value of the business is going to be driven predominantly by the penetration of its recently launched ConfirmMDx test for Prostate Cancer, its test for identifying prostate cancer in biopsy samples," he added. MDxHealth launched the prostate cancer test in May.
Cilengitide is being trialled in newly-diagnosed patients with glioblastoma with a methylated promoter of the methylguanine-DNA methyltransferase (MGMT) gene in the tumour tissue. Prior to patient enrolment, MGMT gene promoter testing was conducted at MDxHealth's laboratories, which contributed to €1.8 million ($2.3 million) in revenue from the firm's clinical trial service division in 2011. The trial started in 2008 and is due to run until April 2017, with final data collection for the primary endpoint (overall survival) slated for March 2013, according to clinicaltrials.gov.
Last year, enrolment in the CENTRIC trial was completed, and MDxHealth and Merck expanded their collaboration to cover a Phase II study, CORE, which is evaluating cilengitide in newly-diagnosed glioblastoma patients (scripintelligence.com, 9 June 2011). This trial will also rely on the MDxHealth test for the stratification of patients. However, while patients enrolled in the CENTRIC trial require a positive methylation status of the MGMT promoter in the tumour, patients in the CORE trial require an unmethylated status of the MGMT gene promoter.
Cilengitide is also in a Phase I/II trial called CERTO in patients with advanced non-small cell lung cancer (NSCLC) and high epidermal growth factor receptor (EGFR) expression in their tumour tissue. This does not use MDxHealth's assay.