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Merck KGaA Drug Fails in Late-Stage Brain Cancer Trial

Al's Comment:

 I sent a similiar story out in the last news blast, but this article points out that they are still testing this drug on GBM patients  with an unmethylated MGMT gene promoter status. These tumors do not respond as well to the standard treatment, and adding a little something extra like this drug may help. Reading between the lines, now that they have the results of the big phase 3 trial, they probably analyzed the outcome in patients who have the methylated vs unmethylated status and must have seen it is worth continuing the trial on unmethylated patients.


 A little background on methylation status: there is a test that can determine what % of cells in the tumor have methylated or unmethylated MGMT promotor genes. If the gene is methylated, the gene becomes inactive and can not be used to produce the MGMT protien, which is a repair enzyme.  Chemotherapy, such as Temodar, work by damaging the DNA in cells so they can not reproduce. MGMT repairs the damage, which makes the tumor resistent to chemotherapy.  So a person who has a high % of methylated MGMT genes will have less repair enzyme and thus better response to chemotherapy than someone who has a low % of methylated MGMT genes. 


This make a huge difference. Time to progression of the tumor is half as long in people who have the unmethylated MGMT gene compared to people who have the methylated status.


Posted on: 02/25/2013

Merck KGaA Drug Fails in Late-Stage Brain Cancer Trial

Merck KGaA’s (MRK) experimental tumor- fighting drug cilengitide failed to help patients with a form of brain cancer in a late-stage clinical trial, adding to recent drug-development setbacks for the company.

The medicine didn’t significantly increase survival in patients with newly diagnosed glioblastoma when added to standard chemotherapy, the Darmstadt, Germany-based drugmaker said in a statement today. Merck shares fell as much as 2.8 percent, the biggest intraday slide in two months, and were down 0.6 percent at 105 euros at 9:45 a.m. in Frankfurt.

The setback comes after the family-controlled chemicals and pharmaceuticals company said in December that a therapy known as L-BLP25 failed to improve survival significantly in lung-cancer patients.

“The results of Centric are disappointing, especially for people who are fighting this devastating and difficult-to-treat cancer,” said Annalisa Jenkins, the head of global drug development and medical for Merck’s prescription medicines division. “We remain committed to advancing our pipeline and developing new treatment options in oncology for patients with high medical need.”

Detailed results of the trial, dubbed Centric, will be submitted for presentation at the American Society of Clinical Oncology meeting this year.

The result is “another blow” for the Merck Serono pharmaceutical division, Odile Rundquist, an analyst at Helvea SA, said in a note to investors.

The drug is still being tested in a mid-stage clinical trial in patients with unmethylated MGMT gene promoter status. Tumors with the MGMT protein don’t respond well to treatment with temozolomide, the current standard of care.

To contact the reporters on this story: Phil Serafino in Paris at pserafino@bloomberg.net; Allison Connolly in Frankfurt at aconnolly4@bloomberg.net

To contact the editor responsible for this story: Heather Harris at hharris5@bloomberg.net

 


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