Exelixis GBM drug set bar for approval
XL-184 has shown to be toxic... Exelixis plans to get approval based on a PIIa with 46 patients....
This sets the bar very low for TLN-4601 FDA approval.
XL-184 is toxic, 87% patient stopped treatment.
XL-184 final data are less impressive than partial data released last month.
https://www.reuters.com/article/rbssHealthcareNews/idUSN3036949120090531
* Independent review shows 15 pct response rate
* Trial will enroll 100 more patients
* Lower dose to be studied
By Deena Beasley
ORLANDO, Fla., May 31 (Reuters) - Exelixis Inc (EXEL.O) andBristol-Myers Squibb Co (BMY.N) plan to enroll 100 additionalpatients in an mid-stage trial of their experimental braincancer drug, known as XL184, and will also test a lower dose ofthe drug,
An independent radiology review of trial results shows that15 percent of 46 evaluated patients with advanced glioblastomamultiforme, the most common and deadly form of brain cancer,had tumor shrinkage, the companies said on Sunday.
Looking only at patients not previously treated withanti-angiogenic drugs, 20 percent responded to the drug.
Those numbers are lower than interim rates reported earlierby trial investigators.
The median duration of response was 2.9 months, accordingto the latest data, reported at a meeting of the AmericanSociety of Clinical Oncology.
The independent review "is a very conservative picture,"said Renzo Canetta, head of global oncology development atBristol-Myers.
XL184 is an oral drug designed to block the vascularendothelial growth factor, the same target as drugs like RocheHolding AG's (ROG.VX) Avastin, as well as MET and RET, twoother drivers of tumor formation,
Avastin was approved recently by U.S. regulators to treatglioblastoma multiforme once the disease has recurred.
"We can only hope that broadening the targets can broadenthe clinical benefits," Canetta said.
The companies are also planning a Phase III trial program,but said the current trial of patients with previously treatedglioblastoma multiforme, may be sufficient for a regulatoryfiling.
Exelixis said 87 percent of patients in the study stoppedtreatment at some point and it will evaluate a lower daily dosein order to provide sustained exposure to the drug.
The companies are also testing the drug in thyroid cancerand lung cancer.
"We have a broad Phase II program to identify the nexttumor type," said Michael Morrissey, president of research anddevelopment at Exelixis.(Editing by Peter Cooney)