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Biotech / Medical : Oncothyreon
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To: scaram(o)uche who wrote (2176)5/23/2013 1:49:04 PM
From: biomachine56  Read Replies (3) of 2344
 
The response rate in the FDA approval for CTX monotherapy was 6% in irinotecan and oxaliplatin refractory patients. In the Karapetis, NEJM, 2008 paper, response was 12.8%.

Response to Treatment
None of the patients in the supportive-care group had an objective tumor response. In the cetuximab group, the response rate among patients with wild-type K-ras tumors was 12.8%, whereas only one patient with a mutated K-ras tumor (1.2%) had a response.

In the PX-866/CTX combo safety arm study, the expected response rate in the 8 patients would have been expected to be 1/8 with tumor response.

Here is what was reported:
4/8 (50% ORR) with tumor response
3/8 (38% ORR) patients with tumor response had no prior EGFR treatment
7/8 with stable disease
Of note, 1 of the patients with tumor response had prior EGFR inhibitor treatment.
3 patients with prior EGFR inhibitor treatment showed disease stabilization.
Disease control in 4/5 patients with prior EGFR inhibitor treatment.
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