At the ECCO/ESMO  meeting in Berlin the data on a large phase III clinical trial from the United Kingdom (COIN) was presented. It was a trial comparing FOLFOX or XELOX in combination with Erbitux.

It is important to know that in the UK Avastin is not approved, and Erbitux was only recently approved in patients with organ limited disease based on the chance of curative resections in patients initially deemed not to be resectable. However it is difficult to judge what the COIN results mean. The response rates in the patients with wild-type KRAS was significantly increased to 64%, so far so good. The problem is that the time to tumor progression and overall survival was not improved in patients with wild-type KRAS and Erbitux therapies. Read the rest of this entry »

Patients with advanced colorectal cancer whose tumors have gotten smaller six weeks after starting treatment with Erbitux had a much longer time before their cancer got worse and almost twice the overall survival as patients whose tumors didn’t shrink.

Patients in the BOND study had already gotten worse on standard chemotherapy and were receiving either Erbitux® (cetuximab) alone or in combination with irinotecan.  CT scans  for about a third of them showed at least a 10 percent decrease in the size of their tumors six weeks into treatment. Read the rest of this entry »

The Food and Drug Administration (FDA) has approved labeling changes for Vectibix and Erbitux to reflect studies that found the two drugs are not effective in patients whose tumors have mutated KRAS.

The FDA has updated the indication and usage for Vectibix™  (panitumumab) and Erbitux® (cetuximab) to include a statement that:

Retrospective subset analyses of metastatic or advanced colorectal cancer trials have not shown a treatment benefit for ERBITUX or VECTIBIX in patients whose tumors had K-ras mutations in codon 12 or 13 and that the use of ERBITUX or VECTIBIX is not recommended for the treatment of colorectal cancer with these mutations. Read the rest of this entry »

Adding Erbitux to standard first line treatment for colorectal cancer of CAPOX with Avastin doesn’t help.  In fact, patients who receive the additional agent have a shorter time until their cancer gets worse and have worse side effects.

Results of a randomized phase III clinical trial that added the monoclonal antibody Erbitux® (cetuximab) to Xeloda® (capecitabine), oxaliplatin, and Avastin® (bevacizumab) showed shorter time to cancer progression for patients who got Erbitux in addition to the standard treatment. There was no difference in whether the tumor shrank or overall survival time. Patients who got Erbitux were about 20 percent more likely to have tumors get worse or to die than patients who didn’t.

This was the first chemotherapy treatment for metastatic cancer that these patients were given.  All of them had metastatic tumors that had spread beyond their colons.

While patients with wild-type (normal) KRAS genes in their tumors had longer progression-free time on Erbitux than those with KRAS mutations, that time did not reach the median progression-free interval for patients in the standard treatment group. Read the rest of this entry »

The Food and Drug Administration’s (FDA) Oncology Drug Advisory Committee (ODAC) is meeting today to discuss whether the labels for Erbitux (cetuximab) and Vectibix (panitumumab) should include a mention of KRAS testing. The discussion at the meeting will have implications for future development of companion diagnostics. C3 President Carlea Bauman will be testifying during the public comment section: Read the rest of this entry »