Results from several late stage clinical trials were published this week, and as has been the case for some time, the results did vary substantially from trial to trial and drug to drug. Here's the summary.
First some really good news. As reported in GEN, Merck Serono's Erbitux received approval in Japan as a first-line treatment for EGFR-expressing colorectal cancer in combination with chemotherapy. Merck jointly markets Erbitux in Japan with Imclone and BMS. Erbitux related sales were $937 M in 2009 and were up 23% over prior year. This was good news for Erbitux following its late 2009 failure in the EU as a treatment for non-small cell lung cancer (NSCLC).
The news out of GenVec today was not so good. As reported in MNT, the TNFerade phase 3 clinical trial (PACT) for pancreatic cancer was halted. Interim analysis led to the conclusion that the product would not meet its endpoints relative to the current standard of care. This result was unfortunate as there are not many, if any, good treatments for pancreatic cancer. TNFerade is an adenovirus vector carrying the tumor necrosis factor alpha (TNF-a) gene. The basis for the treatment is for the vector to induce production of TNF-alpha in the tumor cells - thus a novel approach to treatment. Unfortunately, it failed in this case.
Also from the pages of GEN, Roche and Biogen Idec continue to pursue the use of orelizumab for the treatment of multiple sclerosis (MS). On March 8th this month, the two companies stopped phase III studies with the drug in the treatment of rheumatoid arthritis (RA) due to serious and opportunistic infections in these patients. MS is a different story apparently. The comparative drug in this patient class is Tysabri. Tysabri has been linked to 35 instances and 8 deaths due to PML. It also comes off patent in 2015. The aim is to get orelizumab approved as a safer and as effective alternative to Tysabri for the treatment of relapsing-remitting MS.
Posted by Bruce Lehr March 29th 2010