Advanced melanoma for sure is a challenging enough target: there are no new FDA-approved medications since 20 years, 1-year survival in unresectable melanoma is at the level of 25%, and there are no effective treatments today for recurrent or metastatic melanoma.
BioVex started its pivotal phase III OPTiM trial in April 2009. People close to BioVex are rumoring the trial to be ready soon and announcing very strong results still this year. If that happens, what will be the implication for melanoma patients and oncolytic virus therapies?
First, melanoma patients will benefit greatly. The current ‘gold standard’ adjuvant treatment in advanced melanoma is PROLEUKIN. If OncoVEX delivers in the phase III OPTiM trial similar results to its completed phase II, the amount of responses it generates compared to PROLEUKIN is almost double. This is good news for melanoma patients, and a real advancement achieved with a new class of agents – oncolytic viruses (Table below).
Second, it will definitely be good for oncolytic viruses. BioVex would be the first company to have a replication-competent oncolytic virus product approved in the Western World, after Oncorine being approved in China. With these results it is likely, knowing the SPA approval it got for the pivotal trial in April 2008.
While close to the market, BioVex should have eye on the competition. One promising agent is ipilimumab, an antibody that activates the body’s immune system to fight melanoma by inhibiting the CTLA-4 molecule. Its three previous phase II clinical trials have shown that treatment with ipilimumab results in a one-year survival rate of 47% to 51% for people with stage III or IV melanoma, which is almost double the average — and on par with what BioVex has delivered. Ipilimumab’s phase III continued to deliver similar results in 2010, nearly doubling the 12-month survival rates from 25% to 46%.
One thing is for sure: there are a lot of people eagerly waiting for BioVex trial results.
Timo Ahopelto is VP Strategy at Oncos Therapeutics. He invites you to post your comments and share your views, either by responding to this blog or via email directly firstname dot lastname at oncos dot com.