Welcome to the hall of shame, where blockbuster drug projections go to die. This list includes some drugs that clearly should never have wound up in Phase III to begin with, a few that were steered back to the clinic in a doomed attempt to mine something positive, and a couple of notable exceptions that may have helped advance the field by exploring the outer limits of new drug technology.
After a failed attempt to revive its late-stage program for Stimuvax, Merck KGaA is once again throwing in the towel on the cancer vaccine. The German company's biopharma division will cut its two monotherapy studies in the wake of another recent trial failure in Japan, it said late last week.
About a year ago Merck KGaA made the controversial decision to revive its late-stage program for the cancer vaccine Stimuvax, trying to start off fresh by renaming it tecemotide and pointing it toward a subpopulation of non-small cell lung cancer patients which appeared to respond in its very big failed Phase III. Today, the program is--once again--officially terminated.
Back in 2012, researchers flagged some positive results for patient subgroups in a flunked trial of Merck KGaA's cancer vaccine. But now, the vaccine has hit another snag, failing to hit its primary endpoint--as well as three secondary endpoints--in a Japanese trial, partner Oncothyreon said Monday in an SEC filing.
Tecemotide, Merck KGaA's 9-lived cancer vaccine, has flunked another clinical trial, missing its main goal in a Japanese study and casting further doubts on the program's future.
Merck KGaA has breathed some life back into its lung cancer vaccine, which many wrote off after it tanked in a Phase III trial in late 2012. After vowing to make a renewed effort to find some value in the jab last September, this week the company announced the start of a new Phase III study.
Shares of Oncothyreon soared this morning after its partner Merck KGaA said it would take a second swipe at trying to find some value in Stimuvax, the cancer vaccine (now renamed tecemotide) that has already decisively flunked a Phase III trial.
Despite flunking a Phase III trial in December, Merck KGaA is still talking about its lung cancer vaccine. The company has decided to push on with another ongoing late-phase trial in Asia and is now weighing the options of starting a further study.
After taking its big Phase III study of Stimuvax all the way to a conclusive finish, Merck KGaA said the closely-watched lung cancer vaccine failed to demonstrate a significant improvement in overall survival--a flop that will leave a deep scar at Oncothyreon as well, which licensed out the treatment.
Cancer vaccines are becoming an increasingly attractive focus of study, but there are still perils and pitfalls along the way to success. Two recent studies have looked at ways to get around these, focusing on experimental cancer vaccines boosted by existing drugs.