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.
The cancer vaccine field has seen its share of late-stage disappointments and outright flops, but a number of hopefuls are lining up to present new research backing their experimental shots at this year's upcoming American Society of Clinical Oncology Annual Meeting in Chicago.
Less than two weeks ago, after its cancer vaccine flopped in a Phase III lung cancer trial, GlaxoSmithKline said it would continue looking for improvements among patients with a certain genetic makeup. But no longer: The British drugmaker has put the kibosh on the trial, establishing that it won't be possible to ID a subpopulation that will benefit.
Just days after announcing that investigators had red-flagged a high-profile Phase III study of the cancer vaccine MAGE-A3 after failing to hit two primary endpoints for non-small cell lung cancer, GlaxoSmithKline has decided to bring a last-stab effort to find a subpopulation of patients who could benefit from the therapy to a halt. GSK says it was not possible to find a genetically defined group of patients who responded.
Last month GlaxoSmithKline CEO Andrew Witty gave an upbeat assessment of the prospects of the MAGE-A3 cancer vaccine, with the executive saying the product has several chances to succeed. Now it has one fewer after the vaccine missed its primary endpoints in a Phase III lung cancer trial.
Once a top Phase III program at the pharma giant, MAGE-A3 failed to hit a pair of primary endpoints for non-small cell lung cancer, its second failure since the melanoma flop that occurred in the first hurdle of the study reported last fall.
GlaxoSmithKline's MAGE-A3 cancer vaccine was viewed as a long shot by some analysts even before it missed its first co-primary endpoint last year. Yet while analysts lowered expectations in the wake of the weak data in melanoma patients, GSK is continuing to promote its prospects.
Coming into 2013 GlaxoSmithKline highlighted a cancer vaccine as one of its brightest late-phase candidates. Yet, like many cancer vaccines before it, MAGE-A3 has disappointed at the final hurdle.
GlaxoSmithKline experienced a major R&D setback today, reporting that its targeted cancer immunotherapy MAGE-A3 failed its first co-primary endpoint in a Phase III study for melanoma, failing to beat out a placebo in spurring disease-free survival.
GlaxoSmithKline rolled out its late-stage drug prospects today, putting its best foot forward with a pair of drugs aimed at cancer and heart disease. Altogether the pharma giant says it expects to post pivotal data on 14 therapeutics in the next two years.