A group of the world's biopharma companies are preparing to unveil new data on some of the most closely watched cancer drugs in the pipeline this weekend during the annual meeting of the American Association for Cancer Research in San Diego. And some have begun jostling for the spotlight.
Novartis ($NVS), for example, touted its plans to review early-stage data on 19 of its cancer compounds, including the CDK4/6 inhibitor LEE011 and PI3K inhibitors BKM120 and BYL719. LEE011 and BKM120 are now in Phase III and BYL719 is in Phase I trials for advanced breast cancer. And there will be a few preclinical clues offered for LDK378, one of the FDA's 'breakthrough' drugs, for non-small cell lung cancer.
The biggest show, though, may well be reserved for Pfizer's ($PFE) palbociclib. The pharma giant is in bad need of proving that it can develop new blockbusters, and there's been some considerable enthusiasm among investors and analysts that Pfizer can make that breakthrough with this drug for advanced breast cancer.
Pfizer's investigators have already heralded their "delight" with the top-line results from a 177-patient study, with a primary focus on progression-free survival. But the key to its success is likely to be dependent on overall survival. And the first clear indications on that are expected on Sunday.
"PFE will disclose OS data in its press release and the presentation," writes ISI's Mark Schoenebaum in a note today. "We think (but haven't confirmed) that OS data will be in the abstract. This is the first time we will see data on OS and as a result don't expect it to be fully mature. We expect a Hazard ratio to be released in the press release. In the presentation, we expect information on the number of events accrued for the OS assessment, along with some statistical analyses (including the Hazard ratio)."
Schoenebaum is one of the optimists, expecting that Pfizer could earn billions on dollars for this drug, and has a shot at an early approval under the FDA's new 'breakthrough' drug designation.
Pfizer's R&D arm hasn't had this much positive attention in some time. But when expectations run this high this early in the process, any misstep along the way could have severe consequences.
- here's the release from Novartis