The burst of cancer drug news out of ASCO has spotlighted significant advances on a host of new drug programs, with Merck and Pfizer both benefiting from the limelight. (You can find fresh data on approved cancer drugs over at FiercePharma this morning).
- Pfizer got a boost from an enthusiastic response to the latest data on crizotinib, its lung cancer drug aimed at a small percentage of patients with ALK-positive cases. In another win for targeted drugs, crizotinib was linked to shrinking tumors in a majority of cases. Researchers report that 74 percent of patients were alive after one year and 54 percent remained alive after two years. There was no control arm in the study, but average survival rates for the disease are 44 percent at one year and 12 percent at two years. The response to the drug lingered for 48 weeks. Dr. Nasser H. Hanna of Indiana University called the data "truly brilliant." Los Angeles Times story
- Investigators from Merck and Ariad said that their drug, ridaforolimus, hit its primary endpoint in Phase III, improving progression-free survival in metastatic sarcoma patients compared to a placebo. And the two companies say they're right on track to file for marketing approval later in the year. "These data bring us one step closer to making ridaforolimus available to patients with metastatic sarcoma who need it and reinforces our ongoing commitment to developing innovative therapies to treat cancer," said Eric Rubin, M.D., vice president of clinical oncology research at Merck. Median PFS was 17.7 weeks for those treated with ridaforolimus compared to 14.6 weeks in the placebo group. Furthermore, based on the full analysis of PFS determined by investigator assessment, there was a statistically significant 31 percent reduction by ridaforolimus in the risk of progression or death compared to placebo. Merck release
- Tiny ACT Biotech attracted some kudos for its Phase II data on telatinib, shrinking tumors by at least 30 percent in two third of all patients. As Xconomy notes, the trial included only 39 patients, but demonstrated some real potential for a program that had been discarded by Bayer. Xconomy report
- Investors are reacting negatively this morning to news that Exelixis's experimental cancer drug, cabozantinib, was linked to six deaths in a mid-stage clinical trial. Reuters reports that the deaths were reported in 1 percent of the treated group, including a breast cancer patient, a lung cancer patient, two ovarian cancer patients, a pancreatic cancer patient, and one prostate cancer patient. "While drug safety is of less concern in cancer indications than in others, the apparent morbidities associated with cabo use will confound interpretation of clinical benefit in a trial designed to show anything less than overall survival, in our view," Canaccord analyst George Farmer wrote in a note to investors, as quoted by Reuters. Story
- Two studies may help drug developers as they pursue new treatments for cancer. In one, investigators determined that the number of circulating tumor cells in cancer patients served as a clear indicator on who was most likely to survive. Another lung cancer study zeroed in on genetic mutations that could be used to help physicians when choosing a drug to treat lung cancer. Story
- In related cancer news Ipsen says that its experimental treatment Irosustat failed a mid-stage study, prompting the biotech to shelve efforts to see if it can work as a solo treatment for hormonal cancers. Ipsen says that it will continue to research how the drug works in combination with other therapies. Ipsen has experienced a series of setbacks recently and the developer is expected to outline its development strategy later this week. Story
Editor's Note: This story has been updated with news about deaths linked to Exelixis's experimental cancer drug.