Analysts Foresee U.S. Launch of Five New Pancreatic Cancer Drugs by 2021

High cost-to-benefit ratio will limit acceptance

A new report from business intelligence provider GBI Research states that six pancreatic cancer drugs are expected to gain approval by 2021, all of which have demonstrated significant improvement in progression-free survival and/or overall survival in clinical trials. Market growth is anticipated in the eight major countries of the U.S., Canada, the United Kingdom, France, Germany, Italy, Spain, and Japan.

The five drugs expected to gain U.S. approval within the forecast period are TH-302 (Threshold), G17DT (Cancer Advances), HyperAcute Pancreas (NewLink Genetics), clivatuzumab tetraxetan (Immunomedics), and ruxolitinib phosphate (Incyte), according to analyst Adam Bradbury. However, these drugs are not expected to have a significant impact on the market because of their high cost-to-benefit ratio, which will severely limit their acceptance.

Pancreatic cancer is a disease predominately of the elderly, with approximately 75% of cases being diagnosed in patient’s 75 years of age or older, the report notes. Pancreatic cancer proliferates rapidly and is asymptomatic at its earliest stages. When symptoms do appear, they are usually nonspecific. No methods are currently in use for the early detection of pancreatic cancer.

Currently, the best option for patient survival is resection, which can triple the five-year survival rate to 15% compared with the unresectable stages of pancreatic cancer. Approximately 83% of patients present with advanced, unresectable disease, and their prognosis is extremely poor. Most patients ultimately develop resistant disease; their treatment options have historically been limited, with treatment involving fluorouracil as a monotherapy or used in combination therapy being the standard, the report says. The approval of irinotecan liposome injection (Onivyde, Merrimack Pharmaceuticals) in the U.S. for gemcitabine-refractory disease in 2015 has improved the survival of patients with resistant disease, but there is still a clinical need to diversify the treatment options in this cohort.

The new report states that since pancreatic cancer is a disease with a poor prognosis, developing drugs with adequate cost-to-benefit ratios is difficult, and this is reflected in the disease’s high attrition rate of 91% over all three phases of clinical trials.

“Despite some improvements in failure rates, further elucidations of mutations and their effects on signaling pathways and disease progression will be required before effective combination therapies can be developed and a significantly lower failure rate achieved,” Bradbury explained.

He also noted that the current pancreatic cancer treatment market is dominated by the generic drug gemcitabine, which is the current standard of care and is widely used because of its cost-effectiveness.

“Even if priced similarly to gemcitabine, the very poor efficacies of the pipeline drugs in comparison to existing therapies would not offer strong cost-to-benefit ratios,” Bradbury added. “For this reason, most of the drugs likely to be approved during the forecast period will be administered as combination therapies, which will prevent companies charging premium prices and limit their market share.”

Sources: PR Newswire; January 14, 2016; and GBI Research; December 2015.