It's not always a good thing when a drug developer stops a cancer trial. But in a recent case for Exelixis, a Cabometyx trial ended early because of an undeniable efficacy showing.
In this study, the company’s Ipsen-partnered tyrosine kinase inhibitor Cabometyx (cabozantinib) was studied in patients with advanced pancreatic or extra-pancreatic neuroendocrine tumors who progressed after prior systemic therapy. In the phase 3 Cabinet trial, the drug showed a “dramatic improvement” compared with placebo in prolonging the time without disease progression or death, the company said.
The trial's Independent Data and Safety Monitoring Board (DSMB) unanimously recommended to unblind and end the study, allowing the patients on placebo to switch over to Cabometyx. Now, in the wake of that decision, Exelixis plans to discuss the results with the FDA.
“We are pleased to see that cabozantinib improved outcomes for two additional patient populations living with advanced, difficult-to-treat cancers,” the company’s senior vice president of medical affairs, Will Berg, M.D., said in a statement.
Analysts with William Blair were “pleasantly surprised” by the win, the team wrote to clients. An FDA review in this disease setting will likely take about a year, the team said.
The findings come on the heels of another Cabometyx success. Earlier this week, the drug—paired with Roche’s immuno-oncology star Tecentriq—was able to prolong progression-free survival in patients with pretreated metastatic castration-resistant prostate cancer.
A “trend toward improvement” was also seen in overall survival, the company said, but that metric hadn't met statistical significance as of the last data analysis.
It was a welcome win for the combo, which failed in a kidney cancer study earlier this year and has also struggled in liver cancer and lung cancer. Previously, the drug couldn’t help non-small cell lung cancer patients who had progressed on or after PD-1/L1 inhibitors. The drug also previously failed to beat Bayer’s Naxavar in previously untreated liver cancer.