RE:Ph. 3 study ends early after 'dramatic' benefits A repeat of Ph. 1B is also possible even in a pivotal Ph. 2 or Ph. 3.
Cabometyx Ph.3 study ends early after researchers see 'dramatic' benefits in neuroendocrine tumors, Exelixis says | Fierce Pharma
A bit like our Ph. 1b but for a pivotal Ph. 3 for an advanced pancreatic indication.
That would be interesting if the same would happen with our NMIBC Ph. 2.
Cabometyx Ph. 3 study ends early after researchers see 'dramatic' benefits in neuroendocrine tumors, Exelixis says
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.
https://www.fiercepharma.com/pharma/exelixis-cabometyx-trial-wraps-early-after-proving-dramatic-improvement-pancreatic-tumors