Exelixis, a drug developer, recently halted a cancer trial involving Cabometyx, their tyrosine kinase inhibitor, due to an overwhelming display of efficacy. In partnership with Ipsen, Cabometyx was examined in a phase 3 Cabinet trial for patients with advanced pancreatic or extra-pancreatic neuroendocrine tumors that had progressed after prior systemic therapy. The trial showcased a “dramatic improvement” compared to the placebo in extending the period without disease progression or death.
“As there is no standard of care for patients with advanced pancreatic or extra-pancreatic neuroendocrine tumors whose disease has progressed after prior therapy, we are pleased to see that cabozantinib improved outcomes for two additional patient populations living with advanced, difficult-to-treat cancers. We are grateful for the recommendation of the Data and Safety Monitoring Board to unblind the CABINET study early due to a dramatic improvement in efficacy and look forward to discussing these findings with the U.S. Food and Drug Administration.”
– Will Berg, M.D., Senior Vice President, Medical Affairs, Exelixis
The trial’s Independent Data and Safety Monitoring Board (DSMB) unanimously recommended concluding the study and unblinding the results, allowing patients on placebo to switch to Cabometyx. Exelixis intends to discuss these findings with the FDA, anticipating an approximately year-long FDA review in this disease context.
Financial analysts at William Blair expressed pleasant surprise at this victory, highlighting that the FDA review process could take around a year. This success follows another recent achievement for Cabometyx, where it, in combination with Roche’s Tecentriq, extended progression-free survival in patients with pretreated metastatic castration-resistant prostate cancer.
“Patients with progressive neuroendocrine tumors have limited treatment options. At present, after progression on previous therapies, the treatment path is unclear, underscoring the need for additional options for this disease that is rising in incidence. These promising findings from the CABINET trial, in which cabozantinib showed an efficacy benefit for patients with pancreatic and extra-pancreatic neuroendocrine tumors, are welcome news and show the potential for cabozantinib to address important unmet needs for this community.”
– Jennifer Chan, M.D., M.P.H., study chair for the CABINET trial and Clinical Director of the Gastrointestinal Cancer Center and Director of the Program in Carcinoid and Neuroendocrine Tumors at Dana-Farber Cancer Institute
Although there’s a “trend toward improvement” in overall survival, statistical significance hasn’t been reached in the latest data analysis. This accomplishment is noteworthy for the combination, which faced setbacks in kidney cancer, liver cancer, and lung cancer studies. Notably, Cabometyx was unable to aid non-small cell lung cancer patients who had progressed after PD-1/L1 inhibitors and also couldn’t outperform Bayer’s Naxavar in previously untreated liver cancer.
