Cabometyx trial stopped early after 'dramatic' benefit in neuroendocrine tumours

2023-08-24

临床3期临床结果引进/卖出上市批准

Exelixis said Thursday that a Phase III trial evaluating Cabometyx (cabozantinib) against placebo has been stopped early due to a "dramatic improvement" in efficacy observed at an interim analysis. "As there is no standard of care for patients with advanced pancreatic or extra-pancreatic neuroendocrine tumours whose disease has progressed after prior therapy, we are pleased to see that [Cabometyx] improved outcomes for two additional patient populations living with advanced, difficult-to-treat cancers," remarked Will Berg, head of medical affairs at Exelixis.

The CABINET trial enrolled a total of 290 patients with either advanced pancreatic neuroendocrine tumours or advanced extra-pancreatic neuroendocrine tumours who experienced progression after at least one FDA-approved line of prior therapy other than somatostatin analogues. Participants were randomised into the Cabometyx or placebo arms of the study in each of the two cohorts. Upon disease progression, patients were unblinded, and those receiving placebo were permitted to cross over to open-label therapy with Cabometyx.

The primary endpoint was progression-free survival (PFS), while secondary goals assessed overall survival (OS) and radiographic response rate. According to Exelixis, the interim analysis showed that Cabometyx "substantially prolonged" the time without disease progression or death in both cohorts of the trial. The results prompted an independent data and safety monitoring board to unanimously recommend that the CABINET study be unblinded and stopped early. Detailed findings will be presented at an upcoming medical meeting and discussed with the FDA, the company said.

Back-to-back positive readouts

The latest readout marks another clinical trial win for the drug. Earlier this week, Exelixis and partner Ipsen reported that Cabometyx in combination with Roche's PD-L1 inhibitor Tecentriq (atezolizumab) significantly extended PFS in the Phase III CONTACT-02 study of patients with metastatic castration-resistant prostate cancer. A trend toward improvement in OS was also observed, although those data remain immature.

Cabometyx is currently approved in the US for certain patients with renal cell carcinoma, hepatocellular carcinoma and thyroid cancer. It has also received regulatory nods in the EU and other countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialisation and further clinical development of Cabometyx outside of the US and Japan. The following year, Exelixis granted Takeda rights to the tyrosine kinase inhibitor in Japan.

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