Positive Opinion for Cabometyx® from CHMP
In a significant development for patients with neuroendocrine tumors, Ipsen has announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) regarding Cabometyx® (cabozantinib). If approved, Cabometyx would become the first systemic therapy authorized in the European Union for patients with previously treated advanced neuroendocrine tumors, irrespective of the tumor's site, grade, or previous treatments.
Impact of CABINET Phase III Trial Results
The favorable recommendation is primarily based on findings from the CABINET Phase III clinical trial. This trial showcased notable and statistically significant reductions in the risk of disease progression or death for patients receiving Cabometyx as opposed to those on a placebo.
Key Findings from the CABINET Trial
Significant results were observed in the Phase III trial, which evaluated Cabometyx among adult patients diagnosed with unresectable or metastatic neuroendocrine tumors that had advanced following one or more previous systemic therapies. Specifically, the trial highlighted that at a median follow-up of 13.8 months, the median progression-free survival (PFS) for the pancreatic neuroendocrine tumor (pNET) cohort was recorded at 13.8 months for those treated with Cabometyx, compared to just 4.4 months for patients who received a placebo.
Current Treatment Landscape
The rising incidence of neuroendocrine tumors (NETs) has drawn attention, with their prevalence outpacing that of more commonly known cancers like pancreatic and bladder cancers. These tumors are known to develop slowly and can arise in various body parts, often necessitating several lines of therapy as the disease progresses. However, treatment options can become sparse as the disease advances, particularly for the 27% of patients diagnosed with lung NETs, who lack approved treatment options upon disease progression after receiving non-somatostatin analogue-based systemic therapies.
Prognosis and Patient Outcomes
Survival rates for advanced NETs vary significantly based on the primary site of the disease. Research indicates that five-year survival rates stand at 68% for advanced gastrointestinal NETs and 55% for lung NETs. However, for those diagnosed with pNET, the outlook is considerably less favorable, with only a 23% five-year survival rate. This disheartening statistic underscores the urgency for effective treatment solutions that can extend survival and improve quality of life for patients.
Next Steps and Expectations
Following this positive opinion from the CHMP, a decision by the European Commission is anticipated soon, potentially in the coming months. Ipsen expresses eagerness for the final decision, as the positive opinion not only supports the scientific evidence obtained from the CABINET trial but also strengthens the call for improved treatments for patients suffering from advanced neuroendocrine tumors.
Importance of Cabometyx
Cabometyx represents a critical advancement in the treatment of neuroendocrine tumors, as it functions by inhibiting various receptor tyrosine kinases involved in tumor growth and metastasis. By addressing these pathways, Cabometyx holds the potential to transform the treatment landscape for patients who have exhausted other available therapies.
About Ipsen
As a global biopharmaceutical company, Ipsen is dedicated to delivering innovative treatments to patients in oncology, rare diseases, and neuroscience. With nearly a century of development experience and research collaboration across the globe, Ipsen is committed to enhancing patient care and improving health outcomes worldwide.
Contact Information for Ipsen
For Investor Inquiries:
Khalid Deojee
Email: khalid.deojee@ipsen.com
Phone: +33 666019526
For Media Inquiries:
Sally Bain
Email: sally.bain@ipsen.com
Phone: +1 8573200517
Frequently Asked Questions
What is Cabometyx® approved for?
Cabometyx® is designed to treat advanced neuroendocrine tumors in patients who have progressed after at least one prior systemic therapy.
Why is the CHMP opinion significant?
This opinion marks a preliminary endorsement that could lead to the first systemic therapy approval for neuroendocrine tumors in the EU.
What does the CABINET trial show?
The CABINET trial demonstrated significant improvements in progression-free survival for patients treated with Cabometyx compared to placebo.
How does Cabometyx work?
Cabometyx inhibits multiple receptor tyrosine kinases involved in tumor growth and angiogenesis.
What is Ipsen's commitment?
Ipsen is committed to delivering transformative therapies in oncology and other therapeutic areas while focusing on patient needs and innovation.
