Ipsen expands its collaboration with Exelixis to develop Cabometyx for advanced neuroendocrine tumors following positive results from the CABINET Phase III trial.
Key points:
- The CABINET trial showed significant improvements in progression-free survival for Cabometyx versus placebo in both pancreatic and extra-pancreatic neuroendocrine tumors.
- Ipsen plans to seek marketing authorizations for Cabometyx in these indications outside the U.S. and Japan.
- The expansion addresses a critical need for new therapies in neuroendocrine tumors, where 58% of patients present with metastatic disease at diagnosis.
Market estimate: The global neuroendocrine tumor treatment market was valued at $2.65 billion in 2021 and is expected to reach $3.93 billion by 2029, according to Data Bridge Market Research.
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Pharmaceutical company Ipsen (Euronext: IPN; ADR: IPSEY) has announced an expansion of its collaboration with Exelixis (NASDAQ: EXEL) to develop Cabometyx® (cabozantinib) for advanced neuroendocrine tumors (NETs). This move comes on the heels of promising results from the CABINET Phase III trial, offering new hope for patients with limited treatment options.
Neuroendocrine tumors, which arise from cells of the neuroendocrine system, are often diagnosed at an advanced stage due to their elusive symptoms. With approximately 35 in every 100,000 people living with NETs globally, and a poor prognosis for those with advanced disease, the need for effective treatments is critical.
The CABINET trial, led by the Alliance for Clinical Trials in Oncology, investigated Cabometyx versus placebo in patients with advanced pancreatic NETs (pNETs) and extra-pancreatic NETs (epNETs) whose disease had progressed after prior therapy. The results were striking enough for an independent monitoring board to recommend stopping the trial early, allowing placebo patients to cross over to Cabometyx treatment.
Christelle Huguet, EVP and Head of Research and Development at Ipsen, emphasized the significance of these findings: “The positive results demonstrated for Cabometyx within the CABINET Phase III trial represent clinically meaningful improvements in progression-free survival at a challenging stage of disease where there are few or no available treatment options.”
Key results from the trial include:
- In pNET patients, median progression-free survival was 11.4 months for Cabometyx versus 3.0 months for placebo.
- In epNET patients, median progression-free survival was 8.3 months for Cabometyx versus 3.2 months for placebo.
- The safety profile of Cabometyx was consistent with its known effects, with no new safety concerns identified.
These results are particularly important given the limited treatment landscape for NETs. Currently, Cabometyx is approved for various indications including advanced renal cell carcinoma and hepatocellular carcinoma in over 60 countries outside the U.S. and Japan.
The expanded agreement allows Ipsen to seek potential marketing authorizations for Cabometyx in advanced pNETs and epNETs outside of the U.S. and Japan. This could significantly broaden the treatment options available to patients in these regions.
While specific market projections for Cabometyx in NETs are not available, the global neuroendocrine tumor treatment market is expected to grow from $2.65 billion in 2021 to $3.93 billion by 2029, according to Data Bridge Market Research. This expansion by Ipsen positions the company to potentially capture a significant portion of this growing market.
As Ipsen prepares to engage with regulatory authorities in the European Union and submit a regulatory filing based on the CABINET trial data, the medical community and patients alike are watching closely. If approved, Cabometyx could offer a new lifeline for patients with advanced NETs, potentially extending and improving the quality of life for those facing this challenging diagnosis.
This development underscores the ongoing importance of clinical research and collaboration in addressing rare and difficult-to-treat cancers. As the landscape of cancer treatment continues to evolve, targeted therapies like Cabometyx are playing an increasingly crucial role in offering hope to patients who previously had limited options.
Source: Ipsen Press Release
