Introduction
Surufatinib, developed by HUTCHMED Limited, is a novel oncology drug candidate that has shown significant promise in the treatment of neuroendocrine tumors (NETs), particularly pancreatic and extra-pancreatic NETs. Here, we will delve into the recent development updates, clinical trial results, and market projections for this drug.
Clinical Development and Trial Results
Surufatinib has undergone extensive clinical testing, with two pivotal Phase III trials conducted in China and one study in the United States.
Phase III SANET-p Trial
The SANET-p trial, a randomized, double-blind, placebo-controlled study, demonstrated that surufatinib significantly improved progression-free survival (PFS) in patients with progressive, advanced, well-differentiated pancreatic NETs. The trial showed a hazard ratio of 0.49 (95% CI, 0.32-0.76), indicating a 51% reduction in the risk of disease progression or death compared to the placebo group[1][3].
Phase III SANET-ep Trial
The SANET-ep trial, focusing on non-pancreatic NETs, also yielded positive results, with surufatinib reducing the risk of disease progression or death across multiple subgroups of patients. These results were published in The Lancet Oncology[3].
Regulatory Submissions and Approvals
FDA Submission
HUTCHMED completed a rolling submission for the New Drug Application (NDA) for surufatinib to the U.S. FDA in 2021. This submission was based on data from the Phase III trials in China and the U.S. study. The company is eagerly awaiting FDA approval to provide this therapeutic option to NET patients in the U.S. and globally[1].
Fast Track and Orphan Drug Designations
In the U.S., surufatinib has been granted Fast Track Designations for the development in both pancreatic and non-pancreatic NETs, as well as Orphan Drug Designation for pancreatic NET. These designations highlight the drug's potential to address significant unmet medical needs[5].
Market Performance and Projections
Sales and Revenue
Surufatinib, marketed as SULANDA®, has seen significant growth in sales. In the first half of 2023, in-market sales increased by 66% (79% at constant exchange rates) to $22.6 million, reflecting its growing acceptance and demand in the market[2].
Global Expansion
While HUTCHMED has decided not to file a Japanese NDA for surufatinib based on current clinical trial data, the drug is being evaluated for regulatory interactions in the U.S., Europe, and other regions. This global approach is expected to expand its market reach and patient access[4].
Clinical Collaborations and Future Development
Collaboration with BeiGene
HUTCHMED and BeiGene have entered into a clinical collaboration to evaluate the combination of surufatinib with BeiGene’s anti-PD-1 antibody tislelizumab for various solid tumor cancers. This collaboration aims to explore multiple indications and regions, including the U.S., Europe, China, and Australia[5].
Patient Access and Expanded Programs
Expanded Access Program
An expanded access program for surufatinib is currently underway in the United States, allowing patients to access the drug before its potential FDA approval. This program underscores HUTCHMED's commitment to providing critical therapeutic options to patients in need[1].
Financial and Business Updates
Revenue Recognition
In addition to the sales growth, HUTCHMED has recognized significant revenue from various sources, including a $400 million upfront payment from Takeda for licensing agreements. This financial support is crucial for the ongoing development and commercialization of surufatinib and other drug candidates[2].
Expert Insights and Industry Impact
"Having successfully launched surufatinib in China early this year, we are now looking forward, subject to its approval, to being able to provide access to this important new therapeutic option for NET patients in the U.S. and beyond," said Marek Kania, MD, MBA, Managing Director and Chief Medical Officer of HUTCHMED International Corporation[1].
Key Statistics and Highlights
- Progression-Free Survival (PFS): Median PFS was 10.9 months for patients treated with surufatinib, compared to 3.7 months for the placebo group (HR 0.491; 95% CI 0.391-0.755; p=0.0011)[3].
- Objective Response Rate (ORR): 19.2% for the surufatinib group versus 1.9% for the placebo group[3].
- Sales Growth: 66% increase in in-market sales in the first half of 2023 to $22.6 million[2].
Conclusion
Surufatinib represents a significant advancement in the treatment of neuroendocrine tumors, with robust clinical trial results and growing market acceptance. As HUTCHMED continues to navigate regulatory approvals and expand its global reach, surufatinib is poised to become a critical therapeutic option for patients with NETs worldwide.
Key Takeaways
- Surufatinib has demonstrated significant improvement in PFS for patients with pancreatic and extra-pancreatic NETs.
- The drug has received Fast Track and Orphan Drug Designations in the U.S.
- Sales of surufatinib have shown substantial growth, with a 66% increase in the first half of 2023.
- HUTCHMED is engaged in clinical collaborations to explore combination therapies with other drugs.
- An expanded access program is underway in the U.S. to provide early access to the drug.
FAQs
Q: What is surufatinib used for?
A: Surufatinib is used for the treatment of neuroendocrine tumors (NETs), specifically pancreatic and extra-pancreatic NETs.
Q: What are the key findings from the Phase III trials of surufatinib?
A: The Phase III trials showed that surufatinib significantly improved progression-free survival (PFS) and reduced the risk of disease progression or death by 51% compared to the placebo group.
Q: Has surufatinib received any special designations from regulatory bodies?
A: Yes, surufatinib has received Fast Track Designations and Orphan Drug Designation in the U.S. for the treatment of pancreatic and non-pancreatic NETs.
Q: What is the current status of surufatinib's regulatory submissions?
A: The New Drug Application (NDA) for surufatinib has been submitted to the U.S. FDA and is awaiting approval.
Q: Are there any ongoing clinical collaborations involving surufatinib?
A: Yes, HUTCHMED and BeiGene are collaborating to evaluate the combination of surufatinib with tislelizumab for various solid tumor cancers.
Sources
- Cancer Network: "New Drug Application Complete for Surufatinib to Treat Pancreatic and Extra-Pancreatic NETs"[1].
- BioSpace: "HUTCHMED Reports 2023 Interim Results and Provides Business Updates"[2].
- HUTCHMED: "Chi-Med Highlights Surufatinib Phase III Results in Neuroendocrine Tumors"[3].
- GlobeNewswire: "HUTCHMED Reports 2023 Interim Results and Provides Business Updates"[4].
- GlobeNewswire: "Chi-Med and BeiGene Enter into Clinical Collaboration to Evaluate Combinations of Surufatinib and Fruquintinib with Tislelizumab"[5].