Introduction to Parsaclisib
Parsaclisib is a potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), developed by Incyte. This drug candidate has been making significant strides in the treatment of various hematological conditions, including non-Hodgkin lymphomas and autoimmune hemolytic anemia.
Clinical Trials and Efficacy
Parsaclisib is currently under evaluation in several ongoing Phase 2 studies as part of the CITADEL program. These studies focus on the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)[1][3][5].
Key Findings
- The data from these trials have shown a high rate of rapid and durable responses in patients. For instance, the CITADEL-203, -204, and -205 studies demonstrated promising objective response rates (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS)[5].
- These results were presented at major medical conferences, including the 62nd and 63rd American Society of Hematology Annual Meetings, highlighting the drug's potential in treating these lymphomas[1][5].
Regulatory Milestones
FDA Approval Process
- The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for parsaclisib for the treatment of adult patients with relapsed or refractory FL, MZL, and MCL. Parsaclisib has been granted Priority Review by the FDA, which shortens the review period and indicates that the drug could be a significant improvement over standard treatments[3].
International Approvals
- In China, the New Drug Application (NDA) for parsaclisib has been accepted and granted Priority Review designation by the National Medical Products Administration (NMPA). This is a significant milestone for the clinical research of parsaclisib in China, where Innovent Biologics has the rights to develop and commercialize the drug[4].
Market Projection
Market Growth
- The market for treatments of non-Hodgkin lymphomas and other hematological conditions is expected to grow significantly. The cold agglutinin disease drugs market, which includes parsaclisib as a pipeline therapy, is projected to grow at a compound annual growth rate (CAGR) of 22.6% from 2024 to 2031, reaching USD 558 million by 2031[2].
Market Drivers
- The rising prevalence of cold agglutinin disease and other related conditions, along with growing awareness and increasing research and development activities, are driving the demand for novel treatment options like parsaclisib[2].
Competitive Landscape
- Major players in the market include Sanofi, Novartis, Incyte Corporation, Apellis Pharmaceuticals, and Sobi. The successful development and approval of parsaclisib could provide patients with more treatment options beyond conventional therapies, potentially increasing market share for Incyte and its partners[2].
Pipeline Expansion and Future Trials
Combination Therapies
- Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are underway. Additionally, there are plans to initiate trials evaluating parsaclisib in combination with tafasitamab, including a pivotal trial in B-cell malignancies[1][3][5].
Autoimmune Hemolytic Anemia
- Parsaclisib is also being evaluated for the treatment of autoimmune hemolytic anemia, demonstrating a sustained reduction in serum immunoglobulins and improvement in hematologic parameters in clinical trials[2].
Strategic Collaborations
Incyte and Innovent
- In December 2018, Incyte and Innovent entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib. This collaboration allows Innovent to develop and commercialize parsaclisib in Mainland China, Hong Kong, Macau, and Taiwan[1][4][5].
Expert Insights
Dr. Peter Langmuir, Incyte
- "The promising data add to the body of evidence that support parsaclisib, which has the potential to become a meaningful treatment for patients with relapsed or refractory follicular, marginal zone or mantle cell lymphomas," said Dr. Peter Langmuir, Group Vice President, Oncology Targeted Therapies, Incyte[1].
Dr. Hui Zhou, Innovent
- "Treatment options for relapsed or refractory FL remain limited and there is a huge unmet clinical need. The NDA for parsaclisib in China was accepted and granted Priority Review designation, which is a milestone for the clinical research for parsaclisib," stated Dr. Hui Zhou, Senior Vice President of Innovent[4].
Key Takeaways
- Parsaclisib is a highly selective PI3Kδ inhibitor showing promising results in treating relapsed or refractory non-Hodgkin lymphomas.
- The drug has received Priority Review from the FDA and NMPA in China, indicating its potential as a significant improvement over current treatments.
- Market projections indicate a strong growth trajectory for the cold agglutinin disease drugs market, driven by the need for novel therapies.
- Strategic collaborations between Incyte and Innovent are crucial for the global development and commercialization of parsaclisib.
FAQs
What is Parsaclisib?
Parsaclisib is a potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ) developed by Incyte for the treatment of various hematological conditions.
Which conditions is Parsaclisib being evaluated for?
Parsaclisib is being evaluated for the treatment of relapsed or refractory follicular lymphoma, marginal zone lymphoma, mantle cell lymphoma, autoimmune hemolytic anemia, and myelofibrosis.
What is the current regulatory status of Parsaclisib?
The NDA for parsaclisib has been accepted by the FDA and granted Priority Review for the treatment of adult patients with relapsed or refractory FL, MZL, and MCL. In China, the NDA has also been accepted and granted Priority Review designation by the NMPA.
Who are the key players in the market for Parsaclisib?
Major players include Sanofi, Novartis, Incyte Corporation, Apellis Pharmaceuticals, and Sobi.
What is the projected market growth for Parsaclisib and related therapies?
The cold agglutinin disease drugs market, which includes parsaclisib, is expected to grow at a CAGR of 22.6% from 2024 to 2031, reaching USD 558 million by 2031.
Sources
- Incyte Announces Updated Data Demonstrating Rapid and Durable Responses of Parsaclisib in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas. Biospace.
- Cold Agglutinin Disease Drugs Market Report, Trends, Share. Coherent Market Insights.
- Incyte Announces Acceptance of NDA for Parsaclisib for Three Types of Relapsed or Refractory Non-Hodgkin Lymphomas. Business Wire.
- Innovent Announces the National Medical Products Administration in China Has Accepted and Granted Priority Review Designation to the New Drug Application for Parsaclisib. PR Newswire.
- Incyte Announces Parsaclisib Treatment Results in High Rate of Rapid and Durable Responses in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas. Business Wire.