CLINICAL TRIALS PROFILE FOR PREVYMIS

All Clinical Trials for Prevymis

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03728426 ↗	Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection	Recruiting	Merck Sharp & Dohme Corp.	Phase 2	2019-01-11	The trial will evaluate the safety and efficacy of letermovir antiviral treatment of active cytomegalovirus infection or cytomegalovirus disease in patients with infections that are refractory or resistant to available treatments or who are experiencing organ dysfunction that makes unsafe the use of available antiviral treatments.
NCT03728426 ↗	Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection	Recruiting	Amy C. Sherman, MD	Phase 2	2019-01-11	The trial will evaluate the safety and efficacy of letermovir antiviral treatment of active cytomegalovirus infection or cytomegalovirus disease in patients with infections that are refractory or resistant to available treatments or who are experiencing organ dysfunction that makes unsafe the use of available antiviral treatments.
NCT03728426 ↗	Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection	Recruiting	Dana-Farber Cancer Institute	Phase 2	2019-01-11	The trial will evaluate the safety and efficacy of letermovir antiviral treatment of active cytomegalovirus infection or cytomegalovirus disease in patients with infections that are refractory or resistant to available treatments or who are experiencing organ dysfunction that makes unsafe the use of available antiviral treatments.
NCT04060277 ↗	Triplex Vaccine in Preventing CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplantation	Recruiting	National Cancer Institute (NCI)	Phase 2	2019-10-07	This phase II trial studies how well Triplex vaccine works in preventing cytomegalovirus (CMV) infection in patients undergoing a hematopoietic stem cell transplantation. CMV is a virus that may be carried for life and does not cause illness in most healthy individuals. However, in people whose immune systems are lowered (such as those undergoing stem cell transplantation), CMV can reproduce and cause disease and even death. The Triplex vaccine is made up of 3 small pieces of CMV deoxyribonucleic acid (DNA) (the chemical form of genes) placed into a weakened virus called modified vaccinia Ankara (MVA) that may help produce immunity (the ability to recognize and respond to an infection) and reduce the risk of developing complications related to CMV infection.
NCT04060277 ↗	Triplex Vaccine in Preventing CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplantation	Recruiting	City of Hope Medical Center	Phase 2	2019-10-07	This phase II trial studies how well Triplex vaccine works in preventing cytomegalovirus (CMV) infection in patients undergoing a hematopoietic stem cell transplantation. CMV is a virus that may be carried for life and does not cause illness in most healthy individuals. However, in people whose immune systems are lowered (such as those undergoing stem cell transplantation), CMV can reproduce and cause disease and even death. The Triplex vaccine is made up of 3 small pieces of CMV deoxyribonucleic acid (DNA) (the chemical form of genes) placed into a weakened virus called modified vaccinia Ankara (MVA) that may help produce immunity (the ability to recognize and respond to an infection) and reduce the risk of developing complications related to CMV infection.
NCT04312841 ↗	Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab	Recruiting	Merck Sharp & Dohme Corp.	Phase 2	2020-09-15	This phase II trial studies how well letermovir works for the prevention of cytomegalovirus reactivation in patients with hematological malignancies treated with alemtuzumab. Patients receiving treatment with alemtuzumab may experience cytomegalovirus reactivation. Letermovir may block cytomegalovirus replication and prevent infection.
NCT04312841 ↗	Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab	Recruiting	National Cancer Institute (NCI)	Phase 2	2020-09-15	This phase II trial studies how well letermovir works for the prevention of cytomegalovirus reactivation in patients with hematological malignancies treated with alemtuzumab. Patients receiving treatment with alemtuzumab may experience cytomegalovirus reactivation. Letermovir may block cytomegalovirus replication and prevent infection.

Clinical Trial Conditions for Prevymis

Condition Name

Condition Name for Prevymis
Intervention	Trials
Hematopoietic and Lymphoid Cell Neoplasm	2
Chronic Lymphocytic Leukemia	2
Cytomegalovirus	1
Myelodysplastic Syndrome	1

Condition MeSH

Condition MeSH for Prevymis
Intervention	Trials
Lymphoma	2
Leukemia, Lymphocytic, Chronic, B-Cell	2
Neoplasms	2
Leukemia	2

Clinical Trial Locations for Prevymis

Trials by Country

Trials by Country for Prevymis
Location	Trials
United States	5
Canada	1

Trials by US State

Trials by US State for Prevymis
Location	Trials
California	2
Pennsylvania	1
Ohio	1
Massachusetts	1

Clinical Trial Progress for Prevymis

Clinical Trial Phase

Clinical Trial Phase for Prevymis
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	5
N/A	1

Clinical Trial Status

Clinical Trial Status for Prevymis
Clinical Trial Phase	Trials
Not yet recruiting	4
Recruiting	3

Clinical Trial Sponsors for Prevymis

Sponsor Name

Sponsor Name for Prevymis
Sponsor	Trials
Merck Sharp & Dohme Corp.	4
National Cancer Institute (NCI)	2
City of Hope Medical Center	1

Sponsor Type

Sponsor Type for Prevymis
Sponsor	Trials
Other	7
Industry	4
NIH	3

Prevymis: Clinical Trials, Market Analysis, and Projections

Introduction to Prevymis

Prevymis, also known as letermovir, is an antiviral drug developed by Merck (known as MSD outside the United States and Canada) and AiCuris. It is specifically designed for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients, particularly those undergoing solid organ transplants or hematopoietic stem cell transplants (HSCT)[1][3][4].

Clinical Trials Update

Phase 3 Trials in Kidney Transplant Recipients

A significant Phase 3 clinical trial evaluated the safety and efficacy of Prevymis compared to valganciclovir for CMV prophylaxis in 601 adult kidney transplant recipients at high risk for CMV disease. The trial results showed that Prevymis was effective and non-inferior to valganciclovir in preventing CMV disease at 52 weeks following the transplant. Specifically, 10.4% of the Prevymis group developed CMV disease versus 11.8% of the valganciclovir group. Additionally, Prevymis had a more favorable safety profile, with significantly less myelotoxicity, including lower rates of leukopenia and neutropenia[1].

Extended Prophylaxis in HSCT Recipients

Another Phase 3 trial assessed the safety and efficacy of extending CMV prophylaxis with Prevymis from 100 to 200 days in CMV-seropositive recipients following HSCT. This trial met its primary endpoint, indicating that extended prophylaxis with Prevymis provided additional benefit in preventing clinically significant CMV infection beyond 100 days post-HSCT[1].

Market Analysis

Global Sales and Growth

Prevymis has shown significant growth in global sales. In the third quarter of 2024, Prevymis sales increased by 32% compared to the same period in 2023, driven primarily by higher global demand, particularly in the U.S.[2].

Market Impact

The approval and successful clinical trials of Prevymis have marked a significant shift in the management of CMV infections in immunocompromised patients. Prevymis offers a safer alternative to valganciclovir, which is known for its myelotoxic side effects. This has led to increased adoption in clinical settings, contributing to its growing market presence[1][4].

Competitive Landscape

Prevymis operates in a niche market focused on antiviral therapies for immunocompromised patients. Its unique profile and favorable safety data position it as a preferred option over traditional treatments like valganciclovir. However, the market is also seeing advancements from other companies, such as AiCuris, which is developing other antiviral solutions like pritelivir and AIC468[4].

Projections and Future Outlook

Patent and Generic Entry

Prevymis is protected by several patents, with the earliest date for generic entry projected to be August 30, 2031. This provides a significant window for Merck and AiCuris to maintain market exclusivity and continue to drive sales growth[5].

Market Forecast

Given the strong clinical trial results and increasing global demand, Prevymis is expected to continue its growth trajectory. The drug's unique benefits, such as reduced myelotoxicity, are likely to drive further adoption in both solid organ transplant and HSCT settings.

Geographic Expansion

Prevymis has recently gained approval in Japan for the prevention of CMV disease in adult patients with solid organ transplants, marking a significant milestone in its global expansion. This approval is expected to further boost sales and market presence in the Asia-Pacific region[4].

Key Takeaways

• Clinical Efficacy: Prevymis has demonstrated non-inferior efficacy to valganciclovir in preventing CMV disease in kidney transplant recipients and HSCT recipients.
• Safety Profile: Prevymis has a more favorable safety profile, with significantly less myelotoxicity compared to valganciclovir.
• Market Growth: Prevymis has shown significant sales growth driven by higher global demand, particularly in the U.S.
• Patent Protection: Prevymis is protected by patents until at least August 30, 2031, ensuring market exclusivity.
• Geographic Expansion: Recent approval in Japan is expected to boost sales and market presence in the Asia-Pacific region.

FAQs

What is Prevymis used for?

Prevymis (letermovir) is used for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of solid organ transplants or hematopoietic stem cell transplants (HSCT)[1][3].

How does Prevymis compare to valganciclovir?

Prevymis has been shown to be non-inferior to valganciclovir in preventing CMV disease but has a more favorable safety profile with significantly less myelotoxicity[1].

What are the key safety benefits of Prevymis?

Prevymis has lower rates of leukopenia and neutropenia compared to valganciclovir, making it a safer option for patients[1].

When is the earliest date for generic entry of Prevymis?

The earliest date for generic entry of Prevymis is projected to be August 30, 2031[5].

Has Prevymis been approved in other regions besides the U.S.?

Yes, Prevymis has recently gained approval in Japan for the prevention of CMV disease in adult patients with solid organ transplants[4].

Sources

1. Merck's PREVYMIS™ Demonstrates Efficacy in Phase 3 Study for Prevention of Cytomegalovirus Disease in Adults After Kidney Transplantation. Merck News. October 22, 2022.
2. Merck Announces Third-Quarter 2024 Financial Results. Merck News. October 31, 2024.
3. Net Present Value Model: Prevymis - GlobalData. GlobalData. November 24, 2022.
4. AiCuris Announces Milestone Achievements Further Validating its Pipeline of Anti-viral Solutions for Immuno-compromised Patients. AiCuris. July 17, 2024.
5. When will the patents on PREVYMIS expire, and ... - DrugPatentWatch. DrugPatentWatch.