CLINICAL TRIALS PROFILE FOR PEMFEXY

All Clinical Trials for Pemfexy

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02194738 ↗	Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)	Recruiting	National Cancer Institute (NCI)	N/A	2014-08-18	This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.
NCT02419495 ↗	Selinexor With Multiple Standard Chemotherapy or Immunotherapy Regimens in Treating Patients With Advanced Malignancies	Recruiting	Karyopharm Therapeutics, Inc	Phase 1	2015-06-26	This phase Ib trial studies the side effects and best dose of selinexor when given together with several different standard chemotherapy or immunotherapy regimens in treating patients with malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Selinexor may stop the growth of cancer cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Studying selinexor with different standard chemotherapy or immunotherapy regimens may help doctors learn the side effects and best dose of selinexor that can be given with different types of treatments in one study.
NCT02419495 ↗	Selinexor With Multiple Standard Chemotherapy or Immunotherapy Regimens in Treating Patients With Advanced Malignancies	Recruiting	National Cancer Institute (NCI)	Phase 1	2015-06-26	This phase Ib trial studies the side effects and best dose of selinexor when given together with several different standard chemotherapy or immunotherapy regimens in treating patients with malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Selinexor may stop the growth of cancer cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Studying selinexor with different standard chemotherapy or immunotherapy regimens may help doctors learn the side effects and best dose of selinexor that can be given with different types of treatments in one study.
NCT02419495 ↗	Selinexor With Multiple Standard Chemotherapy or Immunotherapy Regimens in Treating Patients With Advanced Malignancies	Recruiting	M.D. Anderson Cancer Center	Phase 1	2015-06-26	This phase Ib trial studies the side effects and best dose of selinexor when given together with several different standard chemotherapy or immunotherapy regimens in treating patients with malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Selinexor may stop the growth of cancer cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Studying selinexor with different standard chemotherapy or immunotherapy regimens may help doctors learn the side effects and best dose of selinexor that can be given with different types of treatments in one study.
NCT02535325 ↗	Methoxyamine Hydrochloride, Pemetrexed Disodium, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIIA-IV Non-small Cell Lung Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2015-09-30	This phase I trial studies the side effects and best dose of methoxyamine when given together with pemetrexed disodium, cisplatin, and radiation therapy in treating patients with stage IIIA-IV non-small cell lung cancer. Drugs used in chemotherapy, such as methoxyamine hydrochloride, pemetrexed disodium, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving methoxyamine hydrochloride together with pemetrexed disodium, cisplatin, and radiation therapy may kill more tumor cells.

Clinical Trial Conditions for Pemfexy

Condition Name

Condition Name for Pemfexy
Intervention	Trials
Stage IV Lung Cancer AJCC v8	10
Stage IIIC Lung Cancer AJCC v8	9
Stage IIIB Lung Cancer AJCC v8	8
Stage IVA Lung Cancer AJCC v8	8

Condition MeSH

Condition MeSH for Pemfexy
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	22
Lung Neoplasms	19
Carcinoma	11
Adenocarcinoma of Lung	5

Clinical Trial Locations for Pemfexy

Trials by Country

Trials by Country for Pemfexy
Location	Trials
United States	181
Canada	6
Spain	3
Japan	2
Guam	2

Trials by US State

Trials by US State for Pemfexy
Location	Trials
Texas	10
Tennessee	6
Pennsylvania	5
Colorado	5
Ohio	5

Clinical Trial Progress for Pemfexy

Clinical Trial Phase

Clinical Trial Phase for Pemfexy
Clinical Trial Phase	Trials
Phase 3	5
Phase 2/Phase 3	2
Phase 2	12

Clinical Trial Status

Clinical Trial Status for Pemfexy
Clinical Trial Phase	Trials
Not yet recruiting	11
Recruiting	9
Active, not recruiting	2

Clinical Trial Sponsors for Pemfexy

Sponsor Name

Sponsor Name for Pemfexy
Sponsor	Trials
National Cancer Institute (NCI)	14
M.D. Anderson Cancer Center	5
NRG Oncology	2

Sponsor Type

Sponsor Type for Pemfexy
Sponsor	Trials
NIH	14
Other	14
Industry	10

Pemfexy: Clinical Trials, Market Analysis, and Projections

Introduction to Pemfexy

Pemfexy, developed by Eagle Pharmaceuticals, is a ready-to-dilute liquid intravenous formulation of pemetrexed, an antifolate chemotherapy agent. It is designed to eliminate the reconstitution step required for the traditional formulation of pemetrexed, such as Eli Lilly's Alimta. Here, we will delve into the clinical trials, market analysis, and future projections for Pemfexy.

Clinical Trials and FDA Approvals

Pemfexy has undergone significant clinical trials and has received multiple FDA approvals. The most recent approval, received in December 2022, is for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with pembrolizumab and platinum chemotherapy, provided the patients have no EGFR or ALK genomic tumor aberrations[1][3][5].

This approval marks the fifth indication for Pemfexy in the treatment of NSCLC, aligning it with the indications of Alimta. Other approved uses include:

• Locally advanced or metastatic non-squamous NSCLC in combination with cisplatin.
• Maintenance treatment for locally advanced or metastatic non-squamous NSCLC that hasn’t progressed after four cycles of platinum-based chemotherapy.
• Treatment for locally advanced or metastatic NSCLC after previous chemotherapy as a single agent.
• Treatment for certain patients with malignant pleural mesothelioma[3].

Mechanism of Action and Efficacy

Pemetrexed, the active ingredient in Pemfexy, works by inhibiting cell division and growth in cancer cells. It is an antifolate agent that targets multiple folate-dependent enzymes, which are crucial for DNA synthesis and repair. Clinical trials have shown that pemetrexed, when combined with other therapies such as cisplatin and pembrolizumab, significantly improves survival rates and response in patients with NSCLC and mesothelioma[4].

Market Analysis

Global Market Size and Growth

The global pemetrexed market, which includes Pemfexy, is projected to grow significantly. As of 2024, the global market size is estimated to be USD 2541.2 million. This market is expected to expand at a compound annual growth rate (CAGR) of 2.50% from 2024 to 2031, reaching USD 3020.688 million by 2031[2].

Regional Market Breakdown

The market is segmented geographically, with North America holding the largest share, approximately 40% of the global revenue, valued at USD 1016.48 million in 2024. Europe follows with around 30% of the global revenue, valued at USD 762.36 million. The Asia Pacific region holds about 23% of the global revenue, with a market size of USD 584.48 million, and is expected to grow at a CAGR of 4.5% from 2024 to 2031. Latin America and the Middle East and Africa also contribute to the market, though to a lesser extent[2].

Competitive Landscape

Pemfexy competes directly with Alimta, Eli Lilly's pemetrexed formulation. However, Pemfexy offers the advantage of being a ready-to-dilute formulation, eliminating the need for reconstitution. This convenience is expected to drive adoption, especially in settings where time and ease of administration are critical. The market is also seeing the emergence of new therapies, which could pose competition but also open up opportunities for combination treatments[3][4].

Market Projections

Future Growth Drivers

The growth of the pemetrexed market, including Pemfexy, is driven by several factors:

• Increasing Prevalence of Lung Cancer and Mesothelioma: The rising incidence of these cancers globally is a significant driver.
• Technological Advancements: Improvements in biopharmaceuticals and targeted therapies enhance the efficacy of pemetrexed.
• Combination Therapies: The growing adoption of combination therapies, such as with pembrolizumab and platinum chemotherapy, increases the market potential.
• Personalized Medicine: The trend towards personalized medicine approaches further boosts the market[2].

Challenges and Opportunities

While the market is poised for growth, there are challenges to consider:

• Regulatory Approval Processes: Stringent regulatory processes can delay the approval of new formulations and impact market growth.
• Emerging Therapies: New therapies in development could compete with pemetrexed but also offer opportunities for combination treatments[2][4].

Key Takeaways

• Pemfexy has received multiple FDA approvals, including the recent approval for treating metastatic NSCLC in combination with pembrolizumab and platinum chemotherapy.
• The global pemetrexed market is projected to grow from USD 2541.2 million in 2024 to USD 3020.688 million by 2031.
• Regional markets vary, with North America and Europe holding significant shares, and the Asia Pacific region showing high growth potential.
• Pemfexy offers convenience over traditional formulations like Alimta by being ready-to-dilute.
• Future growth is driven by increasing cancer prevalence, technological advancements, and the adoption of combination therapies.

FAQs

Q: What is Pemfexy and how does it differ from Alimta?

A: Pemfexy is a ready-to-dilute liquid intravenous formulation of pemetrexed, differing from Alimta by eliminating the need for reconstitution.

Q: What are the approved indications for Pemfexy?

A: Pemfexy is approved for treating metastatic NSCLC in combination with pembrolizumab and platinum chemotherapy, among other indications for NSCLC and mesothelioma.

Q: What is the projected growth rate of the global pemetrexed market?

A: The global pemetrexed market is expected to grow at a CAGR of 2.50% from 2024 to 2031.

Q: Which regions hold the largest market shares for pemetrexed?

A: North America and Europe hold the largest market shares, with the Asia Pacific region showing significant growth potential.

Q: What are the main drivers of the pemetrexed market growth?

A: The main drivers include the increasing prevalence of lung cancer and mesothelioma, technological advancements, and the adoption of combination therapies.

Sources

1. Eagle Pharmaceuticals Receives FDA Approval for Additional Indication for PEMFEXY - GlobeNewswire
2. Global Pemetrexed Market Report - Cognitive Market Research
3. Eagle's Pemfexy catches up with Lilly's Alimta in lung cancer - FiercePharma
4. Pemetrexed + Cisplatin Drug Insights and Market Forecasts - GlobeNewswire
5. Pemetrexed Injection Receives FDA Approval for Fifth Indication in NSCLC Treatment - Pharmacy Times