Clinical Trials, Market Analysis, and Projections for Pemetrexed (Alimta)
Introduction to Pemetrexed (Alimta)
Pemetrexed, marketed under the brand name Alimta, is a chemotherapy drug developed by Eli Lilly and Company. It is primarily used in the treatment of pleural mesothelioma and non-small cell lung cancer (NSCLC). Here, we will delve into recent clinical trial updates, market analysis, and future projections for this drug.
Recent Clinical Trial Updates
Efficacy in Chordoma
A recent pilot study led by Dr. Santosh Kesari at Saint John’s Cancer Institute has shown promising results for the use of pemetrexed in treating chordoma, a rare type of bone cancer. The trial involved 14 patients with recurrent or advanced chordoma, and the results indicated that 10 patients had their tumors stabilize or shrink, with two patients experiencing tumor shrinkage of more than 30%[1].
Combination Therapies
Pemetrexed is also being explored in combination with other treatments. For instance, a planned clinical trial will investigate the efficacy of pemetrexed combined with the checkpoint inhibitor pembrolizumab (Keytruda) in chordoma patients. This combination has already been approved for use in certain types of lung cancer[1].
Unresectable Pleural Mesothelioma
A Phase III clinical trial (eVOLVE-Meso) is currently underway to evaluate the efficacy and safety of pemetrexed in combination with carboplatin and the experimental drug Volrustomig (MEDI5752) for patients with unresectable pleural mesothelioma. This study compares this combination to standard care treatments such as nivolumab plus ipilimumab or platinum plus pemetrexed[4].
Market Analysis
Current Market Status
The pemetrexed market has seen significant developments with the expiration of its compound patent in the U.S. in January 2017 and in major European countries and Japan in December 2015. Despite this, Eli Lilly and Company has managed to maintain market share through various strategies, including the approval of new indications and the prevention of generic launches until patent expiration in 2022[5].
Generic Competition
The launch of generic versions of pemetrexed by companies such as Eagle Pharmaceuticals Inc. and STADAPHARM GmbH is expected to increase affordability and support market growth. However, these generics have been unable to enter the U.S. market due to Eli Lilly's patent protections[5].
Market Projections
The global pemetrexed market is projected to grow at a moderate Compound Annual Growth Rate (CAGR) of 1.3% from 2018 to 2026, reaching approximately $2,347.6 million by 2026. This growth is driven by frequent approvals for new indications and the high prevalence of diseases such as NSCLC[5].
Regional Market Share
North America is expected to account for the largest market share during the forecast period, primarily due to the high prevalence of NSCLC and a high treatment rate in the region[5].
Impact of Patent Expirations
Loss of Exclusivity
The patent expiration for pemetrexed has led to a decline in sales for the branded version, Alimta. For example, sales of Alimta in the NSCLC market are expected to decrease from $2.1 billion in 2015 to $54 million by 2025, with generic pemetrexed sales projected to reach $266 million by 2025[2].
Generic Uptake
The uptake of generic pemetrexed is anticipated to negatively impact the growth of the NSCLC market, as it will reduce the revenue generated by the branded drug. However, this shift is expected to make the treatment more affordable and accessible to a broader patient population[2].
Future Indications and Combinations
Expanded Indications
Eli Lilly and Company has been expanding the indications for Alimta to generate more revenue. For instance, in 2012, Alimta received FDA approval as maintenance therapy for locally advanced or metastatic NSCLC following initial treatment with Alimta plus cisplatin. In 2018, it received approval for use in combination with carboplatin and pembrolizumab for the initial treatment of patients with metastatic nonsquamous NSCLC[5].
Combination Therapies
The combination of pemetrexed with other therapies, such as checkpoint inhibitors, is a promising area of research. The planned trial combining pemetrexed with pembrolizumab in chordoma patients highlights the potential for such combinations to enhance treatment efficacy[1].
Key Takeaways
- Clinical Efficacy: Pemetrexed has shown promising results in clinical trials for chordoma and is being explored in combination with other treatments for various cancers.
- Market Growth: The global pemetrexed market is expected to grow at a CAGR of 1.3% from 2018 to 2026, driven by new indications and generic launches.
- Generic Competition: The entry of generic pemetrexed is expected to increase affordability but will reduce the revenue of the branded version.
- Regional Dominance: North America is projected to maintain the largest market share due to high disease prevalence and treatment rates.
- Future Directions: Expanding indications and exploring combination therapies are key strategies to enhance the drug's efficacy and market presence.
FAQs
What is pemetrexed used for?
Pemetrexed, marketed as Alimta, is used primarily for the treatment of pleural mesothelioma and non-small cell lung cancer (NSCLC).
What are the recent clinical trial updates for pemetrexed?
Recent trials have shown pemetrexed's efficacy in treating chordoma and its potential in combination with other therapies like pembrolizumab for various cancers.
How does the generic version of pemetrexed affect the market?
The generic version increases affordability but reduces the revenue of the branded version, Alimta, due to patent expirations.
What is the projected market growth for pemetrexed?
The global pemetrexed market is expected to grow at a CAGR of 1.3% from 2018 to 2026, reaching approximately $2,347.6 million by 2026.
Which region dominates the pemetrexed market?
North America is expected to account for the largest market share due to the high prevalence of NSCLC and high treatment rates in the region.
Sources
- Chordoma Foundation - New clinical trial results suggest that pemetrexed is effective against some chordoma tumors.
- GlobalData - NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
- Johnson & Johnson - RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) Approved in the U.S. as a First-Line Chemotherapy-Free Treatment for Patients With EGFR-Mutated Advanced Lung Cancer.
- AstraZeneca Clinical Trials - MEDI5752 in Combination with Carboplatin plus Pemetrexed in Participants with Unresectable Pleural Mesothelioma.
- Coherent Market Insights - Pemetrexed Market to Surpass US$ 2347.6 Million by 2026.
