CLINICAL TRIALS PROFILE FOR TARCEVA

505(b)(2) Clinical Trials for tarceva

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	Genentech, Inc.	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
New Combination	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	University of Arizona	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).

All Clinical Trials for tarceva

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00026338 ↗	Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer	Completed	NCIC Clinical Trials Group	Phase 3	2001-10-29	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as erlotinib use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more effective with or without erlotinib in treating pancreatic cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and without erlotinib in treating patients who have unresectable locally advanced or metastatic pancreatic cancer.
NCT00036647 ↗	OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer	Completed	Canadian Cancer Trials Group	Phase 3	2001-11-01	The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).
NCT00036647 ↗	OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer	Completed	NCIC Clinical Trials Group	Phase 3	2001-11-01	The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).

Clinical Trial Conditions for tarceva

Condition Name

Condition Name for tarceva
Intervention	Trials
Non-Small Cell Lung Cancer	68
Lung Cancer	33
Pancreatic Cancer	31

Condition MeSH

Condition MeSH for tarceva
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	200
Lung Neoplasms	173
Carcinoma	46

Clinical Trial Locations for tarceva

Trials by Country

Trials by Country for tarceva
Location	Trials
Italy	138
Canada	112
Spain	92
Australia	64
Brazil	62

Trials by US State

Trials by US State for tarceva
Location	Trials
California	86
Texas	86
New York	67
Florida	67
Ohio	54

Clinical Trial Progress for tarceva

Clinical Trial Phase

Clinical Trial Phase for tarceva
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	49
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for tarceva
Clinical Trial Phase	Trials
Completed	277
Terminated	77
Unknown status	29

Clinical Trial Sponsors for tarceva

Sponsor Name

Sponsor Name for tarceva
Sponsor	Trials
Genentech, Inc.	96
National Cancer Institute (NCI)	72
Hoffmann-La Roche	63

Sponsor Type

Sponsor Type for tarceva
Sponsor	Trials
Other	486
Industry	351
NIH	73

Tarceva Market Analysis and Financial Projection

TARCEVA (Erlotinib): Clinical Trials Update, Market Analysis, and Projections

Introduction

TARCEVA, also known as erlotinib, is a targeted therapy used in the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer. It works by inhibiting the tyrosine kinase activity of the epidermal growth factor receptor (EGFR), a critical pathway in the growth and proliferation of cancer cells. Here, we will delve into recent clinical trial updates, market analysis, and future projections for TARCEVA.

Clinical Trials Update

Disease-Free Survival and Overall Survival Benefits

Recent updates from the phase 2 EVAN trial highlight the efficacy of erlotinib in patients with EGFR-positive NSCLC. The trial demonstrated that erlotinib significantly improved disease-free survival (DFS) and overall survival (OS) compared to vinorelbine/cisplatin chemotherapy in patients with R0 resected stage IIIA NSCLC. At 43 months of follow-up, the 5-year DFS rate was 48.2% in the erlotinib arm, significantly better than the chemotherapy arm. The median OS was 84.2 months with erlotinib, compared to 61.1 months with chemotherapy[1].

Safety and Efficacy

The BR.21 study, a landmark Phase III trial, showed that erlotinib improved overall survival in patients with advanced NSCLC after failure of at least one prior chemotherapy regimen. Patients receiving erlotinib had a 42.5% improvement in overall survival compared to the placebo arm, with 31% of patients alive at one year versus 22% in the placebo arm[3].

Market Analysis

Current Market Landscape

The global NSCLC market is projected to grow significantly, with sales expected to reach $26.8 billion by 2025, driven by a Compound Annual Growth Rate (CAGR) of 15.7%. Targeted therapies, including EGFR tyrosine kinase inhibitors (TKIs), are major contributors to this growth. However, the market share of TARCEVA is expected to decline due to patent expiration and the rise of generic alternatives. By 2025, sales of generic erlotinib are projected to reach $77 million, while sales of the patented drug are expected to decrease to $18 million[2].

Competitive Landscape

TARCEVA faces stiff competition from newer targeted therapies, particularly from AstraZeneca’s osimertinib (Tagrisso), which is expected to achieve blockbuster status by 2025 with estimated sales of $1.7 billion. Osimertinib is effective in patients with EGFR mutations, including those resistant to first- and second-generation EGFR TKIs like erlotinib. Other competitors include Roche’s Alecensa (alectinib) and Novartis’ Zykadia (ceritinib), which are effective in ALK mutation-positive patients[2].

Regional Market Dynamics

The NSCLC market is expected to grow rapidly in China, with sales projected to increase to $4.3 billion by 2025 at a CAGR of 25.4%. In contrast, the market share in the US and Japan is forecast to decrease, while the European market is expected to increase its share to 34.3% by 2025[2].

Future Projections

Generic and Biosimilar Impact

The expiration of TARCEVA’s patent has led to the emergence of generic erlotinib, which will continue to impact the market. Generic sales are expected to grow, but at a much lower revenue compared to the branded version. This shift will significantly alter the market dynamics, favoring cost-effective alternatives[2].

Next-Generation Therapies

The development of next-generation targeted therapies is expected to further erode the market share of TARCEVA. These newer therapies, such as osimertinib, Alecensa, and Zykadia, offer superior efficacy and overcome resistance to first-generation treatments. They are projected to take significant patient share away from their predecessors, including TARCEVA[2].

Emerging Markets and Acquisitions

The acquisition of TARCEVA by CHEPLAPHARM from Roche expands CHEPLAPHARM’s oncology portfolio and highlights the ongoing interest in this drug despite its declining market share. This move may help in maintaining some market presence for TARCEVA, especially in regions where generic penetration is slower[5].

Key Takeaways

• Clinical Efficacy: Erlotinib (TARCEVA) has shown significant benefits in DFS and OS in patients with EGFR-positive NSCLC, particularly in the adjuvant setting.
• Market Decline: The market share of TARCEVA is expected to decline due to patent expiration and the rise of generic and biosimilar alternatives.
• Competitive Pressure: Newer targeted therapies like osimertinib are expected to dominate the market, offering superior efficacy and overcoming resistance to first-generation treatments.
• Regional Dynamics: The NSCLC market is growing rapidly in China, while the US and Japan markets are expected to decrease in share.
• Future Outlook: Despite declining sales, TARCEVA remains a significant player in the oncology market, especially with strategic acquisitions and regional market dynamics.

FAQs

What are the recent clinical trial findings for TARCEVA in NSCLC?

Recent clinical trials, such as the EVAN trial, have shown that erlotinib significantly improves disease-free survival and overall survival in patients with EGFR-positive NSCLC compared to chemotherapy.

How does TARCEVA compare to newer targeted therapies like osimertinib?

TARCEVA faces significant competition from newer targeted therapies like osimertinib, which offer superior efficacy and are effective in patients resistant to first- and second-generation EGFR TKIs.

What is the impact of patent expiration on TARCEVA sales?

The patent expiration of TARCEVA has led to a decline in sales, with generic erlotinib expected to reach $77 million by 2025, significantly lower than the branded version.

Which regions are expected to drive the growth of the NSCLC market?

The NSCLC market is expected to grow rapidly in China, with sales projected to increase to $4.3 billion by 2025. The European market is also expected to increase its share.

What are the common side effects associated with TARCEVA?

Common side effects of TARCEVA include rash, diarrhea, fatigue, nausea, and anorexia, depending on the patient population and treatment regimen.

Sources

1. OncLive: Erlotinib Displays Long-Term DFS Benefit, Meaningful OS Improvement vs Chemotherapy in EGFR+ NSCLC.
2. GlobalData: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
3. Astellas US: Tarceva(R) (erlotinib) Earns Approval for Lung Cancer Patients in Japan.
4. Targeted Oncology: Available Options for the Treatment of EGFR+ Lung Cancer.
5. CHEPLAPHARM: CHEPLAPHARM expands oncology portfolio with Tarceva® from Roche.