CLINICAL TRIALS PROFILE FOR NECITUMUMAB

Biosimilar Clinical Trials for necitumumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03360734 ↗	Combination of Gatipotuzumab and Tomuzotuximab in Patients With Solid Tumors	Completed	Glycotope GmbH	Phase 1	2017-11-02	This was a single arm phase Ib study to evaluate the safety and efficacy of combined Tomuzotuximab and Gatipotuzumab therapy in patients with metastatic solid tumors expressing EGFR for whom no standard treatment is available. Patients who had relapsed following their most recent line of chemotherapy and who met all other entry criteria at Screening were enrolled to receive Tomuzotuximab and Gatipotuzumab in combination. During the extension phase, instead of Tomuzotuximab a commercially avalaible anti-EGFR antibody, i.e. Cetuximab (including any approved biosimilar), Panitumumab, or Necitumumab could be given to patients with cancers for which their use is approved.

All Clinical Trials for necitumumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00835185 ↗	Study of IMC-11F8 in Participants With Colorectal Cancer	Completed	Eli Lilly and Company	Phase 2	2007-08-01	The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).
NCT00981058 ↗	First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin	Active, not recruiting	ICON Clinical Research	Phase 3	2010-01-07	The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.
NCT00981058 ↗	First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin	Active, not recruiting	Intertek	Phase 3	2010-01-07	The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.
NCT00981058 ↗	First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin	Active, not recruiting	Laboratory Corporation of America	Phase 3	2010-01-07	The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.
NCT00981058 ↗	First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin	Active, not recruiting	Medidata Solutions	Phase 3	2010-01-07	The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.

Clinical Trial Conditions for necitumumab

Condition Name

Condition Name for necitumumab
Intervention	Trials
Non-Small Cell Lung Cancer	3
Carcinoma, Non-small-Cell Lung	2
Stage IV Non-Small Cell Lung Cancer	2
Metastatic Lung Non-Small Cell Carcinoma	2

Condition MeSH

Condition MeSH for necitumumab
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	15
Lung Neoplasms	14
Carcinoma	3
Neoplasms	2

Clinical Trial Locations for necitumumab

Trials by Country

Trials by Country for necitumumab
Location	Trials
United States	93
Spain	17
Italy	9
Canada	7
France	6

Trials by US State

Trials by US State for necitumumab
Location	Trials
California	9
Tennessee	7
Florida	6
New York	6
Pennsylvania	5

Clinical Trial Progress for necitumumab

Clinical Trial Phase

Clinical Trial Phase for necitumumab
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	9
Phase 1/Phase 2	3

Clinical Trial Status

Clinical Trial Status for necitumumab
Clinical Trial Phase	Trials
Completed	11
Active, not recruiting	4
Recruiting	3

Clinical Trial Sponsors for necitumumab

Sponsor Name

Sponsor Name for necitumumab
Sponsor	Trials
Eli Lilly and Company	15
National Cancer Institute (NCI)	3
Laboratory Corporation of America	2

Sponsor Type

Sponsor Type for necitumumab
Sponsor	Trials
Industry	37
Other	11
NIH	3

Necitumumab: Clinical Trials, Market Analysis, and Projections

Introduction to Necitumumab

Necitumumab, marketed as Portrazza, is a recombinant human IgG1 monoclonal antibody designed to block the ligand binding site of the human epidermal growth factor receptor 1 (EGFR). It is primarily used in the treatment of advanced squamous non-small cell lung cancer (NSCLC)[3][4].

Clinical Trials and Efficacy

Phase III Trials

The efficacy of necitumumab was established through the Phase III SQUIRE trial, which demonstrated a significant improvement in overall survival (OS) for patients with stage IV metastatic squamous NSCLC. When combined with gemcitabine and cisplatin, necitumumab showed a median OS of 11.5 months, compared to 9.9 months for those treated with chemotherapy alone[3][4].

Association with Skin Toxicity

A pooled analysis of the SQUIRE and JFCM trials revealed a significant association between necitumumab-induced skin toxicity and efficacy. Patients with grade ≥2 or grade 1 skin toxicity had longer OS compared to those without skin toxicity. This association is consistent with previous findings related to other EGFR inhibitors[1].

Safety Profile

The safety profile of necitumumab includes common adverse events such as skin rash and hypomagnesemia, which can lead to muscular weakness, seizures, and irregular heartbeats. Serious risks include cardiac arrest and sudden death, prompting a boxed warning from the FDA[4].

Market Analysis

Current Market Status

The approval of necitumumab in 2015 marked a new treatment option for patients with advanced squamous NSCLC. However, its use is limited to squamous NSCLC, as it has not shown efficacy in non-squamous NSCLC[4].

Global NSCLC Market

The global NSCLC market is projected to grow significantly, driven by the increasing incidence of NSCLC and the adoption of premium-priced therapies, including immune checkpoint inhibitors and targeted therapies. By 2025, the NSCLC market in the 8 major markets (8MM) is expected to reach $26.8 billion, with a CAGR of 15.7% from 2015 to 2025[2].

Portrazza Market

The Portrazza market, specifically, is expected to grow due to several factors:

• Increasing Incidence of Lung Cancer: The rising number of lung cancer cases, particularly in regions like China, will drive the demand for Portrazza[5].
• Rising Healthcare Expenditure: Increased healthcare spending globally will support the accessibility and research of targeted therapies like Portrazza[5].
• Shift Toward Personalized Medicine: The advancement in genomics and biotechnology will enhance the adoption of personalized treatments, including Portrazza, which targets EGFR expression in NSCLC patients[5].

Market Projections

Growth Drivers

• Increasing Prevalence of Lung Cancer: The estimated number of new lung and bronchus cancer cases is expected to increase, driving the demand for treatments like Portrazza[5].
• Technological Advancements: Integration of robotics, advancements in drug formulation, and the use of artificial intelligence in drug development will contribute to the growth of the Portrazza market[5].
• Healthcare Expenditure: Rising healthcare spending will fuel the growth of the market by supporting research, treatment protocols, and patient accessibility[5].

Regional Growth

• China: The Chinese market is expected to grow rapidly, with a CAGR of 25.4% from 2015 to 2025, driven by an increasing incidence of NSCLC and higher adoption of branded therapies[2].
• Other Regions: While the US and Japan will see a decrease in their market share, the 5EU region is expected to increase its share to 34.3% by 2025[2].

Challenges and Barriers

Patent Expirations

The patent expiration of several blockbuster drugs, including Tarceva and Alimta, will limit the growth of the NSCLC market. However, this does not directly impact necitumumab, as it is a distinct treatment option[2].

Competitive Landscape

The NSCLC market is highly competitive, with other targeted therapies and immunotherapies like Keytruda, Opdivo, and Tecentriq achieving blockbuster status. Portrazza will need to compete within this landscape to maintain its market share[2].

Key Takeaways

• Clinical Efficacy: Necitumumab has shown significant improvement in overall survival for patients with advanced squamous NSCLC when combined with chemotherapy.
• Market Growth: The Portrazza market is expected to grow driven by increasing lung cancer incidence, rising healthcare expenditure, and the shift toward personalized medicine.
• Regional Dynamics: China will be a key driver of growth, while other regions will also see increased adoption of Portrazza.
• Competitive Landscape: Portrazza will face competition from other targeted and immunotherapies in the NSCLC market.

FAQs

What is necitumumab used for?

Necitumumab (Portrazza) is used for the treatment of advanced squamous non-small cell lung cancer (NSCLC) in combination with gemcitabine and cisplatin.

What are the common side effects of necitumumab?

Common side effects include skin rash and hypomagnesemia, which can lead to muscular weakness, seizures, and irregular heartbeats.

Is necitumumab effective in non-squamous NSCLC?

No, necitumumab has not been found to be effective in patients with non-squamous NSCLC.

What drives the growth of the Portrazza market?

The growth is driven by the increasing incidence of lung cancer, rising healthcare expenditure, and the shift toward personalized medicine.

How does necitumumab compare to other NSCLC treatments?

Necitumumab competes with other targeted therapies and immunotherapies like Keytruda, Opdivo, and Tecentriq in the NSCLC market.

Sources

1. Watanabe, S. "A pooled analysis of two randomized clinical trials-SQUIRE and JFCM: Association between efficacy and initial skin toxicity with necitumumab treatment in patients with squamous non-small-cell lung cancer." PubMed, 2024.
2. GlobalData. "NSCLC Market - Global Drug Forecast & Market Analysis to 2025." Drug Development, 2023.
3. Clinical Trials Arena. "Eli Lilly reports positive Phase III trial results of lung cancer drug necitumumab." Clinical Trials Arena, 2014.
4. Aetna. "Necitumumab (Portrazza) - Medical Clinical Policy Bulletins." Aetna, 2023.
5. The Business Research Company. "Portrazza Market Size, Market Share Report 2025 - 2034." The Business Research Company, 2023.

Last updated: 2025-01-17