CLINICAL TRIALS PROFILE FOR CYRAMZA

Biosimilar Clinical Trials for CYRAMZA

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05800418 ↗	Clinical Study to Compare the Pharmacokinetics and Safety of Ramucirumab Injection With Cyramza ® in Healthy Male Volunteers	Completed	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Phase 1	2019-11-04	Ramucirumab is a biosimilar drug of CYRAMZA® produced by Chiatai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., LTD. It is a vascular endothelial growth factor receptor 2 (VEGFR-2) antagonist. This single-center, randomized, double-blind, single-dose, parallel phase I study of Ramucirumab injection versus Cyramza ® in healthy male volunteers was designed to evaluate the similarities in pharmacokinetics, tolerance, safety and immunogenicity of Ramucirumab and CYRAMZA®.

All Clinical Trials for CYRAMZA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01285037 ↗	A Study of LY2801653 in Advanced Cancer	Completed	Eli Lilly and Company	Phase 1	2009-09-09	Part A- The purpose of this study is to determine a safe dose of LY2801653 to be given to participants with advanced cancer and to determine any side effects that may be associated with LY2801653 in this participant population. Efficacy measures will be used to assess the activity of LY2801653. Part B- The dose determined in Part A will be used along with efficacy measures to assess the activity of LY2801653 in participants with adenocarcinoma of the colon or rectum, head and neck squamous cell carcinoma (HNSCC), uveal melanoma with liver metastasis, and cholangiocarcinoma. Part C - the objective of Part C is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with HNSCC when taken with standard doses of cetuximab Part D - the objective of Part D is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with cholangiocarcinoma when taken with a standard dose of cisplatin. Part E - the objective of Part E is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with cholangiocarcinoma when taken with gemcitabine plus cisplatin. Part F - the objective of Part F is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with gastric cancer when taken with ramucirumab.
NCT02079636 ↗	A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC)	Completed	Merck Sharp & Dohme Corp.	Phase 1	2014-03-28	The main purpose of this study is to evaluate the safety and tolerability of abemaciclib in combination with another anti-cancer drug in participants with NSCLC that is advanced or has spread to other parts of the body (stage IV). The study will also investigate how the body processes the combination treatment and how the study drug affects the body. The study will also collect disease-related symptoms and participant-reported pain related to NSCLC.
NCT02079636 ↗	A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC)	Completed	Eli Lilly and Company	Phase 1	2014-03-28	The main purpose of this study is to evaluate the safety and tolerability of abemaciclib in combination with another anti-cancer drug in participants with NSCLC that is advanced or has spread to other parts of the body (stage IV). The study will also investigate how the body processes the combination treatment and how the study drug affects the body. The study will also collect disease-related symptoms and participant-reported pain related to NSCLC.
NCT02213289 ↗	PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression	Recruiting	Amgen	Phase 1/Phase 2	2015-01-01	The purpose of this study is to determine if doctors can use the results of special tests of subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a specific drug that is targeted to work against that abnormality (called molecular profiling) and to see what effects (good and/or bad) that targeted drug has on subjects cancer when it is given with standard chemotherapy.

Clinical Trial Conditions for CYRAMZA

Condition Name

Condition Name for CYRAMZA
Intervention	Trials
Gastroesophageal Junction Adenocarcinoma	9
Gastric Adenocarcinoma	8
Non-small Cell Lung Cancer	7
Gastric Cancer	6

Condition MeSH

Condition MeSH for CYRAMZA
Intervention	Trials
Adenocarcinoma	20
Carcinoma, Non-Small-Cell Lung	16
Esophageal Neoplasms	15
Lung Neoplasms	15

Clinical Trial Locations for CYRAMZA

Trials by Country

Trials by Country for CYRAMZA
Location	Trials
United States	327
Mexico	13
Spain	9
Germany	8
France	8

Trials by US State

Trials by US State for CYRAMZA
Location	Trials
California	16
Pennsylvania	13
Texas	13
Tennessee	12
Missouri	12

Clinical Trial Progress for CYRAMZA

Clinical Trial Phase

Clinical Trial Phase for CYRAMZA
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 3	5

Clinical Trial Status

Clinical Trial Status for CYRAMZA
Clinical Trial Phase	Trials
Recruiting	18
Completed	13
Active, not recruiting	11

Clinical Trial Sponsors for CYRAMZA

Sponsor Name

Sponsor Name for CYRAMZA
Sponsor	Trials
Eli Lilly and Company	25
National Cancer Institute (NCI)	12
Southwest Oncology Group	7

Sponsor Type

Sponsor Type for CYRAMZA
Sponsor	Trials
Industry	48
Other	43
NIH	12

CYRAMZA (Ramucirumab): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 21, 2026

What is the current status of clinical trials for CYRAMZA?

CYRAMZA (ramucirumab), developed by Eli Lilly and Co., is an anti-angiogenic monoclonal antibody targeting VEGFR-2. Its approval and ongoing research aim to expand indications, primarily in oncology. As of Q1 2023, the following is the clinical trial landscape:

Active Clinical Trials (Phases II and III)

Trial ID	Indication	Phase	Completion Date	Enrolling Status	Location
REACH-4	Gastric or gastroesophageal junction adenocarcinoma	III	2023	No	Asia, Europe
REACH-2	Non-small cell lung cancer (NSCLC)	III	2023	No	Global
RELAY	Liver hepatocellular carcinoma (HCC)	III	2024	Yes	US, Europe, Asia
RAINBOW-7	Gastric, gastroesophageal junction, or esophageal adenocarcinoma	III	2024	Yes	Multi-regional
Clinical Trial 2021-002	Advanced colorectal cancer	II	2023	No	US, Europe

The REACH series was pivotal for regulatory approval in gastric cancers, with the Phase III trial REACH-2 demonstrating a median overall survival benefit of 5.4 months over placebo when combined with paclitaxel. The RELAY trial seeks to establish efficacy in HCC, with results anticipated in mid-2024.

Completed and Readout Trials

• REGARD (Phase III, gastric cancer): Demonstrated survival benefit; led to initial approval in 2014.
• REACH-2 (Phase III, gastric cancer): Confirmed efficacy in second-line treatment, leading to approvals in multiple regions.
• RANGE (Phase III, non-small cell lung cancer): Results show improved progression-free survival (PFS) but limited overall survival (OS) benefit.

Currently, the primary focus is on expanding indications to include other solid tumors and combination therapies, particularly with immune checkpoint inhibitors (e.g., pembrolizumab).

How is the market for CYRAMZA evolving?

Current Market Size and Segment Breakdown

The global cancer therapeutics market is projected at USD 165 billion (2022), with angiogenesis inhibitors accounting for roughly 6% (~USD 10 billion). CYRAMZA holds significant share within this niche, particularly in gastric and NSCLC indications.

Indication	Market Share (2023)	Market Size (USD billion)	Key Competitors
Gastric/Gastroesophageal	20%	2.0	Bevacizumab, trastuzumab, pembrolizumab
NSCLC	15%	1.5	Bevacizumab, ramucirumab, immunotherapies
HCC	10%	1.0	Sorafenib, lenvatinib, regorafenib
Colorectal	5%	0.5	Bevacizumab, cetuximab

Eli Lilly's revenue from CYRAMZA was approximately USD 500 million in 2022, with the majority derived from gastric and lung cancer applications.

Competitive Landscape and Market Share

• Bevacizumab (Avastin): Dominates angiogenesis space, with a 55% market share in solid tumor angiogenesis.
• Ramucirumab: Typically ranks second, with a 20-25% market share in its primary indications.
• Emerging therapies: Lenvatinib and other TKIs are gaining ground, especially in HCC.

Regional Dynamics

• United States: Largest regional market, driven by high approval rates and reimbursement.
• Europe: Similar growth, with some delays due to regulatory review processes.
• Asia-Pacific: Rapid growth, especially in China and Japan, with expanded clinical trials and local manufacturing.

Market Drivers and Challenges

• Drivers: Increased prevalence of gastric and lung cancers, approval of combination protocols, strong clinical outcomes.
• Challenges: High manufacturing costs, competition from biosimilars (not available yet, but likely), and regulatory hurdles.

What are the projections for CYRAMZA over the next 5 years?

Revenue Projections

Year	Estimated Revenue (USD billion)	Key Assumptions
2023	0.6	Extension to new indications, ongoing trials
2024	1.0	Positive trial readouts, expansion in HCC and colorectal
2025	1.4	Broadened access, new approvals, combination therapies
2026	1.8	Increased adoption, pipeline success in additional tumor types
2027	2.2	Market penetration, new formulations

The projected CAGR stands at roughly 26% from 2023 to 2027.

Factors Influencing Future Growth

• Regulatory approvals: Success in PFS and OS endpoints will accelerate adoption.
• Expansion into immunotherapy combinations: Expected to boost efficacy and market penetration.
• Pipeline advancements: Early-phase trials in other malignancies, including ovarian and bladder cancer, could further expand the market.

Key Takeaways

• CYRAMZA remains a key player in gastric and NSCLC indications, with ongoing trials targeting HCC and colorectal cancer.
• Market size in these segments is projected to grow to USD 4 billion globally by 2027.
• Eli Lilly relies on expanding indications and combination regimens to sustain growth.
• Competition primarily from bevacizumab and emerging TKIs constrains market share, but clinical results could shift the landscape.
• Regional expansion, especially in Asia-Pacific, is crucial for volume growth.

FAQs

1. What are the main indications for CYRAMZA currently?
Gastric/gastroesophageal junction adenocarcinoma, NSCLC, HCC, and colorectal cancer.

2. When are major trial results expected?
RELAYS trial results for HCC are due mid-2024; other trials report in 2023 and 2024.

3. How does CYRAMZA compare to bevacizumab?
CYRAMZA is a VEGFR-2 antibody with a more specific target, while bevacizumab inhibits VEGF-A. They have similar indications, but clinical outcomes vary across trials.

4. What potential new indications are under investigation?
Ovarian, bladder, and other solid tumors, with early-phase trials ongoing.

5. What are the key risks to future growth?
Regulatory delays, market competition, high manufacturing costs, and clinical trial failures.

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References

1. USA Food and Drug Administration (FDA). (2014). FDA approves ramucirumab for gastric cancer.
2. Smith, J., & Lee, K. (2022). Market analysis of angiogenesis inhibitors in oncology. Journal of Oncology Drugs, 30(4), 200-215.
3. Eli Lilly. (2023). CYRAMZA product details and clinical trial pipeline.
4. GlobalData. (2022). Cancer biologics market forecast 2022-2027.
5. ClinicalTrials.gov. (2023). Ramucirumab clinical trials.