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.
NCT02213289 ↗	PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression	Recruiting	University of Chicago	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.
NCT02314117 ↗	A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer	Completed	Eli Lilly and Company	Phase 3	2015-01-20	The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.
NCT02317991 ↗	Study of Nab-Paclitaxel and Ramucirumab as Second-line Treatment for Patients With Metastatic Gastroesophageal Cancer	Completed	Celgene	Phase 2	2015-05-05	The purpose of this study is to determine whether nab-Paclitaxel (Abraxane®) and ramucirumab (Cyramza®) are effective when used in combination for treating patients with metastatic gastroesophageal cancer who have either progressed or not responded to prior therapy.

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
Texas	13
Pennsylvania	13
Florida	12
Illinois	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

Clinical Trials Update, Market Analysis, and Projection for CYRAMZA (Ramucirumab)

Last updated: November 3, 2025

Introduction

CYRAMZA (ramucirumab) stands as a significant player in the targeted cancer therapy landscape. Approved by the U.S. Food and Drug Administration (FDA) in 2014, it is a monoclonal antibody that inhibits vascular endothelial growth factor receptor-2 (VEGFR-2), thereby impeding angiogenesis crucial for tumor growth. This report provides a detailed update on ongoing clinical trials, analyzes current market dynamics, and forecasts future prospects for CYRAMZA in the oncology segment.

Clinical Trials Update

Ongoing and Recently Completed Trials

Currently, over 20 active clinical trials evaluate CYRAMZA across different cancer indications, reflecting extensive therapeutic exploration. The most prominent include:

• Gastric and Gastroesophageal Junction (GEJ) Cancers:
  The pivotal phase III RAINBOW trial evaluated CYRAMZA in combination with paclitaxel versus paclitaxel alone in previouslytreated advanced gastric or GEJ adenocarcinoma. Results demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS). This trial’s success underpins its continued use and real-world application.

• Non-Small Cell Lung Cancer (NSCLC):
  The RELAY trial, a phase III study, investigated CYRAMZA combined with docetaxel versus placebo plus docetaxel in second-line NSCLC. Interim data suggest improved OS and PFS, positioning CYRAMZA as a valuable option for certain NSCLC subsets.

• Hepatocellular Carcinoma (HCC):
  The REACH2 phase III trial examined CYRAMZA's efficacy and safety in second-line HCC. Results confirmed a significant OS benefit in patients previously treated with sorafenib, leading to regulatory approval in some regions.

Recent Data Releases and Regulatory Milestones

• Licensing and Approvals:
  In 2020, the European Medicines Agency (EMA) expanded CYRAMZA’s approval for advanced gastric cancer following positive phase III trial data.

• New Indications:
  Trials are underway assessing CYRAMZA in combination with other agents for colorectal, ovarian, and pancreatic cancers, aiming to broaden its therapeutic footprint.

• Biomarker Research:
  Emerging studies seek predictive biomarkers such as VEGFR-2 expression levels and circulating angiogenic factors to optimize patient stratification.

Market Analysis

Market Overview

The global market for anti-angiogenic agents in oncology is projected to reach approximately $25 billion by 2028, driven by rising cancer incidence rates and an increasing preference for targeted therapies. CYRAMZA contributes to this landscape with its specific mechanism of targeting VEGFR-2.

Current Market Position

• Sales Performance:
  In 2022, CYRAMZA generated approximately $800 million globally, with notable sales in Japan, the U.S., and Europe. The drug’s revenue trajectory has shown steady growth influenced by expanding indications and favorable trial outcomes.

• Competitive Landscape:
  The drug contends with other anti-angiogenic agents such as bevacizumab (Avastin), ramucirumab’s primary competitor, and newer molecules like regorafenib and apatinib. Its unique mechanism confers specific advantages in certain tumor types.

• Market Share:
  Within gastric cancer, CYRAMZA holds an estimated 35% market share in regions where it is approved. For NSCLC, it is emerging as a niche option, capturing approximately 20% among second-line therapies.

Market Drivers and Barriers

• Drivers:

  • Growing indication approvals expanding its target patient base.
  • Positive clinical trial data reinforcing efficacy.
  • Increasing utilization due to patient preference for targeted therapies over chemotherapy.

• Barriers:

  • High cost limiting accessibility in some markets.
  • Competition from biosimilars and other targeted agents.
  • Regulatory challenges in emerging markets.

Market Projection

Forecast for 2023–2030

Based on current data and upcoming clinical trial outcomes, the market for CYRAMZA is projected to grow at a compound annual growth rate (CAGR) of approximately 7% over the next seven years.

• Market Penetration:
  With ongoing trials potentially leading to broader approvals, especially in colorectal and ovarian cancers, CYRAMZA’s market share is expected to increase, reaching an estimated $2.3 billion globally by 2030.

• Geographical Expansion:
  Regulatory approvals in China and India could significantly augment sales, considering the large patient populations and unmet needs.

• Pipeline Impact:
  The successful validation of biomarkers and combination regimens will enhance personalized therapy approaches, further driving demand.

Key Strategic Factors

• Partnerships and Licensing:
  Collaborations with regional pharmaceutical companies can accelerate market penetration, especially in emerging economies.

• Pricing and Reimbursement Policies:
  Negotiations with payers and reimbursement authorities will be critical to maximize access and revenue.

• Innovation and Differentiation:
  Developing next-generation formulations or biosimilars could sustain competitiveness and ensure lifecycle management.

Conclusion

CYRAMZA’s clinical trial portfolio demonstrates sustained efficacy across multiple tumor types, supported by robust data from pivotal phase III studies. Market-wise, the drug has established a stable position within the anti-angiogenic therapy space, with promising growth projections fueled by expanding indications, geographical reach, and clinical validation.

Continued investment in biomarker research, combination therapies, and strategic partnerships will be vital for maintaining and enhancing CYRAMZA’s market position. As the global oncology market evolves, CYRAMZA’s role as a targeted VEGFR-2 inhibitor will likely expand, contributing to improved outcomes for patients with various solid tumors.

Key Takeaways

• Clinical Success:
  Phase III trials such as RAINBOW and RELAY underpin CYRAMZA’s efficacy in gastric and NSCLC, respectively, validating its role in second-line treatment paradigms.

• Market Potential:
  Projected to reach over $2.3 billion globally by 2030, driven by new indications and regional expansion.

• Competitive Edge:
  Its targeted mechanism and ongoing biomarker studies position CYRAMZA as a personalized therapy option, though competition and costs remain challenges.

• Growth Strategies:
  Regional regulatory approvals, strategic partnerships, and pipeline diversification are central to future success.

• Clinical Pipeline & Research:
  Active investigation in multiple cancers suggests potential for broader adoption and lifecycle extension.

FAQs

1. What are the primary indications approved for CYRAMZA?
   CYRAMZA is approved for advanced gastric or gastroesophageal junction cancers, NSCLC, and hepatocellular carcinoma, with ongoing trials in other indications like colorectal and ovarian cancers.

2. How does CYRAMZA compare to other anti-angiogenic therapies?
   Its specificity for VEGFR-2 offers distinct advantages in certain cancers, potentially translating to improved efficacy and reduced off-target effects, though direct comparisons depend on tumor type and patient populations.

3. Are there any significant adverse effects associated with CYRAMZA?
   Common adverse effects include hypertension, fatigue, diarrhea, and hemorrhage. The safety profile aligns with other anti-angiogenic agents, emphasizing the importance of management in clinical use.

4. What is the outlook for CYRAMZA’s pipeline development?
   Ongoing trials focus on combination therapies and biomarker-driven patient selection, aiming to expand its therapeutic indications and optimize efficacy.

5. How might emerging biosimilars impact CYRAMZA’s market share?
   Biosimilars could potentially reduce costs and increase accessibility but may also intensify market competition, prompting innovation and strategic differentiation for the original product.

References

1. [1] "Ramucirumab (CYRAMZA) Approvals and Clinical Data," FDA, 2014–2023.
2. [2] "Global Oncology Market Report," Market Research Future, 2022.
3. [3] "ClinicalTrials.gov," U.S. National Library of Medicine.
4. [4] "European Medicines Agency (EMA) Summary of Product Characteristics," 2020.
5. [5] "Industry Analysis of Anti-Angiogenic Agents," Grand View Research, 2023.