CLINICAL TRIALS PROFILE FOR CERITINIB

All Clinical Trials for CERITINIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01685060 ↗	LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib	Completed	Novartis Pharmaceuticals	Phase 2	2012-11-26	A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator
NCT01685138 ↗	LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer	Completed	Novartis Pharmaceuticals	Phase 2	2012-12-20	A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anticancer therapy and/or died. LDK378 was continued beyond RECIST defined progressive disease (PD) as assessed by the investigator, if in the judgment of the investigator, there was evidence of clinical benefit. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator. Male and female patients aged 18 or over with ALK-rearranged non-small cell cancer (NSCLC) were screened for eligibility. Patients had to have received no prior crizotinib, and had to be chemotherapy-naïve or been pretreated with cytotoxic chemotherapy (up to three prior lines).
NCT01742286 ↗	Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)	Completed	Novartis Pharmaceuticals	Phase 1	2013-08-28	The purpose of this study was to estimate the maximum tolerated dose and/or recommended dose for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor activity and characterize single and multiple-dose pharmacokinetics when administered orally to pediatric patients with ALK-activated tumors, with and without food.
NCT01828099 ↗	LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer	Active, not recruiting	Novartis Pharmaceuticals	Phase 3	2013-07-09	The primary purpose of the study was to compare the antitumor activity of LDK378 versus reference chemotherapy. Patients in the chemotherapy arm were allowed to cross-over to LDK378 after confirmed progressive disease (PD).
NCT01828112 ↗	LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib	Active, not recruiting	Novartis Pharmaceuticals	Phase 3	2013-06-28	The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib.

Clinical Trial Conditions for CERITINIB

Condition Name

Condition Name for CERITINIB
Intervention	Trials
Non-Small Cell Lung Cancer	9
ALK Positive	3
Lung Cancer	2
Glioblastoma	2

Condition MeSH

Condition MeSH for CERITINIB
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	17
Lung Neoplasms	14
Neoplasms	9
Lymphoma	5

Clinical Trial Locations for CERITINIB

Trials by Country

Trials by Country for CERITINIB
Location	Trials
United States	186
Italy	89
Spain	52
Japan	44
Korea, Republic of	28

Trials by US State

Trials by US State for CERITINIB
Location	Trials
California	14
Texas	12
Massachusetts	9
Florida	8
Washington	8

Clinical Trial Progress for CERITINIB

Clinical Trial Phase

Clinical Trial Phase for CERITINIB
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2	18

Clinical Trial Status

Clinical Trial Status for CERITINIB
Clinical Trial Phase	Trials
Recruiting	13
Completed	9
Active, not recruiting	6

Clinical Trial Sponsors for CERITINIB

Sponsor Name

Sponsor Name for CERITINIB
Sponsor	Trials
Novartis Pharmaceuticals	17
Novartis	5
National Cancer Institute (NCI)	4

Sponsor Type

Sponsor Type for CERITINIB
Sponsor	Trials
Other	46
Industry	35
NIH	4

CERITINIB Market Analysis and Financial Projection

Ceritinib: Clinical Trials, Market Analysis, and Projections

Introduction

Ceritinib, a second-generation anaplastic lymphoma kinase (ALK) inhibitor, has been a significant player in the treatment of ALK-positive non-small cell lung cancer (NSCLC). Here, we delve into the latest updates on clinical trials, market analysis, and projections for this crucial drug.

Clinical Trials and Efficacy

First-Line Treatment

Ceritinib has been evaluated as a first-line treatment for patients with ALK-rearranged NSCLC. A study published in The Lancet highlighted that ceritinib should be considered a new first-line therapeutic option for these patients, demonstrating its efficacy in improving outcomes compared to platinum-based chemotherapy[4].

Comparative Effectiveness

A comparative effectiveness study assessed the outcomes of patients treated with ceritinib versus alectinib, another ALK inhibitor, in the context of crizotinib-refractory ALK-positive NSCLC. The study found that alectinib-treated patients had a lower risk of all-cause mortality compared to those treated with ceritinib, although both drugs showed significant therapeutic benefits[1].

Pharmacokinetics and Safety

Clinical trials have also focused on the pharmacokinetics and safety profile of ceritinib. For instance, a study conducted by the FDA evaluated the effect of ceritinib on the pharmacokinetics of warfarin, a CYP2C9 substrate, and found that ceritinib inhibits CYP2C9, which can impact the dosing of concomitant medications[3].

Additionally, ceritinib has been shown to prolong the QTc interval in a concentration-dependent manner, necessitating careful monitoring and potential dose adjustments in patients with QTc interval prolongation[3].

Market Analysis

Market Size and Growth

The global market for ceritinib, as part of the broader NSCLC treatment landscape, is projected to grow significantly. By 2025, the NSCLC market is expected to reach $26.8 billion in the 8 major markets (8MM), with a moderate Compound Annual Growth Rate (CAGR) of 15%[5].

Targeted Therapies

Targeted therapies, including ceritinib, are expected to contribute substantially to this growth. The sales of targeted therapies in the NSCLC market are projected to reach $9.4 billion by 2025, driven by the uptake of drugs like AstraZeneca’s Tagrisso and Roche’s Avastin[5].

Competitive Landscape

The ceritinib API market faces high competition from other ALK inhibitors and targeted therapies. Key players in the market include Novartis Pharmaceuticals Corporation, the original developer of ceritinib, as well as other pharmaceutical companies like Alembic Pharmaceuticals Limited, Apotex Inc., and Aurobindo Pharma Limited, which are involved in the manufacturing and distribution of ceritinib API[2].

Market Drivers

Several factors drive the growth of the ceritinib market:

• Innovative Advancements: Increased funding in oncology research and development.
• Growing Prevalence: Rising incidence of NSCLC.
• Patient Awareness: Heightening awareness and changing attitudes towards novel treatment options[2].

Market Restraints

Despite the growth drivers, the market faces several restraints:

• Supply Chain Inefficiencies: Logistical challenges affecting API availability.
• Patent Expirations: Intellectual property issues impacting market expansion.
• Competitive Landscape: Presence of alternative ALK inhibitors[2].

Market Opportunities and Challenges

Market Opportunities

• Niche Markets: Identifying specific cancer treatment areas where ceritinib shows promising therapeutic potential.
• Educational Campaigns: Developing campaigns for healthcare professionals to highlight the benefits of ceritinib.
• Collaborations: Promoting ceritinib through collaborations with oncology research institutions worldwide[2].

Market Challenges

• High R&D Costs: Impacting pricing strategies and making the drug less accessible.
• Safety and Efficacy Concerns: Addressing these concerns through enhanced clinical trials and evidence[2].

Regulatory Framework and Manufacturing

Regulatory Approvals

Ceritinib has undergone rigorous regulatory scrutiny. The FDA has recommended postmarketing trials to evaluate the GI tolerability, efficacy, and pharmacokinetics of ceritinib when taken with meals, as well as potential dose adjustments in patients with hepatic impairment and those receiving acid-reducing agents[3].

Manufacturing Process

The manufacturing process for ceritinib API involves complex steps, and companies are focusing on improving formulation techniques, bioavailability, and sustainable manufacturing practices to enhance market penetration[2].

Key Takeaways

• Clinical Efficacy: Ceritinib is a viable first-line treatment for ALK-positive NSCLC and shows significant therapeutic benefits in comparative studies.
• Market Growth: The NSCLC market, including ceritinib, is projected to grow substantially by 2025.
• Competitive Landscape: The market is highly competitive, with several key players involved in the manufacturing and distribution of ceritinib API.
• Market Drivers and Restraints: Innovative advancements, growing prevalence of NSCLC, and patient awareness drive the market, while supply chain inefficiencies, patent expirations, and competitive pressures act as restraints.
• Regulatory and Manufacturing Focus: Ongoing regulatory evaluations and improvements in manufacturing processes are crucial for the drug's success.

FAQs

What is the primary use of ceritinib in cancer treatment?

Ceritinib is primarily used as a second-generation ALK inhibitor for the treatment of ALK-positive non-small cell lung cancer (NSCLC).

How does ceritinib compare to other ALK inhibitors like alectinib?

Studies have shown that while both ceritinib and alectinib are effective, alectinib may have a lower risk of all-cause mortality in patients with crizotinib-refractory ALK-positive NSCLC[1].

What are the key drivers of the ceritinib market?

The market is driven by innovative advancements in oncology research, the growing prevalence of NSCLC, and increasing patient awareness of novel treatment options[2].

What are the main challenges facing the ceritinib market?

The market faces challenges such as high research and development costs, supply chain inefficiencies, patent expirations, and a competitive landscape with alternative ALK inhibitors[2].

How is the regulatory framework impacting the ceritinib market?

The FDA has recommended postmarketing trials to address various aspects of ceritinib's use, including GI tolerability and potential dose adjustments, which can influence its market penetration and acceptance[3].

Sources

1. Assessment of Alectinib vs Ceritinib in ALK-Positive Non–Small Cell Lung Cancer. JAMA Network Open, 2021.
2. Ceritinib API Market Size & Share 2025-2030. 360iResearch.
3. Clinical Pharmacology Review of Ceritinib. FDA, 2014.
4. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged NSCLC. The Lancet, 2017.
5. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025. GlobalData.