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Non-Small Cell Lung Cancer Clinical Trial Pipeline Boom as Over 100 Companies Leading the Charge in Research and Development | DelveInsight

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DelveInsight Business Research, LLP

Jan 14, 2025, 17:31 ET

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Advancements in targeted therapies have transformed the treatment landscape for NSCLC, enabling precision medicine approaches that improve outcomes. These therapies focus on specific genetic mutations or molecular drivers, such as EGFR, ALK, ROS1, BRAF, and MET, which are commonly implicated in NSCLC. Drugs targeting these mutations, such as tyrosine kinase inhibitors (TKIs), offer significant benefits, including higher response rates, improved progression-free survival, and fewer off-target effects compared to traditional chemotherapy. Additionally, continuous innovation has led to the development of next-generation inhibitors that overcome resistance to earlier therapies, further enhancing their efficacy. 

LAS VEGAS, Jan. 14, 2025 /PRNewswire/ -- DelveInsight's 'Non-Small Cell Lung Cancer Pipeline Insight 2025' report provides comprehensive global coverage of pipeline NSCLC therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the NSCLC pipeline domain.

Key Takeaways from the Non-Small Cell Lung Cancer Pipeline Report

  • DelveInsight's NSCLC pipeline report depicts a robust space with 100+ active players working to develop 120+ pipeline therapies for NSCLC treatment. 
  • Key NSCLC companies such as Merck Sharp & Dohme LLC, AbbVie, Qilu Pharmaceutical Co., Ltd., Suzhou Puhe Pharmaceutical Technology Co., LTD, Exelixis, Genmab, OncoResponse, Inc., Next Point Therapeutics, Inc., Light Chain Bioscience - Novimmune SA, Immunitas Therapeutics, Hansoh BioMedical R&D Company, Mythic Therapeutics, Shanghai Henlius Biotech, and others are evaluating new NSCLC drugs to improve the treatment landscape.
  • Promising NSCLC pipeline therapies such as V940, Telisotuzumab Vedotin, QL1706, YK-029A, XL092, PRO1184, OR2805, NPX267, NI-1801, IMT-009, HS-20117, MYTX-011, HLX301, and others are under different phases of NSCLC clinical trials.
  • In December 2024, the FDA granted breakthrough therapy designation to sacituzumab tirumotecan (MK-2870/SKB264/) for the treatment of patients with advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC).
  • In September 2024, AbbVie announced that it had submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for accelerated approval of elotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression.
  • In August 2024, the FDA granted Fast track designation to Deltacel (KB-GDT-01) with low-dose radiation therapy to potentially treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease progressed on 2 or more prior lines of standard-of-care therapy, including immune checkpoint inhibitors, platinum-based chemotherapy, and targeted therapy.
  • In July 2024, Nuvalent announced the first patient dosed in HEROEX-1 Phase Ia/Ib clinical trial of NVL-330, its novel HER2-selective Inhibitor.
  • In April 2024, ABVC BioPharma announced that the Company and its affiliate Rgene Corporation entered into a comprehensive licensing agreement with OncoX for the drug ABV-1501. Under the terms of the agreement, ABVC grants OncoX exclusive rights for one of ABVC's four products in its Oncology pipeline to develop, manufacture, and commercialize BLEX 404.
  • In April 2024, Hansoh Pharma announced that the Class 1 new drug "HS-10504 tablet" independently developed by its subsidiary Jiangsu Hansoh Pharmaceutical Group Co., Ltd. and Shanghai Hansoh Biomedical Technology Co., Ltd. had obtained the clinical trial notification letter issued by the National Medical Products Administration of the People's Republic of China. It is intended for the treatment of advanced non-small cell lung cancer, with specific indications to be determined after clinical trials.
  • In February 2024, the FDA granted breakthrough therapy designation to NVL-520 as a treatment for patients with ROS1-positive metastatic non–small cell lung cancer (NSCLC) who received prior treatment with at least 2 ROS1 tyrosine kinase inhibitors (TKIs).

Request a sample and discover the recent advances in NSCLC treatment drugs @ Non-Small Cell Lung Cancer Pipeline Report

The NSCLC pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage NSCLC drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the NSCLC clinical trial landscape. 

Non-Small Cell Lung Cancer Overview

Non-small cell lung cancer (NSCLC) is the most prevalent form of lung cancer, originating in the tissues of the lungs. Unlike small cell lung cancer, which grows rapidly, NSCLC typically develops more slowly but often spreads to other parts of the body by the time it is diagnosed, emphasizing the need for early detection and treatment. Small-cell lung cancer derives its name from the small, round appearance of its cells under a microscope, while the cells in NSCLC are larger. Despite its slower growth, NSCLC is frequently diagnosed at an advanced stage, further underscoring the importance of early intervention.

In the United States, approximately 230,000 people are diagnosed with lung cancer annually, and it accounts for an estimated 135,000 deaths each year. Lung cancer causes more deaths than prostate, breast, brain, and colorectal cancers combined. It is the leading cause of cancer deaths in men and the second most common in women. However, these figures are declining, largely due to anti-smoking initiatives and reduced tobacco use.

The classification of lung tumors is based on the 2015 World Health Organization (WHO) guidelines, which utilize immunohistochemistry and light microscopy to guide treatment decisions and predict outcomes. NSCLC encompasses several subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. Adenocarcinoma, the most common subtype, accounts for nearly half of all lung cancer cases. Squamous cell carcinoma, once the most prevalent, typically originates in the tracheobronchial tree but is now more frequently found in peripheral lung areas. Large cell carcinoma is a diagnosis of exclusion, characterized by poor differentiation and lack of specific classification through immunohistochemistry or electron microscopy.

The causes of NSCLC can be divided into avoidable and unavoidable risk factors. Tobacco use remains the most significant preventable risk factor, while other causes include alcohol consumption, exposure to secondhand smoke, asbestos, radon, arsenic, chromium, nickel, ionizing radiation, and polycyclic aromatic hydrocarbons.

Diagnosis involves a comprehensive blood count (CBC), a complete metabolic panel (CMP), and imaging studies. Hypercalcemia or elevated alkaline phosphatase may indicate metastasis to bones. Initial imaging with a chest X-ray can help identify nonspecific signs, followed by computed tomography (CT) for detailed characterization. A tissue biopsy is essential for confirming the diagnosis through histopathologic and immunohistochemistry evaluation.

Treatment options for NSCLC include standard therapies like surgery, radiation, chemotherapy, targeted therapy, and immunotherapy, as well as newer approaches like laser therapy, photodynamic therapy (PDT), and cryosurgery. The choice of treatment depends on the cancer's stage, the patient's functional status, comorbidities, and the molecular characteristics of the tumor. Surgery is often required for localized cases, while advanced stages may call for a combination of therapies. Participation in clinical trials can also offer access to emerging treatments.

Managing NSCLC requires a collaborative, interprofessional approach, beginning with prevention. Primary care providers play a critical role in smoking cessation counseling and early detection through lung cancer screening, which can improve prognosis by identifying the disease before it progresses to advanced stages.

Find out more about NSCLC treatment drugs @ Drugs for Non-Small Cell Lung Cancer Treatment

A snapshot of the Non-Small Cell Lung Cancer Pipeline Drugs mentioned in the report:

Drugs

Company

Phase 

MoA

RoA

Telisotuzumab Vedotin 

AbbVie

Preregistration

Proto-oncogene protein c-met inhibitors

Intravenous 

V940

Merck Sharp & Dohme LLC

Phase III

Immunostimulants

Intramuscular

QL1706

Qilu Pharmaceutical Co., Ltd.

Phase III

Antibody-dependent cell cytotoxicity; Cytotoxic T-lymphocyte antigen 4 inhibitors; Programmed cell death 1 receptor antagonists; T lymphocyte stimulants

Intravenous

YK-029A

Suzhou Puhe Pharmaceutical Technology

Phase III

Epidermal growth factor receptor antagonists

Oral

HS-20117

Hansoh BioMedical R&D Company

Phase II/III

Antibody-dependent cell cytotoxicity; T lymphocyte stimulants

Intravenous

OR2805

OncoResponse

Phase I/II

T lymphocyte stimulants

Intravenous

HS-10504 

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Phase I

Epidermal growth factor receptor antagonists

Oral

MYTX-011

Mythic Therapeutics

Phase I

Mitosis inhibitors; Tubulin inhibitors; Tubulin polymerization inhibitors

Intravenous

Learn more about the emerging NSCLC pipeline therapies @ Non-Small Cell Lung Cancer Clinical Trials

Non-Small Cell Lung Cancer Therapeutics Assessment

The NSCLC pipeline report proffers an integral view of the NSCLC emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.

Scope of the Non-Small Cell Lung Cancer Pipeline Report 

  • Coverage: Global 
  • Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
  • Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
  • Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical
  • Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy
  • Therapeutics Assessment By Mechanism of Action: Immunostimulants, Antibody-dependent cell cytotoxicity, Cytotoxic T-lymphocyte antigen 4 inhibitors, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Apoptosis stimulants, Mitosis inhibitors, Tubulin inhibitors, Tubulin polymerization inhibitors, Epidermal growth factor receptor antagonists, Proto-oncogene protein c-met inhibitors
  • Key Non-Small Cell Lung Cancer Companies: Merck Sharp & Dohme LLC, AbbVie, Qilu Pharmaceutical Co., Ltd., Suzhou Puhe Pharmaceutical Technology Co., LTD, Exelixis, Genmab, OncoResponse, Inc., Next Point Therapeutics, Inc., Light Chain Bioscience - Novimmune SA, Immunitas Therapeutics, Hansoh BioMedical R&D Company, Mythic Therapeutics, Shanghai Henlius Biotech, and others 
  • Key Non-Small Cell Lung Cancer Pipeline Therapies: V940, Telisotuzumab Vedotin, QL1706, YK-029A, XL092, PRO1184, OR2805, NPX267, NI-1801, IMT-009, HS-20117, MYTX-011, HLX301, and others 

Dive deep into rich insights for new drugs for NSCLC treatment, visit @ Non-Small Cell Lung Cancer Drugs

Table of Contents

1.

Non-Small Cell Lung Cancer Pipeline Report Introduction

2.

Non-Small Cell Lung Cancer Pipeline Report Executive Summary

3.

Non-Small Cell Lung Cancer Pipeline: Overview

4.

Analytical Perspective In-depth Commercial Assessment

5.

Non-Small Cell Lung Cancer Clinical Trial Therapeutics

6.

Non-Small Cell Lung Cancer Pipeline: Late-Stage Products (Pre-registration)

7.

Non-Small Cell Lung Cancer Pipeline: Late-Stage Products (Phase III)

8.

Non-Small Cell Lung Cancer Pipeline: Mid-Stage Products (Phase II)

9.

Non-Small Cell Lung Cancer Pipeline: Early-Stage Products (Phase I)

10.

Non-Small Cell Lung Cancer Pipeline Therapeutics Assessment

11.

Inactive Products in the Non-Small Cell Lung Cancer Pipeline

12.

Company-University Collaborations (Licensing/Partnering) Analysis

13.

Key Companies

14.

Key Products in the Non-Small Cell Lung Cancer Pipeline

15.

Unmet Needs

16.

Market Drivers and Barriers

17.

Future Perspectives and Conclusion

18.

Analyst Views

19.

Appendix

For further information on the NSCLC pipeline therapeutics, reach out @ Non-Small Cell Lung Cancer Treatment Drugs

Related Reports

Non-Small Cell Lung Cancer Market

Non-Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key NSCLC companies including EMD Serono, Merck, Cellular Biomedicine Group, Inc., Celgene, CellSight Technologies, Inc., BeyondSpring Pharmaceuticals Inc., J Ints Bio, Forward Pharmaceuticals Co., Ltd., AstraZeneca, Bristol-Myers Squibb, Teligene US, Rain Oncology Inc, ReHeva Biosciences, Inc., Amgen, Novartis, RedCloud Bio, Parexel, Vitrac Therapeutics, LLC, Mythic Therapeutics, Instil Bio, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., AstraZeneca, Precision Biologics, Inc, Promontory Therapeutics Inc., Palobiofarma SL, Regeneron Pharmaceuticals, Revolution Medicines, Inc., Cullinan Oncology, LLC, Iovance Biotherapeutics, Inc., Innate Pharma, among others. 

HER2-mutant Non-Small Cell Lung Cancer Pipeline

HER2-mutant Non-Small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HER2-mutant non-small cell lung cancer companies, including Dizal Pharmaceuticals, Puma Biotechnology, AstraZeneca, Jiangsu Hengrui Medicine, among others.

Small Cell Lung Cancer Market

Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key advanced small cell lung cancer companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, Advanced Accelerator Applications, Trillium Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, among others.

Small-cell Lung Cancer Pipeline

Small-cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key small-cell lung cancer companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, GlaxoSmithKline, Advanced Accelerator Applications, Trillium Therapeutics, Vernalis, Oncoceutics, NewBio Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, Xencor, Jiangsu HengRui Medicine, Aileron Therapeutics, Roche, Ipsen, Celgene, Lee's Pharmaceutical Limited, AbbVie, G1 Therapeutics, Chipscreen Biosciences, Luye Pharma Group, Shanghai Henlius Biotech, CSPC ZhongQi Pharmaceutical Technology, Impact Therapeutics, among others.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

Contact Us
Shruti Thakur  
[email protected]  
+14699457679 
www.delveinsight.com 

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SOURCE DelveInsight Business Research, LLP

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