EGFR Non-Small Cell Lung Cancer - Pipeline Insight, 2024

This “EGFR Non-Small Cell Lung Cancer- Pipeline Insight, 2024” report provides comprehensive insights about 40+ companies and 42+ pipeline drugs in EGFR Non-Small Cell Lung Cancer pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

EGFR Non-Small Cell Lung Cancer: Understanding

EGFR Non-Small Cell Lung Cancer: Overview

Epidermal growth factor receptor (EGFR) mutations are the most common oncogenic drivers in non-small-cell lung cancer (NSCLC). Significant developments have taken place which highlight the differences in tumor biology that exist between the mutant and wild-type subtypes of NSCLC. Epidermal growth factor receptor is a trans-membrane glycoprotein with an extracellular epidermal growth factor binding domain and an intracellular tyrosine kinase domain that regulates signaling pathways to control cellular proliferation. Epidermal growth factor receptor binding to its ligand results in autophosphorylation by intrinsic tyrosine/kinase activity, triggering several signal transduction cascades.

Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer cases and has high mortality worldwide. In China, it is also the most common cancer and leading cause of cancer-related deaths. Targeted therapy has led to a new era in the treatment of NSCLC with the development of detection techniques for epidermal growth factor receptor (EGFR) mutations. NSCLC harboring EGFR mutations constitutes about 10-20% of all lung cancer cases in Europe and North America and up to 50% of Asian patients with NSCLC. Exon 19 deletions and exon 21 L858R substitution are the most common mutations, accounting for approximately 90% of mutations in NSCLC; these are termed classic mutations and lead to high sensitivity to tyrosine kinase inhibitor (TKIs). NSCLC patients with exon 19 deletions and exon 21 L858R substitution have longer progression-free survival (PFS) when treated with TKIs compared with traditional chemotherapy.

As the treatment of lung cancer has become progressively more biomarker-driven, and with the rapid emergence of effective matched targeted therapies, organizations have made attempts to define best practices for which tests are necessary and in what target population. This practice has its own set of challenges in keeping up with a rapidly changing field. Although sensitizing mutations in the EGFR gene were first described in 2004, followed by multiple trials showing that EGFR tyrosine kinase inhibitors (TKIs) were superior to chemotherapy in this subgroup of patients, it was not until 2011 that the first provisional recommendation was issued by ASCO endorsing routine testing of all patients with lung adenocarcinoma for EGFR mutations.5 In that same year, crizotinib was approved for treatment of anaplastic lymphoma kinase (ALK)-rearranged NSCLC, illustrating the rapid pace of adoption of targeted therapies and the challenges guidelines would have keeping pace.

A lung cancer diagnosis can be confirmed with a biopsy. Doctors also use biopsies to test cancers for specific gene mutations. It’s now a routine part of diagnosing and staging lung cancer. There are several ways to get the necessary tissue sample including needle aspiration, (procedure to obtain a very small sample of lung tissue, the tissue is then examined with a microscope), bronchoscopy (a procedure that allows to see inside the airways of lungs, If a small piece of tissue is taken during the procedure, it’s called a transbronchial biopsy and is used to diagnose lung conditions), and lung surgery.

Two first-generation EGFR tyrosine kinase inhibitors (TKI) inhibitors, erlotinib and gefitinib, are currently available for patients with advanced/incurable EGFR exon 19 deletion and exon 21, L858R, mutated NSCLC. These drugs are well established in clinical practice and widely used in the first-line treatment of patients with EGFR-mutated NSCLC. Combining existing and new treatments with EGFR-targeted therapy is a potential strategy in combating resistance to treatment in non-small-cell lung cancer. Using agents together is attractive due to the potential synergy of mechanisms and the elimination of resistant clones, but this can come at the cost of greater toxicity. Various combinations of EGFR TKI therapy have been investigated including cytotoxic chemotherapy, antiangiogenic agents, and immune checkpoint inhibitors.

EGFR Non-Small Cell Lung Cancer- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the EGFR Non-Small Cell Lung Cancer pipeline landscape is provided which includes the disease overview and EGFR Non-Small Cell Lung Cancer treatment guidelines. The assessment part of the report embraces, in depth EGFR Non-Small Cell Lung Cancer commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, EGFR Non-Small Cell Lung Cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence EGFR Non-Small Cell Lung Cancer R&D. The therapies under development are focused on novel approaches to treat/improve EGFR Non-Small Cell Lung Cancer.

EGFR Non-Small Cell Lung Cancer Emerging Drugs Chapters

This segment of the EGFR Non-Small Cell Lung Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

EGFR Non-Small Cell Lung Cancer Emerging Drugs

AK112: Akeso BiopharmaAK112, is a first-in-class PD-1/VEGF bi-specific antibody, which is being developed by AKeso Biopharma. The drug is responsible for blocking PD-1 binding to PD-L1 and PD-L2 and also for blocking to VEGF binding to VEGF receptors. In November, 2022, AK112 has been granted as the Breakthrough Therapy Designation in China for the treatment of locally advanced or metastatic Non-Small-Cell Lung Carcinoma (NSCLC). AK112, is currently being evaluated in phase III clinical trial for the treatment of Non-Squamous Non-small Cell Lung Cancer.

CLN-081: Cullinan OncologyCLN-081 is a novel irreversible Epidermal Growth Factor Receptor (EFGR) inhibitor. It is administered through oral route, and is developed by Cullinan Oncology. The therapy is currently being evaluated in the Phase II for EGRF non-small cell lung cancer (NSCLC). In June 2022, Cullinan Oncology announced the completion of its agreement with Taiho Pharmaceutical Co., Ltd. (Taiho) signed in May 2022. As per the terms of the agreement, the companies collaborated on the US development of CLN-081/TAS6417 for the treatment of a genetically defined subset of patients with non-small cell lung cancer (NSCLC).

BPI-361175: Betta PharmaceuticalsBPI-361175 is a novel, oral, highly potent and selective 4th generation EGFR inhibitor developed by Betta Pharmaceutical Co., Ltd. The new chemical entity targets EGFR C797S mutation and other EGFR related mutations that are resistant to 3rd generation EGFR TKI in non-small cell lung cancer (NSCLC) and other solid tumors. It shows excellent inhibitory effect and selectivity in vitro assay and exhibits significant anti-tumor activity in a variety of xenograft models harboring EGFR C797S or other related mutations. The IND application of BPI-361175 has been approved by NMPA. Currently, the drug is the Phase I/II stage of its development for the treatment of Non-small Cell Lung Cancer.

JANX008: Janux TherapeuticsJANX008, is a TRACTr that targets Epidermal Growth Factor Receptor (EGFR), and is being developed by Janux Therapeutics for the treatment of various solid tumors including non-small cell lung cancer. According to preclinical studies, JANX008 showed potent cleavage dependent anti-tumor activity, with limited toxicities in healthy tissues or CRS. JANX008, is currently being evaluated in phase I clinical trial for the treatment of non-small cell lung cancer.

EGFR Non-Small Cell Lung Cancer: Therapeutic Assessment

This segment of the report provides insights about the different EGFR Non-Small Cell Lung Cancer drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in EGFR Non-Small Cell Lung Cancer

• There are approx. 40+ key companies which are developing the therapies for EGFR Non-Small Cell Lung Cancer. The companies which have their EGFR Non-Small Cell Lung Cancer drug candidates in the most advanced stage, i.e. phase III include, Akeso Biopharma.

Phases

This report covers around 42+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

EGFR Non-Small Cell Lung Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

EGFR Non-Small Cell Lung Cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses EGFR Non-Small Cell Lung Cancer therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging EGFR Non-Small Cell Lung Cancer drugs.

EGFR Non-Small Cell Lung Cancer Report Insights

• EGFR Non-Small Cell Lung Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

EGFR Non-Small Cell Lung Cancer Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing EGFR Non-Small Cell Lung Cancer drugs?
• How many EGFR Non-Small Cell Lung Cancer drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of EGFR Non-Small Cell Lung Cancer?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the EGFR Non-Small Cell Lung Cancer therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for EGFR Non-Small Cell Lung Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Alpha Biopharma
• Daiichi Sankyo Company
• Suzhou Puhe Pharmaceutical Technology
• Checkpoint Therapeutics
• AbbVie
• Akeso Biopharma
• Cullinan Oncology
• Betta Pharmaceuticals
• EpimAb Biotherapeutics
• Genor Biopharma
• G1 Therapeutics
• J Ints Bio

Key Products

• AZD-3759
• Patritumab Deruxtecan
• YK 209A
• Olafertinib
• Telisotuzumab Vedotin
• AK112
• CLN-081
• BPI-361175
• EMB-01
• GB 263 T
• G1T38
• JIN-A02

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