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

This “EGFR Non-Small Cell Lung Cancer- Pipeline Insight, 2024” report provides comprehensive insights about 37+ companies and 40+ 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

Lung cancer is one of the leading causes of cancer-related deaths among both men and women, and there continues to be limited treatment options available for advanced-stage disease. Non-small cell lung cancer (NSCLC) which comprises the majority (about 75%) of lung cancer, has proven difficult to treat due to poorly understood pathological mechanisms. The cell signaling pathways that control cell survival have identified genetic and regulatory aberrations that suppress cell death, promote cell division, and induce tumorogenesis. One such discovery is that of epidermal growth factor receptor (EGFR). EGFR is a transmembrane receptor tyrosine kinase protein that is expressed in some normal epithelial, mesenchymal, and neurogenic tissue. Overexpression of EGFR has been reported and implicated in the pathogenesis of many human malignancies, including NSCLC. Studies showed that EGFR expression in NSCLC is associated with reduced survival, frequent lymph node metastasis and poor chemosensitivity.

EGFR belongs to the erbB family of closely related receptor tyrosine kinases, which include erbB1 (also known as EGFR), erbB2 (HER2), erbB3, and erbB4. Although their basic structures are similar, each one has distinct properties, including variation in tyrosine kinase activity. It has an extracellular ligand binding domain, a transmembrane portion, and intracellular tyrosine kinase and regulatory domains. Upon binding of a specific ligand (eg. epidermal growth factor), the normally functioning EGFR undergoes conformational change and phosphorylation of the intracellular domain occurs, leading to downstream signal transduction by various pathways. These include the Raf1-extracellular signal-regulated kinase, PI3K/Akt, and signal transducer and activator of transcription (STAT) factors. Depending on the pathway, the end result is cell proliferation or cell maintenance by inhibition of apoptosis.

There are three generations of EGFR-TKIs approved to treat NSCLC patients bearing EGFR mutations in different clinical settings. First-generation (gefitinib, erlotinib and icotinib) and second-generation (afatinib and dacomitinib) EGFR-TKIs have demonstrated substantial clinical benefit in advanced NSCLC patients with Ex19del and L858R mutations. Despite initial potent responses to first- and second-generation EGFR-TKIs, a large number of patients would develop acquired resistance within 9 to 14 months during or after EGFR-TKI therapy.

“EGFR Non-Small Cell Lung Cancer- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the mechanism of action. 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

• Zipalertinib: Cullinan Oncology

Zipalertinib is a next-generation oral, irreversible, small molecule designed to target EGFR activating mutations, including EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. The FDA granted breakthrough therapy designation to zipalertinib for the treatment of patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations and who have received prior platinum-based chemotherapy.

The drug is currently being evaluated under Phase III clinical studies for the treatment of non-small cell lung cancer.

• BBT-176: Bridge Biotherapeutics

BBT-176 is a novel epidermal growth factor receptor - tyrosine kinase inhibitor (EGFR-TKI), which is designed to inhibit EGFR with C797S mutations, which arise as Tagrisso (osimertinib) resistant mutations following Tagrisso treatment in non-small cell lung cancer (NSCLC). In the pre-clinical studies, BBT-176 exhibited strong anti-tumor efficacy in C797S triple mutations. The drug is in the Phase I/II stage of development for the treatment of non-small-cell lung cancer.

• ORIC-114: ORIC Pharmaceuticals

ORIC-114 is a highly selective, brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, making it a promising therapeutic candidate to address the unmet medical need of having both meaningful systemic as well as CNS antitumor activity. It is currently being evaluated under Phase I clinical study 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. 37+ 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, Cullinan Oncology.

Phases

This report covers around 40+ 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

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal
• Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule
• 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

• Cullinan Oncology
• Taiho Pharmaceutical
• ORIC Pharmaceuticals
• Ono Pharmaceutical
• Nuvalent
• Shanghai Junshi Biosciences
• Janux Therapeutics
• HK inno.N
• HUTCHMED
• Daiichi Sankyo Company

Key Products

• Zipalertinib
• TAS3351
• ORIC-114
• ONO-7475
• NVL-330
• JS-113
• JANX-008
• IN-119873
• HMPL-813
• HER3-DXd

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