HER2-mutant Non-Small Cell Lung Cancer - Pipeline Insight, 2024

This “HER2-mutant Non-Small Cell Lung Cancer- Pipeline Insight, 2024” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in HER2-mutant 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

HER2-mutant Non-Small Cell Lung Cancer: Understanding

HER2-mutant Non-Small Cell Lung Cancer: Overview

Lung cancer is the leading cause of cancer-related deaths worldwide. Non-small cell lung cancer (NSCLC) accounts for more than 80% of all lung cancers. NSCLC is one of the most genomically diverse cancers, making it very difficult to treat. For all NSCLC patients who have the adenocarcinoma subtype, testing for alterations in epidermal growth factor receptor (EGFR), mesenchymal epithelial transition factor (MET), b-raf proto-oncogene (BRAF), anaplastic lymphoma kinase (ALK), ROS proto-oncogene 1 (ROS1), ret proto-oncogene (RET) and neurotrophic tyrosine receptor kinase (NTRK) is recommended by the National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO) guidelines. Non-small-cell lung cancer (NSCLC) harbouring HER2 alterations is now considered a distinct molecular subtype. The activation of HER2 in NSCLC occurs via three mechanisms, i.e. gene mutation (1%-4% of cases), gene amplification (2%-5%) and protein overexpression (2%-30%), with different prognostic and predictive outcomes. Lung cancer is the leading cause of cancer-related mortality worldwide. Non-small-cell lung cancer (NSCLC), the main histologic subtype accounting for 85% of lung cancer cases, is a heterogeneous disease driven by a wide spectrum of molecular alterations. One might notice symptoms in the early stages. Or might mistake them for another illness, such as pneumonia or a collapsed lung. Like other types of lung cancer, symptoms can include: Coughing that lasts or gets worse, chest pain that often hurts more when coughs, laugh, or take deep breaths, hoarseness or voice changes, harsh, raspy sounds when a person breathes, wheezing, weight loss and little appetite. Tests and procedures to diagnose and stage non-small cell lung cancer are often done at the same time. Some of the following tests and procedures may be used: Physical exam and health history: An exam of the body to check general signs of health, including checking for signs of disease, such as lumps or anything else that seems unusual. A history of the patient’s health habits, including smoking, and past jobs, illnesses, and treatments will also be taken, laboratory tests: medical procedures that test samples of tissue, blood, urine, or other substances in the body. These tests help to diagnose disease, plan and check treatment, or monitor the disease over time, chest x-ray: An x-ray of the organs and bones inside the chest. An x-ray is a type of energy beam that can go through the body and onto film, making a picture of areas inside the body.

HER2-mutant 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 HER2-mutant Non-Small Cell Lung Cancer pipeline landscape is provided which includes the disease overview and HER2-mutant Non-Small Cell Lung Cancer treatment guidelines. The assessment part of the report embraces, in depth HER2-mutant 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, HER2-mutant 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 HER2-mutant Non-Small Cell Lung Cancer R&D. The therapies under development are focused on novel approaches to treat/improve HER2-mutant Non-Small Cell Lung Cancer.

HER2-mutant Non-Small Cell Lung Cancer Emerging Drugs Chapters

This segment of the HER2-mutant 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.

HER2-mutant Non-Small Cell Lung Cancer Emerging Drugs

DZD-9008: Dizal Pharmaceuticals DZD9008 is a selective, irreversible EGFR inhibitor, which is currently being evaluated for the treatment of both EGFRexon20 insertion mutation-positive NSCLC and HER2-mutated NSCLC. In the open-label, multicenter phase I/II study (NCT03974022), 220 patients with EGFRexon20 insertion mutation-positive or HER2-positive NSCLC were treated with DZD9008 at doses of 50 mg to 400 mg once daily.

Enhertu: Astra ZenecaEnhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker. Enhertu (5.4mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial. Enhertu (6.4mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastro esophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01trial.

Pyrotinib: Jiangsu Hengrui Medicine Pyrotinib is a novel irreversible and selective EGFR/HER2 tyrosine kinase inhibitor developed by Hengrui. In 2018, pyrotinib was approved in China in combination with capecitabine for the treatment of relapsed or metastatic HER2-positive breast cancer. Currently, two Phase III studies are ongoing to evaluate pyrotinib as 1st-line treatment (NCT03863223) and extended adjuvant treatment (NCT03980054), respectively in HER2-positive breast cancer patients. In addition to breast cancer, pyrotinib demonstrated superior clinical benefits in advanced non-small cell lung cancer (NSCLC) with HER2 exon 20 mutation in a Phase II study. A global Phase III study (NCT04447118) is ongoing to investigate pyrotinib in patients with advanced non-squamous NSCLC with HER2 exon 20 mutation who previously failed platinum-basedchemotherapy.

HER2-mutant Non-Small Cell Lung Cancer: Therapeutic Assessment

This segment of the report provides insights about the different HER2-mutant Non-Small Cell Lung Cancer drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in HER2-mutant Non-Small Cell Lung Cancer

There are approx. 5+ key companies which are developing the therapies for HER2-mutant Non-Small Cell Lung Cancer. The companies which have their HER2-mutant Non-Small Cell Lung Cancer drug candidates in the most advanced stage, i.e. Preregistration include, AstraZeneca.

Phases

This report covers around 5+ 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

HER2-mutant 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
• Ophthalmic
• 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.

HER2-mutant 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 HER2-mutant 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 HER2-mutant Non-Small Cell Lung Cancer drugs.

HER2-mutant Non-Small Cell Lung Cancer Report Insights

• HER2-mutant Non-Small Cell Lung Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

HER2-mutant 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 HER2-mutant Non-Small Cell Lung Cancer drugs?
• How many HER2-mutant 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 HER2-mutant Non-Small Cell Lung Cancer?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the HER2-mutant 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 HER2-mutant Non-Small Cell Lung Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Dizal Pharmaceuticals
• Puma Biotechnology
• AstraZeneca
• Jiangsu Hengrui Medicine
• Spectrum Pharmaceuticals, Inc.

Key Products

• DZD-9008
• Neratinib
• Enhertu
• Pyrotinib
• Poziotinib