ALK Positive Non-Small Cell Lung Cancer - Pipeline Insight, 2024

This “ALK Positive Non-Small Cell Lung Cancer- Pipeline Insight, 2024” report provides comprehensive insights about 6+ companies and 7+ pipeline drugs in ALK Positive 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

ALK Positive Non-Small Cell Lung Cancer: Understanding

ALK Positive Non-Small Cell Lung Cancer: Overview

Fusions of the echinoderm microtubule-associated protein-like 4 (EML4) gene and the anaplastic lymphoma kinase (ALK) gene were first identified as a likely molecular driver in patients with NSCLC. Anaplastic lymphoma kinase (ALK) gene rearrangements occur in a small portion of patients with non-small cell lung cancer (NSCLC). These gene rearrangements lead to constitutive activation of the ALK kinase and subsequent ALK driven tumor formation. Patients with tumors harboring such rearrangements are highly sensitive to ALK inhibitors such as crizotinib, ceritinib, and alectinib. About 90% of those diagnosed with ALK-positive cancer are diagnosed when the cancer has already spread to other parts of the body (known as metastatic cancer, or stage 4 cancer). Without any cancer treatment, half of patients with metastatic ALK cancer would die within less than 12 months, but with modern treatments that has that has increased more than six-fold, to over six years, in the last decade, and that median survival is continuing to increase as research discovers improved treatments and better medicines.

Lung cancer may not show symptoms until you’ve had it long enough for it to spread to other parts of the body. The symptoms associated with the lung cancer are coughing, worse chest pain with deep breathing or laughing, hoarseness, coughing up blood, weak or tired feeling, and wheezing.

Currently, ALK is diagnosed by genetic testing, known as molecular testing, of a sample. The National Comprehensive Cancer Center Network (NCCN) in the United States recommends that testing be performed via a broad, panel-based approach, typically by NGS. For patients who don’t have identifiable driver oncogenes by DNA NGS, consider RNA-based NGS to maximize detection of fusion events. To obtain a sample, it is necessary to undergo a biopsy, typically through a needle biopsy or a small surgical procedure.

Several organizations worked together to develop guidelines on who should be tested for an ALK mutation. The consensus was that all patients with advanced-stage adenocarcinoma should be tested for both ALK and EGFR mutations, regardless of gender, smoking history, other risk factors, and race. Patients diagnosed with lung cancer have to be proactive in requesting molecular testing for lung cancer mutations.

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

ALK Positive Non-Small Cell Lung Cancer Emerging Drugs Chapters

This segment of the ALK Positive 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.

ALK Positive Non-Small Cell Lung Cancer Emerging Drugs

• SY-3505: Shouyao Holdings

Ficonalkib (SY-3505) is a highly potent, adenosine triphosphate-competitive, CNS-penetrant, 3rd-gen ALK TKI. In vitro kinase assay revealed that ficonalkib exhibits potent inhibition against both wild-type ALK and a diverse spectrum of mutants observed in patients resistant to 1st- and 2nd-gen ALK TKI, including L1196M, G1202R, F1174L, G1269S, and R1275Q20. The drug exhibits high kinase selectivity and has very weak inhibition on tropomyosin receptor kinase (TRK). The drug is currently being evaluated under Phase III clinical trials for the treatment of NSCLC.

• APG-2449: Ascentage Pharma

APG-2449 is an orally available, small-molecule FAK/ALK/ROS1 TKI and the first China-developed third-generation ALK inhibitor entering clinical development. The updated results at the ASCO indicated favorable safety and promising antitumor activity in patients with NSCLC, and the preliminary efficacy observed in patients who were resistant to second-generation ALK inhibitors was particularly encouraging. APG-2449 is currently being evaluated in Phase I clinical trial for Non-Small Cell Lung Cancer.

ALK Positive Non-Small Cell Lung Cancer: Therapeutic Assessment

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

Major Players in ALK Positive Non-Small Cell Lung Cancer

There are approx. 6+ key companies which are developing the therapies for ALK Positive Non-Small Cell Lung Cancer. The companies which have their ALK Positive Non-Small Cell Lung Cancer drug candidates in the most advanced stage, i.e. Phase III include, Shouyao Holdings.

Phases

This report covers around 7+ 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

ALK Positive 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.

ALK Positive 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 ALK Positive 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 ALK Positive Non-Small Cell Lung Cancer drugs.

ALK Positive Non-Small Cell Lung Cancer Report Insights

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

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

Key Players

• Nuvalent
• Shouyao Holdings
• Xuanzhu Biopharmaceutical
• Fochon Pharmaceutical

Key Products

• NVL-655
• SY-3505
• XZP-3621
• SAF 189

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