HER2-mutant non-small cell lung cancer (NSCLC) is an area of significant unmet medical need, spurring intense research and development efforts. Several companies are currently engaged in developing innovative therapies targeting this specific subset of lung cancer, with multiple drugs in various stages of clinical trials.
Current Pipeline Landscape
DelveInsight's "HER2-mutant Non-Small Cell Lung Cancer Pipeline Insight 2024" report highlights a dynamic landscape with over five companies actively pursuing more than five pipeline therapies. These therapies encompass a range of approaches, including targeted small molecules and antibody-drug conjugates (ADCs).
Key Players and Emerging Therapies
AstraZeneca is evaluating Trastuzumab deruxtecan (Enhertu), a HER2-directed ADC, in the DESTINY-Lung05 trial (Phase 2) for patients with HER2-mutant metastatic NSCLC who have progressed on prior therapies. Enhertu has shown promise in other HER2-positive cancers, leveraging Daiichi Sankyo's DXd ADC technology, which links a HER2 monoclonal antibody to a topoisomerase I inhibitor.
Dizal Pharmaceuticals is developing DZD-9008, a selective, irreversible EGFR inhibitor, currently in Phase I/II trials. This oral agent is being assessed for its efficacy in NSCLC patients harboring EGFR exon 20 insertion mutations or HER2 mutations. Initial data from the NCT03974022 study, involving 220 patients, are anticipated to provide insights into its clinical potential.
Jiangsu Hengrui Medicine is investigating Pyrotinib, an irreversible EGFR/HER2 tyrosine kinase inhibitor. Already approved in China for HER2-positive breast cancer, Pyrotinib is now under evaluation in a global Phase III study (NCT04447118) for advanced non-squamous NSCLC with HER2 exon 20 mutations, specifically in patients who have failed platinum-based chemotherapy.
Puma Biotechnology is studying Poziotinib in a Phase II trial at M.D. Anderson Cancer Center for NSCLC patients with EGFR or HER2 exon 20 mutations. Poziotinib aims to inhibit tumor growth by blocking enzymes essential for cell proliferation.
Clinical Trial Focus
These clinical trials are designed to assess the safety and efficacy of novel treatments, with endpoints including progression-free survival, overall survival, and objective response rates. The trials often include patients with advanced or metastatic disease who have limited treatment options, reflecting the unmet need in this area.
Route of Administration and Molecule Types
The pipeline includes diverse routes of administration, such as oral, intravenous, and subcutaneous, catering to different patient needs and preferences. The molecule types range from small molecules to peptides and oligonucleotides, reflecting the breadth of scientific approaches being explored.
