Zongertinib
- Generic Name
- Zongertinib
Boehringer Ingelheim Launches Phase II Trial of First-in-Class Oral Treatment for Geographic Atrophy
• Boehringer Ingelheim has initiated the JADE Phase II clinical study to evaluate BI 1584862, a potential first-in-class oral treatment for geographic atrophy, a severe form of age-related macular degeneration.
• Geographic atrophy affects over 5 million people worldwide with more than 40% considered legally blind, creating a significant unmet need for treatments that can slow disease progression and preserve vision.
• The company is simultaneously advancing a second compound, BI 771716, an antibody fragment designed to penetrate retinal layers, demonstrating Boehringer's dual-pathway approach to addressing this debilitating eye condition.
AACR Annual Meeting 2025 to Bridge Gap Between Cancer Science and Clinical Practice
• The American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago will focus on "Unifying Cancer Science and Medicine" with presentations spanning from basic research to practice-changing clinical trials.
• Program chairs Dr. Lillian Siu and Dr. Matthew Vander Heiden emphasize cross-disciplinary collaboration, encouraging attendees to explore topics outside their expertise to foster innovation in cancer research.
• Key clinical trials to be presented include promising data on zongertinib for HER2-mutant lung cancer, dostarlimab for rectal cancer, and an off-the-shelf CAR NK cell therapy for hematologic malignancies.
Boehringer Ingelheim and Tessellate Bio Form €500M Partnership to Target ALT-Positive Cancers
• Boehringer Ingelheim has secured global commercialization rights for treatments co-developed with Tessellate Bio targeting tumors dependent on alternative lengthening of telomeres (ALT), present in 10-15% of all cancers.
• The partnership, valued at over €500 million, aims to develop first-in-class oral precision therapies using synthetic lethality approaches for hard-to-treat cancers with poor prognosis and limited treatment options.
• Tessellate Bio has developed inhibitors of an undisclosed target essential for ALT-positive cancer cell growth, which induce DNA damage and cell death specifically in cancer cells while sparing healthy tissue.
Boehringer Ingelheim Prepares for Multiple New Product Launches in 2025 Following Strong R&D Investment
• Boehringer Ingelheim reached 66 million patients in 2024, an 8% increase from the previous year, while investing €6.2 billion (23.2% of net sales) in research and development.
• The company is preparing to launch zongertinib, potentially the first oral targeted therapy for HER2-mutated lung cancer, and nerandomilast for pulmonary fibrosis, with both anticipated for US release in late 2025.
• Human Pharma sales rose 7% to €21.9 billion, led by JARDIANCE® and OFEV®, with over ten new Phase II and III trials planned in the next 12-18 months.
Daiichi Sankyo and Alteogen Partner on $300M Deal to Develop Subcutaneous Enhertu
• Daiichi Sankyo has entered a $300 million partnership with Alteogen to develop a subcutaneous formulation of the cancer drug Enhertu, potentially making it the first injectable ADC.
• The collaboration leverages Alteogen's Hybrozyme platform with ALT-B4 enzyme technology, receiving $20 million upfront with $280 million in potential milestone payments.
• Enhertu's strong market performance, with $1.77 billion in sales during H1, could be further enhanced by this development, helping maintain its competitive edge against emerging oral therapies.
FDA Grants Priority Review to Boehringer's Zongertinib for HER2-Mutant Advanced Lung Cancer
• Boehringer Ingelheim's zongertinib could become the first oral targeted therapy for previously treated HER2-mutant advanced non-small cell lung cancer, with FDA decision expected in Q3 2025.
• Phase Ib trial demonstrated impressive 71% objective response rate in 75 previously treated NSCLC patients, with favorable safety profile and low treatment discontinuation rate.
• The drug addresses a significant unmet need in HER2-mutant NSCLC patients, who currently face poor prognosis with limited treatment options and less than 30% five-year survival rate.
Nuvalent's Lung Cancer Drug Shows Promise Amid Risks
Nuvalent, Inc., a clinical-stage biotechnology company, is making significant strides in the development of brain-penetrant tyrosine kinase inhibitors for non-small cell lung cancer (NSCLC). With promising early-stage clinical trial results for its lead candidates, zidesamtinib and NVL-655, and a strong financial foundation, Nuvalent is poised for potential commercialization. However, the company faces challenges in a competitive NSCLC treatment market and risks associated with clinical trial setbacks.
Zongertinib Shows Promising Efficacy and Tolerability in HER2-Mutant NSCLC
• Zongertinib demonstrates a 71% confirmed objective response rate in pretreated advanced HER2-mutant NSCLC patients.
• The treatment exhibits a favorable safety profile with mostly mild, manageable adverse events and low rates of dose reduction.
• A 6-month progression-free survival rate of 69% and a 73% duration of response were observed, indicating durable efficacy.
• Ongoing phase 3 trial is evaluating zongertinib as a first-line treatment for HER2-mutant advanced NSCLC.
FDA Approves SpringWorks' Gomekli (Mirdametinib) for Neurofibromatosis Type 1
• The FDA has approved Gomekli (mirdametinib) for both adult and pediatric patients with Neurofibromatosis Type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.
• Approval was based on Phase 2b ReNeu trial data, demonstrating a 41% ORR in adults and 52% in children, alongside deep and durable tumor volume reductions and manageable safety profiles.
• Gomekli is the first and only medicine approved for both adults and children with NF1-PN, addressing a significant unmet need, particularly for adult patients who previously lacked approved treatments.
• SpringWorks received a rare pediatric disease priority review voucher from the FDA, potentially expediting the review of future drug candidates.
WCLC 2024: Novel Therapies and Biomarkers Advance Lung Cancer Treatment
• Perioperative nivolumab demonstrates superior event-free survival compared to neoadjuvant nivolumab in resectable NSCLC, showing benefit even in PD-L1 negative cases.
• Amivantamab plus lazertinib shows improved overall survival versus osimertinib in first-line EGFR-mutated advanced NSCLC, with a favorable trend in intracranial progression-free survival.
• Ivonescimab significantly prolongs progression-free survival compared to pembrolizumab as first-line treatment for PD-L1-positive advanced NSCLC in a Chinese patient cohort.
• Zongertinib demonstrates a high objective response rate in HER2-mutated NSCLC, paving the way for combination regimens with ADCs or use as second-line therapy.
Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025
• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.
• EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration.
• Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option.
• Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.
Robust Clinical Trial Pipeline Fuels Hope for Renal and Breast Cancer Advances
• The renal cancer clinical trial pipeline is robust, with over 70 companies developing more than 75 therapies, including novel immunotherapies and targeted agents.
• Breast cancer research is also thriving, with over 100 companies exploring 120+ new drugs, such as antibody-drug conjugates and PARP inhibitors, in clinical trials.
• Recent FDA actions, including Fast Track and Breakthrough Therapy designations, highlight the potential of emerging therapies for both renal and breast cancer.
• Advances in diagnostics, such as PET imaging agents for clear cell renal cell carcinoma, are also contributing to improved management of these diseases.
Zongertinib Shows Promise in HER2-Mutated NSCLC: Boehringer Ingelheim Reports Positive Phase Ib Results
• Boehringer Ingelheim's zongertinib demonstrated a 66.7% objective response rate in HER2-mutated NSCLC patients previously treated, showcasing potential efficacy.
• The Beamion LUNG-1 trial indicated that zongertinib is well-tolerated, with tumor shrinkage observed in a significant portion of patients across tested doses.
• Zongertinib may offer activity against brain metastases, addressing a critical unmet need in non-small cell lung cancer treatment, according to initial data.
• The 120mg dose of zongertinib was selected for further evaluation after an interim analysis, aiming to optimize efficacy and safety in future trials.
Zongertinib Shows Promise in HER2-Mutated NSCLC, Phase 3 Trial Underway
• Zongertinib demonstrates significant activity in pretreated NSCLC patients with HER2 mutations, including those with brain metastases, showing a promising objective response rate.
• The novel HER2-specific TKI, zongertinib, selectively binds to the HER2 tyrosine kinase domain, sparing EGFR, potentially reducing EGFR-mediated toxicities.
• Clinical trial data from the Beamion LUNG-1 study reveals a manageable safety profile for zongertinib, with low rates of high-grade adverse events and no reported cases of ILD or pneumonitis.
• A phase 3 confirmatory study, Beamion LUNG-2, is currently enrolling patients to compare zongertinib with standard of care as a first-line treatment for advanced HER2-mutant NSCLC.
Novel Therapies and Treatment Strategies Highlighted for Non-Small Cell Lung Cancer at WCLC 2024
• Perioperative durvalumab plus chemotherapy demonstrates improved event-free survival and pathological complete response in resectable NSCLC, establishing a new standard of care.
• BAY 2927088, an oral tyrosine kinase inhibitor, shows a 72.1% objective response rate in pretreated patients with advanced HER2-mutant NSCLC.
• Firmonertinib, a brain-penetrant EGFR inhibitor, exhibits an 81.9% overall response rate in NSCLC patients with EGFR PACC mutations, including those with brain metastases.
Boehringer Ingelheim Plans 25 New Treatments by 2030, Bolstered by Oncology and Metabolic Disease Programs
• Boehringer Ingelheim aims to launch 25 new treatments by 2030, focusing on oncology, mental health, cardiovascular, renal, and metabolic diseases.
• Key candidates include Brigimadlin, an MDM2-p53 agonist for dedifferentiated liposarcoma, and zongertinib, a HER2 tyrosine kinase inhibitor, showing promising early data.
• Survodutide, a glucagon/GLP-1 candidate, demonstrated significant improvement in liver disease due to metabolic dysfunction-associated steatohepatitis in Phase II trials.
• Despite slow sales of its Humira biosimilar, Cyltezo, Boehringer reported a 9.7% net sales increase in 2023, driven by Jardiance and Ofev.
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