BAY-2927088
- Generic Name
- BAY-2927088
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.
BAY 2927088 Shows Promise in HER2-Mutant NSCLC with High Response Rates in Phase I/II Trial
• New oral HER2-targeted tyrosine kinase inhibitor BAY 2927088 demonstrates significant efficacy in treating previously treated HER2-mutant non-small cell lung cancer patients.
• The SOHO-01 Phase I/II trial reveals promising response rates and sustained disease control, marking a potential advancement in targeted therapy for NSCLC.
• Initial safety data indicates a manageable adverse event profile, suggesting BAY 2927088 could be a well-tolerated treatment option for this patient population.
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.
Bayer Advances Pharma Pipeline with Regulatory Filings and Clinical Milestones
• Bayer is preparing regulatory submissions for darolutamide for prostate cancer and finerenone for heart failure, building on their market leadership.
• Elinzanetant met all endpoints in a Phase III trial (OASIS 4) for vasomotor symptoms caused by breast cancer treatments, marking a significant milestone.
• Bemdaneprocel, a stem cell-based therapy for Parkinson's disease, will advance directly to Phase III clinical development after promising Phase I data.
Bayer's BAY 2927088 Advances to Phase 3 Trial for HER2-Mutated NSCLC
• Bayer has initiated a Phase 3 trial (SOHO-02) for BAY 2927088 as a first-line treatment for HER2-mutated non-small cell lung cancer (NSCLC).
• The trial will compare BAY 2927088 to pembrolizumab with chemotherapy, the current standard of care for this specific type of lung cancer.
• BAY 2927088, an oral drug inhibiting both HER2 and EGFR, has received breakthrough therapy designations in the US and China as a second-line treatment.
• Bayer is also due to present results from the phase 1/2 SOHO-01 study of BAY 2927088 as a second-line therapy for HER2-altered NSCLC at the World Conference on Lung Cancer (WCLC).
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.
Bayer's BAY 2927088 Shows Promise in HER2-Mutant NSCLC
• Bayer's BAY 2927088 demonstrated a 72.1% objective response rate in HER2-mutant NSCLC patients in an early to mid-stage study.
• Patients with HER2 YVMA insertions showed a 90% ORR, with a median duration of response of 9.7 months and PFS of 9.9 months.
• The Phase I/II SOHO-01 study indicates a manageable safety profile for BAY 2927088, supporting further investigation in advanced NSCLC.
• Bayer has initiated a Phase III study (SOHO-02) to evaluate BAY 2927088 as a first-line therapy for advanced HER2-mutant NSCLC.
BAY 2927088 Demonstrates Promising Activity in HER2-Mutant NSCLC
• BAY 2927088, a novel oral TKI, showed a 72.1% objective response rate in pretreated HER2-mutant NSCLC patients in the SOHO-01 trial.
• The disease control rate with BAY 2927088 was 83.7%, with a median duration of response of 8.7 months and progression-free survival of 7.5 months.
• A subgroup analysis revealed a 90% objective response rate in patients with YVMA insertion mutations, a common and difficult-to-treat HER2 mutation.
• The most common treatment-related adverse event was diarrhea, with a low discontinuation rate of 6.8% observed in the study cohort.
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.
IL-21 Enhanced NK Cells Show Promise in Glioblastoma; Pembrolizumab Trials Halted
• IL-21-modified natural killer (NK) cells demonstrated superior safety and long-term tumor control compared to IL-15 NK cells in targeting glioblastoma (GBM).
• Merck's phase 3 trials of pembrolizumab combined with stereotactic body radiotherapy (SBRT) were halted due to lack of improvement in event-free or overall survival.
• NXP800 received FDA orphan drug designation for ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers, showing antitumor effects.
• A phase 3 trial has begun evaluating BAY 2927088, a HER2-mutant-selective TKI, versus standard of care for advanced NSCLC with activating HER2 mutations.
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