AMG-193
- Generic Name
- AMG-193
Amgen Reports Strong Global Demand in Q1 2025, Bolstering Long-Term Growth Outlook
• Amgen announced positive first quarter 2025 financial results, citing strong global demand across its product portfolio and successful new product launches.
• Chairman and CEO Bob Bradway expressed confidence in Amgen's long-term growth prospects, supported by recent successful Phase 3 clinical trial results for several products.
• The biotechnology company, which employs over 28,000 people globally, continues to focus on its mission of harnessing biology and technology to combat serious diseases.
Bayer Secures Global License for Novel PRMT5 Inhibitor Targeting MTAP-Deleted Tumors
• Bayer has entered into a global licensing agreement with Chinese biotech Puhe BioPharma for an oral PRMT5 inhibitor (BAY 3713372) that selectively targets MTAP-deleted tumors, which occur in 10-30% of all cancers.
• The compound demonstrates brain penetration capabilities, potentially addressing difficult-to-treat cancers with poor prognosis such as pancreatic cancer and glioblastoma, where treatment options remain limited.
• Bayer has already initiated a Phase I dose escalation trial for BAY 3713372, joining competitors AstraZeneca, Bristol Myers Squibb, and Amgen in the race to develop effective PRMT5 inhibitors for MTAP-deleted tumors.
Amgen and Ideaya Terminate Cancer Combination Trial for PRMT5 and MAT2A Inhibitors
• Amgen and Ideaya Biosciences have mutually agreed to discontinue their clinical collaboration testing the combination of AMG 193 and IDE397 for solid tumors.
• Ideaya will pivot to studying IDE397 in combination with its own PRMT5 inhibitor IDE892 for non-small cell lung cancer treatment.
• Amgen continues development of AMG 193 monotherapy, which showed 21.4% objective response rate across multiple tumor types, and has initiated Phase II trials in NSCLC.
IDEAYA Biosciences Reports Strong Pipeline Progress and $1.1B Cash Position for 2024
• IDEAYA Biosciences advances multiple oncology programs, with over 230 patients enrolled in potential registration-enabling trial for darovasertib in metastatic uveal melanoma, targeting key readouts by end of 2025.
• Company strengthens its position with approximately $1.1 billion cash reserve as of December 2024, expected to fund operations into at least 2028.
• Pipeline expansion includes progress on DLL3 TOP1i ADC IDE849 showing 73% response rate in early SCLC data, and advancement of three new candidates targeting solid tumors.
Pipeline Analysis Reveals 75+ Drug Candidates in Development for Advanced Cervical Cancer Treatment
• DelveInsight's comprehensive analysis identifies over 70 pharmaceutical companies actively developing 75+ pipeline drugs for advanced cervical cancer treatment.
• AstraZeneca's Imfinzi (durvalumab) leads late-stage developments, currently in Phase III trials for locally advanced cervical cancer, building on its success in lung cancer treatment.
• Key clinical trials include promising immunotherapy combinations, with Merck's pembrolizumab plus chemoradiotherapy and AstraZeneca's volrustomig studies scheduled for significant developments in 2025.
IDEAYA Biosciences Navigates Oncology Landscape with Precision Medicine Approach
• IDEAYA Biosciences focuses on precision medicine in oncology, leveraging molecular diagnostics to develop targeted therapies for specific patient populations.
• The company's pipeline includes candidates like darovasertib (IDE196) and IDE397 (MAT2A), with darovasertib currently in Phase 2/3 trials.
• IDEAYA has collaborations with major pharmaceutical companies like GSK and Pfizer, enhancing research capabilities and providing financial support.
• As of September 30, 2024, IDEAYA reported cash reserves of $1.2 billion, supporting ongoing clinical development and operational activities.
IDEAYA Biosciences, Inc. (IDYA) BCG Matrix Analysis 2024
IDEAYA Biosciences, Inc. (IDYA) is analyzed through the Boston Consulting Group Matrix, revealing its strategic positioning in 2024. With a strong pipeline in precision oncology and significant cash reserves, IDEAYA faces challenges including an accumulated deficit and reliance on external financing. The analysis covers the company's Stars, Cash Cows, Dogs, and Question Marks, highlighting its future potential and current challenges.
ESMO 2024: Novel Therapies Show Promise in Bladder, Lung, Kidney, and Gastric Cancers
• Circulating tumor DNA (ctDNA) clearance may predict favorable outcomes in cisplatin-ineligible bladder cancer patients treated with durvalumab, tremelimumab, and enfortumab vedotin.
• AMG 193, a PRMT5 inhibitor, demonstrated antitumor activity in MTAP-deleted advanced solid tumors, including lung and pancreatic cancers, with a manageable safety profile.
• Ipilimumab plus nivolumab significantly improved overall survival in non-clear cell renal cell carcinoma, particularly in patients with PD-L1 expression.
• T-DXd combinations show efficacy in HER2-positive gastric cancers, with a reduced-dose triplet regimen of T-DXd, fluoropyrimidine, and pembrolizumab being further evaluated.
IDEAYA Biosciences Advances Precision Medicine Pipeline with Multiple Clinical Programs
• IDEAYA Biosciences reports positive progress in multiple clinical programs, including darovasertib for uveal melanoma and IDE397 for MTAP-deletion cancers.
• The company is targeting the initiation of a Phase 3 registration-enabling trial for darovasertib in neoadjuvant uveal melanoma in the first half of 2025.
• IDE397 demonstrates confirmed objective response rates (ORR) of 40% in urothelial cancer and 38% in squamous non-small cell lung cancer.
• IDEAYA is expanding clinical trials for IDE397 in combination with AMG 193 and Trodelvy, and for IDE161 with Keytruda in endometrial cancer.
Ideaya's IDE397 Shows Promise in MTAP-Deletion Cancers
• Ideaya Biosciences reports positive Phase 1 data for IDE397, a MAT2A inhibitor, in urothelial and non-small cell lung cancer patients with MTAP-deletion.
• The study showed a ~33% overall response rate and a ~93% disease control rate in heavily pre-treated patients at the 30mg once-daily dose.
• IDE397 demonstrated a manageable safety profile with no drug-related serious adverse events or discontinuations at the expansion dose.
• The company plans to advance IDE397 in combination with Trodelvy in urothelial cancer, with expansion targeted for Q4 2024.
Amgen Presents Early-Stage Clinical Trial Data at ESMO 2024, Showcasing Oncology Pipeline
• Amgen is presenting data from early-stage trials at ESMO 2024, highlighting targeted therapies for various cancers, including colorectal, lung, prostate, and gastric, showcasing the breadth of their oncology pipeline.
• The CodeBreaK 101 study reveals initial findings of LUMAKRAS combined with Vectibix and FOLFIRI as a first-line treatment for KRAS G12C-mutated metastatic colorectal cancer.
• First-in-human study results of xaluritamig in metastatic castration-resistant prostate cancer are being presented, alongside Phase 1 data for AMG 193 in MTAP-deleted solid tumors.
• Additional data includes long-term outcomes of sotorasib in pre-treated KRAS G12C-mutated advanced NSCLC and biomarker analysis for bemarituzumab in advanced gastric cancers.
Drug Development Updates
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