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FDA to Convene Advisory Committee for Eli Lilly's Alzheimer's Drug Donanemab

Monoclonal AntibodyNeurologyPrecision Medicine
• The FDA has announced plans to convene a Peripheral and Central Nervous System Drugs Advisory Committee to review donanemab's efficacy and safety profile before making a final approval decision.
• Donanemab's TRAILBLAZER-ALZ 2 trial employed innovative biomarker strategies, using both Amyvid® and Tauvid™ PET scans to identify early-stage patients with confirmed amyloid plaques most likely to benefit from treatment.
• Experts view anti-amyloid therapies like donanemab as just the first line of defense, with approximately 75% of Alzheimer's drugs in development now exploring novel targets related to aging pathways including inflammation and vascular dysfunction.

Merck and Daiichi Sankyo Form $22 Billion Alliance for Three Novel Antibody-Drug Conjugates

OncologyTargeted TherapyPrecision Medicine
• Merck will pay Daiichi Sankyo $4 billion upfront plus $1.5 billion in continuation payments, with potential additional milestone payments reaching a total of $22 billion.
• The collaboration focuses on three investigational antibody-drug conjugates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd), and raludotatug deruxtecan (R-DXd), targeting multiple solid tumors.
• Patritumab deruxtecan has received Breakthrough Therapy Designation for EGFR-mutated non-small cell lung cancer, with a biologics license application planned by March 2024.

A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

NCT04707248Active, Not RecruitingPhase 1
Daiichi Sankyo
Posted 12/22/2020

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

NCT04619004Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 2/2/2021

Samuraciclib Shows Promise in Advanced Breast Cancer Patients After CDK4/6 Inhibitor Failure

OncologyTargeted TherapyPrecision Medicine
  • Phase I clinical trials demonstrate samuraciclib, a selective CDK7 inhibitor, has an acceptable safety profile with manageable gastrointestinal side effects and shows clinical activity in various advanced solid tumors.
  • In HR+/HER2- breast cancer patients who progressed on CDK4/6 inhibitors, the combination of samuraciclib with fulvestrant achieved a clinical benefit rate of 36% and median progression-free survival of 3.7 months.
  • Exploratory analysis revealed patients without TP53 mutations had significantly longer progression-free survival (7.4 months vs 1.8 months), suggesting TP53 status may serve as a potential biomarker for treatment response.

Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies

NCT03363893CompletedPhase 1
Carrick Therapeutics Limited
Posted 11/14/2017

Tagrisso Plus Savolitinib Shows Promising 49% Response Rate in EGFR-Mutated Lung Cancer with MET Resistance

Targeted TherapyOncologyPrecision Medicine
• Preliminary results from the SAVANNAH Phase II trial demonstrated that Tagrisso (osimertinib) plus savolitinib achieved a 49% objective response rate in EGFR-mutated NSCLC patients with high levels of MET overexpression who progressed on Tagrisso.
• MET was identified as the most common resistance biomarker in EGFR-mutated lung cancer, with 62% of patients screened showing MET overexpression and/or amplification after progression on Tagrisso.
• The combination therapy showed the highest response rate (52%) in patients with high MET levels who had not received prior chemotherapy, potentially offering a less toxic alternative to the current standard of chemotherapy after targeted therapy failure.

Cullinan Oncology and Taiho Pharmaceutical Forge $275M Strategic Collaboration for EGFR Inhibitor CLN-081/TAS6417

Targeted TherapyOncologyPrecision Medicine
  • Taiho Pharmaceutical will acquire Cullinan Pearl for $275 million upfront plus up to $130 million in regulatory milestones, gaining exclusive global rights to CLN-081/TAS6417 outside the U.S.
  • CLN-081/TAS6417 is an oral, irreversible EGFR inhibitor targeting exon 20 insertion mutations in non-small cell lung cancer, which affect approximately 2-3% of NSCLC patients globally.
  • The companies will jointly develop and co-commercialize the drug in the U.S. with equal profit sharing, while Taiho will commercialize in territories outside the U.S. and China.

Tempus Receives First FDA Clearance for AI-Based Atrial Fibrillation Risk Detection Algorithm

AIPrecision Medicine
  • Tempus received FDA 510(k) clearance for its Tempus ECG-AF device, marking the first FDA clearance for an atrial fibrillation indication in the cardiovascular machine learning-based notification software category.
  • The AI-based algorithm uses electrocardiogram data to help identify patients who may be at increased risk of atrial fibrillation and flutter.
  • This regulatory milestone represents a significant advancement in AI-enabled cardiovascular risk assessment and precision medicine applications.
  • The clearance positions Tempus to expand its AI capabilities beyond oncology into cardiovascular disease detection and prevention.

Amazon Invests $14.7 Million in Proteome Analysis Company Nautilus Biotechnology

Drug DiscoveryPrecision Medicine
  • Amazon disclosed a $14.7 million investment in Nautilus Biotechnology, a pre-revenue company developing proteome measurement technology for drug discovery and clinical diagnostics.
  • Nautilus has built a prototype device that aims to measure more than 95% of the human proteome, compared to current mass spectrometers that only capture a small percentage of proteins.
  • The investment represents Amazon's continued expansion into healthcare following its $753 million PillPack acquisition and development of Amazon Care telehealth services.
  • Nautilus expects its first revenue in 2022 and has partnered with Roche-owned Genentech to use its proteome analysis system for research applications.

FDA-Approved and Emerging Biomarkers Transform Immune Checkpoint Inhibitor Patient Selection

Precision Medicine
  • Three FDA-approved biomarkers—PD-L1, microsatellite instability/deficient mismatch repair (MSI/dMMR), and tumor mutational burden (TMB)—currently guide immune checkpoint inhibitor treatment decisions, though each has distinct limitations and variable predictive accuracy across cancer types.
  • Emerging gene signature biomarkers, including T cell-inflamed gene expression profiles and tumor immune dysfunction signatures, demonstrate superior predictive performance compared to single biomarkers and may better identify responders among immunologically cold tumors.
  • Combinational biomarker approaches, such as pairing gene expression profiles with TMB, show enhanced predictive value and could address the complex, multifactorial nature of immune checkpoint inhibitor response.
  • An integrated nucleic acid biomarker signature incorporating DNA and RNA markers from tumor microenvironment, neoantigenicity, and multipotency factors represents the future direction for more comprehensive and accurate patient selection.

Inavolisib Combination Significantly Improves Survival in PIK3CA-Mutant Advanced Breast Cancer

Precision Medicine
  • The phase 3 INAVO120 trial demonstrated that adding inavolisib to palbociclib and fulvestrant significantly improved overall survival in patients with PIK3CA-mutant, hormone receptor-positive, HER2-negative, endocrine-resistant advanced breast cancer.
  • This triple combination therapy represents a potential new treatment standard for this specific patient population with endocrine-resistant disease.
  • The findings highlight the importance of targeting PIK3CA mutations in hormone receptor-positive breast cancer patients who have developed resistance to endocrine therapy.

UK NHS PROGRESS Trial Shows 95% of Patients Carry Genetic Variants Affecting Drug Metabolism

Precision Medicine
  • The UK National Health Service's PROGRESS trial found that 95% of 500 patients tested carried genetic variants that directly influence how they metabolize common medications.
  • One in four patients had their prescriptions adjusted based on genetic test results, leading to safer and more effective treatments.
  • The trial demonstrates the clinical value of pharmacogenomic testing in improving prescribing precision and patient outcomes.

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