MedPath

Tagged News

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.

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.

First Immunotherapy Success in Prostate Cancer Shows Promise for DNA Repair-Deficient Tumors

Precision Medicine
  • A landmark clinical trial demonstrates that pembrolizumab immunotherapy provides survival benefits for a subset of men with advanced, otherwise untreatable prostate cancer.
  • Of 258 men treated with pembrolizumab, 38% remained alive after one year and 11% continued treatment without disease progression.
  • Men with DNA repair gene mutations in their tumors showed higher response rates, suggesting genetic testing could identify optimal candidates for immunotherapy.
  • Researchers are planning a new trial specifically targeting prostate cancer patients with DNA repair mutations to validate this precision medicine approach.

Landmark TAILORx Trial Shows 70% of Early-Stage Breast Cancer Patients Can Safely Skip Chemotherapy

Precision MedicineOncology
• The TAILORx trial, involving over 10,000 women, demonstrates that approximately 70% of patients with hormone-receptor positive, HER2-negative early breast cancer can safely avoid chemotherapy when guided by genetic testing. • Women over 50 with Oncotype DX recurrence scores of 0-25 showed no significant survival benefit from adding chemotherapy to hormone therapy alone. • The findings could spare an estimated 65,000 women annually in the US from chemotherapy's toxic side effects while maintaining excellent long-term outcomes. • This precision medicine approach represents the largest breast cancer trial to date and marks a paradigm shift toward personalized treatment strategies.

D3Bio's Novel KRAS-G12C Inhibitor Shows Promising Results in Phase 1 Cancer Trial

OncologyPrecision MedicineTargeted Therapy
  • A multinational study led by Chinese University researchers found that D3S-001, a mainland-developed KRAS-G12C inhibitor, demonstrated significant efficacy with over 70% of patients experiencing tumor shrinkage or disappearance.
  • The novel compound from D3Bio inhibits KRAS-G12C mutations at a faster rate and potentially longer duration than existing treatments, according to Dr. Herbert Loong from CUHK's Department of Clinical Oncology.
  • Researchers are planning phase 3 trials with the goal of positioning D3S-001 as a first-line treatment option for patients with KRAS-G12C-driven cancers of the lung, pancreas, and colon.
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy