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Genor Biopharma Secures NMPA Approval for Lerociclib CDK4/6 Inhibitor in Advanced Breast Cancer

  • Genor Biopharma Holdings Ltd. received China National Medical Products Administration (NMPA) approval for Lerociclib (GB491), a novel CDK4/6 inhibitor for advanced breast cancer treatment.
  • The oral bioavailable drug targets hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer in adult patients.
  • Lerociclib will be used in combination with aromatase inhibitors as initial therapy or with fulvestrant following endocrine therapy progression.
  • The approval represents a significant milestone resulting from successful collaboration between Genor Biopharma and G1 Therapeutics Inc.

FDA Clears Phase 1b Trial for Novel Nectin-4 Targeted Radiopharmaceutical AKY-1189 Across Multiple Cancer Types

  • The FDA has cleared investigational new drug applications for Aktis Oncology's AKY-1189, a first-in-class Nectin-4 targeted radiopharmaceutical, enabling initiation of the NECTINIUM-2 Phase 1b trial.
  • The multicenter trial will evaluate AKY-1189 in approximately 150 patients with locally advanced or metastatic urothelial carcinoma, triple negative breast cancer, and other Nectin-4 expressing solid tumors.
  • Previous data demonstrated substantial tumor uptake across multiple cancer types with limited normal tissue exposure, suggesting a potentially wide therapeutic window for this precision oncology approach.

TTF-1 Biomarker Predicts Survival Outcomes for KRAS Inhibitor Sotorasib in Lung Cancer

  • MD Anderson researchers identified TTF-1 as a predictive biomarker for survival outcomes in advanced KRAS G12C-mutated non-small cell lung cancer patients treated with sotorasib.
  • Patients with high TTF-1 expression achieved significantly better outcomes with median progression-free survival of 8.1 months versus 2.8 months for low TTF-1 expression.
  • The study analyzed 429 patients from CodeBreaK clinical trials and found that rapid circulating tumor DNA clearance was linked to improved treatment response.
  • TTF-1 testing is already routinely performed in lung cancer diagnosis, providing physicians an immediate tool to personalize sotorasib treatment decisions.

ADC Market in NSCLC Projected to Reach $3.9 Billion by 2032, Led by AstraZeneca's Datroway

  • The antibody-drug conjugate (ADC) market in non-small-cell lung cancer is projected to grow at a 6.8% CAGR across seven major markets and exceed $3.9 billion by 2032.
  • AstraZeneca and Daiichi Sankyo's Datroway is expected to dominate the market with over 32.6% market share, generating more than $1.2 billion by 2032.
  • The ADC pipeline in NSCLC remains active with 29 ongoing Phase III trials, as companies increasingly focus on first-line and early disease settings.
  • Manufacturing capacity expansions by Lonza and AstraZeneca are underway to meet rising ADC demand, with facilities expected operational by 2028-2029.

Onco-Innovations Initiates Manufacturing of PNKP Inhibitor for Preclinical Testing

  • Onco-Innovations has partnered with Dalton Pharma Services to begin manufacturing 50 grams of their proprietary PNKP inhibitor A83B4C63 for preclinical testing.
  • The nanoparticle-formulated inhibitor previously demonstrated significant survival benefits in colorectal cancer models, extending median survival from 23 to 60 days in PTEN-deficient mice.
  • This manufacturing milestone represents a critical transition from early research to production scale-up, supporting the company's planned IND submission to the FDA this year.

Iran Becomes First Asian Country to Develop Electrochemotherapy Cancer Treatment Technology

  • Iran has successfully launched the first domestically-developed production line for electrochemotherapy (ECT) ablative devices, joining only Italy and the United Kingdom in producing this advanced cancer treatment technology.
  • The electrochemotherapy system uses electric pulses to increase cancer cell membrane permeability, significantly enhancing the effectiveness of anti-cancer drugs for targeted tumor treatment.
  • Over 1,000 patients have been treated with ECT technology, with more than 200 cases achieving successful outcomes that prevented the need for amputation procedures.
  • This achievement represents a major milestone for Iran's biotechnology sector and positions the country as a leader in advanced cancer treatment technologies within Asia.

Abbisko's FGFR4 Inhibitor Irpagratinib Receives China's Breakthrough Therapy Designation for Hepatocellular Carcinoma

  • Abbisko Therapeutics' irpagratinib (ABSK011) has received Breakthrough Therapy Designation from China's NMPA for treating hepatocellular carcinoma, marking the first precision-targeted therapy using molecularly defined biomarkers for this indication.
  • The highly selective FGFR4 inhibitor targets FGF19 overexpression, which affects approximately 30% of HCC patients worldwide and is associated with significantly worse prognosis.
  • Clinical data from the 2024 ESMO GI Congress showed irpagratinib combined with atezolizumab achieved a 50% objective response rate in FGF19-positive HCC patients previously treated with immune checkpoint inhibitors.
  • The designation will expedite regulatory approval processes, potentially making irpagratinib the first globally approved FGFR4 inhibitor for HCC treatment.

Nuvalent to Present First Clinical Data for Next-Generation ALK Inhibitor NVL-655 at AACR-NCI-EORTC Symposium

• Nuvalent will present preliminary dose-escalation data from the ALKOVE-1 Phase 1/2 trial of NVL-655, marking the first clinical disclosure for this next-generation ALK inhibitor. • NVL-655 is designed to overcome key limitations of existing ALK inhibitors, including resistance mutations, poor brain penetrance, and CNS adverse events. • The drug targets advanced ALK-positive non-small cell lung cancer and has been engineered to remain active against multiple resistance mutations including the challenging G1202R solvent front mutation. • The presentation will occur at the 35th AACR-NCI-EORTC Symposium in Boston on October 13, 2023, with a planned conference call the same day.

Pfizer's BRAFTOVI Combination Therapy Halves Death Risk in BRAF-Mutant Metastatic Colorectal Cancer

  • Pfizer announced that its BRAFTOVI® combination regimen demonstrated a 50% reduction in death risk for patients with BRAF V600E-mutant metastatic colorectal cancer.
  • The targeted therapy represents a major advance in treating this specific genetic subtype of colorectal cancer.
  • This breakthrough could significantly improve survival outcomes for patients harboring the BRAF V600E mutation in metastatic disease.

Enhanced Premedication Protocol Reduces Infusion Reactions in NSCLC Patients Receiving Amivantamab

  • The SKIPPirr trial demonstrated that an enhanced premedication protocol significantly reduced infusion-related reactions (IRRs) for amivantamab from 67% to 22.5% in NSCLC patients.
  • The protocol includes dexamethasone 8 mg twice daily for two days prior to infusion plus standard premedications with diphenhydramine and acetaminophen.
  • Current NSCLC management faces critical gaps including optimal approaches for early-stage disease, tumor heterogeneity challenges, and understanding immunotherapy nonresponse mechanisms.
  • Institutional hypersensitivity guidelines are recommended for common NSCLC treatments including platinum agents, taxanes, monoclonal antibodies, and immunotherapy agents.
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