Celldex Advances Barzolvolimab Phase 3 Program in Chronic Urticaria with Strong Pipeline Progress
• Celldex Therapeutics reports significant progress in Phase 3 trials of barzolvolimab for chronic spontaneous urticaria (CSU), with active enrollment ongoing across 40 countries and 500 sites.
• The company's Phase 2 CSU study demonstrated unprecedented efficacy with 71% of patients achieving complete response at Week 52, setting a new standard in disease treatment.
• Celldex expands its portfolio by initiating Phase 2 trials in atopic dermatitis and launching CDX-622, their first bispecific antibody targeting inflammatory diseases.
FDA Approves Takeda's Exkivity as First Oral Therapy for EGFR Exon20 NSCLC
• Takeda's Exkivity (mobocertinib) receives FDA approval as the first oral therapy specifically designed for NSCLC patients with EGFR exon20 insertion mutations after chemotherapy.
• Clinical trials demonstrated Exkivity's efficacy with 28% tumor shrinkage rate and median progression-free survival of seven months in treated patients.
• The approval strengthens Takeda's Wave1 pipeline portfolio, with the drug projected to reach $600 million in peak sales pending potential first-line treatment approval.
FDA Approves Voranigo: First Targeted Therapy for IDH-Mutant Glioma Brain Cancer
• The FDA has approved Voranigo, marking a historic breakthrough as the first targeted therapy for grade 2 IDH-mutant glioma, offering new hope for brain cancer patients.
• Clinical trials demonstrated that Voranigo, an oral medication, significantly delays the need for aggressive interventions like radiation, surgery, and chemotherapy in glioma patients.
• This breakthrough treatment particularly benefits younger patients in their 30s and 40s who are diagnosed with this incurable brain tumor while in the prime of their lives.
TiNivo-2 Trial Highlights Challenges in ICI Retreatment for Advanced RCC
The phase 3 TiNivo-2 trial reveals that combining tivozanib with nivolumab does not improve clinical outcomes over tivozanib monotherapy in advanced renal cell carcinoma patients previously treated with immune checkpoint inhibitors, underscoring the challenges of ICI rechallenge.
Imlunestrant Shows Promise in Advanced ER+/HER2- Breast Cancer Treatment
• Imlunestrant monotherapy significantly improved progression-free survival (PFS) in advanced breast cancer patients with ESR1 mutations compared to standard endocrine therapy.
• The combination of imlunestrant and abemaciclib demonstrated a statistically significant improvement in PFS compared to imlunestrant alone, regardless of ESR1 mutation status.
• The EMBER-3 trial results suggest imlunestrant, particularly in combination with abemaciclib, could offer a new all-oral targeted therapy option for pre-treated advanced breast cancer.
• Safety data from the trial indicated that imlunestrant, both as a monotherapy and in combination, was generally well-tolerated, with manageable adverse events.
ADELA Phase III Trial Explores Elacestrant and Everolimus Combination for Advanced Breast Cancer
• The ADELA trial investigates elacestrant combined with everolimus for ER+/HER2- advanced breast cancer with ESR1 mutations, addressing endocrine therapy resistance.
• Presented at SABCS 2024, the study aims to improve outcomes for patients who have progressed after standard first-line treatments.
• The international, randomized, double-blind trial evaluates progression-free survival, overall survival, toxicity, and quality of life.
• MEDSIR's involvement highlights its commitment to personalized oncology and overcoming tumor resistance, potentially leading to regulatory approval.
DLL3-Targeted Therapies Show Promise in Neuroendocrine Prostate Cancer
• DLL3 is emerging as a promising therapeutic target for neuroendocrine prostate cancer due to its high expression in these aggressive tumors.
• Clinical trials of DLL3-targeted T-cell engagers, such as Tarlatamab and MK-6070, have demonstrated potential efficacy in treating neuroendocrine carcinomas.
• Patient selection and addressing tumor heterogeneity are critical factors in optimizing the use of DLL3-targeted therapies for prostate cancer.
• Combination therapies and co-targeting strategies may be necessary to address mixed tumor populations and improve treatment outcomes.
ZetaFuse Demonstrates Bone Fusion in Lung Cancer Patient with Degenerative Disc Disease
• ZetaFuse (Zeta-ZF-002) showed radiographic fusion at all three cervical levels in a Stage 4 lung cancer patient with multi-level degenerative disc disease (DDD).
• The patient, who had comorbidities and was undergoing chemotherapy, experienced bone healing exceeding expectations after ZetaFuse administration.
• ZetaFuse has received FDA Breakthrough Designation for spine fusion and shares a mechanism of action with Zetagen's oncology drug candidate, ZetaMet.
• The case study suggests potential for ZetaFuse in treating cancer patients with orthopedic fusion needs, where limited approved resources exist.
DLL3-Targeted Therapies Show Promise in Neuroendocrine Prostate Cancer
• Delta-like ligand 3 (DLL3) is emerging as a potential therapeutic target for aggressive neuroendocrine prostate cancer, which often develops resistance to standard treatments.
• Early clinical trials of DLL3-targeted T cell engagers, such as MK-6070, have demonstrated promising anti-tumor activity in patients with relapsed or refractory neuroendocrine prostate cancer.
• PET imaging with 89Zr-SC16 may help in detecting and quantifying DLL3 expression in tumors, potentially improving patient selection for DLL3-targeted therapies.
• While tarlatamab showed limited efficacy in a broad neuroendocrine prostate cancer cohort, ongoing research focuses on refining patient selection and exploring combination strategies to enhance treatment outcomes.
MRD Testing Evolution and Clinical Applications in Lymphoma Explored at SOHO 2024
• Next-generation sequencing and ctDNA assays have significantly advanced minimal residual disease (MRD) testing, enhancing sensitivity across lymphoma subtypes.
• Clinical trials are increasingly utilizing MRD status to guide lymphoma therapy, influencing treatment escalation, de-escalation, consolidation, and therapy initiation/cessation.
• Research is paving the way for personalized lymphoma treatments using ctDNA assays, which offer insights into tumor biology and may transform clinical decision-making.
Hoth Therapeutics' HT-001 Shows Promise in Treating EGFRI-Associated Skin Toxicities
• Hoth Therapeutics reports positive data from a human case study using HT-001 to treat EGFR inhibitor-associated papulopustular eruptions (PPEs).
• A metastatic breast cancer patient experienced rapid symptom improvement after one week of HT-001 treatment, leading to treatment cessation.
• The patient showed no new lesion development in the three weeks following treatment, suggesting HT-001's potential efficacy and safety.
• A Phase 2a clinical trial is underway to further evaluate HT-001's efficacy and safety in managing EGFRI-associated skin toxicities.
NH TherAguix's AGuIX Brain Metastases Trial Advances Following DSMB Validation
• NH TherAguix received DSMB validation to continue its Phase II NANOBRAINMETS trial evaluating AGuIX for brain metastases treatment.
• The trial assesses AGuIX plus stereotactic radiotherapy versus stereotactic radiotherapy alone, showing a favorable safety profile.
• To date, 96 of the planned 134 patients have been randomized, with an interim efficacy analysis expected by year-end.
• Final Phase II results are anticipated in Q2-Q3 2026, crucial for AGuIX's clinical development and potential commercial approval.
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