Intermountain Health Pioneers First Remote CAR-T Cell Collection Site in Southern Utah
Intermountain Health has established the nation's first remote CAR-T cell collection site at St. George Regional Hospital, bringing advanced cancer treatment closer to patients in Southern Utah and Nevada.
Colorectal Cancer Leads in Real-World Data Volume, But Oncology Trials Need Modernization
Phesi's analysis of 167 million patient records reveals colorectal cancer has the largest volume of real-world data with nearly six million records, outpacing breast, lung, liver, and prostate cancers.
FDA Grants Orphan Drug Designation to LBL-034 for Multiple Myeloma
The FDA has granted orphan drug designation to LBL-034 for treating multiple myeloma, a rare and life-threatening cancer.
Moderna's Combo COVID-19 and Flu Vaccine Shows Promising Results in Early Trial
Moderna announced positive data from an early-stage study of its mRNA-based combination vaccine for COVID-19 and influenza, showing similar or stronger immune responses compared to standalone vaccines in older adults.
Lorlatinib Shows Promising Efficacy in ALK-Rearranged NSCLC with 21.8 Month Median PFS
A real-world study of lorlatinib in ALK-rearranged non-small cell lung cancer demonstrated a median progression-free survival of 21.8 months, significantly higher than in previous trials.
KYV-101 Receives Orphan Drug Status in Europe for Myasthenia Gravis
KYV-101, an experimental cell therapy, has been granted orphan drug status by the European Medicines Agency for the treatment of myasthenia gravis (MG).
Trastuzumab Deruxtecan Shows Promise in HER2-Mutated NSCLC
Trastuzumab deruxtecan (T-DXd) has demonstrated efficacy in patients with previously treated HER2-mutated non-small cell lung cancer (NSCLC).
Elicera's iTANK-Armed CAR T-Cell Therapy Shows Complete Response in Lymphoma Patients
Elicera Therapeutics reports that two out of three patients in the first cohort of the CARMA study achieved complete metabolic response with ELC-301, an iTANK-armed CD20-targeting CAR T-cell therapy.
Zanidatamab Plus Chemotherapy Shows Promising Results in Heavily Pretreated HER2-Positive Breast Cancer
Zanidatamab, a novel HER2-targeted bispecific antibody, demonstrated a 36.4% objective response rate and 86.4% disease control rate when combined with chemotherapy in heavily pretreated HER2-positive breast cancer patients.
Oncolytic Virus Plus Nivolumab Shows Promise in Muscle-Invasive Bladder Cancer
A phase 1b trial investigated the combination of an oncolytic virus and nivolumab in patients with muscle-invasive bladder cancer.
Cilta-Cel Shows Promise in Earlier Multiple Myeloma Treatment Lines
Cilta-cel demonstrates significant survival benefits in multiple myeloma patients, even in late and early relapse scenarios.
Sanofi's Amlitelimab Shows Promising Results in Atopic Dermatitis Trial Following $1.45bn Kymab Acquisition
Sanofi's amlitelimab (formerly KY1005), acquired through its $1.45 billion Kymab purchase, demonstrated significant efficacy in a Phase 2a trial for moderate to severe atopic dermatitis with an 80% improvement in EASI scores at the low dose.
Parkinson's Disease Research Focuses on Disease-Modifying Therapies
Clinical research in the seven major markets (7MM) for Parkinson's disease (PD) is heavily focused on disease-modifying therapies (DMTs) to address unmet needs.
CDK4/6 Inhibitors Maintain Key Role in ER+/HER2- Breast Cancer Treatment Strategies
The PARSIFAL trial indicated no significant efficacy difference between palbociclib combined with fulvestrant versus letrozole, suggesting current practices of using CDK4/6 inhibitors with aromatase inhibitors remain valid.
Federal Circuit Upholds Pfizer's Victory in Gene Therapy Patent Dispute for Hemophilia Treatment
The Federal Circuit has affirmed the Patent Trial and Appeal Board's decision invalidating two patents covering experimental gene therapy for hemophilia treatment, handing Pfizer a significant legal victory.
E7386 Shows Promising Results in Advanced Endometrial Cancer Trial with 30% Response Rate
Eisai's Phase Ib trial of E7386 in combination with lenvatinib demonstrated a 30% overall response rate in advanced endometrial cancer patients who progressed after platinum-based chemotherapy and immunotherapy.
Dapirolizumab Pegol Shows Promise in Phase 3 Trial for Systemic Lupus Erythematosus
Dapirolizumab pegol (DZP) met its primary endpoint in the Phase 3 PHOENYCS GO trial, demonstrating statistically significant improvement in systemic lupus erythematosus (SLE) disease activity.
Johnson & Johnson Seeks Approval for Darzalex Faspro in High-Risk Smoldering Multiple Myeloma
Johnson & Johnson has submitted applications to the FDA and EMA for Darzalex Faspro to treat high-risk smoldering multiple myeloma.
Puma Biotechnology Initiates Phase II Trial of Alisertib for HR+/HER2- Metastatic Breast Cancer
Puma Biotechnology has commenced the ALISCA-Breast1 Phase II trial to evaluate alisertib combined with endocrine therapy for HR+/HER2- metastatic breast cancer patients.
HSK21542 Demonstrates Superior Efficacy in Two Phase 3 Trials for Postoperative Pain Management
HSK21542, a novel kappa opioid receptor agonist, demonstrated statistically significant superiority over placebo in reducing postoperative pain intensity in two phase 3 trials involving 658 patients across 47 centers in China.