Clinical Trial News
FDA Authorizes Eli Lilly's Bamlanivimab for Early-Stage COVID-19 Treatment
• The FDA granted emergency use authorization (EUA) to Eli Lilly's bamlanivimab (LY-CoV555) for treating mild-to-moderate COVID-19 in adults and pediatric patients.
• Bamlanivimab, a monoclonal antibody, is authorized for patients with positive SARS-CoV-2 test results who are at high risk of progressing to severe COVID-19 or hospitalization.
• The drug should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset, according to Eli Lilly.
• Bamlanivimab is not authorized for patients hospitalized due to COVID-19, as studies suggest it may not be beneficial and could potentially worsen outcomes in these cases.
Exscientia Strengthens AI Drug Discovery Leadership with AstraZeneca Veteran as New CTO
• Former AstraZeneca head of hit discovery Dr. Garry Pairaudeau joins Exscientia as Chief Technology Officer, bringing 25 years of expertise in AI, machine learning, and drug discovery.
• Pairaudeau's appointment comes as Exscientia advances its AI-driven drug discovery platform, which has already produced the first AI-designed drug molecule to enter clinical trials for OCD treatment.
• The move reflects the growing importance of AI in pharmaceutical R&D, with the global AI healthcare market projected to grow from $2.1 billion in 2018 to $36 billion by 2025.
Exploring New Frontiers in Non-Small Cell Lung Cancer Treatment
Recent discussions and studies highlight the evolving landscape of non-small cell lung cancer (NSCLC) treatment, focusing on antibody-drug conjugates (ADCs) and their potential benefits, sequencing strategies, and management of toxicities. Key trials such as EVOKE-01, HERTHENA-Lung01, and MARIPOSA are examined for their impact on patient care.
Subcutaneous Isatuximab Plus Pd Shows Promise in R/R Multiple Myeloma Treatment
Recent clinical trials reveal that subcutaneous isatuximab combined with Pd meets coprimary endpoints and is noninferior to IV administration in treating relapsed/refractory multiple myeloma, marking a significant advancement in care.
Liso-cel Plus Ibrutinib Shows Promise in Relapsed/Refractory CLL/SLL: Primary Results from TRANSCEND CLL 004 Study
• Primary results from the phase 1/2 TRANSCEND CLL 004 study demonstrate efficacy of lisocabtagene maraleucel (liso-cel) combined with ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.
• The combination therapy showed manageable safety profile with reduced incidence of severe cytokine release syndrome compared to historical CAR-T monotherapy data in this difficult-to-treat patient population.
• This novel approach represents a potential advancement in cellular therapy options for CLL/SLL patients who have failed previous treatment regimens, addressing a significant unmet need in hematologic oncology.
Exploring Immunotherapy as a Potential Treatment for Penile Cancer
Recent research highlights the potential of immunotherapy in treating penile cancer, a rare malignancy with a poor prognosis in advanced stages. The study focuses on the role of HPV in the disease's carcinogenesis and the ongoing clinical trials investigating immune-modifying treatments.
PSMA PET-CT Improves Prostate Cancer Metastasis Detection
• PSMA PET-CT imaging proves more accurate than standard CT and bone scans in detecting prostate cancer metastasis, with 92% accuracy versus 65%.
• The use of PSMA PET-CT led to a change in treatment plans for 28% of patients, compared to 15% with standard imaging, optimizing patient care.
• PSMA PET-CT reduces inconclusive results (7% versus 23%), minimizing the need for additional scans and biopsies, streamlining diagnosis.
• FDA approved Gallium (Ga) 68 PSMA-11 for PET imaging in prostate cancer, enhancing detection of spread and recurrence based on PSA levels.
Acalabrutinib, Venetoclax, and Obinutuzumab Triplet Shows High Efficacy in CLL
• Acalabrutinib, venetoclax, and obinutuzumab (AVO) triplet therapy demonstrates high activity in previously untreated CLL patients, including those with high-risk TP53 aberrations.
• The AVO regimen achieved a bone marrow undetectable MRD (BM-uMRD) rate of 78% after 15 months, indicating deep remission in a significant proportion of patients.
• The triplet therapy exhibited a favorable safety profile, with low rates of severe infections and atrial fibrillation, and no tumor lysis syndrome (TLS) related to venetoclax ramp-up.
• The ongoing phase 3 trial (CL-311, NCT03836261) is further evaluating AVO, potentially establishing a new standard frontline treatment for CLL.
Highlighted Clinical Trials:
Dana-Farber Cancer Institute
Posted 8/7/2018
Acerta Pharma BV
Posted 2/25/2019
Phase 3 DESTINY-Breast05 Trial Compares Trastuzumab Deruxtecan to T-DM1 in High-Risk HER2+ Early Breast Cancer
• Daiichi Sankyo and AstraZeneca have initiated the DESTINY-Breast05 phase 3 trial comparing ENHERTU (trastuzumab deruxtecan) to T-DM1 as adjuvant therapy in high-risk HER2+ early breast cancer patients with residual disease after neoadjuvant treatment.
• The global trial will enroll up to 1,600 patients across 400 sites and is being conducted in collaboration with major research groups including NSABP, GBG, AGO-B, and SOLTI, with invasive disease-free survival as the primary endpoint.
• This marks the first evaluation of ENHERTU in early breast cancer, building on its established efficacy in metastatic HER2+ breast cancer where it showed a 60.3% objective response rate in the DESTINY-Breast01 trial.
Ring 20 Syndrome: Ultra-Rare Epilepsy Faces Diagnostic Challenges in Era of Modern Gene Sequencing
• Ring Chromosome 20 Syndrome (R20), an ultra-rare form of epilepsy affecting at least 150 people worldwide, causes uncontrollable seizures and cognitive decline but remains resistant to current treatments.
• Despite advances in genomic technology, R20 diagnoses are declining as modern gene sequencing methods cannot detect ring chromosomes, requiring traditional karyotype analysis of 100+ cells for accurate diagnosis.
• Ring 20 Research and Support, led by Allison Watson, is launching initiatives including a natural history study, biomarker research, and global patient registry to advance understanding and awareness of the condition.