Clinical Trial News

Relay Therapeutics collaborates with Pfizer to evaluate a triplet combination of RLY-2608, atirmociclib, and fulvestrant in PI3Kα-mutated HR+/HER2- metastatic breast cancer patients, aiming for trial initiation by end of 2024. RLY-2608 is a mutant selective PI3Kα inhibitor, potentially benefiting over 250,000 patients annually in the U.S.

Bayer's Future Clinical Trials project in Finland aimed to make drug development more data-driven and patient-centric, leveraging Finland's healthcare data and ecosystem. Completed in May 2024, it introduced efficient trial methods and fostered collaboration, showcasing Finland as an attractive location for pharmaceutical innovation.

Capricor Therapeutics reported positive 3-year results from the HOPE-2 study of CAP-1002 for Duchenne Muscular Dystrophy, showing benefits in skeletal muscle function and cardiac function stabilization. Results were shared with the FDA, supporting CAP-1002's long-term impact and safety profile.

Uproleselan showed significant improvement in median overall survival (31.2 months) for primary refractory AML patients compared to placebo (10.1 months). Adverse events aligned with chemotherapy profiles. GlycoMimetics plans further studies with NCI and Alliance for Clinical Trials in Oncology, focusing on frontline AML in older adults.

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Stealth BioTherapeutics announced FDA acceptance of its NDA for elamipretide, a potential first therapy for Barth syndrome, a rare, life-shortening cardioskeletal disease affecting about 150 in the U.S. Supported by Phase 3 trial data, elamipretide has received multiple FDA designations, aiming to address the urgent unmet need for treatment.

The San Antonio Breast Cancer Symposium (SABCS) 2024 highlighted key breast cancer research and treatments. PATINA trial showed Palbociclib improves progression-free survival in HER2-positive metastatic breast cancer. The Lancet Breast Cancer Commission emphasized global inequities and future directions. COMET trial suggested active monitoring for low-risk DCIS is viable. EBCTCG found elevated BMI increases breast cancer recurrence and mortality risks. OlympiA trial demonstrated olaparib's long-term efficacy for BRCA mutation carriers. DECRESCENDO and SUPREMO trials explored less intensive treatment options with promising outcomes.

Chime Biologics and Mabgeek have reached a significant milestone in their collaboration by completing the Process Performance Qualification (PPQ) for MG-K10, a humanised anti-IL-4Rα monoclonal antibody, paving the way for Phase III clinical trials targeting Th2-mediated inflammatory conditions.

Rivoceranib plus camrelizumab showed improved survival over sorafenib in advanced HCC, with median OS of 23.8 vs 15.2 months and PFS of 5.6 vs 3.7 months. The combination's safety profile supports its use as a first-line treatment, despite FDA concerns over manufacturing site deficiencies.

Amivantamab-vmjw plus lazertinib significantly improved progression-free survival (PFS) over osimertinib in high-risk EGFR-mutant NSCLC patients, showing a 30% reduced risk of disease progression or death and a 7.1-month PFS improvement. Superior outcomes were noted in patients with TP53 co-mutations, detectable ctDNA, brain, and liver metastases.