Clinical Trial News

Recent studies and FDA approvals have marked significant progress in cancer treatment, including advancements in immunotherapy, targeted therapies, and the exploration of new drug combinations for various cancer types.

Ensifentrine, a novel inhaled dual phosphodiesterase 3 and 4 inhibitor, showed significant improvements in lung function and COPD symptoms in Phase 2b trials, offering potential as a first-in-class therapy combining bronchodilator and anti-inflammatory effects.

Network meta-analysis found no significant differences in efficacy and toxicity among PARPi regimens for BRCA-mutated ovarian cancer. ASCO value framework showed similar clinical benefits and toxicity, but higher costs for combined therapies. Upfront PARPi regimens are less toxic than relapse treatments. Cost-effectiveness should guide regimen choice.

The RESMAIN study, evaluating resminostat for advanced-stage CTCL maintenance, continues without protocol changes after a positive DSMB safety review. Enrollment increased to 190 patients to expedite unblinding, with results expected by mid-2021. Yakult Honsha discontinued a Phase II study in Japan, with no financial impact on 4SC.

A NYU study found that a single psilocybin dose with psychotherapy significantly improves emotional and existential distress in cancer patients, with effects lasting nearly five years. The treatment showed sustained reductions in anxiety, depression, and improved quality of life, offering a promising approach for cancer-related psychological care.

Despite a 2007 law and a 2017 'final rule' by NIH and FDA requiring clinical trial results to be reported on ClinicalTrials.gov, many sponsors fail to comply, with minimal enforcement by federal officials.

Measurable residual disease (MRD) post-induction chemotherapy predicts relapse and shorter survival in AML patients, aiding in risk stratification and treatment response assessment. Recent studies at the ASH Meeting highlighted MRD's role in predicting relapse post-allo-HSCT. The Spanish AML12 trial demonstrated risk-adapted treatment feasibility based on AML genetics and MRD presence, involving 812 adults across 15 hospitals.

The San Antonio Breast Cancer Symposium (SABCS) 2024 concluded with record attendance, featuring groundbreaking clinical trial studies and a strong sense of community among participants. Highlights and updates from the event are available online, with plans already underway for SABCS 2025.

Recent advances in multiple myeloma treatment, including proteasome inhibitors, immunomodulators, and antibody therapies, have significantly improved patient prognosis, with overall response rates nearing 100%. The use of minimal residual disease (MRD) status as a surrogate endpoint in clinical trials is being explored, with studies showing MRD-negative responses correlate with superior survival outcomes. The FDA and Duke-Margolis Center for Health Policy have discussed MRD's potential as a surrogate endpoint, emphasizing the need for it to meet specific criteria to predict clinical benefit effectively.

PARP inhibitors show promise in frontline treatment for advanced ovarian cancer, especially for BRCA-associated and HRD tumors. FDA approvals include olaparib for BRCA-associated cancers and niraparib for all patients. Factors like FDA indication, dosing, toxicity, and cost influence treatment decisions. Ongoing research explores PARP inhibitor resistance and combination therapies.