Clinical Trial News

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.

A clinical trial, NRG Oncology GY017, investigates the use of Anti PD-L1 (atezolizumab) as an immune primer and concurrently with extended field chemoradiotherapy for node-positive locally advanced cervical cancer. This study aims to address the unmet need for therapeutic options in patients with para-aortic lymph node metastases, focusing on the synergistic effects of immunotherapy and radiation. The trial explores the optimal sequencing of atezolizumab and chemoradiation to enhance immune activation and improve clinical outcomes.

Analysis of eight clinical trials showed CDK4/6 inhibitors combined with endocrine therapy significantly improved progression-free survival (PFS) and overall survival (OS) in advanced breast cancer patients, compared to endocrine therapy alone. Adverse events like bone marrow suppression increased, but gastrointestinal toxicity did not. The study underscores the efficacy and safety of CDK4/6 inhibitors in breast cancer treatment.

Replimune Group Inc. has announced the enrollment of the first patient in its Phase 1 clinical trial of RP2, an oncolytic immuno-gene therapy, both as a single agent and in combination with Opdivo (nivolumab) for treating advanced solid tumors. This trial aims to assess the safety, tolerability, and optimal dosage of RP2, which expresses an anti-CTLA-4 antibody-like protein to enhance immune response against cancer.

The final analysis of the RESONATE study, with up to six years of follow-up, highlights the efficacy and safety of ibrutinib compared to ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Ibrutinib demonstrated significantly longer progression-free survival (PFS) and overall survival (OS) benefits, especially in high-risk patients. The study also noted the long-term tolerability of ibrutinib, with a decrease in adverse events over time.

A meta-analysis evaluated minimal residual disease (MRD) status as a surrogate for progression-free survival (PFS) in newly diagnosed multiple myeloma (NDMM). Analyzing 3283 patients across six studies, MRD negativity rates varied (0.06-0.70), showing strong correlation between MRD-negative response and PFS, supporting MRD as a valid PFS surrogate in NDMM.

Doxycycline prophylaxis shows promise in preventing bacterial STIs among men who have sex with men, with initial trials indicating high efficacy. Future research should focus on efficacy, target populations, community acceptability, and antimicrobial resistance. Studies are underway to explore doxycycline's role in STI prevention, addressing knowledge gaps and challenges.