Clinical Trial News

The combination of avutometinib and defactinib showed a 28% ORR in recurrent low-grade serous ovarian cancer patients, with a 93% DCR. KRAS-mutated and wild-type patients had similar ORRs. The FDA chose the combination over monotherapy for further analysis. Verastem Oncology plans to use RAMP-201 and FRAME trial data for potential accelerated approval. The treatment was well-tolerated, with common AEs being mild to moderate.

A new clinical trial aims to compare methadone and buprenorphine effectiveness for opioid addiction treatment in office settings, addressing fentanyl's impact. Amidst calls for expanded methadone access, the study seeks to inform future treatment flexibility, highlighting the restrictive U.S. OTP system and advocating for office-based methadone prescriptions.

Interest in metformin for cancer treatment is declining due to disappointing trial results. However, new research suggests potential in targeting mitochondrial metabolism, altering gut microbiota, and enhancing immunotherapy. Metformin may also prevent cancer in high-risk groups, supported by early clinical data. Future studies should focus on well-designed trials in selected populations.

Doxy-PEP, a strategy involving doxycycline post-condomless sex, significantly reduces STIs like gonorrhea, chlamydia, and syphilis in MSM and transgender women. Preliminary results show a minor increase in resistant bacteria strains. The approach targets individuals with recurrent STIs, aiming to decrease antibiotic use. Further studies are needed to assess long-term resistance impacts.

RETAIN, a phase II trial at GU ASCO 2023, tested sparing cystectomy in muscle-invasive bladder cancer patients with excellent neoadjuvant chemotherapy response. Despite not meeting the primary endpoint of 64% two-year metastasis-free survival (achieved 72%), 46% on surveillance retained their bladder. Findings suggest aggressive treatment for local recurrences and highlight the need for better patient selection in future trials.

The U.S. Food and Drug Administration (FDA) has approved Lamzede (velmanase alfa-tycv) for the treatment of non-central nervous system manifestations of alpha-mannosidosis in both adult and pediatric patients. This marks a significant advancement as Lamzede becomes the first and only enzyme replacement therapy available in the United States for this ultra-rare, progressive lysosomal storage disorder.

US health advisers to review Emergent BioSolutions' Narcan nasal spray for over-the-counter sale, aiming to increase access amid opioid crisis. FDA advisory panels to assess safety for nonprescription use, with a decision expected by March 29.

The American College of Rheumatology launches TIMELY and new CME to address racial disparities in lupus clinical trials, focusing on African American and Hispanic patients. TIMELY combines MIMICT and LuCTT models to improve trial participation, starting in Raleigh-Durham and Rochester. New CME targets dermatologists and nephrologists for better lupus care.

The National Cancer Institute has chosen two assays, Avantect® by ClearNote Health and Shield™ by Guardant Health, for the Vanguard Study on multi-cancer detection tests, aiming to evaluate their feasibility in reducing cancer-related deaths through early detection.

Metformin, a low-cost diabetes drug, aids weight loss and may slow aging, preventing cancers and dementia. Research suggests it mimics fasting benefits, promoting autophagy and metabolism changes. Despite potential side effects, its anti-aging and antiviral properties are under study, with a major trial, TAME, aiming to explore its impact on aging-related diseases.