Dr Salani on Novel Trial Designs and Therapies in Gynecologic Malignancies

"We need to think outside the box a little bit. [Designing] clinical trials without using such a large number of patients so we can get answers efficiently, effectively, and at less cost is important, and that's something we need to think about as we move forward with clinical trial design."

Ritu Salani, MD, MBA, gynecologic oncologist, professor of obstetrics and gynecology in the David Geffen School of Medicine, and director of Gynecologic Oncology at UCLA Health, discusses key considerations in clinical trial design and the evolving role of novel therapies such as HER2-targeted antibody-drug conjugates (ADCs) in gynecologic malignancies.

A critical aspect of future clinical research will revolve around optimizing trial design to generate meaningful data more efficiently and cost-effectively, Salani explains. Traditional large-scale trials can be resource-intensive and time-consuming; innovative approaches, such as adaptive trial designs and smaller, biomarker-driven studies, may facilitate the rapid evaluation of novel therapeutics without compromising scientific rigor, she continues. Implementing these strategies could allow for faster translation of promising agents into clinical practice, providing timely benefits to patients.

Regarding novel therapies emerging in the space, Salani highlights HER2-targeted ADCs, which could represent a significant advancement in the treatment of gynecologic malignancies. Although these agents have demonstrated clinical benefit in smaller patient cohorts, their impact has been substantial, she says. The efficacy of HER2-directed ADCs underscores the potential of targeted therapies in select populations and reinforces the need for biomarker-driven treatment approaches. However, as these therapies become more integrated into clinical practice, understanding and managing their unique toxicity profiles remains a priority, Salani notes.

The emergence of HER2-directed ADCs has brought novel adverse effect profiles that require heightened clinical awareness. Effective toxicity management necessitates a multidisciplinary approach, incorporating medical oncologists, pharmacists, and supportive care specialists, she continues. Proactive monitoring and intervention strategies can mitigate the risk of severe toxicities and preserve treatment efficacy, and as experience with these agents grows, establishing standardized management protocols will be essential to optimize patient outcomes.