The OncFive: Top Oncology Articles for the Week of 8/25

Welcome to OncLive^®’s OncFive! Every week, we will compile the top 5 stories in oncology, ranging from pivotal regulatory decisions to news updates and expert interviews spanning tumor types.

Here’s what you may have missed this week:

FDA Grants Priority Review to Mirdametinib for NF1-Associated Plexiform Neurofibromas

A new drug application (NDA) seeking the approval of mirdametinib in the treatment of adult and pediatric patients with neurofibromatosis type 1–associated plexiform neurofibromas (NF1-PN) has been accepted by the FDA and granted priority review status. The NDA is based on findings from the phase 2b ReNeu trial (NCT03962543) in which the agent induced an objective response rate of 41% per blinded independent central review in adult patients and 52% in children aged 2 years or older who had NF1-PN causing significant morbidity. The application has been assigned an action date of February 28, 2025.

DESTINY-Breast06 Redefines Treatment Paradigms, Calls Necessity of HER2 Testing for T-DXd into Question in HR+ Breast Cancer

In this exclusive interview, Jason A. Mouabbi, MD, an assistant professor in the Departments of Breast Medical Oncology and General Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, in Houston, discussed data from the phase 3 DESTINY-Breast06 trial (NCT04494425) of fam-trastuzumab deruxtecan-nxki (Enhertu) in patients with endocrine-resistant, hormone receptor–positive, HER2-low and -ultralow breast cancer. He also delved into whether extensive HER2 status testing is needed for the administration of the agent given its broad efficacy in this population and highlighted areas of ongoing antibody-drug conjugate development in the space.

Dissemination vs Misinformation: Social Media’s Role in the Evolution of Cancer Care

As the dissemination of information in oncology is spread using social media platforms, the potential for misinformation remains a key hurdle. This article features insights from Laura Huppert, MD, an oncologist at University of California, San Francisco (UCSF), UCSF Health; Eric Kumar Singhi, MD, a medical oncologist at the University of Texas MD Anderson Cancer Center in Houston; Vinayak Venkataraman, MD, a medical oncologist at Dana-Farber Cancer Institute and Harvard Medical School in Boston, Massachusetts; and Emre Yekedüz, MD, a research fellow at Dana-Farber Cancer Institute.

FDA Grants Fast Track Designation to BGB-16673 in Previously Treated CLL/SLL

The regulatory agency granted fast track designation to BGB-16673—a bivalent molecule harboring a BTK-binding moiety, linker, and E3 ligase binder that results in BTK degradation through polyubiquitination—for use as a potential therapeutic option in adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received 2 or more prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. The agent was found to elicit an ORR of 72% in heavily pretreated patients enrolled in the phase 1/2 CaDAnCe-101 trial (BGB-16673-101; NCT05006716).

Time-Limited Bispecific Antibodies Could Represent Next Shift in Myeloma Treatment

As bispecific antibodies have become more engrained in the treatment arsenal for patients with relapsed or refractory multiple myeloma, ongoing research efforts could shift how these drugs are being leveraged. In this exclusive interview, Rahul Banerjee, MD, FACP, physician-researcher and an assistant professor in the Clinical Research Division of Fred Hutchinson Cancer Center and assistant professor in the Division of Hematology and Oncology at the University of Washington in Seattle, expanded on the efficacy and safety of these agents in this population.