The OncFive: Top Oncology Articles for the Week of 2/9

Welcome to OncLive®’s OncFive!

Every week, we bring you a quick roundup of the 5 top stories from the world of oncology—ranging from pivotal regulatory decisions to key pipeline updates to expert insights on breakthroughs that are moving the needle in cancer care. This resource is designed to keep you informed on the latest updates in the space, in just a matter of minutes.

Here’s what you may have missed this week:

FDA Approves Mirdametinib for NF1-Associated Plexiform Neurofibromas

The regulatory agency gave the green light to mirdametinib (Gomekli) for the treatment of adult and pediatric patients aged 2 years and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection. The decision was based on findings from the phase 2 ReNeu study (NCT03962543) in which the agent elicited confirmed overall response rates (ORRs) of 41% (95% CI, 29%-55%) and 52% (95% CI, 38%-65%) in adult (n = 58) and pediatric (n = 56) patients. “For this population, this is a big win. Adults with NF1 have been without an FDA-approved drug for quite some time,” Christopher L. Moertel, MD, of the University of Minnesota, said in an exclusive interview.

Oncology Experts Preview Top Abstracts From 2025 ASCO GU

This exclusive preview article spotlights the most anticipated presentations from the 2025 Genitourinary Cancers Symposium, according to Bradley McGregor, MD, of Dana-Farber Cancer Institute; Guru P. Sonpavde, MD, of AdventHealth Cancer Institute; Vikram M. Narayan, MD, of Winship Cancer Institute; and David Braun, MD, PhD, of Yale Cancer Center. An abstract that made two of these experts’ lists? Abstract 664 on updated data from the phase 3 EV-302 study (NCT04223856) comparing enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) with chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

FDA Approves Brentuximab Vedotin Plus Lenalidomide/Rituximab for R/R LBCL

Findings from the phase 3 ECHELON-3 trial (NCT04404283) supported the FDA approval of the combination comprised of brentuximab vedotin (Adcetris), lenalidomide (Revlimid), and rituximab (Rituxan) in adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma, after 2 or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation or CAR T-cell therapy. The triplet (n = 112) led to a median overall survival of 13.8 months (95% CI, 10.3-18.8) vs 8.5 months (95% CI, 5.4-11.7) with lenalidomide plus rituximab (n = 118; HR; 0.63; 95% CI, 0.45-0.89; P = .0085).

NCCN Updates ctDNA Stance in Colon, Rectal, and MCC Guidelines

The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines in Oncology for colon and rectal cancer to include circulating tumor DNA (ctDNA) as a high-risk factor for recurrence in the adjuvant setting. Moreover, the NCCN Clinical Practice Guidelines in Oncology for Merkel cell carcinoma (MCC) have been updated to state that ctDNA can be used to examine disease burden in virus-positive and -negative disease; they noted that ctDNA typically becomes positive prior to or at the time of a clinically evident recurrence and that the test is often obtained every 3 months when used for surveillance. “The inclusion of ctDNA testing in NCCN guidelines for these histologies is another step toward more personalized care for patients with cancer,” Alexey Aleshin, MD, of Natera, stated in a news release.

FDA Approves Vimseltinib for Symptomatic Tenosynovial Giant Cell Tumor

The regulatory agency cleared vimseltinib (Romvimza) for use in patients with symptomatic tenosynovial giant cell tumor for whom surgical resection will potentially cause worsening functional limitation or severe morbidity based on data from the phase 3 MOTION trial (NCT05059262). The agent induced an ORR of 40% (95% CI, 29%-51%) at week 25 compared with 0% (95% CI, 0%-9%) with placebo (difference, 40%; 95% CI, 29%-51%; P < .0001). The median duration of response was not reached. Most patients (85%) achieved a DOR of 6 months or longer and 58% experienced a DOR of 9 months or longer. “We’re very excited to have vimseltinib recently approved,” Willian Tap, MD, of Memorial Sloan Kettering Cancer Center, told OncLive. “TGCT, especially the diffuse type, can be a very devastating disease for people. It’s not something that generally threatens their life, but it can really alter the trajectory of their life.”