The OncFive: Top Oncology Articles for the Week of 11/2

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 Subcutaneous Daratumumab for High-Risk Smoldering Multiple Myeloma

The FDA has cleared subcutaneous daratumumab and hyaluronidase-fihj (Darzalex Faspro) for the treatment of adult patients with high-risk smoldering multiple myeloma, signifying the first therapy approved for this population. The decision was based on findings from the phase 3 AQUILA trial (NCT03301220), in which subcutaneous daratumumab significantly extended progression-free survival (PFS) vs active monitoring (HR, 0.49; 95% CI, 0.36-0.67; P < .0001). Additional analyses revealed improvements in overall survival (OS; HR, 0.52; 95% CI, 0.27-0.98) and PFS on frontline treatment for multiple myeloma (HR, 0.58; 95% CI, 0.35-0.96). Treatment-emergent adverse effects (TEAEs) were experienced by 96.9% of patients, with grade 3/4 TEAEs reported in 40.4%; toxicities led to treatment discontinuations for 5.7% of patients. The recommended dose of subcutaneous daratumumab is 1800 mg with 30,000 units of hyaluronidase, given on a gradually reduced dosing schedule over 36 months.

FDA Adds REMS Guidelines for Pexidartinib in Tenosynovial Giant Cell Tumor

The regulatory agency also implemented new Risk Evaluation and Mitigation Strategy (REMS) guidelines for pexidartinib (Turalio) to reduce the risk of serious and potentially fatal liver injury, including vanishing bile duct syndrome, in patients with tenosynovial giant cell tumor (TGCT). Under the TURALIO REMS program, only certified prescribers, pharmacies, and enrolled patients may prescribe, dispense, or receive the agent. Liver function tests—including aspartate and alanine aminotransferase and bilirubin—must be closely monitored on a weekly basis for the first 8 weeks, every 2 weeks for the next month, and every 3 months thereafter, with dose modifications or discontinuation required based on toxicity severity. Pexidartinib became the first systemic therapy approved for TGCT in August 2019, supported by findings from the phase 3 ENLIVEN trial (NCT02371369), in which the agent elicited an overall response rate (ORR) of 38% at week 25 vs 0% with placebo (P < .0001). The most common adverse effects included elevated liver enzymes, hair color changes, and increased cholesterol levels.

UGN-103 Yields High 3-Month CR Rate in Low-Grade, Intermediate-Risk NMIBC

Preliminary data from the phase 3 UTOPIA trial (NCT06331299) indicated that UGN-103 (mitomycin) for intravesical solution elicited a 3-month complete response (CR) rate of 77.8% (95% CI, 68.3%-85.5%) in patients with recurrent low-grade, intermediate-risk non–muscle-invasive bladder cancer (NMIBC). The FDA agreed that the data support submission of a new drug application for UGN-103, with plans for submission in 2026. UGN-103 is designed to improve upon the previously approved mitomycin formulation, UGN-102 (Zusduri), by offering a shorter manufacturing process and simplified reconstitution without compromising intravesical drug exposure. The prior formulation was cleared by the regulatory agency in June 2025 based on findings from the phase 3 ENVISION trial (NCT05243550), in which a comparable 3-month CR rate of 78% and durable responses lasting up to 25 months were reported. The single-arm UTOPIA trial continues to evaluate durability, safety, and pharmacokinetic outcomes to further support regulatory review.

First-Line Sacituzumab Govitecan After Endocrine Therapy Fails to Improve PFS in HR+/HER2-Negative Breast Cancer

The phase 3 ASCENT-07 trial (NCT05840211) comparing sacituzumab govitecan-hziy (Trodelvy) with physician’s choice of chemotherapy in patients with hormone receptor–positive, HER2-negative metastatic breast cancer did not meet its primary end point of improving PFS in the frontline setting after endocrine therapy. Although OS data were immature at the time of analysis, an early trend favored the antibody-drug conjugate, and follow-up will continue to assess this secondary end point. The safety profile of the agent was consistent with previous trials, and no new safety signals were observed. Despite the missed PFS end point, sacituzumab govitecan remains a standard of care for pretreated HR-positive/HER2-negative disease based on OS improvements observed in the phase 3 TROPiCS-02 study (NCT03901339), and ongoing trials like ASCENT-05 (NCT05633654) continue to assess the ADC in earlier and additional disease settings.

Immune-Modulatory and mRNA-Based Cancer Vaccines Could Boost Benefit With ICIs Across Solid Tumors

At the 2025 ESMO Congress, investigators presented encouraging data supporting the potential of therapeutic cancer vaccines across solid tumors. For example, in the phase 3 IOB-013 study (NCT05155254), the immune-modulatory vaccine IO102-IO103 plus pembrolizumab (Keytruda) showed efficacy in metastatic melanoma by targeting immunosuppressive cells in the tumor microenvironment, offering a novel mechanism beyond traditional checkpoint inhibition. Moreover, a phase 2 basket trial (NCT05077709) examining IO102-IO103 plus pembrolizumab in PD-L1–high head and neck squamous cell carcinoma (HNSCC) and non–small cell lung cancer (NSCLC) indicated that the regimen was safe and met its primary end point of ORR in HNSCC, with promising activity in NSCLC. Experts noted this approach may help enhance responses in those who derive limited benefit from PD-1 monotherapy. Sign up to access the exclusive conference recap, which is packed full of expert insights.