The OncFive: Top Oncology Articles for the Week of 10/26

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:

Belzutifan-Based Combinations Meet DFS, PFS End Points in Renal Cell Carcinoma

The phase 3 LITESPARK-011 (NCT04586231) and LITESPARK-022 (NCT05239728) trials both met their respective primary end points of progression-free survival (PFS) and disease-free survival with belzutifan (Welireg)–based regimens in renal cell carcinoma (RCC). In LITESPARK-011, belzutifan plus lenvatinib (Lenvima) significantly improved PFS and objective response rate (ORR) vs cabozantinib (Cabometyx) in patients with advanced RCC previously treated with anti–PD-1/L1 therapy, although overall survival (OS) did not reach statistical significance at interim analysis. LITESPARK-022 showed that adjuvant belzutifan plus pembrolizumab (Keytruda) led to a significant and clinically meaningful DFS benefit vs pembrolizumab plus placebo in patients with clear cell RCC after nephrectomy, with OS data pending. These data position belzutifan combinations as potential new standards in both the advanced and adjuvant RCC settings, marking the first phase 3 successes for a hypoxia-inducible factor-2α inhibitor in combination with a VEGF TKI or an immune checkpoint inhibitor.

FDA Sets PDUFA Date for LNTH-2501 in Imaging of SSTR+ Neuroendocrine Tumors

The FDA has set a Prescription Drug User Fee Act target action date of March 29, 2026, for LNTH-2501 (gallium-68 edotreotide), a diagnostic kit for PET imaging of somatostatin receptor (SSTR)–positive neuroendocrine tumors (NETs) in adults and pediatric patients. The product’s diagnostic performance was examined in two prospective trials (NCT01619865; NCT01869725), showing strong concordance with reference standards. In the first study, which involved 177 patients, PET/CT with gallium-68 edotreotide demonstrated positive and negative agreement rates of 90%-91% and 86%-89%, respectively, vs Octreoscan SPECT plus contrast-enhanced CT. In the second study, 59 evaluable patients showed positive and negative percent agreements of 90%-92% and 75%, respectively, vs standard indium 111-pentetreotide imaging. These data suggest LNTH-2501 may provide clinicians with a reliable and accessible tool for identifying and managing SSTR-positive NETs.

EVX-01 Plus Pembrolizumab Drives Durable Disease Control, T-Cell Responses in Advanced Melanoma

Treatment with the personalized peptide-based neoantigen vaccine EVX-01 plus pembrolizumab elicited potent and durable T-cell responses in patients with previously untreated, stage III/IV unresectable melanoma, according to 2-year follow-up findings from a phase 2 trial (NCT05309421). Evaluable patients (n = 16) achieved an ORR of 75%, with responses persisting in 11 of 12 responders at 24 months and deepened responses observed in 54% of evaluable patients. Safety data showed no grade 3 or higher adverse effects specifically related to EVX-01, with only two grade 2 and 18 grade 1 vaccine-related events; one patient experienced grade 3 pancreatitis and grade 4 diabetic ketoacidosis linked to combination therapy.

LEAP-012 Trial of Pembrolizumab/Lenvatinib/TACE to Close Following Missed OS End Point in Unresectable HCC

The phase 3 LEAP-012 trial (NCT04246177) found that adding pembrolizumab and lenvatinib to transarterial chemoembolization (TACE) did not significantly improve OS vs TACE alone in patients with unresectable, nonmetastatic hepatocellular carcinoma (HCC). Although the study was closed early due to a low likelihood of meeting the OS end point, prior analyses confirmed a PFS benefit with the triplet regimen. LEAP-012 enrolled 480 patients who were randomly assigned 1:1 to receive TACE plus pembrolizumab and lenvatinib or TACE plus dual placebo. The primary end points were blinded independent central review–assessed PFS and OS. Published data in The Lancet showed a median PFS of 14.6 months with lenvatinib plus pembrolizumab vs 10.0 months with dual placebo (HR, 0.66); 2-year OS rates were 75% vs 69% (HR, 0.80; P = .087). Safety data were consistent with what has previously been reported.

Tackling Drug Shortages in Hematologic Oncology Care Requires Nuance and Adaptability

Drug shortages remain a significant challenge in hematologic oncology, affecting backbone therapies and lymphodepleting regimens essential for CAR T-cell therapy. As of October 2025, azacitidine is on the FDA’s shortage list; decitabine can serve as a substitute, although it carries higher risks of high-grade anemia, febrile neutropenia, and leukopenia. Experts stress the importance of identifying safe alternative regimens to avoid treatment delays and maintain efficacy, particularly in acute leukemias where timely therapy is essential. Artificial intelligence (AI) could help alleviate shortages by predicting supply-demand mismatches, identifying alternate suppliers, and optimizing production and distribution based on factors such as market trends, weather, and geopolitical events. Predictive models leveraging AI have already demonstrated promise. Sign up to access the exclusive feature.