The OncFive: Top Oncology Articles for the Week of 11/9

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 Ziftomenib for NPM1+ R/R Acute Myeloid Leukemia

The regulatory agency cleared ziftomenib (Komzifti) for use in adults with relapsed/refractory acute myeloid leukemia harboring a susceptible NPM1 mutation, based on data from the phase 1/2 KOMET-001 trial (NCT04067336). Ziftomenib led to a complete remission (CR) plus CR with full or partial hematologic recovery rate (CR/CRh) of 21.4%, with a median duration of 5 months. Additional data shared at the 2025 ASCO Annual Meeting showed a combined CR/CRh rate of 23% and a median time to response of 2.8 months. The trial also demonstrated an overall response rate (ORR) of 33% and notable minimal residual disease negativity in 63% of responding patients. Transfusion independence was observed in a portion of previously dependent patients. Safety data revealed expected hematologic toxicities and differentiation syndrome, with an overall profile determined to be manageable.

FDA Accepts NDA For 177Lu-edotreotide for GEP-NETs

The FDA has accepted a new drug application (NDA) seeking approval of 177Lu-edotreotide (ITM-11) for the treatment of adults with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The Prescription Drug User Fee Act target action date is August 28, 2026. The NDA is supported by phase 3 COMPETE trial (NCT03049189) findings, in which 177Lu-edotreotide significantly improved median progression-free survival (PFS) vs everolimus (Afinitor; 23.9 vs 14.1 months; HR, 0.67; P = .022) and elicited a higher ORR (21.9% vs 4.2%; P < .0001) per blinded independent central review, meeting its primary and key secondary end points. Additional data from the 2025 ESMO Congress showed consistent PFS and ORR advantages by local assessment and highlighted a favorable toxicity profile with fewer treatment-related discontinuations and dose modifications compared with everolimus. The agent also holds fast track designation from the regulatory agency, reflecting its potential to meaningfully advance treatment options for patients with progressive GEP-NETs.

FDA Approves OncoMate MSI Dx as Companion Diagnostic for Pembrolizumab/Lenvatinib in MSS Endometrial Cancer

The FDA has given the green light to the Promega OncoMate® MSI Dx Analysis System as a companion diagnostic to identify patients with microsatellite stable (MSS) endometrial carcinoma who may benefit from pembrolizumab (Keytruda) combined with lenvatinib (Lenvima). This decision builds on the 2021 FDA approval of the doublet for advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair–deficient, which was supported by findings from the phase 3 KEYNOTE-775/Study 309 trial (NCT03517449). Five-year follow-up data confirmed durable survival benefits, with overall survival (OS) rates of 16.7% for pembrolizumab plus lenvatinib vs 7.3% for standard chemotherapy in the mismatch repair–proficient subgroup. Treatment-related adverse effects (AEs) remained common with the combination, including hypertension (61.8%), hypothyroidism (55.7%), diarrhea (43.3%), and fatigue (28.8%), and led to discontinuation in 40.1% of patients. The OncoMate MSI Dx Analysis System also holds FDA clearance for Lynch syndrome screening in colorectal cancer.

Bezuclastinib Plus Sunitinib Shows PFS Benefit in Second-Line GIST

The addition of bezuclastinib (CGT9486) to sunitinib (Sutent) significantly improved PFS vs sunitinib monotherapy in patients with imatinib (Gleevec)-resistant or intolerant gastrointestinal stromal tumors (GISTs), meeting the primary end point of the phase 3 PEAK trial (NCT05208047). At the data cutoff date of September 30, 2025, the regimen reduced the risk of disease progression or death by 50% (HR, 0.50; 95% CI, 0.39-0.65; P < .0001), with median PFS of 16.5 months vs 9.2 months; the respective ORRs were 46% and 26%. The combination was generally well tolerated, with the most common grade 3 or higher toxicities being hypertension, neutropenia, elevations in alanine and aspartate aminotransferase levels, anemia, and diarrhea. Only 7.4% of patients discontinued treatment due to AEs. Full analyses from the PEAK trial are ongoing, with complete data expected to read out at a major medical conference in the first half of 2026. A new NDA for bezuclastinib in GIST is planned to be filed to the FDA.

FDA Grants Fast Track Designation to AVZO-1418/DB-1418 for EGFR+, TKI-Pretreated NSCLC

The FDA has granted fast track designation to AVZO-1418/DB-1418 for use as a potential therapeutic option in patients with unresectable, locally advanced, or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R mutations who have progressed on EGFR TKIs. Avenzo Therapeutics, in partnership with Duality Bio, will develop, manufacture, and commercialize the antibody-drug conjugate (ADC) globally, excluding China. Preclinical data indicate that AVZO-1418/DB-1418 has additive EGFR/HER3 binding, higher internalization than bivalent ADCs, and superior in vivo efficacy in NSCLC, renal cell carcinoma, colon cancer, and head and neck cancer models. The first-in-human phase 1/2 AVZO-1418-1001 trial (NCT07038343) has recently been launched, and it is examining the safety, tolerability, and efficacy of the agent as a monotherapy and in combination. Primary end points include dose-limiting toxicities, identification of the maximum tolerated dose/recommended phase 2 dose, and ORR. Secondary end points include duration of response, disease control rate, PFS, OS, and pharmacokinetics.