OncLive’s OncFive highlights five top oncology developments, ranging from regulatory submissions and designations to late-stage clinical data that could change practice.
A new drug application has been submitted to the FDA seeking approval of rusfertide for adult patients with polycythemia vera, supported by data from the phase 3 VERIFY trial (NCT05210790) and the phase 2 REVIVE study (NCT04057040). In VERIFY part 1a, rusfertide met the primary endpoint and all key secondaries, demonstrating durable hematocrit control and reduced phlebotomy requirements versus placebo. At week 32, 76.9% of patients treated with rusfertide achieved a response versus 32.9% with placebo, and 62.6% maintained hematocrit below 45%. Updated 52-week data showed sustained responses and increased objective response rates, including durable control among patients who crossed over from placebo.
The combination of tafasitamab-cxix (Monjuvi) plus lenalidomide (Revlimid) and R-CHOP significantly improved investigator-assessed progression-free survival versus R-CHOP alone in newly diagnosed diffuse large B-cell lymphoma in the phase 3 frontMIND trial (NCT04824092). The study met its primary endpoint of PFS (HR 0.75; 95% CI, 0.59–0.96; P = .019) and a key secondary endpoint of event-free survival, with no new safety signals reported. Incyte plans to submit a supplemental biologics license application to the FDA in the first half of 2026. Tafasitamab previously received accelerated approval in combination with lenalidomide for relapsed/refractory DLBCL based on the phase 2 L-MIND trial (NCT02399085).
The FDA granted fast track designation to ETX-19477, a poly(ADP-ribose) glycohydrolase inhibitor, for BRCA-mutated, platinum-resistant high-grade serous ovarian cancer. The designation was supported by preclinical data and emerging clinical activity from the ongoing phase 1/2 ERADIC8 study (NCT06395519), which is evaluating ETX-19477 as a single agent in a dose-escalation and -expansion design in patients with BRCA-mutated solid tumors. The trial’s primary objectives include safety and tolerability, with preliminary efficacy assessed by RECIST 1.1.
The FDA granted breakthrough therapy designation to zoldonrasib (RMC-9805-001), a RAS(ON) G12D-selective inhibitor, for adult patients with KRAS G12D–mutated locally advanced or metastatic non–small cell lung cancer previously treated with anti–PD-1/PD-L1 therapy and platinum-based chemotherapy. The decision was supported by phase 1 data (NCT06040541) showing an objective response rate of 61% and a disease control rate of 89% at a 1,200 mg daily dose, with a median time to response of 1.4 months and no grade 4 or 5 treatment-related adverse events observed. Zoldonrasib is under evaluation across multiple tumor types.
Several FDA decisions are expected in Q1 2026 that could expand treatment and diagnostic options. Anticipated reviews include tabelecleucel (Ebvallo) for Epstein-Barr virus–positive post-transplant lymphoproliferative disease based on the phase 3 ALLELE trial (NCT03394365); pembrolizumab (Keytruda) plus chemotherapy with or without bevacizumab (Avastin) for platinum-resistant recurrent ovarian cancer from the phase 3 KEYNOTE-B96/ENGOT-ov65 study (NCT05116189); decitabine/cedazuridine (Inqovi) plus venetoclax (Venclexta) for newly diagnosed acute myeloid leukemia from the phase 2b ASCERTAIN-V trial (NCT04657081); and imaging agents piflufolastat F 18 (CONDOR; NCT03739684) and gallium-68 edotreotide (LNTH-2501) for neuroendocrine tumors.
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