OncLive’s OncFive summarizes five top oncology news items this week.
A new drug application has been submitted to the FDA for rusfertide to treat adults with polycythemia vera, based on results from the phase 3 VERIFY trial (NCT05210790) and the phase 2 REVIVE study (NCT04057040). In VERIFY part 1a, rusfertide met the primary end point and all key secondary end points, delivering durable hematocrit control and reducing phlebotomy requirements versus placebo. At week 32, 76.9% of rusfertide-treated patients 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 phase 3 frontMIND trial (NCT04824092) reported that adding tafasitamab-cxix (Monjuvi) and lenalidomide (Revlimid) to R-CHOP significantly improved investigator-assessed progression-free survival versus R-CHOP alone in newly diagnosed diffuse large B-cell lymphoma. The study met its primary end point (HR 0.75; 95% CI, 0.59–0.96; P = .019) and a key secondary end point of event-free survival, with no new safety signals observed. Incyte said it 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 phase 1/2 ERADIC8 study (NCT06395519), which is evaluating ETX‑19477 as a single agent in BRCA‑mutated solid tumors using a dose‑escalation and expansion design. The trial’s primary objectives are safety and tolerability, with preliminary efficacy assessed by RECIST 1.1 criteria.
Zoldonrasib (RMC‑9805‑001), a RAS(ON) G12D‑selective inhibitor, received breakthrough therapy designation from the FDA for use in adults 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. In the phase 1 RMC‑9805‑001 study (NCT06040541), patients treated with 1,200 mg daily achieved an objective response rate of 61% and a disease control rate of 89%, with a median time to response of 1.4 months. No grade 4 or 5 treatment‑related adverse events were observed. Zoldonrasib is being evaluated across multiple tumor types.
Several FDA decisions are anticipated in Q1 2026 that could expand oncology treatment and diagnostic options. Expected 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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