OncLive’s OncFive highlights five top oncology stories this week, covering regulatory approvals, breakthrough designations and pivotal trial results.
The FDA approved a subcutaneous formulation of mosunetuzumab (Lunsumio VELO) on December 22, 2025, for adult patients with relapsed or refractory follicular lymphoma after two or more prior systemic therapies. Approval was based on the phase 1/2 GO29781 trial (NCT02500407), which reported a 75% overall response rate (95% CI, 64%–83%), a 59% complete response rate (95% CI, 48%–69%) and a median duration of response of 22.4 months (95% CI, 16.8–22.8) with the fixed‑duration subcutaneous regimen.
The FDA granted breakthrough therapy designation to fam‑trastuzumab deruxtecan‑nxki (T‑DxD; Enhertu) for post‑neoadjuvant treatment of adult patients with HER2‑positive early breast cancer who have residual invasive disease and are at high risk of recurrence. The decision was supported by results from the phase 3 DESTINY‑Breast05 trial (NCT04622319) presented at ESMO 2025 and published in The New England Journal of Medicine, which showed a 3‑year invasive disease–free survival rate of 92.4% with T‑DxD versus 83.7% with ado‑trastuzumab emtansine (T‑DM1) (HR, 0.47; 95% CI, 0.34–0.66; P < .0001).
The phase 3 LATIFY trial (NCT05450692) reported that the combination of ceralasertib (AZD6738) and durvalumab (Imfinzi) did not improve overall survival versus docetaxel in patients with advanced non‑small cell lung cancer without actionable genomic mutations who progressed after prior immunotherapy and platinum‑based chemotherapy, missing the trial’s primary endpoint. The regimen was generally well tolerated with a safety profile consistent with the known toxicities of each agent. Detailed LATIFY data will be presented at a future medical meeting.
The biparatopic HER2‑targeted antibody–drug conjugate JSKN003 received FDA breakthrough therapy designation for adults with advanced or metastatic, platinum‑resistant, recurrent epithelial ovarian, primary peritoneal or fallopian tube cancers with HER2 expression of 1+ to 3+ by immunohistochemistry who have received prior bevacizumab. A pooled analysis of phase 1 JSKN003‑101 (NCT05494918) and phase 1/2 JSKN003‑102 (NCT05744427) trials showed an overall response rate of 63.0% (95% CI, 47.5%–76.8%) in 46 patients with platinum‑resistant disease, a complete response rate of 4.3%, a disease control rate of 93.5% (95% CI, 82.1%–98.6%), median progression‑free survival of 7.7 months (95% CI, 5.7–9.7) at a median follow‑up of 9.3 months, and a 9‑month overall survival rate of 89.9% (95% CI, 75.0%–96.1%).
China’s National Medical Products Administration approved pimicotinib (ABSK021) as a systemic treatment for adult patients with symptomatic tenosynovial giant cell tumor for whom surgical resection would likely cause functional limitation or severe morbidity. The decision was supported by the global phase 3 MANEUVER study (NCT05804045), which reported an objective response rate of 54.0% at week 25 per RECIST 1.1 by blinded independent review versus 3.2% with placebo (P < .0001).
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