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:
On December 22, 2025, FDA approved a subcutaneous formulation of mosunetuzumab (Lunsumio VELO) for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more prior lines of systemic therapy.
The regulatory decision was based on data from the phase 1/2 GO29781 trial, (NCT02500407), which showed that patients treated with the fixed-duration subcutaneous formulation achieved an overall response rate (ORR) of 75% (95% CI, 64%-83%), including a complete response (CR) rate of 59% (95% CI, 48%-69%) and a median duration of response (DOR) of 22.4 months (95% CI, 16.8-22.8).
The FDA awarded breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for the post-neoadjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease in the breast and/or axillary lymph nodes following neoadjuvant treatment and who are at high risk of disease recurrence.
The designation was supported by findings from the phase 3 DESTINY-Breast05 trial (NCT04622319). Data presented at the
The combination of ceralasertib (AZD6738) and durvalumab (Imfinzi) failed to improve overall survival (OS) vs docetaxel in patients with advanced non–small cell lung cancer (NSCLC) without actionable genomic mutations who experienced disease progression on prior immunotherapy and platinum-based chemotherapy, missing the primary end point of the phase 3 LATIFY trial (NCT05450692).
The combination regimen was generally well tolerated, and ceralasertib plus durvalumab displayed a safety profile consistent with the known toxicities of each agent. Data from LATIFY will be presented at a future medical meeting.
The biparatopic HER2-targeted antibody-drug conjugate JSKN003 received FDA breakthrough therapy designation for the treatment of adult patients with advanced or metastatic, platinum-resistant, recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancers with a HER2 expression of 1+, 2+, and 3+ by immunohistochemistry who have received prior treatment with bevacizumab (Avastin).
Findings from a pooled analysis of the phase 1 JSKN003-101 (NCT05494918) and phase 1/2 JSKN003-102 (NCT05744427) clinical trials supported the regulatory decision, and the demonstrated that patients with platinum-resistant ovarian cancer who received JSKN003 (n = 46) achieved an ORR of 63.0% (95% CI, 47.5%-76.8%), with a CR rate of 4.3% and a disease control rate of 93.5% (95% CI, 82.1%-98.6%). At a median follow-up of 9.3 months, the median progression-free survival was 7.7 months (95% CI, 5.7-9.7), and the 9-month OS rate was 89.9% (95% CI, 75.0%-96.1%).
China’s National Medical Products Administration (NMPA) approved pimicotinib (ABSK021) as a systemic treatment for adult patients with symptomatic tenosynovial giant cell tumor for whom surgical resection is expected to result in functional limitation or relatively severe morbidity.
The approval was supported by data from the global phase 3 MANEUVER study (NCT05804045), which showed that patients treated with pimicotinib experienced an objective response rate (ORR) of 54.0% at week 25 per RECIST 1.1 criteria as assessed by a blinded independent review committee vs 3.2% for those given placebo (P < .0001).