The OncFive: Top Oncology Articles for the Week of 3/29

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 Brexu-Cel for Relapsed/Refractory MCL

The FDA has converted brexucabtagene autoleucel (Tecartus; brexu-cel) to traditional approval for adult patients with relapsed/refractory mantle cell lymphoma (MCL), based on findings from the phase 2 ZUMA-2 trial (cohorts 1 and 2, NCT02601313; cohort 3, NCT04880434). In the confirmatory cohort 3, which enrolled patients naive to BTK inhibition and who had received a median of 1 prior line of therapy, evaluable patients (n = 86) experienced an overall response rate (ORR) of 91% (95% CI, 82.5%-95.9%), which included a complete response (CR) rate of 79% (95% CI, 69.0%-87.1%). At a median follow-up of 23.0 months, the median duration of response was not reached (95% CI, 26.2 months-not evaluable). In the heavily pretreated cohort 1, who had received a median of 3 prior lines of therapy (n = 60), the ORR was 87% (95% CI, 75%-94%) and the CR rate was 62% (95% CI, 48%-74%) at a median follow-up of 8.6 months. Pooled safety data (n = 168) showed cytokine release syndrome (CRS) in 93% of patients (grade ≥ 3, 12%) and neurologic events in 80% (grade ≥ 3, 33%).

FDA Grants Priority Review to Lirafugratinib for FGFR2+ Pretreated Cholangiocarcinoma

The regulatory agency also accepted and granted priority review to a new drug application (NDA) seeking approval of lirafugratinib (RLY-4008) for second-line use in patients with pretreated cholangiocarcinoma (CCA) harboring FGFR2 fusions or rearrangements. A Prescription Drug User Fee Act (PDUFA) target action date of September 27, 2026, has been set. The NDA was supported by findings from the phase 1/2 ReFocus trial (NCT04526106), in which FGFR inhibitor–naive patients with CCA who had previously received chemotherapy (n = 114) achieved an ORR of 46.5% (95% CI, 37.1%-56.1%) per independent review committee (IRC) assessment, a disease control rate of 96.5% (95% CI, 91.3%-99.0%), and a median DOR of 11.8 months (95% CI, 7.5-13.0). The median progression-free survival (PFS) and overall survival (OS) were 11.3 months (95% CI, 9.2–14.8) and 22.8 months (95% CI, 18.1–27.2), respectively. The safety profile was consistent with on-target FGFR2 inhibition.

FDA Receives NDA Submission for Bezuclastinib in Imatinib-Treated GIST

Cogent Biosciences has completed submission of an NDA to the FDA for bezuclastinib in combination with sunitinib (Sutent) in patients with gastrointestinal stromal tumors (GIST) previously treated with imatinib (Gleevec). The application was submitted under the regulatory agency’s Real-Time Oncology Review program and was supported by findings from the phase 3 PEAK trial (NCT05208047), which showed that bezuclastinib plus sunitinib significantly improved median PFS vs sunitinib monotherapy at 16.5 months and 9.2 months, respectively (HR, 0.50; 95% CI, 0.39-0.65; P < .0001). The ORRs also favored the combination, at 46% and 26%, respectively (P < .0001). The combination was generally well tolerated with no unique safety signals vs sunitinib monotherapy. Full PEAK data are planned for presentation at a major medical meeting in the first half of 2026. Moreover, a phase 2 trial examining bezuclastinib plus sunitinib in the first-line setting for patients with GIST with exon 9 mutations is set to launch this quarter.

FDA Extends Review of BLA for Orca-T in Hematologic Malignancies

The regulatory agency has extended its review of the biologics license application (BLA) for Orca-T in patients with hematologic malignancies, setting a new PDUFA target action date of July 6, 2026, after submission of updated chemistry, manufacturing, and controls information classified as a major amendment. No additional clinical data were requested. The BLA was supported by data from the phase 3 Precision-T trial (NCT04013685), in which Orca-T significantly improved 1-year moderate-to-severe chronic graft-vs-host disease (GVHD)–free survival vs conventional allogeneic hematopoietic stem cell transplant (allo-HSCT) in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS; 78% [95% CI, 65%-87%] vs 38% [95% CI, 26%-51%]; HR, 0.26; P < .00001; vs control). The 1-year OS rate was 94% (95% CI, 86%-97%) with Orca-T vs 83% (95% CI, 73%-90%) with allo-HSCT (HR, 0.49; P = .11823), and non-relapse mortality was 3% vs 13%, respectively. Grade 3/4 acute GVHD occurred in 6% of patients in the Orca-T arm vs 17% of patients in the allo-HSCT arm, with no new safety signals identified. Orca Bio noted that the manufacturing amendment does not appear to affect the risk-benefit conclusion of the application.

Neoadjuvant Anbenitamab Plus Docetaxel Elicits Responses in HER2+ Early Breast Cancer

Data from the phase 3 Neo-Healer trial (KN026-004; NCT06747338) showed that neoadjuvant anbenitamab (KN026), a HER2-directed bispecific antibody, plus albumin-bound docetaxel (HB1801) led to a statistically significant improvement in total pathologic complete response rate by blinded independent review committee (BIRC) assessment vs standard treatment in patients with HER2-positive early or locally advanced breast cancer. The trial randomly assigns patients 1:1 to receive anbenitamab plus albumin-bound docetaxel with or without carboplatin, or trastuzumab (Herceptin) plus pertuzumab (Perjeta) and docetaxel with or without carboplatin, with a planned enrollment of 520 patients. Detailed efficacy data are planned for presentation at an upcoming international academic meeting. Anbenitamab has also received breakthrough therapy designation from the National Medical Products Administration of China for HER2-positive gastric cancer, and an orphan drug designation from the FDA for HER2-positive or -low gastric cancer.

Honorable Mentions

• The exclusive March 2026 regulatory roundup provides everything you need to know, right at your fingertips—all the topline data that supported the decisions and expert insights detailing clinical practice implications.
• During CRC Awareness Month, OncLive sat down with Jeremy Kortmansky, MD, to discuss frequently asked questions about the complexities of colorectal cancer (CRC) management and the rising incidence of the disease in young adults. The exclusive FAQ, adapted from the conversation, provides clinical insights into potential risk factors for CRC in young adults, gaps in screening and early symptom identification contributing to this phenomenon, and more.