The OncFive: Top Oncology Articles for the Week of 1/25

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 Daratumumab and Hyaluronidase Plus VRd for Newly Diagnosed Multiple Myeloma

The FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (VRd) for the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma. The regulatory decision was supported by findings from the phase 3 CEPHEUS trial (NCT03652064), in which the Darzalex Faspro combination led to higher minimal residual disease negativity rates than VRd alone, at 52.3% and 34.8%, respectively (P = .0005). Darzalex Faspro regimen also significantly improved progression-free survival (PFS), although median PFS was not reached in either arm (HR, 0.60; 95% CI, 0.41-0.88; P = .0078). Safety data proved to be consistent with the known profile of daratumumab-based therapy, with infections among the most common adverse effects (AEs).

FDA Approves Larger Vial Size for Nelarabine Injection in T-ALL and T-LBL

The FDA cleared a new 375-mg/75-mL vial size of nelarabine injection (SH-111) for use in adult and pediatric patients with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. This marks the second approved vial size for the formulation, after the 250-mg/50-mL vial, and is intended to improve dosing flexibility and reduce drug waste. Nelarabine injection remains indicated for patients whose disease has progressed following at least 2 previous chemotherapy regimens. The decision continues to be supported by complete response data from 2 previous studies, with no randomized trials showcasing a survival benefit.

FDA Accepts BLA for Ivonescimab Plus Chemotherapy in EGFR-Mutant NSCLC After TKI Progression

The FDA accepted a biologics license application for ivonescimab (AK112; SMT112) plus platinum-doublet chemotherapy in the treatment of patients with EGFR-mutated, locally advanced or metastatic nonsquamous non–small cell lung cancer following progression on third-generation EGFR TKIs. The submission was supported by data from the phase 3 HARMONi trial (NCT06396065), which demonstrated a significant PFS benefit with ivonescimab plus chemotherapy (n = 172) vs placebo plus chemotherapy (n = 173), at a median of 6.8 months vs 4.4 months, respectively (HR, 0.52; 95% CI, 0.41-0.66; P < .0001). A trend toward improved overall survival (OS) was observed with ivonescimab (n = 219) vs placebo (n = 219; HR, 0.79; 95% CI, 0.62-1.01; P = .0570). However, the OS data derived from a time point at which the North American and European Union (EU) follow-up data were not yet mature. The Prescription Drug User Fee Act goal date for this application is November 14, 2026.

FDA Approval Sought for Lirafugratinib in Second-Line, FGFR2-Altered Cholangiocarcinoma

A new drug application (NDA) has been submitted to the FDA seeking approval of lirafugratinib (RLY-4008) as a second-line treatment for patients with FGFR2 fusion– or rearrangement–positive cholangiocarcinoma. The application is supported by findings from the phase 1/2 ReFocus trial (NCT04526106), in which FGFR inhibitor–naive patients who had prior chemotherapy (n = 116) achieved an independent review committee–assessed objective response rate of 46.5% (95% CI, 37.1%-56.1%) and a median duration of response of 11.8 months (95% CI, 7.5-13.0). Disease control was observed in 96.5% (95% CI, 91.3%-99.0%) of patients, with a manageable safety profile consistent with selective FGFR2 inhibition. The most common any-grade and grade 3 or higher treatment-related AEs (TRAEs) were nail toxicities (87.9%, 12.1%), Palmar-plantar erythrodysesthesia (81.9%; 32.8%), stomatitis (78.4%; 12.1%).

Third NDA for Rivoceranib/Camrelizumab Is Resubmitted to FDA for Unresectable HCC

The FDA has accepted a third NDA resubmission seeking approval of rivoceranib plus camrelizumab for first-line use in patients with unresectable hepatocellular carcinoma, restarting formal review after 2 prior complete response letters related to manufacturing and inspection issues. Earlier reviews by the regulatory agency did not identify deficiencies in the regimen’s clinical efficacy or safety data, nor concerns with the manufacturing site for rivoceranib. The application is supported by findings from the phase 3 CARES-310 trial (NCT03764293), which showed significant improvements in OS and PFS with rivoceranib plus camrelizumab vs sorafenib (Nexavar). The median OS in the respective arms was 23.8 months (95% CI, 20.6-27.2) vs 15.2 months (95% CI, 13.2-18.5; HR, 0.64; 95% CI, 0.52-0.79; P < .0001); the median PFS in the respective arms was 5.6 months (95% CI, 5.5-7.4) vs 3.7 months (95% CI, 3.1-3.7; HR, 0.54; 95% CI, 0.44-0.67; P < .0001). Grade 3 or higher TRAEs with the combination included hypertension, palmar-plantar erythrodysesthesia syndrome, and elevated liver enzymes.