The OncFive: Top Oncology Articles for the Week of 3/22

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 Relacorilant Plus Nab-Paclitaxel for Platinum-Resistant Ovarian Cancer

The FDA has approved relacorilant (Lifyorli) plus nab-paclitaxel (Abraxane) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received 1 to 3 systemic regimens, including at least one with bevacizumab (Avastin). The decision was based on findings from the phase 3 ROSELLA trial (NCT05257408), in which the combination (n = 188) led to a median progression-free survival (PFS) of 6.5 months (95% CI, 5.6-7.4) vs 5.5 months (95% CI, 3.9-5.9) with nab-paclitaxel alone (n = 193; HR, 0.70; 95% CI, 0.54-0.91; P = .0076). The median overall survival (OS) also favored the combination at 16.0 months (95% CI, 13-18.3) vs 11.9 months (95% CI, 10-13.8) with monotherapy (HR, 0.65; 95% CI, 0.51-0.83; P = .0004). Safety considerations include neutropenia, severe infections, and adrenal insufficiency, with a contraindication in patients requiring corticosteroids for life-saving indications.

Selinexor Plus Ruxolitinib Hits SVR Primary End Point in Myelofibrosis

The phase 3 SENTRY trial (NCT04562389) showed that adding selinexor (Xpovio) to ruxolitinib (Jakafi) significantly improved spleen volume reduction of 35% or more (SVR35) at week 24 vs placebo plus ruxolitinib, at 50% vs 28%, respectively (1-sided P < .0001) in JAK inhibitor–naive patients with myelofibrosis. However, the co-primary end point of absolute total symptom score improvement at week 24 was not met, with both arms achieving comparable symptom relief from baseline (9.89-point improvement vs. 10.86-point improvement). An immature OS analysis revealed a favorable trend for the selinexor arm (HR, 0.43; 95% CI, 0.19-1.00), although data require further follow-up. The toxicity profile was in line with known toxicities of each agent, with higher rates of thrombocytopenia (59% vs 43%), nausea (57% vs 17%), and grade 3 or higher treatment-emergent adverse effects (TRAEs; 70% vs 50%) in the combination (n = 234) vs the placebo (n = 116) arm. Karyopharm Therapeutics plans to meet with the FDA to discuss a supplemental new drug application filing.

Osimertinib Plus Chemotherapy Doubles PFS in EGFR-, TP53-Mutant Advanced NSCLC

Data from the phase 3 TOP trial (NCT04695925), presented at the 2026 European Lung Cancer Congress, showed that osimertinib (Tagrisso) paired with platinum-based doublet chemotherapy (n = 146) nearly doubled median PFS vs osimertinib monotherapy (n = 148), at 34.0 months (95% CI, 24.9-36.4) and 15.6 months (95% CI, 13.0-18.3), respectively (HR, 0.44; 95% CI, 0.32-0.60; P <.001) in patients with EGFR-mutant advanced non–small cell lung cancer harboring concurrent TP53 mutations. A preplanned interim OS analysis also favored the combination, at 48.4 months (95% CI, 42.7-not evaluable [NE]) and 36.5 months (95% CI, 28.1-NE), respectively (HR, 0.57; 95% CI, 0.38-0.88). The overall response rate was higher in the combination vs the monotherapy arm, at 82.9% (95% CI, 75.8%-88.6%) and 71.6% (95% CI, 63.6%-78.7%), respectively. However, grade 3 or higher TRAEs were substantially more common with the combination, including notable rates of anemia, decreased neutrophil count, and hepatic toxicities.

IBCG Risk Stratification Model Is Added to 2026 NCCN Guidelines for IR-NMIBC

The National Comprehensive Cancer Network (NCCN) has incorporated the International Bladder Cancer Group 5-factor clinical risk stratification model into its Clinical Practice Guidelines for intermediate-risk non–muscle-invasive bladder cancer, allowing more individualized treatment decisions. The model stratifies patients into lower- (0 risk factors), intermediate- (1-2), and higher-risk (≥ 3) subgroups based on tumor multifocality, size ≥ 3 cm, early recurrence within 1 year, frequent recurrences (> 1 per year), and prior intravesical therapy failure. A 2024 multicenter retrospective study (n = 677) validated the model, revealing 3-year recurrence rates of 29.5% (95% CI, 23.3%-37.1%), 36.9% (95% CI, 31.5%-42.8%), and 67.5% (95% CI, 55.7%-78.8%) across the lower- (n = 231), intermediate- (n = 364), and higher-risk (n = 82) subgroups, respectively. Patients in the intermediate and higher-risk subgroups had significantly worse recurrence-free survival vs the lower-risk subgroup (HR, 1.47; 95% CI, 1.08-2.01; P = .013 and HR, 3.36; 95% CI, 2.31-4.91; P < .001, respectively).

EMA Approves Daratumumab Administration by Patients/Caregivers for Multiple Myeloma

The European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use has approved a Type II variation allowing patients with multiple myeloma or their caregivers to self-administer subcutaneous daratumumab (Darzalex) starting from the fifth dose, making it the first oncology injectable cleared for self-administration in Europe. The updated label covers all 10 previously approved EMA indications for subcutaneous daratumumab across newly diagnosed and relapsed/refractory multiple myeloma settings, as well as newly diagnosed systemic light chain amyloidosis. Self-administration is allowed after appropriate assessment by a healthcare professional and completion of proper training, with the established toxicity profile and efficacy of daratumumab remaining unchanged.