The OncFive: Top Oncology Articles for the Week of 3/15

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 Nivolumab Plus AVD for Untreated Classical Hodgkin Lymphoma

The FDA approved nivolumab (Opdivo) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients aged 12 years or older with previously untreated, stage III or IV classical Hodgkin lymphoma. This decision was supported by findings from Study CA209-8UT (NCT03907488). At a median follow-up of 13.7 months, the median progression-free survival (PFS) was not reached (NR) with nivolumab/AVD vs brentuximab vedotin (BV; Adcetris)/AVD; PFS outcomes favored the nivolumab arm (HR, 0.42; 95% CI, 0.27-0.67; P < .0001). After a median follow-up of 36.7 months, the median overall survival (OS) was NR in either arm with a total of 26 deaths; 1.8% deaths occurred in the nivolumab/AVD arm, and 3.4% deaths were reported in the BV/AVD arm. The agency also granted traditional approval to nivolumab for adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or after at least 3 previous lines of systemic therapy, including autologous HSCT.

FDA Approves MyChoice CDx Companion Diagnostic for Niraparib in Ovarian Cancer

The FDA cleared the MyChoice CDx Test as the companion diagnostic to identify patients with homologous recombination deficiency–positive advanced ovarian cancer eligible to receive niraparib (Zejula). The decision was supported by data from the phase 3 PRIMA trial (NCT02655016), in which the test was leveraged to identify and stratify patients by HRD status. In the study, niraparib significantly improved median PFS to 21.9 months (95% CI, 19.3-not evaluable [NE]) vs 10.4 months (95% CI, 8.1-12.1) with placebo (HR, 0.43; 95% CI, 0.31-0.59; P < .0001); 5-year PFS rates with the respective approaches were 35% and 16%. Niraparib led to a 5% reduction in the risk of death vs placebo, with a median overall survival of 71.9 months (95% CI, 55.5-NE) with niraparib vs 69.8 months (95% CI, 51.6-NE) with placebo (HR, 0.95; 95% CI, 0.71-1.29).

FDA Accepts NDA for Bezuclastinib for Nonadvanced Systemic Mastocytosis

The regulatory agency accepted a new drug application seeking approval of bezuclastinib (CTG9486) for the treatment of patients with nonadvanced systemic mastocytosis and set a Prescription Drug User Fee Act decision date of December 30, 2026. Findings from the phase 2 SUMMIT trial (NCT05186753) through 48 weeks showcased progressive and sustained improvements in symptoms over time, suggesting the potential for durable clinical benefit with extended treatment. Findings also highlighted the impact of bezuclastinib on bone mineral density and signals suggestive of disease modification. The agent had an acceptable safety profile. Any-grade treatment-emergent adverse effects (TEAEs) occurred in 98.3% of patients, most commonly hair color changes, altered taste, and nausea. Serious TEAEs were reported in 4.2% of patients.

Talazoparib Plus Enzalutamide Hits Primary End Point in HRR Gene–Mutated mCSPC

Talazoparib (Talzenna) plus enzalutamide (Xtandi) significantly improved radiographic progression-free survival vs enzalutamide alone in patients with homologous recombination repair gene–mutated metastatic castration-sensitive prostate cancer, meeting the primary end point of the phase 3 TALAPRO-3 study (NCT04821622). A strong trend toward improvement in terms of OS in favor of the combination arm was also reported at the time of the interim analysis. Moreover, secondary end points, including overall survival, overall response rate, duration of response, and time to prostate-specific antigen progression, also favored the combination. The results will be submitted for presentation and discussed with global health authorities for possible regulatory submissions.

GLSI-100 Yields Low Recurrence Rate in High-Risk HER2+ Breast Cancer After Perioperative Therapy

In the open-label portion of the phase 3 FLAMINGO-01 trial (NCT05232916), GLSI-100 immunotherapy led to a recurrence rate of less than 1% per year in patients with HLA-A02–negative, HER2-positive breast cancer who had residual disease or a high-risk pathologic complete response at surgery and who had completed trastuzumab-based therapy. These data compare favorably with the 4% annual recurrence reported in the historical KATHERINE trial (NCT01772472), according to Greenwich LifeSciences. The double-blind portion of FLAMINGO-01 is ongoing in patients with HLA-A02–positive disease, randomized to GLSI-100 plus granulocyte-macrophage colony-stimulating factor or placebo over 3 years. Preliminary safety and immune response data in the open-label cohort were consistent with prior phase 2b (NCT00524277) findings.

Honorable Mentions

• The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology to include nogapendekin alfa inbakicept-pmln (Anktiva) plus BCG for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary-only disease. The guidelines for bladder cancer were also updated to include nadofaragene firadenovec-vncg (Adstiladrin) as a category 2A recommendation for the treatment of patients with BCG-unresponsive NMIBC with papillary tumors (+Ta/T1) without carcinoma in situ.
• The NCCN also updated its Clinical Practice Guidelines in Oncology for breast cancer to categorize sacituzumab govitecan-hziy (Trodelvy) as a category 1 preferred regimen for the first-line treatment of patients with metastatic triple-negative breast cancer whose disease is PD-L1 negative and has no germline BRCA1/2 pathogenic variants.