The OncFive: Top Oncology Articles for the Week of 12/7

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 Niraparib/Abiraterone Acetate Plus Prednisone for BRCA2+ mCSPC

The FDA cleared niraparib (Zejula) and abiraterone acetate (Zytiga; Akeega) plus prednisone for adult patients with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer based on findings from the phase 3 AMPLITUDE trial (NCT04497844). In this group, treatment with the combination (n = 162) led to a median radiographic progression-free survival that was not estimable (NE; 95% CI, 41-NE) vs 26 months (95% CI, 18-28) with abiraterone acetate alone (n = 161; HR, 0.46; 95% CI, 0.32-0.66). Exploratory analyses showed the rPFS benefit was confined to the BRCA2-mutated population and did not extend to patients without BRCA2 alterations. Safety data were consistent with known toxicities of PARP inhibition and androgen pathway blockade, and included hypertension, cytopenias, fatigue, and gastrointestinal and cardiovascular adverse effects.

FDA Grants Priority Review to sBLA For Nivolumab Plus AVD in Untreated Classical Hodgkin Lymphoma

The regulatory agency also accepted and granted priority review to a supplemental biologics license application seeking approval of nivolumab (Opdivo) plus doxorubicin, vinblastine, and dacarbazine (AVD) for use in adult and pediatric patients aged 12 years or older with previously untreated stage III or IV classical Hodgkin lymphoma. The decision date has been set to April 8, 2026, under the Prescription Drug User Fee Act. The application is supported by data from the phase 3 SWOG S1826 trial (NCT03907488), in which nivolumab plus AVD (n = 487) significantly improved progression-free survival (PFS) vs brentuximab vedotin (Adcetris) plus AVD (n = 483; HR, 0.48; 99% CI, 0.27-0.87; P < .001). The PFS rates in the respective arms at 1 year were 94% (95% CI, 91%-96%) and 86% (95% CI, 82%-90%). The most common any-grade adverse effects (AEs) included nausea, decreased neutrophil count, and fatigue in the nivolumab arm, and nausea, peripheral sensory neuropathy, and fatigue in the control arm.

Toripalimab Plus Chemo Maintains Survival Benefit After 6 Years in Recurrent/Metastatic NPC

After 6 years of follow-up, toripalimab-tpzi (Loqtorzi) combined with gemcitabine and cisplatin maintained an overall survival (OS) advantage over chemotherapy alone in patients with recurrent or metastatic nasopharyngeal carcinoma, according to findings from the phase 3 JUPITER-02 trial (NCT03581786). In an exploratory post-hoc analysis shared during the 2025 ESMO Asia Congress, the median OS was 64.8 months with toripalimab plus chemotherapy vs 33.7 months with chemotherapy alone (HR, 0.62; 95% CI, 0.45-0.85). Earlier results from the study showed significant improvements in PFS and OS, supporting the 2023 FDA approval of toripalimab with cisplatin and gemcitabine in the frontline setting. The safety profile included immune-mediated AEs and common toxicities such as nausea, vomiting, decreased appetite, hypothyroidism, rash, diarrhea, and peripheral neuropathy.

Phase 3 STAR-221 Study of First-Line Domvanalimab/Zimberelimab Plus Chemo in Upper GI Cancers to Be Discontinued

The phase 3 STAR-221 trial (NCT05568095) examining domvanalimab plus zimberelimab and chemotherapy as frontline treatment in patients with advanced gastric and esophageal cancers is being discontinued for futility after an interim OS analysis did not reveal any improvement vs nivolumab plus chemotherapy. The independent data monitoring committee reported comparable safety between the domvanalimab-based regimen and the control arm, with no new signals identified. As a result, the phase 2 EDGE-Gastric study (NCT05329766), which previously showed encouraging efficacy with domvanalimab plus zimberelimab and chemotherapy, will also be discontinued. Arcus Biosciences and Gilead Sciences stated they are working with investigators to identify next steps for patients and will shift development priorities toward other pipeline programs.

FDA Grants Orphan Drug Designation to Risvutatug Rezetecan for SCLC

The FDA has granted orphan drug designation to risvutatug rezetecan (GSK’227), a B7-H3–targeted antibody-drug conjugate (ADC), as a potential therapeutic option in patients with small cell lung cancer (SCLC) based on preliminary phase 1 ARTEMIS-001 (NCT05276609) data. In those with extensive-stage SCLC, the agent elicited overall response rates ranging from 50% to 61% and disease control rates ranging from 81% to 96%. The median duration of response with the ADC ranged from 6.4 months to 8.9 months, and median progression-free survival ranged from 5.9 months to 7.3 months. Safety data revealed grade 3 or higher treatment-related AEs like decreased neutrophils, white blood cells, lymphocytes, platelets, and anemia. The trial enrolled adults with advanced solid tumors, including SCLC previously treated with platinum-based chemotherapy, and demonstrated activity independent of B7-H3 expression.

Honorable Mention: This week, the FDA also approved omidubicel-onlv (Omisirge) for use in adults and pediatric patients 6 years or older with severe aplastic anemia after reduced-intensity conditioning and for whom a compatible donor is not available, making it the first hematopoietic stem cell transplant therapy cleared to treat patients with this condition.