The OncFive: Top Oncology Articles for the Week of 4/13

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 Receives sBLA for Nogapendekin Alfa Inbakicept in Papillary NMIBC

The regulatory agency has received a supplemental biologics license application seeking the approval of nogapendekin alfa inbakicept-pmln (Anktiva) for use in patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with papillary disease, which was supported by findings from cohort B of the phase 2/3 QUILT-3.032 trial (NCT0302285). At a median follow-up of 20.7 months (range, 2.9-37.1), the agent led to a median disease-free survival (DFS) of 19.3 months (95% CI, 7.4-not reached) in those with papillary NMIBC. The 12-month DFS rate 55.4% (95% CI, 42.0%-66.8%); the 18- and 24-month DFS rates were 51.1% (95% CI, 37.6%-63.1%) and 48.3% (95% CI, 34.5%-60.7%).

Bexmarilimab Plus Azacitidine Meets ORR End Point in R/R Higher-Risk MDS

The primary end point of the phase 2 BEXMAB study (NCT05428969) was met when bexmarilimab (FP-1305) paired with azacitidine (Vidaza) elicited an overall response rate (ORR) of 63% in patients with relapsed or refractory higher-risk myelodysplastic syndrome (MDS). Topline data also showed that the median overall survival (OS) was consistent with what has previously been reported in this population. The population of patients with treatment-naive higher-risk MDS achieved a slightly higher ORR of 76%. The full dataset from the analysis has been submitted for presentation at the 2025 ASCO Annual Meeting. “This is one of the strongest datasets ever seen in an all-comer population of treatment-resistant high-risk MDS,” Juho Jalkanen, MD, PhD, of Faron Pharmaceuticals, stated in a news release.

Apalutamide Boosts 24-Month OS in Real-World Metastatic Castration-Sensitive Prostate Cancer

Data shared during the 50th Annual Oncology Nursing Society Congress showed that apalutamide (Erleada) provided consistent 24-month OS benefits in real-world patients with metastatic castration-sensitive prostate cancer (mCSPC) as those treated in the phase 3 TITAN trial (NCT02489318). Twenty-four months after treatment initiation, those who were not previously treated with androgen receptor pathway inhibitors and received apalutamide experienced a 23% reduction in the risk of death vs those treated with enzalutamide (Xtandi; HR, 0.77; 95% CI, 0.62-0.96; P = .019). Patients treated with apalutamide after 24 months post-index had a 26% reduction in the risk of death vs those treated with abiraterone acetate (Zytiga; HR, 0.74; 95% CI, 0.59-0.93; P = .010).

Bria-IMT Plus Checkpoint Inhibition Yields Potential OS Benefit in Pretreated HR+ Breast Cancer

Findings from a phase 2 study (NCT03328026) showed that when Bria-IMT (SV-BR-1-GM) paired with immune checkpoint inhibition resulted in OS outcomes that exceeded historical data reported with the antibody-drug conjugate sacituzumab govitecan-hziy (Trodelvy) in heavily pretreated patients with metastatic hormone receptor–positive breast cancer. The median OS was 17.3 months in patients who received the cell-based immunotherapy with retifanlimab (Zynyz; n = 25). “We look forward to further confirming this clinical data in our ongoing pivotal phase 3 [BRIA-ABC] study [NCT06072612] with OS as its primary end point,” William V. Williams, MD, of BriaCell Therapeutics, stated in a news release.

MRD-Guided Zanubrutinib Triplet Induces Deep Remissions in R/R CLL

Findings from the phase 2 CLL2-BZAG study (NCT04515238) indicated that time-limited, minimal residual disease (MRD)–guided treatment with the triplet regimen comprised of zanubrutinib (Brukinsa), venetoclax (Venclexta), and obinutuzumab (Gazyva) resulted in deep MRD responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). All patients in the full analysis set (n = 40) responded, 7.5% experiencing complete responses (CR) or CRs with incomplete marrow recovery (CRi) and 92.5% experiencing partial responses. Moreover, 52.5% of patients achieved undetectable MRD in peripheral blood (95% CI, 36.1%-68.5%), including 40% of those with prior exposure to a BTK inhibitor and/or venetoclax and 53.3% of those with TP53 aberrations.