The OncFive: Top Oncology Articles for the Week of 4/20

April 26, 2025

Penpulimab gets green light from FDA for nasopharyngeal carcinoma, sacituzumab govitecan combination boosts PFS in TNBC, and more.

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 Penpulimab for Non-Keratinizing Nasopharyngeal Carcinoma

The regulatory agency approved penpulimab-kcqx in combination with platinum-based chemotherapy for first-line use in adult patients with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma, and as a monotherapy in patients with disease progression after prior therapies. The combination approval was based on the phase 3 AK105-304 study (NCT049743980), which showed a median progression-free survival (PFS) of 9.6 months (95% CI, 7.1-12.5) with penpulimab (n = 144) vs 7.0 months (95% CI, 6.9-7.3) with placebo plus chemotherapy (n = 147; HR, 0.45; 95% CI, 0.33-0.62; P < .0001). The single-agent approval was supported by the phase 2 AK105-202 study (NCT03866967), in which penpulimab (n = 125) elicited an overall response rate of 28% (95% CI, 20%-37%) with a median duration of response that was not yet reached (95% CI, 9.2-not evaluable). The agent was generally well tolerated, although common toxicities included hypothyroidism, nausea, and musculoskeletal pain.

Sacituzumab Govitecan Plus Pembrolizumab Improves PFS in PD-L1+ mTNBC

Data from the phase 3 ASCENT-04/KEYNOTE-D19 study (NCT05382286) showed that the combination of sacituzumab govitecan-hziy (Trodelvy) and pembrolizumab (Keytruda) led to a PFS improvement compared with pembrolizumab paired with chemotherapy in patients with treatment-naive, PD-L1–positive, metastatic triple-negative breast cancer. An early trend toward an overall survival improvement was also reported with the doublet, although data remain immature. “These data suggest that the combination of sacituzumab govitecan and pembrolizumab may offer a new treatment approach—bringing together a potent antibody-drug conjugate with immunotherapy to improve outcomes for patients,” Sara Tolaney, MD, MPH, of Dana-Farber Cancer Institute, stated in a news release.

T-DXd/Pertuzumab Yields PFS Benefit vs THP in HER2+ Metastatic Breast Cancer

In the phase 3 DESTINY-Breast09 trial (NCT04784715), the combination of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) and pertuzumab (Perjeta) significantly improved PFS vs standard taxane plus trastuzumab (Herceptin) and pertuzumab (THP) in the first-line treatment of HER2-positive metastatic breast cancer. This PFS benefit was consistent across all prespecified patient subgroups, and although OS data were not yet mature, early trends favored the T-DXd combination. The safety profile of the combination therapy was consistent with known profiles of the individual agents, and full data will be shared at an upcoming medical meeting. The trial also includes ongoing evaluation of T-DXd monotherapy vs THP, with final PFS data still pending.

First-Line Ivonescimab Plus Chemo Improves PFS in Advanced Squamous NSCLC

The primary end point of the phase 3 HARMONi-6 trial (NCT05840016) was met in that ivonescimab (SMT112) combined with chemotherapy significantly improved PFS vs tislelizumab (Tevimbra) plus chemotherapy in patients with advanced squamous non–small cell lung cancer (NSCLC). The PFS benefit was observed in both PD-L1–positive and –negative populations, supporting ivonescimab’s potential as a first-line treatment regardless of PD-L1 status. The agent demonstrated a safety profile comparable to the control group, with no new safety signals and similar rates of severe bleeding events. “With its combined immune and antiangiogenic mechanisms, ivonescimab offers a promising new treatment option for patients with advanced squamous carcinoma,” Shun Lu, MD, PhD, of Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, stated in a news release.

Oncology Experts Preview Top Abstracts From AUA 2025

In this exclusive preview, the following experts spotlight what presentations they are most excited to learn more about during the 2025 American Urological Association Annual Meeting: Roberto Contieri, MD, of IRCCS Istituto Nazionale Tumori, Fondazione “G. Pascale”; Alireza Ghoreifi, MD, of Duke University; and Mark D. Tyson, II, MD, MPH, of Mayo Clinic. A couple to make the list include abstracts PD12-01 and MP15-05 spotlighting the use of UGN-102 in non–muscle-invasive bladder cancer. Sign up to access the rest of the list and check back for additional coverage from the meeting.

Interested in healthcare news beyond the realm of oncology? Check out The HCPFive, from our sister publication HCPLive.