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 Grants Accelerated Approval to Telisotuzumab Vedotin In Pretreated Advanced NSCLC With c-MET Overexpression
The FDA has granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis), a first-in-class antibody-drug conjugate (ADC), for adults with previously treated, locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) exhibiting high c-MET protein overexpression. Approval was supported by the phase 2 LUMINOSITY trial (NCT03539536), which demonstrated a 35% overall response rate (ORR) and a median duration of response (DOR) of 7.2 months in this patient population. Concurrently, the regulatory agency greenlit Roche’s VENTANA MET (SP44) RxDx Assay as a companion diagnostic to identify eligible patients via immunohistochemistry. Safety findings were consistent with known ADC toxicities, including peripheral neuropathy and fatigue. This decision marks a significant step forward for biomarker-driven lung cancer therapy, addressing a critical unmet need in patients with high c-MET expression.
FDA Approves Retifanlimab for Advanced Anal Cancer
The FDA has cleared retifanlimab-dlwr (Zynyz) paired with carboplatin and paclitaxel as a first-line treatment for adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC), and as monotherapy for those with disease progression after platinum-based chemotherapy. These approvals are based on results from the phase 3 POD1UM-303/InterAACT2 trial (NCT04472429), which showed that the combination significantly improved progression-free survival and overall survival (OS) vs chemotherapy alone. Retifanlimab plus chemotherapy achieved a 56% ORR, with a median DOR of 14 months, and showed a manageable toxicity profile with no new safety signals. Data from the phase 2 POD1UM-202 trial (NCT03597295) also supported the monotherapy approval, showing a 14% ORR and disease control in nearly half of previously treated patients. This marks a major advancement for SCAC treatment, addressing a long-standing gap in options for this rare and often overlooked cancer.
FDA Clears Belzutifan for Advanced Pheochromocytoma and Paraganglioma
The FDA has greenlit belzutifan (Welireg) for adults and adolescents aged 12 and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma. The decision is based on data from the phase 2 LITESPARK-015 trial (NCT04924075), where belzutifan achieved a 26% ORR and a median DOR of 20.4 months, with over half of responders maintaining benefit for at least a year. Notably, 32% of patients reduced their use of antihypertensive medications by at least 50% for 6 months or more, signaling a clinical benefit beyond tumor shrinkage. Belzutifan demonstrated a manageable safety profile, with anemia, fatigue, and musculoskeletal pain among the most common adverse effects. This marks the third FDA-approved indication for belzutifan, expanding its role as a targeted therapy across rare and difficult-to-treat tumors.
Breast Cancer Experts Bookmark Top Abstracts to Watch at the 2025 ASCO Annual Meeting
As excitement builds for the 2025 ASCO Annual Meeting, breast cancer experts are closely watching several high-impact studies that could reshape treatment paradigms. Among the most anticipated is the ASCENT-04 trial (NCT05382286), which may establish sacituzumab govitecan-hziy (Trodelvy) plus pembrolizumab (Keytruda) as a new first-line option for PD-L1–positive metastatic triple-negative breast cancer. The SERENA-6 trial (NCT04964934) is also generating buzz for challenging conventional sequencing by using circulating tumor DNA to guide early intervention with camizestrant in hormone receptor–positive, HER2-negative disease. Experts are eager to see if DESTINY-Breast09 (NCT04784715) data will shift the first-line standard in HER2+ metastatic breast cancer by favoring trastuzumab deruxtecan-nxki (Enhertu)–based regimens. Sign up to access the full breast cancer preview.
Lung Cancer Experts Highlight the Most Anticipated Abstracts at the 2025 ASCO Annual Meeting
With the meeting approaching, lung cancer experts are also eagerly anticipating data from several high-stakes trials that are poised to reshape standards of care. Leading the conversation is the phase 3 DeLLphi-304 trial (NCT05740566), where tarlatamab-dlle (Imdelltra) has shown a significant OS benefit over chemotherapy in relapsed small cell lung cancer. The IMforte trial (NCT05091567) is also generating interest for its potential to establish lurbinectedin (Zepzelca) plus atezolizumab (Tecentriq) as a new maintenance regimen in extensive-stage disease. In the non–small cell setting, eyes are on CheckMate 816 (NCT02998528)’s OS update and promising HER2-targeted therapies like BAY 2927088. Additional excitement surrounds novel approaches in stage III disease, EGFR-resistant populations, and adaptive biomarker-driven strategies that signal a shift toward more personalized care. Sign up to access the resource.
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