The OncFive: Top Oncology Articles for the Week of 8/17

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:

Adjuvant Atezolizumab Boosts DFS, OS in MIBC After Positive MRD Test

Adjuvant atezolizumab (Tecentriq) led to a significant improvement in disease-free survival (DFS) and overall survival (OS) vs placebo in patients with muscle-invasive bladder cancer who had minimal residual disease (MRD) positive by the Signatera assay and free from recurrence on imaging, according to topline data from the phase 3 IMvigor011 trial (NCT04660344). Approximately 760 patients were enrolled into surveillance after surgery, and those who tested MRD positive within 1 year were randomly assigned to receive atezolizumab or placebo. Full data will be shared at an upcoming medical meeting, and Natera intends to submit a premarket approval application to the FDA to seek approval of Signatera as a companion diagnostic. Previously reported data from IMvigor011 showed favorable 12- and 18-month survival outcomes in patients who remained MRD negative during the surveillance period.

FDA Approves MMR IHC Panel pharmDx as a Companion Diagnostic for Nivolumab/Ipilimumab in MSI-H/dMMR CRC

The FDA approved the MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic to identify patients with mismatch repair–deficient (dMMR) colorectal cancer (CRC) eligible for treatment with nivolumab (Opdivo) alone or with ipilimumab (Yervoy). The panel, used exclusively with the Agilent Dako Omnis system, is the only FDA-approved immunohistochemistry-based test that detects loss of MLH1, PMS2, MSH2, and MSH6 proteins in formalin-fixed paraffin-embedded CRC tissue. This decision follows the approval of the doublet in April 2025 for patients aged 12 years and older with dMMR or microsatellite instability–high unresectable or metastatic CRC. Supporting data from the phase 3 CheckMate-8HW trial (NCT04008030) showed significantly improved progression-free survival (PFS) with the combination compared with nivolumab alone.

Novocure Files Premarket Approval Application to FDA for Tumor Treating Fields in Locally Advanced Pancreatic Cancer

A premarket approval application has been submitted to the FDA for Tumor Treating Fields (TTFields) in locally advanced pancreatic cancer, with a decision expected in the second half of 2026. The application is supported by data from the phase 3 PANOVA-3 trial (NCT03377491), in which TTFields combined with gemcitabine and nab-paclitaxel (Abraxane) improved OS vs chemotherapy alone. The median OS was 16.2 months with TTFields vs 14.2 months with chemotherapy alone (HR, 0.82; 95% CI, 0.68-0.99; P = .039). Additional analyses showed improvements in pain-free survival and distant progression-free survival, although PFS, local PFS, and objective response rate (ORR) were not improved. TTFields was well tolerated, with the most common device-related adverse effects (AEs) being mild to moderate skin effects.

NCCN Adds Zongertinib to Clinical Practice Guidelines in NSCLC

The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines in Oncology for non–small cell lung cancer to include zongertinib tablets (Hernexeos) as a preferred subsequent therapy for patients with advanced or metastatic HER2-mutant disease after previous systemic therapy. The update, which was issued on August 15, 2025, allows use after progression on first- or second-line therapy in zongertinib-naive patients. The agent was granted accelerated approval from the FDA based on the phase 1 Beamion LUNG-1 trial (NCT04886804), which showed ORRs of 75% in patients previously treated with chemotherapy and 44% in those also exposed to HER2-targeted antibody-drug conjugates (ADCs). Safety was manageable, with most AEs being grade 1 or 2, most commonly diarrhea and rash.

Ifinatamab Deruxtecan Earns FDA Breakthrough Therapy Designation for Extensive-Stage Small Cell Lung Cancer

Ifinatamab deruxtecan (I-DXd), a B7-H3–directed DXd ADC, has received FDA breakthrough therapy designation for patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed following platinum-based chemotherapy. The decision was supported by data from the phase 2 IDeate-Lung01 trial (NCT05280470) and the phase 1/2 IDeate-PanTumor01 trial (NCT04145622). IDeate-Lung01 is a randomized, global, open-label phase 2 study evaluating I-DXd in patients with ES-SCLC who previously received platinum-based chemotherapy; ORR serves as the primary end point. IDeate-PanTumor01 is a first-in-human phase 1/2 trial assessing the safety, efficacy, and pharmacokinetics of I-DXd spanning several advanced solid tumors.

Honorable mention: Removal of REMS Requirements Improves Access to CAR T-Cell Therapy Across Hematologic Malignancies

The FDA has removed the REMS requirements for all approved CD19- and BCMA-directed autologous CAR T-cell therapies, reflecting confidence in the oncology community’s ability to manage toxicities and supported by growing real-world and clinical trial safety data. This decision, which also reduced monitoring requirements for certain products, is expected to ease socioeconomic, geographic, and logistical barriers, significantly expanding patient access to these potentially life-saving treatments.