Oncology Report – August 2025


Oncology Updates — August 2025

August 2025 delivered practice-relevant oncology updates worldwide — fresh guideline shifts, pivotal trial readouts, new approvals, diagnostics/devices, and high-impact AI tools. Below is a concise, clinician-first roundup, capped with a focused deep dive on the updated ASCO NSCLC guidelines. 🎗️

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📋Clinical findings & guideline changes

ASCO updates NSCLC pathways (driver+ and driver–)

Living guideline revision widens targeted options (HER2/MET/RET/NTRK) and refines IO strategies by PD-L1 status and stage.

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KEYNOTE-585: pembro+chemo misses OS in advanced gastric cancer

Final analysis shows no OS advantage over chemotherapy alone despite earlier promise.

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Breastfeeding after breast cancer in BRCA carriers appears safe

Emerging evidence supports breastfeeding in survivorship planning for BRCA-mutated patients.

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💊New drugs

Zongertinib gets FDA AA for HER2+ NSCLC

New HER2-targeted option based on early response data in a defined NSCLC subset.

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Dordaviprone (Modeyso) wins FDA AA for diffuse midline glioma

Addresses H3 K27M-mutated disease in pediatric and young adult populations.

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Nirogacestat approved in EU for desmoid tumors

Gamma-secretase inhibitor expands access for patients with desmoid tumors across Europe.

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🛠️Diagnostics & devices

MMR IHC pharmDx approved as CRC IO companion diagnostic

Enables nivolumab/ipilimumab selection in MSI-H/dMMR colorectal cancer.

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Haystack MRD test gains FDA Breakthrough Device designation

Stage II CRC assay may refine adjuvant decisions by detecting minimal residual disease.

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Early device study shows high bladder tumor clearance

Minimally invasive approach eliminated tumors in 4 of 5 cases in preliminary data.

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🤖Specialty software & AI

ArteraAI Prostate: first FDA-cleared AI prognostic in oncology

Regulatory milestone for AI-based long-term outcome prediction in prostate cancer.

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Mount Sinai debuts AI to enhance tissue analysis

Institutional platform aims to speed and standardize histopathology interpretation.

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🎯Deep Dive — ASCO NSCLC Guideline Revisions

What changed and why it matters for clinic tomorrow

Driver-positive disease: Clearer first-line sequences and expanded targeted options for HER2, MET, RET, and NTRK alterations; reinforce rapid reflex testing to avoid chemo/IO missteps.

Driver-negative disease: Immunotherapy pathways refined by PD-L1 strata; guidance on combinations vs monotherapy and sequencing at progression.

Stage III/IV: Consolidation IO after CRT clarified with timing/selection points; emphasis on sustained surveillance and toxicity management.

Diagnostics: Upfront comprehensive molecular profiling and PD-L1 testing emphasized to anchor first-line decision-making.

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Sharing the latest updates in oncology

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Regeneron Acquires 23andMe Research Division for $256M in Bankruptcy Auction Context: As 23andMe navigates Chapter 11 proceedings, key assets tied to its vast genomic database and pharma partnerships have drawn industry attention. What's New? Regeneron has secured a $256 million deal to acquire 23andMe’s therapeutics subsidiary, aiming to leverage the platform’s extensive genotypic and phenotypic data to fuel its precision medicine pipeline. Why it Matters? This acquisition gives Regeneron a...

Cullinan and Taiho Reveal Positive NSCLC Data Ahead of FDA Filing Context: Cullinan Oncology and Taiho are developing CLN-081, an EGFR exon 20 insertion–targeting therapy for NSCLC—a mutation subtype with limited approved options. What's New? At ASCO, the companies presented data showing a response rate of 41% and a 12.7-month median duration of response for CLN-081. The results are expected to support an FDA submission in the second half of 2024. Why it Matters? These findings position...

Roche’s Itovebi Cuts Risk of Death by 33% in HER2-Positive Breast Cancer Context: HER2-positive breast cancer remains an aggressive subtype despite advances in targeted therapies. What's New? In updated data presented at ASCO, Roche’s anti-HER2 therapy Itovebi (trastuzumab duocarmazine) reduced the risk of death by 33% in pretreated HER2-positive breast cancer, significantly improving overall survival compared to standard therapies. Why it Matters? This reinforces Itovebi’s growing role in...