GENOMIC TESTING

David Craig, PhD, discusses how AI is transforming cancer histopathology.

Data from the phase 2 ROME trial were presented by Andrea Botticelli, MD, during the ESMO Targeted Anticancer Therapies Congress 2025.

Colin P.N. Dinney, MD, PhD, discussed updated analyses of the BOND-003 and CORE-001 trials in bladder cancer.

Rapid breast cancer research offers new hope, as discussed by Joyce O’Shaughnessy, MD, regarding HR+/HER2– and HER2+ disease.

Xiaojie Zhang, MD, and Akshat Singhal, PhD, discuss their research leveraging deep learning to predict how patients with ER+/HER2- breast cancer will respond to palbociclib.

A phase 1 open-label trial is underway, evaluating the safety and efficacy of CT-95 in patients with mesothelin-expressing advanced solid tumors.

The FDA has fully approved larotrectinib for adult and pediatric patients with solid tumors that harbor an NTRK gene fusion.

The FDA is evaluating a new drug application for taletrectinib in patients with ROS1 fusion–positive non–small cell lung cancer.

The FDA cleared the investigational new drug application for ALX2004, with phase 1 trials expected to begin in mid-2025 for EGFR+ solid tumors.

Dual checkpoint inhibitors led to longer overall survival in patients with high-risk endometrial cancer who displayed inactivating PPP2R1A mutations vs patients with wild-type PPP2R1A.

Paige PanCancer Detect has gained FDA breakthrough device designation, a first for AI identifying diverse cancers across tissues.

Vepdegestrant extended PFS vs fulvestrant in patients with ESR1m+, ER+/HER2– breast cancer who progressed on CDK 4/6 inhibitors and endocrine therapy.

The antibody-drug conjugate FOR46 showed the strong potential of using CD46 as a new therapeutic target in metastatic castration-resistant prostate cancer.

The TKI zongertinib is currently being reviewed by the FDA for a potential approval for patients with HER2 mutation–positive non–small cell lung cancer.

Mutant KRAS in ctDNA in patients with localized pancreatic cancer was shown to be a biomarker for metastatic progression and overall survival.

A real-world study reveals the need for increased homologous repair deficiency and BRCA1/2 testing in patients with ovarian and breast cancers.

ST316, a β-catenin/BCL9 antagonist, demonstrated safety, target engagement, and early antitumor activity in advanced solid tumors.

This review discusses the current state of multicancer early detection tests, the role of machine learning in their development, and their implications for oncology practice and patient care.