January 2025 Targeted Pulse

The FDA approved subcutaneous nivolumab for solid tumors, tiselizumab for advanced gastric and GEJ cancers, and key 2024 breast cancer breakthroughs are reviewed. Experts provide perspective on treatment choices for gastric adenocarcinoma and ctDNA monitoring and clearing in HER2-positive breast cancer.

In 2024, lung cancer treatment saw significant strides, including the approval of ensartinib for ALK-positive NSCLC and tarlatamab for SCLC. Advances also included December approvals, promising ADC research in NSCLC, and potential future FDA approvals under consideration.

Nivolumab demonstrated superior efficacy in LA-HNSCC, whereas the combination of durvalumab and cetuximab showed limited success. Abenacianine received fast track designation for lung cancer surgery, the combination of amivantamab and Lazertinib showed OS improvement in NSCLC, and sunvozertinib has been granted priority review status for NSCLC.

Dato-DXd for breast cancer and sotorasib/panitumumab for CRC have gained FDA approval and a new drug is under FDA review for BCG-unresponsive, high-risk NMIBC. We also explore the controversy surrounding CDK4/6 inhibitors in adjuvant breast cancer therapy and discuss the MARIPOSA data for EGFR-mutated NSCLC.

The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer, based on phase 3 DESTINY-Breast06 trial results.

Aspirin reduced recurrence by 50% in PIK3CA-mutated colorectal cancer, the DCISionRT test earned FDA breakthrough status for predicting radiotherapy benefit in DCIS, and nivolumab plus chemotherapy sustained efficacy in gastric/GEJ/esophageal cancers. We also provide an overview of key abstracts from ASCO GI and molecular oncology and how it is changing care.