The OncFive: Top Oncology Articles for the Week of 2/2

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:

Encorafenib/Cetuximab Plus Chemo Improves Survival in BRAF V600E+ mCRC

One of the dual primary end points of the phase 3 BREAKWATER trial (NCT04607421) has been met, as encorafenib (Braftovi) paired with cetuximab (Erbitux) and fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) significantly improved progression-free survival over chemotherapy alone when used in the first-line treatment of patients with metastatic colorectal cancer and a BRAF V600E mutation. The regimen was also found to significantly improve overall survival, meeting an important secondary end point of the study. This has “the potential to be practice-changing for this patient population,” Roger Dansey, MD, of Pfizer stated in a news release.”

FDA Accepts BLA for Pertuzumab Biosimilar in HER2+ Breast Cancer

A biologics license application seeking the approval of the biosimilar HLX11 referencing pertuzumab (Perjeta) in the treatment of select patients with HER2-positive breast cancer has been accepted by the regulatory agency for review. The application for the agent is supported by findings from a phase 1 trial (NCT04411550) and a phase 3 trial (NCT05346224). The new drug application for the biosimilar was previously accepted by the National Medical Products Administration of China.

Ziftomenib Meets CR/CRh End Point in NPM1+ AML

The phase 2 KOMET-001 trial (NCT04067336) met its primary end point of complete remission (CR) plus CR with partial hematological recovery rate with ziftomenib given once daily in patients with relapsed or refractory acute myeloid leukemia harboring NPM1 mutations. Moreover, the risk:benefit profile with the menin inhibitor was acceptable, as well as its safety and tolerability in this population. Trial data have been submitted to be shared at an upcoming medical meeting and are intended to support a new drug application submission to the FDA in the second quarter of this year.

OncLive’s FDA Approval Report: The Regulatory Rundown for January 2025

This is your guide to all of the oncologic therapeutic options that the FDA approved for use in January 2025. The roundup provides everything you need to know about these decisions—all the topline findings that supported them and expert insights on what they mean for clinical practice. There were 4 approvals total, spanning mantle cell lymphoma; KRAS G12C–mutated colorectal cancer; unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer; and pretreated HER2-low and -ultralow metastatic breast cancer.

Case Closed: Experts Piece Together the Top Takeaways From 2025 ASCO GI

The 2025 Gastrointestinal Cancers Symposium has officially wrapped, leaving behind a trail of groundbreaking research, debates, and a few ongoing mysteries in the ever-twisting plot of oncology. Over 3 days in San Francisco, California, Only Oncologists in the Building, Emil Lou, MD, PhD, FACP, of University of Minnesota Medical School and M Health Fairview Masonic Cancer Clinic; Shruti Patel, MD, of Stanford Medicine; and Shaalan Beg MD, MBA, FASCO, of UT Southwestern; gathered to crack the case on emerging data. This exclusive roundup comprises their top takeaways from the meeting.