The OncFive: Top Oncology Updates for the Week of 6/1

Welcome to OncLive®’s OncFive!

Every week, we bring you a quick roundup of the 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:

The 2025 ASCO Annual Meeting

The eyes of the oncology world shifted to Chicago in the final days of May and early days of June for the 2025 ASCO Annual Meeting, which again featured a wealth of new research and potentially practice-changing data. In particular, the breast cancer space saw new phase 3 data read out across multiple subtypes, including the DESTINY-Breast09 trial (NCT04784715) in HER2-positive breast cancer; the SERENA-6 (NCT04964934) and VERITAC-2 (NCT05654623) studies in hormone receptor–positive disease; and the ASCENT-04/KEYNOTE-D19 trial (NCT05382286) in triple-negative breast cancer.

To catch up on those presentations and many more, revisit OncLive’s coverage from ASCO 2025.

FDA Approves Darolutamide for mCSPC

On June 3, 2025, the FDA approved darolutamide (Nubeqa) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). This expanded the indication for the androgen receptor pathway inhibitor, which was previously approved in August 2022 in combination with docetaxel for adult patients with mCSPC.

The approval of darolutamide without chemotherapy was supported by data from the phase 3 ARANOTE trial (NCT04736199), which showed that patients treated with darolutamide plus androgen deprivation therapy (ADT; n = 446) experienced a median radiographic progression-free survival that was not reached (NR; 95% CI, NR-NR) compared with 25.0 months (95% CI, 19.0-NR) for those given ADT plus placebo (n = 223; HR, 0.54; 95% CI, 0.41-0.71; P < .0001).

FDA Grants Priority Review to Ziftomenib in NPM1-Mutant R/R AML

The FDA has granted priority review to the new drug application (NDA) seeking the full approval of ziftomenib (KO-539) for the treatment of adult patients with relapsed/refractory acute myeloid leukemia (AML) harboring an NPM1 mutation. This NDA is based on data from phase 1/2 KOMET-001 trial (NCT04067336); findings from the study presented at ASCO demonstrated that at a median follow-up of 4.1 months (range, 0.1-19.7), patients treated during the phase 2 portion of the study (n = 92) experienced a complete remission (CR)/CR with partial hematologic recovery (CRh) rate of 23%. The CR rate was 14%, and the CRh rate was 9%. Patients experienced an overall response rate (ORR) of 33%, with respective rates of CR with incomplete hematologic recovery/CR with incomplete platelet recovery, morphologic leukemia-free state, and partial response of 3%, 5%, and 1%.

NCCN Adds 2 Tests to CRC Screening Guidelines

In its latest update to the Guidelines for Colorectal Cancer (CRC) Screening, the National Comprehensive Cancer Network (NCCN) added both the ColoSense test and Shield test. ColoSense is a noninvasive stool-based test that, in May 2024, was FDA-approved as a screening test for adults 45 years of age or older who are at typical average risk for developing CRC.

Shield is designed to detect CRC signals in the bloodstream via circulating tumor DNA; this test was also FDA approved in July 2024 for CRC screening in adults 45 years of age and older who are at average risk for developing the disease. Notably, the NCCN Guidelines recommend Shield only for patients who are not willing to undergo screening through another modality, due to "its modest performance, particularly among advanced precancerous lesions."

Experts Underscore the Top Abstracts to Watch at the 2025 EHA Congress

Although ASCO 2025 is now in the rearview mirror, it’s time to look ahead to the next big meeting: the 2025 EHA Congress. Before the meeting kicks off in Milan, Italy, on June 12, OncLive asked experts from across the hematologic oncology field to preview some of the top abstracts they’re anticipating at the Congress.