The OncFive: Top Oncology Articles for the Week of 8/24

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:

FDA Approves 3-Month Version of Leuprolide Mesylate for Advanced Prostate Cancer

The FDA has approved a 3-month, 21-mg subcutaneous depot formulation of leuprolide mesylate (Camcevi ETM) for the palliative treatment of adult patients with advanced prostate cancer. The regulatory decision was supported by data from a global, open-label, single-arm phase 3 trial (NCT03261999), in which 97.9% of patients in the intention-to-treat population (n = 144) achieved castration levels of serum testosterone by day 28, with suppression maintained through day 168. Among evaluable patients (n = 143), 98.6% achieved castration by day 28 with a mean testosterone level of 17.8 ng/dL. No mean increase was noted following the second injection. A 6-month, 42-mg formulation of leuprolide mesylate was previously cleared by the agency in 2021 for the same indication.

FDA to Review Gedatolisib NDA in HR+/HER2–, PIK3CA Wild-Type Advanced Breast Cancer

The FDA has agreed to review a new drug application (NDA) for gedatolisib under its Real-Time Oncology Review program for patients with hormone receptor–positive, HER2-negative advanced breast cancer. Data from the phase 3 VIKTORIA-1 trial (NCT05501886) indicated that gedatolisib combined with fulvestrant (Faslodex) and palbociclib (Ibrance) reduced the risk of disease progression or death by 76% vs fulvestrant alone; the median progression-free survival (PFS) was 9.3 vs 2.0 months, respectively. Gedatolisib plus fulvestrant also reduced the risk of progression or death by 67% vs fulvestrant alone, with a median PFS of 7.4 vs 2.0 months. Celcuity plans to begin rolling submission of the NDA in September 2025 and complete it in the fourth quarter.

Adjuvant Abemaciclib Plus Endocrine Therapy Improves OS in High-Risk HR+/HER2– Breast Cancer

The phase 3 monarchE trial (NCT03155997) demonstrated that adjuvant abemaciclib (Verzenio) plus 2 years of endocrine therapy significantly improved overall survival vs endocrine therapy alone in patients with high-risk, node-positive, hormone receptor–positive, HER2-negative early breast cancer. Sustained benefit in invasive disease-free survival and distant relapse-free survival was also observed in the abemaciclib arm at the 7-year landmark analysis. At the time of analysis, all patients had completed or discontinued abemaciclib, and no new safety signals were observed. Additional data will be presented at an upcoming medical meeting, submitted for publication, and shared with regulatory agencies.

PDS0101 Plus Pembrolizumab Yields Durable Survival Benefit in HPV16+ HNSCC

Final topline data from the phase 2 VERSATILE-002 trial (NCT04260126) showed that Versamune HPV (formerly PDS0101) combined with pembrolizumab (Keytruda) led to a median overall survival of 39.3 months in patients with HPV16-positive recurrent and/or metastatic head and neck squamous cell carcinoma with a combined positive score of at least 1. Outcomes compared favorably with historically published results of 17.9 months for pembrolizumab alone or with chemotherapy. At a median follow-up of 18.4 months, the overall response rate was 35.8%, the disease control rate was 77.4%, and the median duration of response was 21.8 months. The most common treatment-related adverse effects were injection site reactions, fatigue, and headache.

Experts Highlight Key Topics to Watch at the IASLC 2025 World Conference on Lung Cancer

The IASLC 2025 World Conference on Lung Cancer will highlight new data in thoracic oncology, including the management of EGFR-mutated and ROS1-positive non–small cell lung cancer (NSCLC), advances in small cell lung cancer (SCLC), and the role of antibody-drug conjugates (ADCs). Experts, including Ticiana A. Leal, MD; Misako Nagasaka, MD, PhD; and Jacob Sands, MD; previewed the most anticipated abstracts, which include the final overall survival data from the phase 3 FLAURA2 trial (NCT04035486) of osimertinib with or without chemotherapy in EGFR-mutated NSCLC. Other key data include efficacy and safety findings for the ROS1 inhibitor zidesamtinib from the phase 1/2 ARROS-1 trial (NCT05118789), and data for ADCs ifinatamab deruxtecan (IDeate-Lung01; NCT05280470) and ABBV-706 (NCT05147272) in relapsed/refractory SCLC. Sign up to access the exclusive preview.