The OncFive: Top Oncology Updates for the Week of 6/8

June 14, 2025

The FDA has approved new options in head and neck cancer, lung cancer, and bladder cancer—and more from OncLive this week.

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 Perioperative Pembrolizumab for Resectable, Locally Advanced HNSCC

The regulatory agency has approved perioperative pembrolizumab (Keytruda) for use in adult patients with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 with a combined positive score (CPS) of 1 or higher, marking a significant shift in treatment for this population. This decision was supported by the phase 3 KEYNOTE-689 trial (NCT03765918), which demonstrated a statistically significant improvement in event-free survival (EFS) compared with standard-of-care adjuvant therapy. The trial also showed a meaningful benefit in major pathological response, with safety findings consistent with prior pembrolizumab studies. Although a numerical trend toward improved overall survival (OS) was noted in patients with a CPS of 10 or higher, formal testing of OS in the broader population is still pending.

**FDA Clears Taletrectinib for ROS1+ Advanced NSCLC**

The FDA has also granted approval to taletrectinib (Ibtrozi) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC), supported by efficacy data from the phase 2 TRUST-I (NCT04395677) and TRUST-II (NCT04919811) trials. In treatment-naive patients, the overall response rate (ORR) exceeded 85%, and those previously treated with a ROS1 TKI experienced ORRs ranging from 52% to 62%, along with encouraging intracranial activity in patients with brain metastases. The drug also demonstrated durable responses, with a median duration of response of over 44 months in TKI-naive patients, and a manageable safety profile characterized primarily by elevated liver enzymes and gastrointestinal effects. Taletrectinib’s approval offers a new, brain-penetrant treatment option in a setting with limited therapies, particularly for patients with central nervous system involvement.

FDA Approves Intravesical Mitomycin for Recurrent, Low-Grade, Intermediate-Risk NMIBC

The regulatory agency decided to greenlight mitomycin intravesical solution (UGN-102; Zusduri) for the treatment of adult patients with recurrent, low-grade, intermediate-risk non–muscle-invasive bladder cancer (NMIBC), based on results from the phase 3 ENVISION trial (NCT05243550) showing a 3-month complete response (CR) rate of nearly 80% and encouraging durability at 12 and 18 months. The therapy, delivered via weekly outpatient instillations, was generally well tolerated, although 12% of patients experienced serious adverse effects (AEs), including rare instances of urinary retention and urethral stenosis. Despite a narrow 5-to-4 FDA Oncologic Drugs Advisory Committee vote against its risk/benefit profile in May 2025 due to concerns over the single-arm trial design, the agency ultimately approved the drug as a nonsurgical option for this patient population. UGN-102’s approval marks a notable advancement for patients with NMIBC, especially those seeking alternatives to repeated surgical interventions.

First-Line Lurbinectedin Plus Atezolizumab Maintenance Under Priority Review for ES-SCLC

The FDA has granted priority review to the supplemental biologics license application seeking approval of lurbinectedin (Zepzelca) plus atezolizumab (Tecentriq) as first-line maintenance therapy for patients with extensive-stage small cell lung cancer (ES-SCLC) following initial induction with atezolizumab, carboplatin, and etoposide, with a decision expected by October 7, 2025. The application is supported by the phase 3 IMforte trial (NCT05091567), which demonstrated significant improvements in progression-free survival (PFS; 5.4 vs 2.1 months) and overall survival (13.2 vs 10.6 months) compared with atezolizumab alone. Additional findings showed higher 12-month survival and response rates, including a confirmed ORR of 19.4% in the combination arm vs 10.4% with monotherapy. The safety profile revealed higher rates of treatment-related AEs with the combination, although most were manageable and consistent with known toxicities.

FDA Lifts Partial Clinical Hold on Phase 3 Trial Evaluating IFx-2.0 in Advanced Merkel Cell Carcinoma

The regulatory agency has lifted the partial clinical hold placed on the phase 3 trial evaluating IFx-2.0 plus pembrolizumab for first-line treatment of advanced or metastatic Merkel cell carcinoma, allowing the study to proceed under a special protocol assessment. The randomized trial will enroll 118 patients to compare IFx-2.0 plus pembrolizumab vs pembrolizumab plus placebo, with ORR serving as the primary end point and PFS representing a key secondary end point. The decision follows promising phase 1b (NCT04160065) data showing that IFx-2.0 may reverse resistance to PD-1/PD-L1 inhibitors, with some patients achieving durable responses after prior progression. If positive, the trial could support regular FDA approval of the combination without the need for a post-marketing confirmatory trial.