Significance of TNBC Day: Megan Kruse, MD
Megan Kruse, MD, of Cleveland Clinic, discusses ongoing challenges and treatment evolution for patients with triple-negative breast cancer (TNBC). She emphasized the aggressive nature of TNBC and the need to continue improving outcomes despite overall advances in breast oncology. Kruse unpacked recent 2025 clinical trial findings supporting the integration of immunotherapy and antibody-drug conjugates to enhance standards of care for metastatic TNBC. She underscored the need for a more granular understanding of TNBC subtypes to tailor therapies and optimize treatment efficacy spanning diverse patient populations.
Background of the KEYNOTE-B15 Trial in MIBC: Matthew D. Galsky, MD
Matthew D. Galsky, MD, of Mount Sinai Tisch Cancer Center, discusses the rationale for integrating systemic therapy with radical cystectomy in patients with muscle-invasive bladder cancer (MIBC). He spotlighted the phase 3 KEYNOTE-B15/EV-304 trial (NCT04700124), which is examining enfortumab vedotin-ejfv (EV; Padcev) plus pembrolizumab (Keytruda) in the neoadjuvant and adjuvant setting for cisplatin-eligible patients with MIBC. Although radical cystectomy and neoadjuvant cisplatin-based chemotherapy are standard care, a significant proportion of patients still experience metastatic recurrence, he noted, which underscores the need for combination strategies. He emphasized that previous data from KEYNOTE-905/EV-303 (NCT03924895) in cisplatin-ineligible patients supported the investigation of EV plus pembrolizumab in this broader patient population.
Use of Amivantamab Plus Pembrolizumab and Carboplatin in HNSCC: Ranee Mehra, MD
Ranee Mehra, MD, of the University of Maryland, discusses the addition of pembrolizumab to subcutaneous amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). She highlighted durable responses and tumor shrinkage in cohort 2 of the phase 1/2 OrigAMI-4 study (NCT06385080) among PD-L1–positive patients. Mehra noted that the phase 3 OrigAMI-5 trial (NCT07276399) is evaluating amivantamab plus pembrolizumab and carboplatin compared with standard chemotherapy irrespective of PD-L1 expression, expanding eligibility. She emphasized that this broader enrollment allows more patients to access the combination therapy, with coprimary end points of OS and objective response rate.
Significance of the PANOVA-3 Study for Future TTField Development in Pancreatic Cancer: Vincent J. Picozzi, MD
Vincent Picozzi, MD, of Virginia Mason Medical Center, discusses the FDA approval of Optune Pax for use with gemcitabine and nab-paclitaxel (Abraxane) in patients with locally advanced pancreatic cancer. He highlighted the phase 3 PANOVA-3 trial (NCT03377491), which demonstrated a 2-month median OS improvement and reduced systemic disease progression with tumor treating fields (TTFields). Picozzi noted that PANOVA-3 represents the first positive study in this stage of pancreatic cancer, signifying a historical landmark. He added that the phase 2 PANOVA-4 trial (NCT06390059) is examining TTFields with immunotherapy in metastatic disease, suggesting synergy with evolving therapies like KRAS and PARP inhibitors.