Welcome to The Five Under 5, your go-to roundup of the top 5 videos of the week.
These short videos are designed for busy oncologists to view on the go, and feature expert insights on breaking news, regulatory updates, practice-changing data shared at medical meetings, and other key topics in the realm of oncology.
Here’s what you may have missed:
FDA Approval of Pembrolizumab Plus Enfortumab Vedotin in MIBC: Matthew D. Galsky, MD
Matthew Galsky, MD, of the Mount Sinai Tisch Cancer Center, examines the significance of the July 2026 Food and Drug Administration (FDA) approval of pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), each in combination with enfortumab vedotin-ejfv (Padcev), as neoadjuvant treatment followed by adjuvant treatment after cystectomy in adult patients with muscle-invasive bladder cancer (MIBC). The decision was supported by data from the phase 3 KEYNOTE-B15/EV-304 study (NCT04700124). In KEYNOTE-B15, patients who received perioperative pembrolizumab and enfortumab vedotin (n = 405) experienced a median event-free survival (EFS) that was not reached (NR; 95% CI, NR-NR) vs 48.5 months (95% CI, 43.3-NR) with neoadjuvant gemcitabine and cisplatin (n = 403; HR, 0.53; 95% CI, 0.41-0.70; P < .0001).Median overall survival (OS) was not reached in either arm (HR, 0.65; 95% CI, 0.48-0.89; P = .0029). Building on the phase 3 KEYNOTE-905/EV-303 trial (NCT03924895), which established the regimen for cisplatin-ineligible patients, this approval now provides an evidence-based option for virtually all patients with MIBC, regardless of cisplatin eligibility. Galsky concluded that all patients with MIBC should now be referred from urology to medical oncology, as this approval eliminates the need to pre-filter patients based on cisplatin eligibility before initiating a systemic therapy discussion.
Significance of the FDA Approval of Orally Disintegrating Nilotinib Tablets for CML: Elias Jabbour, MD
Elias Jabbour, MD, of The University of Texas MD Anderson Cancer Center, details the significance of the June 2026 FDA approval of an orally disintegrating tablet formulation of nilotinib (Cavhanza) for adult patients with newly diagnosed Philadelphia (Ph) chromosome–positive chronic myeloid leukemia (CML) in chronic phase, as well as those with chronic or accelerated phase Ph-positive CML with resistance or intolerance to prior therapy including imatinib (Gleevec), dosed at 120 mg twice daily and 160 mg twice daily, respectively. This formulation allows for concomitant use of acid-reducing agents without timing restrictions—a meaningful practical advantage given that intolerance to TKIs is encountered more commonly in clinical practice than resistance and can compromise treatment effectiveness. Jabbour emphasized that expanding the TKI armamentarium with better-tolerated formulations is always beneficial, as achieving improved survival and treatment-free remissions requires patients to sustain therapy long term. He concludes that the individual profile of each patient remains central to personalizing CML treatment, and a greater number of available options allows clinicians to select regimens that best fit those profiles.
FDA Approval of Subcutaneous Isatuximab in Myeloma: Claudio Cerchione, MD, PhD
Claudio Cerchione, MD, PhD, of the Universita di Bologna and the Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRCCS), reviews the July 2026 FDA approval of subcutaneous isatuximab-irfc (Sarclisa Escena) delivered via an on-body delivery system (OBDS) in multiple myeloma across newly diagnosed and relapsed/refractory settings—including in combination with pomalidomide (Pomalyst) and dexamethasone, carfilzomib (Kyprolis) and dexamethasone, or bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone. The decision was supported by the noninferiority phase 3 IRAKLIA trial (NCT05405166). In IRAKLIA, subcutaneous isatuximab plus pomalidomide and dexamethasone elicited an overall response rate (ORR) of 71.1% (95% CI, 65.2%-76.5%) vs 70.5% (95% CI, 64.7%-75.9%) with the intravenous (IV) formulation, with a subcutaneous/IV geometric mean ratio for observed steady-state Ctrough of 1.53 (90% CI, 1.32-1.78). Cerchione characterized the OBDS as a meaningful advance for patient quality of life, noting that both patients and hospital staff benefit from a fast, simple administration tool that frees clinical resources and may expand access to isatuximab-based therapy. He concluded that subcutaneous delivery represents one of the most significant advances in multiple myeloma management, building on the established efficacy and tolerability of isatuximab across both treatment settings.
Safety Profile of Optune Pax in Pancreatic Cancer: Andrew Ko, MD
Andrew H. Ko, MD, of the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, outlines the safety profile and clinical implementation of Optune Pax, cleared by the FDA in February 2026 for concomitant use with gemcitabine and nab-paclitaxel (Abraxane) in adult patients with locally advanced pancreatic cancer. The decision was based on findings from the phase 3 PANOVA-3 study (NCT03377491), which demonstrated a statistically significant 2-month improvement in OS vs chemotherapy alone (HR, 0.82; 95% CI, 0.68-0.99; P = .039). Optune Pax did not increase the systemic toxicity typically linked with gemcitabine plus nab-paclitaxel, with no new safety signals identified; device-related adverse effects (AEs) were primarily dermatologic, occurring in 76.3% of patients—the vast majority grade 1 or 2. Grade 3 or higher skin AEs were reported in 7.7% of patients, and fatigue was the most common nondermatologic device-related AE at 5.1%. Ko acknowledged that wearing the device for the recommended 14 to 16 hours per day involves a logistical burden, but characterizes the AEs as mild and manageable—a favorable trade-off for the observed survival benefit with no device-related deaths or unexpected safety signals reported. He concluded that Optune Pax serves as a safe and effective adjunct to systemic therapy in the locally advanced setting.
Real-World Data for Zanubrutinib vs Acalabrutinib in Older CLL: Daniel A. Ermann, MD
Daniel Ermann, MD, of Huntsman Cancer Institute, highlights real-world data comparing first-line zanubrutinib (Brukinsa), acalabrutinib (Calquence), and ibrutinib (Imbruvica) in older patients with chronic lymphocytic leukemia (CLL), presented at the 2026 ASCO Annual Meeting, underscoring that in the absence of head-to-head prospective trials, such analyses are essential to address gaps that clinical trials often cannot. Among Medicare beneficiaries, patients who received zanubrutinib (n = 3,006) experienced a median time to treatment discontinuation (TTD) that was NR (95% CI, NR-NR) vs 24 months (95% CI, 22-25) with acalabrutinib (n = 4,309) and 14 months (95% CI, 13-15) with ibrutinib (n = 3,208), with respective times to next treatment (TTNT) of NR (95% CI, 45-NR), 40 months (95% CI, 38-42), and 30 months (95% CI, 29-32). Median OS not reached across all groups. Ermann noted that with sufficient follow-up and sample size, these data reveal meaningful differences between BTK inhibitors, with zanubrutinib demonstrating superior TTD, TTNT, and OS versus acalabrutinib. He concluded that these data have the potential to inform clinical practice and help answer the long-standing question of comparative effectiveness among BTK inhibitors in this patient population.
