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:
Significance of the FDA Approval of Brexu-cel for MCL: Lore Gruenbaum, PhD
Lore Gruenbaum, PhD, of Blood Cancer United, discusses the April 2026 FDA approval of brexucabtagene autoleucel (Tecartus; brexu-cel) for patients with relapsed or refractory mantle cell lymphoma (MCL). The decision was supported by findings from the phase 2 ZUMA-2 trial (cohorts 1 and 2, NCT02601313; cohort 3, NCT04880434). At a median follow-up of 23.0 months, brexu-cel induced an overall response rate (ORR) of 91%, a complete response (CR) rate of 79%, and a median duration of response (DOR) that was not reached (NR; 95% CI, 26.2 months-not evaluable) in cohort 3 (n = 86), which were patients who had received a median of 1 prior line of therapy. The ORR was 87% in cohort 1 (n = 60), which were patients who had received a median of 3 prior lines of therapy; in this group, the CR rate was 62% and the median DOR that was also NR. Gruenbaum underscored the importance of having several approved options in MCL, given that comorbidities and individual patient circumstances affect treatment eligibility. She noted limitations around access to and eligibility for CAR T-cell therapy despite the impressive response data. She concluded that optimal treatment sequencing after brexu-cel, including the potential role of bispecific antibodies for patients who relapse after CAR T-cell therapy, represents a critical area for the MCL field to explore next.
Notable Design Features of the AMPLIFY Trial in CLL: Jennifer R. Brown, MD, PhD
Jennifer R. Brown, MD, PhD, of Dana-Farber Cancer Institute and Harvard Medical School, discusses the phase 3 AMPLIFY trial (NCT03836261) that supported the February 2026 FDA approval of acalabrutinib (Calquence) plus venetoclax (Venclexta) for patients with chronic lymphocytic leukemia. AMPLIFY was an international phase 3 trial examining the combination plus or minus obinutuzumab (Gazyva) vs chemoimmunotherapy. Data showed that those in the combination arm (n = 291) experienced a 3-year progression-free survival (PFS) rate of 76.5% (95% CI, 71.0%-81.1%) vs 66.5% (95% CI, 59.8%-72.3%) for those in the chemoimmunotherapy arm (n = 290). Outside of high infection rates potentially attributable to the concurrent COVID-19 pandemic, the combination was well tolerated, with grade 3 or higher adverse effects (AEs) including neutropenia (32.3%), infection (12.4%), hypertension (2.7%), and atrial fibrillation or flutter (0.3%). Brown noted that antiemetics administered as premedication are a viable strategy for managing common venetoclax-associated nausea. She concluded that patients do well with this combination, as many AEs like low blood counts, neutropenia, and tumor lysis syndrome are often resolved during treatment.
Efficacy of ADT Plus Pembrolizumab in Salivary Gland Cancer: Manish R. Patel, DO
Manish Patel, DO, of the University of Minnesota Health and University of Minnesota Medical School, discusses the rationale for the phase 2 BTCRC HN17-111 trial (NCT03942653) investigating androgen deprivation therapy (ADT) in combination with pembrolizumab (Keytruda) in patients with advanced-stage, androgen receptor–positive salivary gland carcinoma. The diverse histotypes within salivary gland cancers have historically prevented the establishment of a standard of care for advanced or recurrent disease, and previous research, including small-scale trials and retrospective studies focused on immunotherapy, has shown low response rates in this population. A key driver for this research was the systemic barrier of insurance providers frequently denying coverage for novel treatment strategies, leaving cytotoxic chemotherapy as the only accessible option for many patients and underscoring a critical gap in the understanding of effective treatments for these rare malignancies. Patel concluded that addressing this knowledge deficiency is crucial to developing more successful, targeted approaches that move beyond the limitations of traditional chemotherapy for patients with salivary gland cancers.
Efficacy Data With Lirafugratinib in FGFR2-Altered Cholangiocarcinoma: Lipika Goyal, MD
Lipika Goyal, MD, of the Stanford Cancer Institute of Stanford University, unpacks findings from the phase 1/2 ReFocus trial (NCT04526106) examining lirafugratinib (RLY-4008) in patients with FGFR2-altered cholangiocarcinoma (CCA). Data from the pivotal cohort presented at the 2026 Gastrointestinal Cancers Symposium showed that among FGFR inhibitor–naive, chemotherapy-exposed patients (n = 114), the independent review committee–assessed ORR was 46.5% (95% CI, 37.1%-56.1%), with a CR rate of 2.6%, partial response rate of 43.9%, stable disease rate of 50.0%; the disease control rate was 96.5% (95% CI, 91.3%-99.0%). Moreover, the median DOR was 11.8 months (95% CI, 7.5-13.0), the median PFS was 11.3 months (95% CI, 9.2-14.8), and the median overall survival was 22.8 months (95% CI, 18.1-27.2). These findings supported a new drug application for lirafugratinib as a second-line treatment for pretreated CCA harboring FGFR2 fusions or rearrangements, which was granted priority review by the FDA in March 2026. A Prescription Drug User Fee Act target action date of December 3, 2026, has been set.
Background of the Phase 4 OPTYX Trial in Advanced Prostate Cancer: Rana R. McKay, MD
Rana R. McKay, MD, of UC San Diego School of Medicine, explains the rationale for the phase 4 OPTYX trial (NCT05467176) examining the real-world use of relugolix (Orgovyx) in patients with advanced prostate cancer. Relugolix is the only FDA-approved oral gonadotropin-releasing hormone receptor antagonist, and data from the phase 3 HERO trial (NCT03085095) showcased more rapid and sustained testosterone suppression, a favorable safety and tolerability profile, more rapid testosterone recovery upon discontinuation, and improved cardiovascular outcomes vs standard ADT. OPTYX is a prospective, multicenter, observational study enrolling adult patients in the United States receiving relugolix as a single agent or in combination. The study is assessing quality of life via Functional Assessment of Cancer Therapy–Prostate (FACT-P) criteria at baseline and at 3 and 6 months, treatment adherence via the Simplified Medication Adherence Questionnaire, and safety per incidence of serious AEs, treatment discontinuation, and death. Data from OPTYX were presented in a poster at the 2026 Genitourinary Cancers Symposium, supplementing the HERO data with real-world evidence on relugolix use in clinical practice.
