Five Under 5: Top Oncology Videos for the Week of 9/7

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:

Potential Role for Subcutaneous Amivantamab in EGFR-Mutant NSCLC: Sun-Min Lim, MD, PhD

Sun-Min Lim, MD, PhD, of Severance Hospital within Yonsei University Health System, highlighted findings from the phase 2 PALOMA-2 study (NCT05498428), which evaluated first-line subcutaneous amivantamab-vmjw (Rybrevant) plus chemotherapy in patients with advanced EGFR exon 20 insertion–mutant non–small cell lung cancer (NSCLC). Among 63 patients, the objective response rate (ORR) was 76% (95% CI, 64%-86%) by investigator assessment, consistent with data from the intravenous formulation evaluated in the phase 3 PAPILLION trial (NCT04538664). The confirmed ORR in PALOMA-2 was 71% (95% CI, 59%-82%) by investigator assessment and 67% (95% CI, 54%-78%) by independent central review, with no new safety signals identified. Lim explained that the subcutaneous formulation offers convenience and tolerability without compromising efficacy, as further supported by findings from the phase 3 PALOMA-3 trial (NCT05388669). She concluded that the broader applicability of subcutaneous formulations is expected to drive additional regulatory approvals and expand use in clinical practice.

FDA Approval of the Gemcitabine Intravesical System for NMIBC: Joseph Jacob, MD, MCR

Joseph Jacob, MD, MCR, of State University of New York Upstate Medical University, discussed the significance of the FDA approval of the gemcitabine intravesical system (formerly TAR-200; Inlexzo) for patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC). On September 9, 2025, the regulatory agency cleared this therapy for adult patients with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors, based on results from cohort 2 of the phase 2b SunRISe-1 trial (NCT04640623). In this study, treatment with gemcitabine intravesical system monotherapy (n = 83) led to a confirmed complete response rate of 82% (95% CI, 72%-90%). Jacob emphasized that this approval addresses a major unmet need, providing a highly effective alternative to radical cystectomy while preserving bladder function for many patients. He concluded that this represents not only a therapeutic breakthrough for bladder cancer but also a broader paradigm shift in managing bladder-related diseases.

Updated Efficacy and Safety Data With Taletrectinib in ROS1+ NSCLC: Geoffrey Liu, MSc, MD

Geoffrey Liu, MSc, MD, of Princess Margaret Cancer Centre and the University of Toronto, discussed updated findings from the global phase 2 TRUST-II trial (NCT04919811) of taletrectinib (Ibtrozi) in ROS1-positive NSCLC. At the 2025 IASLC World Conference on Lung Cancer, results showed durable efficacy in both TRUST-II and the China-based phase 2 TRUST-I trial (NCT04395677). In TRUST-II, ROS1 TKI–naive patients (n = 54) achieved a confirmed ORR of 85.2%, with median progression-free survival (PFS) and duration of response (DOR) not yet reached. In TKI-pretreated patients (n = 47), taletrectinib induced a confirmed ORR of 61.7%, a median PFS of 11.8 months, and a median DOR of 19.4 months. Liu noted that safety remained favorable with no new signals, and the similar survival curves and response rates between TRUST-I and TRUST-II support the broad global applicability of these results.

Remaining Gaps in Biomarker Testing for Early-Stage Resected NSCLC: Sandip P. Patel, MD

Sandip P. Patel, MD, of UCSD Moores Cancer Center, discussed challenges in biomarker testing for early-stage NSCLC at the 2025 IASLC World Conference on Lung Cancer. He highlighted that the biggest hurdle is balancing the need for rapid results on EGFR and ALK mutation status with the limited insurance coverage for next-generation sequencing (NGS), which is often more expensive and slower. He added that NGS is more efficient in terms of tissue use, especially since cell-free DNA is less reliable in early-stage disease. Patel suggested that digital pathology and artificial intelligence–based algorithms could help prioritize single-gene or expedited NGS testing, but reimbursement remains critical. He emphasized prioritizing EGFR, ALK, and PD-L1 testing, noting that ongoing neoadjuvant and perioperative trials will increasingly rely on NGS despite these logistical challenges.

Safety of Botensilimab Plus Balstilimab in Pretreated MSS CRC: Benjamin L. Schlechter, MD

Benjamin L. Schlechter, MD, of Dana-Farber Cancer Institute, discussed the safety profile of botensilimab (AGEN1181) plus balstilimab (AGEN2034) in patients with refractory microsatellite-stable metastatic colorectal cancer without active liver metastases. Updated findings from the phase 2 C-800-01 trial (NCT03860272) demonstrated that the most common immune-mediated adverse effect (imAE) was diarrhea/colitis, occurring in 41% of patients, with grade 3 events occurring in 15% of patients. Investigators found that early initiation of tumor necrosis factor inhibitors, such as infliximab (Remicade), was critical to patient safety and maintaining treatment. Overall, any-grade imAEs occurred in 58% of patients, and included immune thyroiditis (7%), pneumonitis (5%), hepatitis (5%), adrenal insufficiency (3%), and dermatologic events (3%). No treatment-related deaths occurred. Schlechter concluded that the safety profile of botensilimab plus balstilimab was manageable, with no new safety signals identified.