Roman Fabbricatore

Event-free survival, overall survival, and pathologic complete rate data from the phase 3 KEYNOTE-905 trial support the agency’s decision.

The investigational BCG-containing regimen conferred a weighted anytime CR rate of 69.7% vs 53.4% with nadofaragene firadenovec in this NMIBC group.

Investigators evaluated how tisagenlecleucel and cilta-cel altered adverse effect timelines for patients treated for hematologic malignancies.

The incidence rate of occlusions per 1000 central line days was 10.68 in the pre-EBP change cohort and 21.00 in the post-EBP change cohort.

Phase 1/2 findings from the BGB-11417-201 trial support the FDA approval of sonrotoclax in relapsed/refractory mantle cell lymphoma.

The 36-month DOR rate was 64.5% among patients who achieved a 3-month CR with mitomycin for low-grade, intermediate-risk non–muscle-invasive bladder cancer.

Grade 3 or higher TRAEs occurred in 14% of patients treated with NDI-101150, including 1 incidence of grade 4 aplastic anemia across all comers in the study.

According to the developers, the agency’s decision could accelerate and expand the registration pathway for JNJ-1900 in head and neck cancer.

Hematologic oncologists discussed long-term survival data from the SEQUOIA and ALPINE trials exploring zanubrutinib in frontline and R/R CLL/SLL.

Based on the clinical efficacy, ODAC members collectively voted to support the sNDA for capivasertib in this PTEN-deficient HSPC population.

The simlukafusp alfa–containing triplet displayed a profile comparable to the safety of each individual drug in this RCC population.

A data monitoring committee recommended the halt for futility of the phase 3 FLASH2 trial evaluating synthetic hypericin in cutaneous T-cell lymphoma.

A total of 48.0% of patients treated with duvelisib experienced a response, 33.3% of whom experienced a complete response.

The safety profile of zocilurtatug pelitecan among patients with extrapulmonary neuroendocrine carcinomas was consistent with prior reports in SCLC.

Recently, conservative management has grown in popularity, especially among older patients and those with higher neighborhood-level socioeconomic status.

Patrick A. Kenney, MD; and David A. Braun, MD, PhD, discussed parameters they use to determine a patient’s eligibility for cytoreductive nephrectomy.

The safety profiles of the pembrolizumab-based combination regimens were consistent with those observed in previously reported studies.

The panel discussed key considerations in the relapsed/refractory setting, including toxicity management and sequencing strategies for targeted agents.

Findings from the phase 3 EV-304 trial support the supplemental biologics license application for enfortumab vedotin/pembrolizumab in patients with MIBC.

At the MRD assessment on day 45, patients with large B-cell lymphoma treated with cema-cel saw a median decrease of 97.7% in their plasma ctDNA levels.

Alexander Z. Wei, MD, highlighted key clinical trials presented at ASCO GU and initiated at Columbia University to “move the needle” in bladder cancer.

According to the phase 3 TORPEdO investigators, where IMPT is not used routinely for OPSCC, IMRT remains the standard of care.

Most treatment-related adverse effects were grades 1 or 2, and no grade 4 adverse effects or treatment-related deaths were observed with Lu-PSMA-617.

Although numerous bispecific agents are FDA approved for large B-cell lymphoma, many did so based on single-arm studies requiring confirmation studies.

Investigators of a prospective validation study highlighted the potential of a urine-based assay to reduce surgical biopsies deemed unnecessary.

The totality of evidence from the phase 2 ZUMA-2 study formed the basis of the regulatory decision.

Phase 2 Cyto-KIK findings showed that a subset of patients with high-risk kidney cancer exhibited responses and underwent monitoring post-cabozantinib.

The project will be focused on increasing awareness and early detection of the disease and generate high-quality data to inform improvement of care.

Experts discussed the clinical implications of the LITESPARK-011 trial of belzutifan plus lenvatinib following a presentation of efficacy findings at ASCO GU.

Three experts in surgery, radiation, and integrative care disclosed the most salient advances and keen insights in their respective fields.