Memorial Sloan Kettering Cancer Center

AbbVie announced updated results from the Phase 1b/2 EPCORE NHL-2 trial showing 96% overall response rate and 87% complete response rate with epcoritamab + lenalidomide + rituximab in relapsed or refractory follicular lymphoma patients, with 89% of complete responders remaining in CR at 18 months.

Genmab's Phase 1b/2 EPCORE® NHL-2 trial showed 96% overall response rate and 87% complete response rate in relapsed/refractory follicular lymphoma patients, with 80% progression-free survival at 21 months and 90% two-year overall survival rate. FDA granted breakthrough therapy designation for the combination therapy. Adverse events included neutropenia (62%), cytokine release syndrome (51%), and COVID-19 complications affecting 57% of patients, leading to treatment discontinuation in 13% of cases, with five fatal outcomes.

Dr. Eugene Pietzak discusses the challenges of evaluating comparative effectiveness of FDA-approved treatments for BCG-unresponsive bladder cancer, emphasizing the need for stage-specific clinical trials, better biomarkers, and objective measures for minimal residual disease to guide treatment selection and improve patient care.

Combination gemcitabine-BCG demonstrated strong early oncological efficacy and safety in BCG-exposed non–muscle invasive bladder cancer (NMIBC), with a 98% complete response (CR) rate at 3 months and 94% at 6 months. The study, presented at the Society of Urologic Oncology (SUO) 25th Annual Meeting, highlighted the need for combination strategies to enhance BCG effectiveness. A phase 3 trial, GAIN, is planned for May 2025.

SOPHiA GENETICS launches MSK-IMPACT® powered with SOPHiA DDM™, enabling global access to Memorial Sloan Kettering Cancer Center's comprehensive genomic profiling. This enhances precision oncology analysis, making advanced tumor profiling more accessible, especially in underserved populations.

FDA approval of revumenib (Revuforj) in Nov 2024 offers hope for patients with KMT2A-rearranged relapsed/refractory acute leukemia, showing a 21.2% CR/CRh rate in the AUGMENT-101 study. This new, well-tolerated oral therapy could significantly improve survival outcomes for this difficult-to-treat group.

Revumenib (Revuforj) received FDA approval on November 15, 2024, for treating relapsed/refractory acute leukemia with KMT2A translocations, offering an oral, targeted therapy that induces durable remission and enables more patients to proceed to allogenic stem cell transplantation. The approval was supported by the AUGMENT-101 study, showing 21.2% of patients achieved complete remission (CR) or CR with partial hematologic recovery (CRh). Key toxicities include QTc prolongation and differentiation syndrome, managed with regular monitoring and supportive measures. Revumenib's potential future roles include integration into frontline treatment and combination strategies.

Ryvu Therapeutics initiated Phase II trial POTAMI-61, dosing first subject with CDK 8/19 inhibitor RVU120 for myelofibrosis (MF). The study will assess RVU120's efficacy and safety as a single agent and in combination with ruxolitinib. Key endpoints include bone marrow fibrosis reduction, spleen volume reduction, and total symptom score improvement. The trial is divided into two parts, with potential expansion based on initial outcomes, aiming to enroll up to nearly 230 subjects.

Merus N.V. announced US FDA approval of Bizengri (zenocutuzumab-zbco), the first treatment for advanced unresectable or metastatic pancreatic adenocarcinoma or NSCLC with NRG1 gene fusion, based on ORR and DOR. Continued approval contingent on confirmatory trials. Expected to be available to patients soon.