Memorial Sloan Kettering Cancer Center

Johnson & Johnson seeks FDA approval for Darzalex Faspro-based quadruple regimen for newly diagnosed multiple myeloma patients not initially planning stem cell transplant. The D-VRd combo, already approved for transplant-eligible patients, showed significant benefits in the CEPHEUS trial, including higher MRD-negativity rates and reduced disease progression risk.

Fred Hutch Cancer Center research highlights include the formation of the Cancer AI Alliance, expansion of research facilities, advancements in vaginal microbiome and HIV risk, and increased industry-sponsored clinical cancer research. New grants support pancreatic cancer and rare liver cancer studies, while diversity initiatives like the Atlas of Inspiring Hispanic/Latinx Scientists aim to improve representation. Volunteer stories showcase patient involvement and community impact.

The CEPHEUS trial demonstrated that adding daratumumab and hyaluronidase-fihj (D-VRd) to standard bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved minimal residual disease (MRD)–negativity rates and complete response (CR) rates in transplant-ineligible or deferred newly diagnosed multiple myeloma patients. The study met its primary endpoint with 60.9% MRD-negativity in the D-VRd group vs 39.4% in the VRd group. The regimen also showed superior progression-free survival (PFS) and ongoing overall survival (OS) benefits, prompting a supplemental biologics license application to the FDA.

MRD negativity maintained for at least 1 year after stopping lenalidomide maintenance in multiple myeloma patients, with 85% MRD-negativity rate at 12 months post-maintenance cessation.

The NEXICART-2 trial evaluating NXC-201 CAR-T therapy for r/r AL amyloidosis has moved to its expansion cohort, using a dose of 450 million CAR+T cells. The trial's primary endpoints are the complete response rate and overall response rate, with Memorial Sloan Kettering Cancer Center as the lead site. Positive data from the NEXICART-1 trial showed a 92% overall response rate and a 28.0-month duration of response.

NCT02955394 was an open-label randomized phase II trial of fulvestrant with or without enzalutamide for ER+/HER2- breast cancer, conducted at the Universities of Colorado, Tennessee, and Memorial Sloan Kettering Cancer Center. The study involved 61 patients, assessing safety, antitumor effects, and tissue acquisition through biopsies and plasma samples. Key assessments included PEPI score, RPPA, metabolomics, and gene expression analysis to evaluate treatment efficacy and safety.

Isabel Preeshagul, DO, MBS, emphasizes the importance of shared decision-making in selecting optimal treatment for EGFR-mutated NSCLC, highlighting the expanded options from FLAURA2 and MARIPOSA trials. She discusses the need for patient-centered care, considering comorbidities and treatment tolerability, and the complexities of perioperative vs neoadjuvant approaches without head-to-head comparisons.

The phase III SIERRA trial reported in the Journal of Clinical Oncology by Gyurkocza et al. showed higher rates of durable complete remissions with the anti-CD45 radioconjugate iodine-131–apamistamab compared to conventional care followed by allogeneic hematopoietic cell transplantation (allo-HCT) in patients aged ≥ 55 years with relapsed or refractory acute myeloid leukemia. The study involved 153 patients randomly assigned to receive I-131–apamistamab or conventional care, with the primary outcome being durable complete remission lasting 180 days. Results indicated a durable complete remission rate of 17.1% in the I-131–apamistamab group versus 0% in the conventional care group (P < .0001). Median overall survival was 6.3 months in the I-131–apamistamab group vs 5.9 months in the conventional care group, with a median event-free survival of 3.2 vs 0 months. The regimen was well tolerated, with grade ≥ 3 treatment-related adverse events occurring in 59.7% of the I-131–apamistamab group and 59.2% of the conventional care group.

Subcutaneous daratumumab plus VRd showed higher MRD-negativity and CR rates vs VRd alone in transplant-ineligible multiple myeloma patients, with 60.9% vs 39.4% MRD-negativity and 81.2% vs 61.6% CR rates, suggesting potential as a new frontline regimen.

The Cancer AI Alliance (CAIA) brings together scientists from Johns Hopkins to develop AI-driven precision cancer care, addressing challenges in data analysis and privacy. CAIA aims to provide computing infrastructure for processing high volumes of cancer data, maintaining data security and privacy, and using a federated AI learning framework to uncover insights without sharing raw data.