Articles related to CLINICAL TRIALS

This report includes 3-year follow-up of the pivotal ZUMA-2 study of KTE-X19 in relapsed/refractory MCL. At a median follow-up of 35.6 months, the objective response rate among all 68 treated patients was 91%, with 68% complete responses. Medians for duration of response, progression-free survival, and overall survival were 28.2 months, 25.8 months, and 46.6 months, respectively. “These data, representing the longest follow-up of CAR T-cell therapy in patients with MCL to date, suggest that KTE-X19 induced durable long-term responses with manageable safety in patients with relapsed/refractory MCL and may also benefit those with high-risk characteristics.”

Dr. Mohyudding summarizes key findings ASCO reports, including updates on teclistamab in CAR-T, the DETERMINATION trial assessing auto-transplantation, cilta-cel (covered by HCN here), and the ATLAS study evaluating carfilzomib with lenalidomide and dexamethasone as maintenance vs. lenalidomide alone.

This report provides longer-term results from the CARTITUDE-1 trial of ciltacabtagene autoleucel (cilta-cel) in heavily pretreated patients with relapsed/refractory multiple myeloma. This update covers 97 patients at a median follow up of ~28 months. The overall response rate was 97.9%, with an 82% stringent complete response across both standard and high-risk subgroups. These longer-term data from CARTITUDE-1 in triple-class exposed patients with RRMM demonstrate deep and durable responses to cilta-cel over time, including in high-risk subgroups.

Three-hundred-twenty-four (324) patients with stage II or III rectal adenocarcinoma were treated with induction chemotherapy followed by chemoradiotherapy (INCT-CRT) or chemoradiotherapy followed by consolidation chemotherapy (CRT-CNCT). Patients then underwent total mesorectal excision (TME) or were assigned to a watch-and-wait status on the basis of tumor response. Three-year TME-free survival was 41% in the INCT-CRT group and 53% in the CRT-CNCT group. Organ preservation is achievable in half of the patients with rectal cancer treated with total neoadjuvant therapy, without an apparent detriment in survival.

This multicenter, open-label, randomized phase III trial conducted in Japan compared 3 versus 6 months of postoperative adjuvant chemotherapy in patients with curatively resected stage III colon cancer. Study participants received either a modified fluorouracil, leucovorin, and oxaliplatin, regimen, or capecitabine and oxaliplatin (CAPOX) regimen. Five-year OS rates were comparable between the two groups: 87.0% in the 3-month treatment group and 86.4% in the 6-month treatment group. Peripheral sensory neuropathy lasting longer than 5 years was twice as common in the 6- compared with 3-month treatment group (16% v 8%, respectively) and in those receiving mFOLFOX6 compared with CAPOX (14% v 11%, respectively).

In a small study of the PD-1 blocker dostarlimab, 100% of patients with locally advanced mismatch repair–deficient Stage II or III rectal adenocarcinoma experienced remission. The study participants were treated with dostarlimab monotherapy infused every three weeks for six months. The original intent was to follow dostarlimab with chemotherapy, radiation and surgery, but that turned out to be unnecessary.Read the study summary here.