Articles related to CLINICAL TRIALS

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.

A commentary with perspective on the clinical practice implications of the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial, which demonstrated short-term noninferiority of antibiotic therapy vs. surgical therapy for patients diagnosed with acute appendicitis.

This randomized, open-label, phase III trial compared elacestrant, a novel, oral selective ER degrader, vs. standard of care endocrine monotherapy in patients with ER-positive/HER2-negative advanced breast cancer who had one-two lines of endocrine therapy, required pretreatment with a cyclin-dependent kinase 4/6 inhibitor, and ≤ 1 chemotherapy. Elacestrant showed a significant PFS improvement versus SOC both in the overall population and in patients with ESR1 mutations.