Colorectal cancer: © Peterschreiber.media – Stock.adobe.com
Bristol-Myers Squibb is conducting a Phase 3 RELATIVITY study investigating nivolumab (Opdivo) and relatlimab (Opdualag) in patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer (CRC). -123 study (NCT05328908) has been completed and will not progress beyond 1. It is more effective than 4-line treatment because it is ineffective. Based on a planned analysis by an independent data monitoring board, the trial is not expected to meet its primary endpoint, according to a press release.1
The safety profile was consistent with previously reported studies of the combination of nivolumab and leratorimab, and the trial was not stopped due to safety concerns.
“Metastatic colorectal cancer is a cancer with high unmet need and is difficult to treat. Although progress has been made in the treatment of patients with microsatellite instability high/deficient mismatch repair colorectal cancer, microsatellite stable tumors Treatment options remain limited for subsequent treatment of patients.While we acknowledge that historically immunotherapy has shown limited efficacy against MSS colorectal cancer, we We had hoped to demonstrate meaningful clinical benefit in this patient population, but we are disappointed with these results,” said Jeffrey Walch, MD, PhD, vice president and global program lead at Bristol-Myers. said the doctor. Squibb said in a press release.
The primary endpoints of the study were overall survival (OS) in randomized patients with a PD-L1 composite positive score (CPS) ≥1 and OS in all randomized patients. Secondary endpoints included objective response rate (ORR) by blinded independent central review (BICR) in patients with PD-L1 CPS ≥ 1, ORR by BICR in all patients, progression-free survival (PFS) by BICR, Duration of response (DOR by BICR for patients with PD-L1 CPS ≥ 1; DOR by BICR for all patients). Safety was also evaluated in this study by the incidence of adverse events (AEs), serious AEs, immune-mediated AEs, and AEs leading to discontinuation.2
Patients in the experimental group received a fixed-dose combination of nivolumab and leratorimab. Patients in the active comparison group received regorafenib (Stivarga) or TAS-102 (Lonsurf).
In a previous study, the combination of nivolumab and leratorimab improved survival in previously untreated melanoma patients. The survey results are New England Medical Journal. For the combination of nivolumab and leratolimab, PFS was 10.1 months (95% CI, 6.4-15.7) versus 4.6 months (95% CI, 3.4-5.6) for nivolumab alone (HR, 0.75; 95% CI, 0.62-0.92; 95% CI, 0.62-0.92; P =.006). PFS at 12 months was 47.7% (95% CI, 41.8% to 53.2%) in the nivolumab plus leratolimab group compared with 36.0% (95% CI, 30.5% to 41.6%) in the nivolumab alone group. did.3
On this basis, evaluation of fixed-dose combination therapy of nivolumab and leratlimab as a treatment for other tumor types will continue. The results of the RELATIVITY-123 study do not affect the currently approved indication for patients with unresectable or metastatic melanoma.
“We will continue to [immune-oncology] We would like to thank the researchers, patients, and their loved ones who developed treatments such as nivolumab and ipilimumab for MSI-H/dMMR colorectal cancer and who participated in this trial,” Walch said in a press release. .1