Change clinical practice! Opdivo assists in the treatment of muscle-immersive urethra cancer (MIUC): significantly extends disease-free survival!

2021 // -- BMS recently announced the results of the key Phase 3 CheckMate-274 trial.
the trial evaluated opdivo (Odivo, generic name: nivolumab, Navuliyu monoanti) as an auxiliary (postoperative) therapy for patients with high-risk muscle-invasive urethra cancer (MIUC) who had underwent surgical removal.
results showed that the study reached two main endpoints: Opdivo-assisted therapy significantly improved disease-free survival (DFS) compared to placebo in all randomized patients and in the subgroup of tumor expression PD-L1≥1 percent.
note that CheckMate-274 was the first positive Phase 3 trial to evaluate an immunotherapy-assisted treatment of MIUC.
CheckMate-274 was a randomized, double-blind, multi-center study conducted in MIUC patients with a high risk of recurrence after undergoing root-and-treat surgery.
, depending on the patient's characteristics, the patient may or may not have underwent new assisted (preoperative) chemotherapy before surgery.
study, 709 patients were randomly assigned a 1:1 ratio and treated with Opdivo or placebo for one year.
endpoints were disease-free survival (DFS) in all randomized patients (intentional treatment groups, ITT) and tumor expression PD-L1 (≥1%) subgroups.
critical secondary endpoints include total lifetime (OS), non-urinary path skin recurrence (NUTRFS), and disease-specific lifetime (DSS).
results showed that (1) Opdivo-assisted therapy nearly doubled the disease-free life of all randomized patients (ITTs) compared to placebo: the middle DFS in the placebo group was 10.9 months, compared with 2 in the Opdivo treatment group At 1.0 months, the risk of recurrence was significantly reduced by 30% (HR s 0.70; 98.31% CI: 0.54-0.89, p<0.001).
(2) In the subgroup of tumor expression PD-L1≥1%, the medium DFS in the Opdivo treatment group was not yet reached, while the placebo group was 10.8 months (HR-0.53, 98.87% CI:0.34-0.84, p<0.001).
In addition, Opdivo has shown improvements in key secondary endpoints, including non-urinary tract skin recurrence (NUTRFS), defined as the patient's survival time without recurrence of the disease outside the bladder, ureter, or kidney.
in all randomized patients, the middle NUTRFS in the Opdivo treatment group was more than 2 years (24.6 months), while the placebo group was 13.7 months (HR -0.72, 95% CI: 0.58-0.89).
in the subgroup of tumor expression PD-L1≥1%, the mid-level NUTRFS in the Opdivo treatment group was not reached, while the placebo group was 10.9 months (HR=0.54, 95% CI:0.38-0.77).
the study, Opdivo's safety was consistent with previously reported solid tumor studies.
the rate of adverse events (TRAEs) associated with treatment was 77.5 per cent in the Opdivo treatment group, 55.5 per cent in the placebo group, and 17.9 per cent and 7.2 per cent in the 3rd or 4th stage TRAE group, respectively.
Dr Dean Bajorin, M.D., a urological oncologist at memorial Sloan Kettering Cancer Center, said: "Patients with muscle-immersive urethra (MIUC) often undergo major surgery to remove their bladders as a life-saving measure, but their risk of cancer recurrence is still around 50 per cent.
in the CheckMate-274 trial, patients treated with Opdivo had no recurrence for almost twice as long as the placebo group.
these clinically significant outcomes have the potential to change the way doctors treat MIUC and help address the urgent need for effective, toned treatment after surgery. "By transferring immunotherapy to the early stages of cancer, we may have the opportunity to interrupt the course of the disease, reduce recurrence, and provide patients with better prognosis," said Dana Walker, vice president of cancer development programs at
's HundredThshetStaple Urological Systems Cancer Development Program.
Opdivo-based treatment not only has an auxiliary therapeutic effect on urethra skin cancer, but also on early melanoma, esophageal cancer and lung cancer.
we are excited about the significance of CheckMate-274 results to patients, and we thank the patients and researchers involved in the trial.
look forward to working with regulators around the world to bring this treatment to patients who may benefit.
" bladder cancer (photo source - medscape.com) bladder cancer is the 10th most common cancer in the world, with about 550,000 new cases confirmed each year and about 200,000 deaths from the disease.
(UC) is the most common type of bladder cancer, accounting for about 90 to 95 percent of all cases.
muscle-infused urethra carcinoma (MIUC) is a UC that has spread to the muscles of the bladder, ureter, or kidney.
about 25 percent of new cases of bladder cancer are diagnosed with muscle-immersive disease, with a worse prognosis than non-muscle-immersive urethra (non-MIUC).
most UCs are diagnosed at an early stage, and the goal of early treatment of MIUC is to reduce the risk of disease relapsing or spreading to other parts of the body.
but the recurrence rate and disease progression rate are high, with more than 50% of MIUC patients experiencing a recurrence of the disease after a cure operation and requiring more postoperative treatment options.
patients with relapsed metastatic cancer had poor prognosis, with a total survival of about 12-24 months when systematically treated.
It's worth noting that CheckMate-274 was the first and only Phase 3 trial to show that in patients with muscle-immersive urethroma (MIUC) patients with a high risk of recurrence after root-and-treat surgery, an immunotherapy method used to aid (postoperative) treatment reduced the risk of recurrence.
so far, Opdivo has shown clinical efficacy in the complementary (postoperative) treatment of three types of tumors, including bladder cancer, melanoma and esophageal/gastroesophageal junction cancer.
Opdivo is a PD-(L)1 tumor immunotherapy designed to use the body's own immune system to fight cancer and kill cancer cells by blocking the PD-1/PD-L1 signaling path, with the potential to treat multiple types of tumors.
, Opdivo has become the basic treatment for many types of cancer.
in China, Opdivo was approved in June 2018 as the first approved immuno-tumor (I-O) treatment in the Chinese market.
In March 2020, the National Drug Administration (NMPA) approved Opdivo for the treatment of patients with advanced or relapsed stomach or gastroesophageal adenocarcinoma who had previously received two or more systemic treatment options.
The approval of the gastric/gastroesophageal junction adenocarcinoma adaptation is also the third adaptation approved in China, following non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (SCCHN).
origin: Adjuvant Treatment with Opdivo (nivolumab) Stations Statistically And Clinically Meaningful In Development in Disease-Free Survival in Patients with Muscle-Invasive Urothelial Carcinoma in Phase 3 CheckMate -274 Trial<!--/ewebeditor:page->