Treatment with Opdivo (nivolumab) after surgery significantly reduces the risk of disease recurrence or death in people with high-risk, muscle-invasive urothelial cancer — a form of bladder cancer — an interim analysis from a Phase 3 trial shows.
The CheckMate -274 (NCT02632409) met its primary goals of extended disease-free survival both in the overall population and in patients whose tumors produce the PD-L1 protein — a marker that predicts better responses to Opdivo.
This is the first time adjuvant (post-surgery) immunotherapy was found to reduce the risk of relapse in these patients.
“The positive results from CheckMate -274 point to the potential for nivolumab to become a new standard of care in the adjuvant setting, extending disease-free survival for post-surgery patients with muscle-invasive urothelial cancer without the use of chemotherapy,” Matthew Galsky, MD, professor of medicine at the Icahn School of Medicine at Mount Sinai, said in a press release.
“With currently available therapies, more than 50% of patients with bladder cancer will experience recurrence after surgery, and each year, the disease takes the lives of nearly 200,000 patients,” he added. “Advances like immunotherapy have helped bring hope to patients across a growing number of cancer types, including previously treated advanced urothelial carcinoma.”
Opdivo, developed by Bristol Myers Squibb, is an immune checkpoint inhibitor designed to block a mechanism commonly used by the cancer cells to evade immune attacks. It specifically binds the PD-1 receptor in T-cells and prevents its interaction with the PD-L1 ligand in cancer cells, boosting immune responses.
The global CheckMate -274 trial is investigating whether adjuvant Opdivo improves the outcomes of muscle-invasive urothelial cancer patients at high risk of recurrence after radical surgery.
A total of 709 participants were enrolled, regardless of chemotherapy use before surgery, and randomly assigned to receive either Opdivo or a placebo for up to one year.
The trial’s main goals were to determine if Opdivo outperforms the placebo at extending the time patients lived without disease recurrence, both in the overall patient population and in a subgroup with PD-L1-positive tumors.
Secondary endpoints include overall survival, time to death due to bladder cancer, and the time patients live without the disease appearing in regions outside the urothelial tract.
In addition to meeting its primary goals, the trial showed a safety profile that was consistent with previously reported studies of Opdivo in patients with solid tumors.
The company plans to fully evaluate the CheckMate -274 data, present the findings at a future medical conference, and submit data to health authorities. As the trial continues, secondary endpoint analyses will be conducted.
Opdivo has now demonstrated clinically meaningful efficacy as an add-on therapy to treat bladder cancer, melanoma, and esophageal junction cancer.
“As we advance the science of immunotherapy, we’re discovering that these treatments may play an important role in earlier stages of cancer when the immune system is generally more intact and potentially more responsive,” said Mark Rutstein, vice president of Opdivo development at Bristol Myers Squibb.
“We would like to thank the patients and investigators who participated in the trial and contributed to our collective scientific understanding,” he added.
