Bristol-Meyer Squibb’s therapy Opdivo (nivolumab) improved cancer regression in patients with metastatic urothelial carcinoma resistant to platinum therapy, while maintaining the patients’ quality of life, according to the results of a Phase 2 clinical trial.
These findings were presented recently at the European Society for Medical Oncology (ESMO) 2016 Congress, in Copenhagen.
Although the majority of bladder cancers are diagnosed at an early stage, about 78% of patients will have cancer relapse within five years. Urothelial carcinoma, the most common type of bladder cancer, accounts for nearly 90% of all cases.
“The prognosis for patients with metastatic urothelial carcinoma progressing despite platinum-based chemotherapy is poor, and treatment options have historically been quite limited,” Matthew Galsky, MD, from the Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai, said in a press release.
To assess whether Opdivo, an anti-PD-1 immunotherapy, could improve patients’ prognosis, Bristol-Myers Squibb, in collaboration with Ono Pharmaceutical, conducted the CheckMate -275 Phase 2 study (NCT02387996) assessing Opdivo in 270 patients with metastatic or unresectable urothelial carcinoma, who progressed or recurred following platinum-based therapy, or within a year after neoadjuvant/adjuvant platinum therapy.
During the treatment period, patients received an injection of Opdivo (3 mg/kg) every two weeks and were assessed for response eight weeks after the start of the treatment, every eight weeks until 48 weeks, and then every 12 weeks until progression or treatment discontinuation.
Efficacy was assessed by analyzing the proportion of patients with cancer regression in all treated patients, as well as in patients showing more than 1% PD-L1 expression, or more than 5% PD-L1 expression. Other parameters, such as progression-free survival (PFS), overall survival (OS), safety, and quality of life also were assessed in the study.
Results indicated that 19.6% of all treated patients showed cancer regression. Better responses were observed in patients with PD-L1 expression above or equal to 1% and 5% (23.8% and 28.4%, respectively), but patients with lower PD-L1 expression also were responsive to Opdivo.
Moreover, median PFS was two months and median OS was approximately nine months among all treated patients. Opdivo also maintained quality of life in patients receiving treatment for 41 weeks, as measured by the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 and the EQ-5D Visual Analog Scale.
The safety profile of Opdivo in these patients was consistent with previous results obtained in other tumor types. The most common side effects included fatigue, itching, diarrhea, decreased appetite, nausea, weakness and rash.
“In the CheckMate -275 study, we observe that with Opdivo, patients who responded experienced rapid and durable responses, including patients with PD-L1 expressing and non-expressing tumors. These results are encouraging and provide new information to the scientific community on the potential of Opdivo as a treatment option for this type of advanced bladder cancer,” said Galsky.
Opdivo acts upon a protein called programmed death-1 (PD-1), which inhibits the immune system’s ability to detect cancer cells. By inhibiting PD-1, Opdivo restores the body’s capacity to activate the anti-tumor response and fight cancer cells. Because of its potential role as an enhancer of the immune system’s response, Opdivo is under evaluation in a broad range of clinical trials across all phases in a variety of tumor types.