BMS announced the latest results of the Phase III CheckMate -214 study on February 11.Opdivo (nivolumab) in combination with low-dose Yervoy (ipilimumab) significantly improved OS compared with sunitinib in patients with untreated advanced or metastatic renal cells at a median follow-up of 30 months.And at 30 months, the ORR of OPDIVO in combination with low-dose YERVOY in the intermediate-high risk population was similar to the previous 17.The analysis was improved at 5 months.
CheckMate- 214 is a random.Open-label phase III study evaluating nivolumab plus ipilimumab versus sunitinib in treatment-naive patients with advanced or metastatic renal cell carcinoma (RCC).Patients in the combination group received nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks, followed by sequential nivolumab 3 mg/kg every 2 weeks for 4 cycles followed by single-agent Opdivo; patients in the control group received sunitinib 50 mg once daily for 4 weeks followed by 2 weeks of rest before continuing in the next cycle.Both groups were treated continuously until disease progression or intolerable toxicity.The primary study endpoint was overall survival (OS) in the intermediate-high risk population (approximately 75% of patients).Progression-free survival (PFS) and objective response rate (ORR).The results showed:
ORR: ORR was 42% in the group receiving OPDIVO in combination with low-dose YERVOY; ORR was 29% in the sunitinib group (p = 0.0001).More than half (52%) responded to OPDIVO in combination with low-dose YERVOY, with responses lasting at least 18 months in intermediate-high risk patients and 28% responding to sunitinib.
Complete Response (CR): The CR rate was 11% with OPDIVO plus low-dose YERVOY and 1% with sunitinib.
The results were similar and significantly improved in the intent-to-treat (ITT, i.e., all randomized) population receiving OPDIVO in combination with low-dose YERVOY:
OS: In patients receiving OPDIVO in combination with low-dose YERVOY, the OS rate at 30 months was 64% in the ITT population compared with 56% in patients receiving sunitinib [HR = 0.71 (95% CI: 0.59, 0.86); p = 0.0003].
ORR: In patients treated with OPDIVO in combination with low-dose YERVOY, the ORR was 41% in the ITT population and 34% with sunitinib (p = 0.015).
CR: In patients treated with OPDIVO in combination with low-dose YERVOY, the CR rate in the ITT population was 11%, while the CR rate with sunitinib was 2%.
At the same time, the overall safety of receiving OPDIVO in combination with low-dose YERVOY at 30 months was similar to 17.The minimal follow-up analysis at 5 months was consistent with previously reported results in patients with RCC.There were no new safety signals or drug-related deaths with extended follow-up.
"The 30-month follow-up results from the CheckMate -214 study are meaningful because they continue to demonstrate that in patients with advanced renal cell carcinoma, there is a substantial unmet treatment need in a population where long-term survival benefit may be achieved with OPDIVO plus YERVOY."Researchers in the CheckMate -214 trial.Nizar M., Department of Urological Oncology, Department of Cancer Medicine, MD Anderson Cancer Center.Dr. Tannir said.
"We are pleased that the results of CheckMate -214 continue to provide clinical evidence that the combination of Opdivo and Yervoy can prolong survival in some patients with advanced renal cell carcinoma," said Dr. Arvin Yang, Head of Melanoma and Urogenital Tumor Development at BMS.
These data will be presented in an oral presentation (abstract 547) at the American Society of Clinical Oncology Genitourinary Cancer Symposium (ASCO-GCS) 2019, San Francisco, February 16, 2019.