Opdivo+Yervoy first-line treatment of advanced renal cell carcinoma shows 30-month long-term survival benefit
BMS announced the latest results of the Phase III CheckMate-214 study on February 11. Opdivo (nivolumab) combined with low-dose Yervoy (ipilimumab) significantly improved OS in the 30-month median follow-up period compared with the sunitinib group for patients with untreated advanced or metastatic renal cells. And at 30 months, Opdivo combined with low-dose Yervoy had an improved ORR in the mid-high-risk population compared to the previous 17.5-month analysis.
CheckMate-214 is a randomized, open phase III study evaluating the efficacy of nivolumab in combination with Ipilimumab versus sunitinib in patients with advanced advanced or metastatic renal cell carcinoma (RCC). Patients in the combination group received Nivolumab 3 mg/kg in combination with Ipilimumab 1 mg/kg once every 3 weeks, followed by 4 cycles of sequential Nivolumab 3 mg/kg, once every 2 weeks for single-agent Opdivo; control group received sultanate Nie 50mg, once a day, for 4 weeks of continuous medication, rest for 2 weeks, and continue to the next cycle. Both groups of patients were given continuous medication until disease progression or intolerable toxicity. The primary end point was overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) in moderate-high-risk populations (about 75% of patients). The results show:
OS: In the moderate-high-risk population, the overall survival rate was 60% at 30 months compared with Opdivo combined with low-dose Yervoy, and the overall survival rate was 47% in patients receiving sunitinib [HR=0.66 (95 %CI: 0.54, 0.80); P < 0.0001].
ORR: Accepted Opdivo combined with low-dose Yervoy, ORR reached 42%; sunitinib group ORR was 29% (p=0.0001). More than half (52%) responded to Opdivo in combination with low-dose Yervoy, with moderate-high-risk patients responding for at least 18 months and 28% responding to sunitinib.
Complete response (CR): The CR rate of Opdivo combined with low-dose Yervoy was 11%, and the rate of CR in the sunitinib group was 1%.
The results of the intent-to-treat (ITT, or all randomized) population of Opdivo combined with low-dose Yervoy were similar and were also significantly improved:
OS: Patients receiving Opdivo in combination with low-dose Yervoy had a 10-month OS rate of 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: Patients receiving Opdivo in combination with low-dose Yervoy had an ORR of 41% in the ITT population and 34% in sunitinib (p=0.015).
CR: Patients receiving Opdivo in combination with low-dose Yervoy had a CR rate of 11% in the ITT population and a 2% Sunitinib CR rate.
At the same time, the overall safety at 30 months of treatment with Opdivo combined with low-dose Yervoy was consistent with the results of a minimal follow-up analysis of 17.5 months and previously reported RCC patients. No new safety signals or drug-related deaths occurred during 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 are a large number of people who do not meet the treatment needs, and it is possible to achieve long-term treatment with Opdivo in combination with Yervoy. Survival benefits. "Researcher of the CheckMate-214 trial, Dr. Nizar M. Tannir, Department of Urology, Department of Cancer Medicine, MD Anderson Cancer Center, MD.
"We are pleased that the results of CheckMate-214 continue to provide clinical evidence that the combination of Opdivo and Yervoy can prolong the survival of certain patients with advanced renal cell carcinoma," said Dr. Arvin Yang, BMS melanoma and genitourinary tumor development director. Subsequent data reinforces our scientific approach and is constantly working to provide treatment options to help patients with this ruthless disease prolong life."
These data will be presented in an oral report (Abstract #547) at the 2019 American Society of Clinical Oncology Genitourinary Cancer Symposium (ASCO-GCS), held in San Francisco on February 16, 2019.
CheckMate-214 is a randomized, open phase III study evaluating the efficacy of nivolumab in combination with Ipilimumab versus sunitinib in patients with advanced advanced or metastatic renal cell carcinoma (RCC). Patients in the combination group received Nivolumab 3 mg/kg in combination with Ipilimumab 1 mg/kg once every 3 weeks, followed by 4 cycles of sequential Nivolumab 3 mg/kg, once every 2 weeks for single-agent Opdivo; control group received sultanate Nie 50mg, once a day, for 4 weeks of continuous medication, rest for 2 weeks, and continue to the next cycle. Both groups of patients were given continuous medication until disease progression or intolerable toxicity. The primary end point was overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) in moderate-high-risk populations (about 75% of patients). The results show:
OS: In the moderate-high-risk population, the overall survival rate was 60% at 30 months compared with Opdivo combined with low-dose Yervoy, and the overall survival rate was 47% in patients receiving sunitinib [HR=0.66 (95 %CI: 0.54, 0.80); P < 0.0001].
ORR: Accepted Opdivo combined with low-dose Yervoy, ORR reached 42%; sunitinib group ORR was 29% (p=0.0001). More than half (52%) responded to Opdivo in combination with low-dose Yervoy, with moderate-high-risk patients responding for at least 18 months and 28% responding to sunitinib.
Complete response (CR): The CR rate of Opdivo combined with low-dose Yervoy was 11%, and the rate of CR in the sunitinib group was 1%.
The results of the intent-to-treat (ITT, or all randomized) population of Opdivo combined with low-dose Yervoy were similar and were also significantly improved:
OS: Patients receiving Opdivo in combination with low-dose Yervoy had a 10-month OS rate of 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: Patients receiving Opdivo in combination with low-dose Yervoy had an ORR of 41% in the ITT population and 34% in sunitinib (p=0.015).
CR: Patients receiving Opdivo in combination with low-dose Yervoy had a CR rate of 11% in the ITT population and a 2% Sunitinib CR rate.
At the same time, the overall safety at 30 months of treatment with Opdivo combined with low-dose Yervoy was consistent with the results of a minimal follow-up analysis of 17.5 months and previously reported RCC patients. No new safety signals or drug-related deaths occurred during 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 are a large number of people who do not meet the treatment needs, and it is possible to achieve long-term treatment with Opdivo in combination with Yervoy. Survival benefits. "Researcher of the CheckMate-214 trial, Dr. Nizar M. Tannir, Department of Urology, Department of Cancer Medicine, MD Anderson Cancer Center, MD.
"We are pleased that the results of CheckMate-214 continue to provide clinical evidence that the combination of Opdivo and Yervoy can prolong the survival of certain patients with advanced renal cell carcinoma," said Dr. Arvin Yang, BMS melanoma and genitourinary tumor development director. Subsequent data reinforces our scientific approach and is constantly working to provide treatment options to help patients with this ruthless disease prolong life."
These data will be presented in an oral report (Abstract #547) at the 2019 American Society of Clinical Oncology Genitourinary Cancer Symposium (ASCO-GCS), held in San Francisco on February 16, 2019.
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