First line treatment of renal cell carcinoma! The long-term effect of opdivo + yevoy is better than SUTENT, and the 42 month survival rate is more than 50%!

February 17, 2020 / BIOON / -- BMS recently held ASCO-GU in San Francisco In 2020), the latest results of the research on opdivo combined with low dose yevoy (ipilimumab, ipilimumab) in the first-line treatment of advanced or metastatic renal cell carcinoma (RCC) stage III checkmate-214 were published Data continue to show that opdivo + yevoy immunocombination therapy has a long-term survival benefit compared with the targeted anticancer drug SUTENT (SUTENT, generic name: sunitinib, sunitinib) Checkmate-214 is a randomized, open label study that evaluated the efficacy and safety of opdivo (3mg / kg) and low-dose yevoy (1mg / kg) combination therapy (o3y1) versus standard first-line therapy SUTENT (sunitinib) for first-line treatment in patients with advanced or metastatic RCC who had not previously been treated The data of the minimum follow-up of 42 months showed that the combination of opdivo and yevoy continued to show better overall survival (OS), objective response rate (ORR), response duration (DOR), complete response rate (CR) compared with SUTENT Compared with SUTENT treatment, opdivo + yevoy treatment showed significant OS benefits in moderate and high risk (IP) RCC patients and intention to treat (ITT) patients According to independent evaluation, 84% of patients in IP group and 86% of patients in ITT Group continued their remission In the IP group, patients treated with opdivo + yevoy showed significant improvement in the following endpoints: (1) in terms of OS, at 42 months, the OS rate was 52% in the opdivo + yevoy group and 39% in the SUTENT group (HR = 0.66, 95% CI: 0.55-0.80) (2) In terms of orr, according to independent evaluation, 42% in the opdivo + yervoy group and 26% in the SUTENT group (P = 0.0001) (3) In terms of DOR, the median dor of opdivo + yervoy treatment group has not been achieved, and that of SUTENT treatment group is 24.8 months (95% CI: 19.4-27.3) (4) In terms of Cr, according to independent evaluation, 11% in the opdivo + yervoy group and 2% in the SUTENT group The results were similar in ITT population Patients treated with opdivo + yevoy showed significant improvement in the following endpoints: (1) in OS, at 42 months, the OS rate in opdivo + yevoy group was 56%, while that in SUTENT group was 47% (HR = 0.72, 95% CI: 0.61-0.86) (2) In terms of orr, according to independent evaluation, 39% in the opdivo + yervoy group and 33% in the SUTENT group (P = 0.02) (3) In terms of DOR, the median dor of opdivo + yervoy treatment group has not been achieved, and that of SUTENT treatment group is 24.8 months (95% CI: 19.4-27.3) (4) In terms of Cr, according to independent evaluation, 11% in the opdivo + yervoy group and 2% in the SUTENT group In the study, the safety of opdivo + yevoy immunocombination therapy was consistent with the previous results, and there was no new safety signal or drug-related death during long-term follow-up Nizar, researcher of checkmate-214 study, researcher of Department of urogenital oncology, Department of cancer medicine, MD Anderson Cancer Center, University of Texas M "The 42 month follow-up results from the checkmate-214 study reinforce previous observations and add more and more evidence that opdivo + yevoy immunotherapy can significantly improve the long-term survival of patients with advanced renal cell carcinoma," said Dr tannir In particular, a higher proportion of patients treated with opdivo + yevoy have achieved complete remission, and most of these complete remissions are permanent " "These positive results from the checkmate-214 study continue to demonstrate the complementarity of dual immunotherapy and enhance the depth and persistence of remission in patients treated with opdivo and yervoy in combination," said Dr Brian Lamon, head of cancer development in the urogenital system at Bristol Myers Squibb We look forward to continuing to explore the potential of this combination for refractory cancer patients " Opdivo + yervoy combination: the first immunooncology combination therapy for high-risk RCC in the first-line treatment is the most common type of renal cancer in adults, with more than 140000 deaths every year in the world The incidence rate of RCC in males is 2 times that of women, and the highest incidence rate in North America and Europe Globally, the 5-year survival rate of patients with metastatic or advanced renal cancer is only 12.1% Opdivo and yevoy are tumor immunotherapy They target different regulatory elements in the immune system and use the immune system of human body to fight against tumor Opdivo targets to block PD-1 / PD-L1 pathway, yevoy targets to block CTLA-4 In the United States and the European Union, opdivo + yervoy immunocombination therapy was approved in April 2018 and January 2019 respectively, becoming the first immunooncology combination therapy (I-O / I-O combination) for high-risk RCC patients in the first-line treatment Up to now, opdivo + yervoy immunotherapy has been approved for: (1) treatment of unresectable or metastatic melanoma; (2) first-line treatment of patients with advanced renal cell carcinoma (RCC); and (3) treatment of children aged 12 and over and adults with high microsatellite instability (MSI-H) or mismatch repair defect (dmmr) metastatic colorectal cancer (mCRC) At present, the supplementary application of opdivo + yevoy immunocombination therapy for second-line treatment of advanced liver cancer (HCC), first-line treatment of metastatic or recurrent non-small cell lung cancer (NSCLC) without EGFR or ALK genomic tumor distortion is under the priority review of FDA in the United States The target dates of PDUFA are March 10, 2020 and May 15, 2020 Original source: Opera (nivolumab) plus yevoy (ipilimumab) strategies continued survival benefit at 42 month follow up in patients with previously untreated advanced or metastatic internal cell cardioma