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This article from the NEJM meta-Journal (NEJM Journal Watch) New Therapeutic Options for Advanced Kidney Cancer advanced kidney cancer new treatment options Comments Author: Robert Dreicer, MD, MS, MACP, FASCO in this phase 3 trial, Lun cutting imatinib The combination with pembrolizumab showed an overall survival benefit over sunitinib.
Both lenvatinib and pembrolizumab showed anticancer activity against advanced renal cell carcinoma, and everolimus also showed anticancer activity (the US FDA has approved everolimus monotherapy and everolimus Combination therapy with lenvatinib and lenvatinib).
In a multinational phase 3 trial, patients with previously untreated advanced renal cell carcinoma were randomly divided into 3 groups and received lenvatinib + pembrolizumab (Len/Pem; lenvatinib daily, Pembrolizumab is administered intravenously every 3 weeks), lenvatinib + everolimus (Len/Eve; both drugs are administered daily) or sunitinib (treatment for 4 weeks, drug withdrawal for 2 weeks) treatment.
Among 1,069 patients, the median age of the three groups was 61 to 64 years, and 64% belonged to the memorial Sloan Kettering Cancer Center (MSKCC) medium prognostic risk group.
The progression-free survival (primary endpoint) of the Len/Pem group was significantly longer than that of the sunitinib group (median, 23.
9 months vs.
9.
2 months; hazard ratio, 0.
39; P <0.
001), and none of the Len/Eve group The progression survival time was also significantly longer than that of the sunitinib group (median, 14.
7 months vs.
9.
2 months; hazard ratio, 0.
65; P<0.
001).
These results are applicable to all MSKCC risk groups.
At the time of writing, none of the three treatment groups reached the median overall survival.
However, the overall survival of the Len/Pem group was significantly higher than that of the sunitinib group (hazard ratio, 0.
66; P=0.
005).
At 24 months, 79.
2% of patients in the Len/Pem group were still alive, compared with 66.
1% in the Len/Eve group and 70.
4% in the sunitinib group.
There was no difference in overall survival between the Len/Eve group and the sunitinib group.
In the Len/Pem group and the Len/Eve group, the incidence of grade 3 or higher adverse events was slightly higher than that of the sunitinib group.
Comment This trial shows that compared with the historical control sunitinib, lenvatinib combined with pembrolizumab has a significant overall survival benefit.
The higher complete remission rate (16.
1%) in the Len/Pem group is interesting.
Assuming that the above-mentioned combination treatment plan is approved by the US FDA, when clinicians treat patients with previously untreated metastatic renal cell carcinoma, there will be an additional treatment plan that can be considered.
Unfortunately, there is currently no comparative data to assist us in making treatment decisions.
Motzer R et al.
Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma.
N Engl J Med 2021 Feb 13; [e-pub].
(https://doi.
org/10.
1056/NEJMoa2035716) Related reading NEJM journal The NEJM Journal Watch is published by NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field to help doctors understand and use the latest developments.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers in Medicine" jointly created by Jiahui Medical Research and Education Group (JMRE) and "New England Journal of Medicine" (NEJM).
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities.
Both lenvatinib and pembrolizumab showed anticancer activity against advanced renal cell carcinoma, and everolimus also showed anticancer activity (the US FDA has approved everolimus monotherapy and everolimus Combination therapy with lenvatinib and lenvatinib).
In a multinational phase 3 trial, patients with previously untreated advanced renal cell carcinoma were randomly divided into 3 groups and received lenvatinib + pembrolizumab (Len/Pem; lenvatinib daily, Pembrolizumab is administered intravenously every 3 weeks), lenvatinib + everolimus (Len/Eve; both drugs are administered daily) or sunitinib (treatment for 4 weeks, drug withdrawal for 2 weeks) treatment.
Among 1,069 patients, the median age of the three groups was 61 to 64 years, and 64% belonged to the memorial Sloan Kettering Cancer Center (MSKCC) medium prognostic risk group.
The progression-free survival (primary endpoint) of the Len/Pem group was significantly longer than that of the sunitinib group (median, 23.
9 months vs.
9.
2 months; hazard ratio, 0.
39; P <0.
001), and none of the Len/Eve group The progression survival time was also significantly longer than that of the sunitinib group (median, 14.
7 months vs.
9.
2 months; hazard ratio, 0.
65; P<0.
001).
These results are applicable to all MSKCC risk groups.
At the time of writing, none of the three treatment groups reached the median overall survival.
However, the overall survival of the Len/Pem group was significantly higher than that of the sunitinib group (hazard ratio, 0.
66; P=0.
005).
At 24 months, 79.
2% of patients in the Len/Pem group were still alive, compared with 66.
1% in the Len/Eve group and 70.
4% in the sunitinib group.
There was no difference in overall survival between the Len/Eve group and the sunitinib group.
In the Len/Pem group and the Len/Eve group, the incidence of grade 3 or higher adverse events was slightly higher than that of the sunitinib group.
Comment This trial shows that compared with the historical control sunitinib, lenvatinib combined with pembrolizumab has a significant overall survival benefit.
The higher complete remission rate (16.
1%) in the Len/Pem group is interesting.
Assuming that the above-mentioned combination treatment plan is approved by the US FDA, when clinicians treat patients with previously untreated metastatic renal cell carcinoma, there will be an additional treatment plan that can be considered.
Unfortunately, there is currently no comparative data to assist us in making treatment decisions.
Motzer R et al.
Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma.
N Engl J Med 2021 Feb 13; [e-pub].
(https://doi.
org/10.
1056/NEJMoa2035716) Related reading NEJM journal The NEJM Journal Watch is published by NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field to help doctors understand and use the latest developments.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers in Medicine" jointly created by Jiahui Medical Research and Education Group (JMRE) and "New England Journal of Medicine" (NEJM).
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities.
