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*It is only for medical professionals to read for reference.
ASCO's popularity continues to show you the latest developments in lenvatinib
.
The 2021 American Society of Clinical Oncology (ASCO) annual meeting ended on June 8.
The conference announced more than ten researches on the application of lenvatinib alone or in combination with pembrolizumab in different tumor types.
The relevant abstracts in the fields of renal cell carcinoma (RCC), melanoma, endometrial cancer (EC), gastric cancer, colorectal cancer, cholangiocarcinoma, and neuroendocrine tumors (NETs) are sorted out for readers
.
1 CLEAR study: lenvatinib + pembrolizumab in the treatment of RCC renewed good news Abstract number: 4560 CLEAR study: lenvatinib + pembrolizumab and sunitinib treatment group in selected subgroups of the depth of response And efficacy evaluation
.
The CLEAR study is a multi-center, randomized, open-label, phase III clinical trial that enrolled 1609 patients with advanced renal cancer
.
The detailed data of the study was reported at the previous 2021 ASCO GU meeting: The objective response rate (ORR) of lenvatinib + pembrolizumab in the first-line treatment reached 71%, and the complete response (CR) was 16%.
The median progression-free survival (PFS) is 23.
9 months, and the median overall survival (OS) has not yet been reached
.
This time, ASCO announced the results of exploring the correlation between the depth of response of patients and OS based on the efficacy of selected subgroups of patients
.
The results showed that in patients with renal target disease, compared with sunitinib, lenvatinib + pembrolizumab improved PFS, OS and ORR
.
Overall, the 24-month OS rate of patients who received lenvatinib + pembrolizumab and the target lesion was reduced by more than 75% was similar to that of CR patients (91.
7% vs 100%)
.
2CLEAR post-analysis: Survival benefit of lenvatinib + everolimus may be underestimated Abstract number: 4562 CLEAR study showed that lenvatinib + everolimus had a significant PFS benefit compared with sunitinib (HR 0.
65 , 95%CI 0.
53-0.
80, P<0.
001) and ORR improved (RR 1.
48, 95% CI 1.
26-1.
74), but there was no significant difference in OS data
.
The post-mortem analysis of this study: the effect of follow-up treatment on OS in the lenvatinib+everolimus and sunitinib treatment groups
.
In the CLEAR study, given that the median treatment time of sunitinib was shorter than that of lenvatinib + everolimus (7.
8 months vs 11.
0 months), more patients in the sunitinib group were surviving During the follow-up period, he received follow-up anti-tumor treatment
.
Among patients receiving follow-up treatment, the median time from randomization to the start of follow-up treatment was longer in the lenvatinib+everolimus group compared with the sunitinib group (8.
0 months and 6.
6 months, respectively) ), consistent with the significant benefit of lenvatinib + everolimus PFS
.
These exploratory analysis results show that in the CLEAR study, subsequent systemic anti-cancer treatment has an important impact on the outcome of OS
.
3Lenvatinib + Pembrolizumab: for RCC patients to obtain a higher quality of life Abstract number: 4502Lenvatinib + Pembrolizumab/everolimus versus sunitinib in the treatment of advanced renal cell carcinoma ( aRCC) Health-related quality of life (HRQoL) analysis of the Phase III CLEAR trial of patients
.
In the first-line treatment of aRCC patients, lenvatinib + pembrolizumab improved PFS, OS and ORR compared with sunitinib; lenvatinib + everolimus compared with sunitinib Improved PFS and ORR
.
The ASCO reported the results of the HRQoL, the secondary endpoint of the CLEAR trial.
At the 46th week, the overall change in the lenvatinib + pembrolizumab group compared with baseline was better than that of the sunitinib group.
There are significant differences in disease-related symptoms between patients [least squares mean difference (LS MD) (95% CI): 3.
0 (0.
5, 5.
5)], including fatigue [-2.
8 (-5.
5, -0.
1)], breathing difficulty [-2.
8 (-5.
3, -0.
3)] constipation, and [-2.
2 (-4.
2, -0.
2)] and the like
.
Compared with the sunitinib group, patients in the lenvatinib+pembrolizumab group had similar or milder symptoms and better HRQoL
.
4 The hope of patients with metastatic RCC: OS is as long as 30.
3 months, lenvatinib + pembrolizumab can live up to expectations Abstract number: e16542 lenvatinib + pembrolizumab in the treatment of metastatic clear cell renal cell carcinoma Patients: Patients whose previous treatment plan does not include ICI have OS for more than 30 months
.
A phase 1b trial of lenvatinib + pembrolizumab was carried out in multiple tumor types and was expanded into a phase II cohort study (NCT02501096), including previous treatment with immune checkpoint inhibitors (ICI) , Patients with metastatic RCC who have not received treatment or have not included ICI in the previous program
.
The ASCO reported the final results of the RCC cohort study and conducted long-term follow-up
.
The data showed that the median follow-up time was 19.
8 months
.
The 24th week ORR (ORRwk24) of patients who received ICI treatment was 55.
8%, the ORRwk24 of untreated patients was 72.
7%, and the ORRwk24 of patients who did not include ICI treatment was 41.
2%
.
The median OS of patients who did not include ICI treatment in the previous program was 30.
3 months, while the other groups did not reach the median OS
.
The results suggest that lenvatinib+pembrolizumab has shown encouraging anti-tumor activity and controllable safety in patients with metastatic RCC (including those who have previously received ICI therapy)
.
5Break the boundaries, lenvatinib + pembrolizumab actively explore non-clear cell renal cell carcinoma.
Abstract number: TPS4595 lenvatinib + pembrolizumab as the first-line treatment of non-clear cell renal cell carcinoma (nccRCC) opening Label Phase II study (KEYNOTE-B61)
.
Most of the tissue types of renal cell carcinoma are clear cell carcinoma, and the other types are non-clear cell renal cell carcinoma, which belong to a class of heterogeneous tumors; due to the strong invasiveness and lack of effective systemic treatment methods, nccRCC urgently needs treatment A breakthrough is made, which is a relatively shortcoming in the treatment of advanced kidney cancer
.
In the previous KEYNOTE-581 phase III study (NCT02811861), lenvatinib + pembrolizumab showed strong anti-tumor activity in the first-line treatment of patients with metastatic ccRCC, suggesting that this combination may be an excellent treatment option for nccRCC Currently, a Phase II, open-label, single-arm KEYNOTE-B61 study (NCT04704219) is being carried out to evaluate the potential of lenvatinib + pembrolizumab as the first-line treatment of nccRCC
.
6Lenvatinib+pembrolizumab in the treatment of melanoma strength verification: ORR is as high as 33.
3%, OS up to 14 months Abstract number: 9504 lenvatinib+pembrolizumab in the treatment of late or clear application of PD- 1 or melanoma patients with disease progression after PD-L1 inhibitors: the latest discovery of LEAP-004
.
This time ASCO released updated data and new ORR subgroup analysis of the open-label, single-arm, phase II LEAP-004 study (NCT03776136)
.
The results showed that the ORR of the Independent Central Neuroimaging Blind Evaluation (BICR) was still 21.
4%
.
The disease control rate (DCR) was 66.
0%
.
The median duration of response (DOR) increased to 8.
2 months, and the estimated value of DOR≥9 months was 37.
2%
.
The ORR of patients who used anti-PD-1+anti-CTLA-4 for the treatment of disease progression (PD) was 33.
3%, and the ORR of patients who had only used anti-PD-1/L1 was 18.
2%
.
The median PFS and OS of the total population were 4.
2 months and 14.
0 months, respectively; the estimated 12-month PFS and OS rates were 17.
8% and 54.
5%, respectively
.
These data support that lenvatinib + pembrolizumab can be used as a potential treatment option for melanoma patients with high demand for treatment in the late stage or after the application of PD-1 or PD-L1 inhibitors
.
7Lenvatinib+Pembrolizumab: Improve the quality of life of patients with advanced endometrial cancer Abstract number: 5570 Advanced endometrial treated with lenvatinib+pembrolizumab or doctor-selected treatment (TPC) regimen HRQoL of patients with cancer (aEC)
.
In the 309/KEYNOTE-775 study, compared with TPC, lenvatinib + pembrolizumab showed significant and clinically significant OS, PFS and ORR in patients with aEC who had previously received systemic platinum therapy Improve
.
In view of the medical complexity and age of EC patients, quality of life analysis is very important, but it is rarely reported
.
This time ASCO announced the HRQoL results reported by the patients in the study
.
No significant difference was observed in the HRQoL scores between the treatment groups, but because there is no standard treatment method after the failure of platinum therapy, these data and the efficacy and safety results reported in the previous study further support lenvatinib + pembrolizide Compared with chemotherapy, resistance has overall favorable benefit/risk characteristics
.
8LEAP-005: Lenvatinib + Pembrolizumab highlights the potential for the treatment of gastrointestinal tumors LEAP-005 (NCT03797326) is a phase II, multi-cohort, non-randomized, open-label study designed to evaluate lenvatinib+ The efficacy and safety of pembrolizumab in patients with advanced solid tumors who have previously received treatment, this time ASCO announced the LEAP-005 gastric cancer cohort (abstract number: 4030), colorectal cancer cohort (abstract number: 3564) and The results of the cholangiocarcinoma cohort (abstract number: 4080)
.
Gastric cancer cohort: Among 31 gastric cancer patients who received lenvatinib + pembrolizumab, the ORR was 10%; 1 patient got CR (3%), 2 patients got PR (6%), and 12 patients ( 39%) were SD, DCR was 48%, median PFS was 2.
5 months, and median OS was 5.
9 months
.
It suggests that lenvatinib+pembrolizumab shows strong anti-tumor activity and controllable safety in patients with advanced gastric cancer who have previously received 2-line treatment
.
Based on this, the number of recruits for the gastric cancer cohort was expanded to 100 cases
.
Colorectal cancer cohort: Among 32 patients with colorectal cancer treated with lenvatinib + pembrolizumab, the ORR can reach 22%
.
It is suggested that in patients with advanced non-MSI-H (highly unstable microsatellites)/mismatch repair protein deficiency (dMMR) colorectal cancer who have received previous treatment, the combination regimen has strong anti-tumor activity and controllable safety
.
Based on this, the number of recruits for the colorectal cancer cohort was expanded to 100 cases
.
Cholangiocarcinoma cohort: Among the 31 cholangiocarcinoma patients treated with lenvatinib and pembrolizumab, 3 cases (10%) were PR and 18 cases (58%) were SD
.
The ORR was 10%, the DCR was 68%, and the median DOR was 5.
3 months
.
The median PFS was 6.
1 months
.
The median OS was 8.
6 months
.
It suggests that lenvatinib+pembrolizumab has good efficacy and safety in patients with advanced cholangiocarcinoma who have received first-line treatment
.
Based on these data, the number of recruits in the cholangiocarcinoma cohort was expanded to 100 cases
.
9 Targeting angiogenesis and cell growth factors: lenvatinib shows its talents in the field of NETs Abstract number: 4113 The plasma biomarker study of lenvatinib in patients with gastrointestinal pancreatic neuroendocrine tumors (NETs) revealed Ang2 And FGF2 are predictors of treatment response: results from the international phase II TALENT trial (GETNE1509)
.
The TALENT trial is a multicenter prospective phase II study designed to evaluate the treatment of G1/G2 advanced NETs derived from pancreas (panNETs) and gastrointestinal tract (giNETs) with lenvatinib.
ASCO announced the study's plasma biomarkers this time.
The result of the exploration of the object
.
In both cohorts, the plasma pro-angiogenic characteristics of patient samples revealed that high Ang2 and low FGF2 are predictive biomarkers of lenvatinib treatment response
.
In patients pretreated with anti-angiogenesis, Ang2 and VEGFR2 levels can significantly predict the treatment response of panNETs
.
Summary In addition to hepatocellular carcinoma (HCC), lenvatinib + pembrolizumab targets renal cell carcinoma, gastric cancer, endometrial cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, melanoma, cholangiocarcinoma, and urothelial carcinoma 13 tumor types such as colorectal cancer and colorectal cancer have layouts.
This ASCO conference presented the research progress of several of these tumor types, opening the way for multiple tumor types of lenvatinib + pembrolizumab.
Soil, provide more evidence-based support
.
In the future, it is expected that the joint program will bring more breakthroughs and benefit more cancer patients! Scan the QR code to download relevant abstracts* This article is only used to provide scientific information to medical professionals, and does not represent the views of this platform
ASCO's popularity continues to show you the latest developments in lenvatinib
.
The 2021 American Society of Clinical Oncology (ASCO) annual meeting ended on June 8.
The conference announced more than ten researches on the application of lenvatinib alone or in combination with pembrolizumab in different tumor types.
The relevant abstracts in the fields of renal cell carcinoma (RCC), melanoma, endometrial cancer (EC), gastric cancer, colorectal cancer, cholangiocarcinoma, and neuroendocrine tumors (NETs) are sorted out for readers
.
1 CLEAR study: lenvatinib + pembrolizumab in the treatment of RCC renewed good news Abstract number: 4560 CLEAR study: lenvatinib + pembrolizumab and sunitinib treatment group in selected subgroups of the depth of response And efficacy evaluation
.
The CLEAR study is a multi-center, randomized, open-label, phase III clinical trial that enrolled 1609 patients with advanced renal cancer
.
The detailed data of the study was reported at the previous 2021 ASCO GU meeting: The objective response rate (ORR) of lenvatinib + pembrolizumab in the first-line treatment reached 71%, and the complete response (CR) was 16%.
The median progression-free survival (PFS) is 23.
9 months, and the median overall survival (OS) has not yet been reached
.
This time, ASCO announced the results of exploring the correlation between the depth of response of patients and OS based on the efficacy of selected subgroups of patients
.
The results showed that in patients with renal target disease, compared with sunitinib, lenvatinib + pembrolizumab improved PFS, OS and ORR
.
Overall, the 24-month OS rate of patients who received lenvatinib + pembrolizumab and the target lesion was reduced by more than 75% was similar to that of CR patients (91.
7% vs 100%)
.
2CLEAR post-analysis: Survival benefit of lenvatinib + everolimus may be underestimated Abstract number: 4562 CLEAR study showed that lenvatinib + everolimus had a significant PFS benefit compared with sunitinib (HR 0.
65 , 95%CI 0.
53-0.
80, P<0.
001) and ORR improved (RR 1.
48, 95% CI 1.
26-1.
74), but there was no significant difference in OS data
.
The post-mortem analysis of this study: the effect of follow-up treatment on OS in the lenvatinib+everolimus and sunitinib treatment groups
.
In the CLEAR study, given that the median treatment time of sunitinib was shorter than that of lenvatinib + everolimus (7.
8 months vs 11.
0 months), more patients in the sunitinib group were surviving During the follow-up period, he received follow-up anti-tumor treatment
.
Among patients receiving follow-up treatment, the median time from randomization to the start of follow-up treatment was longer in the lenvatinib+everolimus group compared with the sunitinib group (8.
0 months and 6.
6 months, respectively) ), consistent with the significant benefit of lenvatinib + everolimus PFS
.
These exploratory analysis results show that in the CLEAR study, subsequent systemic anti-cancer treatment has an important impact on the outcome of OS
.
3Lenvatinib + Pembrolizumab: for RCC patients to obtain a higher quality of life Abstract number: 4502Lenvatinib + Pembrolizumab/everolimus versus sunitinib in the treatment of advanced renal cell carcinoma ( aRCC) Health-related quality of life (HRQoL) analysis of the Phase III CLEAR trial of patients
.
In the first-line treatment of aRCC patients, lenvatinib + pembrolizumab improved PFS, OS and ORR compared with sunitinib; lenvatinib + everolimus compared with sunitinib Improved PFS and ORR
.
The ASCO reported the results of the HRQoL, the secondary endpoint of the CLEAR trial.
At the 46th week, the overall change in the lenvatinib + pembrolizumab group compared with baseline was better than that of the sunitinib group.
There are significant differences in disease-related symptoms between patients [least squares mean difference (LS MD) (95% CI): 3.
0 (0.
5, 5.
5)], including fatigue [-2.
8 (-5.
5, -0.
1)], breathing difficulty [-2.
8 (-5.
3, -0.
3)] constipation, and [-2.
2 (-4.
2, -0.
2)] and the like
.
Compared with the sunitinib group, patients in the lenvatinib+pembrolizumab group had similar or milder symptoms and better HRQoL
.
4 The hope of patients with metastatic RCC: OS is as long as 30.
3 months, lenvatinib + pembrolizumab can live up to expectations Abstract number: e16542 lenvatinib + pembrolizumab in the treatment of metastatic clear cell renal cell carcinoma Patients: Patients whose previous treatment plan does not include ICI have OS for more than 30 months
.
A phase 1b trial of lenvatinib + pembrolizumab was carried out in multiple tumor types and was expanded into a phase II cohort study (NCT02501096), including previous treatment with immune checkpoint inhibitors (ICI) , Patients with metastatic RCC who have not received treatment or have not included ICI in the previous program
.
The ASCO reported the final results of the RCC cohort study and conducted long-term follow-up
.
The data showed that the median follow-up time was 19.
8 months
.
The 24th week ORR (ORRwk24) of patients who received ICI treatment was 55.
8%, the ORRwk24 of untreated patients was 72.
7%, and the ORRwk24 of patients who did not include ICI treatment was 41.
2%
.
The median OS of patients who did not include ICI treatment in the previous program was 30.
3 months, while the other groups did not reach the median OS
.
The results suggest that lenvatinib+pembrolizumab has shown encouraging anti-tumor activity and controllable safety in patients with metastatic RCC (including those who have previously received ICI therapy)
.
5Break the boundaries, lenvatinib + pembrolizumab actively explore non-clear cell renal cell carcinoma.
Abstract number: TPS4595 lenvatinib + pembrolizumab as the first-line treatment of non-clear cell renal cell carcinoma (nccRCC) opening Label Phase II study (KEYNOTE-B61)
.
Most of the tissue types of renal cell carcinoma are clear cell carcinoma, and the other types are non-clear cell renal cell carcinoma, which belong to a class of heterogeneous tumors; due to the strong invasiveness and lack of effective systemic treatment methods, nccRCC urgently needs treatment A breakthrough is made, which is a relatively shortcoming in the treatment of advanced kidney cancer
.
In the previous KEYNOTE-581 phase III study (NCT02811861), lenvatinib + pembrolizumab showed strong anti-tumor activity in the first-line treatment of patients with metastatic ccRCC, suggesting that this combination may be an excellent treatment option for nccRCC Currently, a Phase II, open-label, single-arm KEYNOTE-B61 study (NCT04704219) is being carried out to evaluate the potential of lenvatinib + pembrolizumab as the first-line treatment of nccRCC
.
6Lenvatinib+pembrolizumab in the treatment of melanoma strength verification: ORR is as high as 33.
3%, OS up to 14 months Abstract number: 9504 lenvatinib+pembrolizumab in the treatment of late or clear application of PD- 1 or melanoma patients with disease progression after PD-L1 inhibitors: the latest discovery of LEAP-004
.
This time ASCO released updated data and new ORR subgroup analysis of the open-label, single-arm, phase II LEAP-004 study (NCT03776136)
.
The results showed that the ORR of the Independent Central Neuroimaging Blind Evaluation (BICR) was still 21.
4%
.
The disease control rate (DCR) was 66.
0%
.
The median duration of response (DOR) increased to 8.
2 months, and the estimated value of DOR≥9 months was 37.
2%
.
The ORR of patients who used anti-PD-1+anti-CTLA-4 for the treatment of disease progression (PD) was 33.
3%, and the ORR of patients who had only used anti-PD-1/L1 was 18.
2%
.
The median PFS and OS of the total population were 4.
2 months and 14.
0 months, respectively; the estimated 12-month PFS and OS rates were 17.
8% and 54.
5%, respectively
.
These data support that lenvatinib + pembrolizumab can be used as a potential treatment option for melanoma patients with high demand for treatment in the late stage or after the application of PD-1 or PD-L1 inhibitors
.
7Lenvatinib+Pembrolizumab: Improve the quality of life of patients with advanced endometrial cancer Abstract number: 5570 Advanced endometrial treated with lenvatinib+pembrolizumab or doctor-selected treatment (TPC) regimen HRQoL of patients with cancer (aEC)
.
In the 309/KEYNOTE-775 study, compared with TPC, lenvatinib + pembrolizumab showed significant and clinically significant OS, PFS and ORR in patients with aEC who had previously received systemic platinum therapy Improve
.
In view of the medical complexity and age of EC patients, quality of life analysis is very important, but it is rarely reported
.
This time ASCO announced the HRQoL results reported by the patients in the study
.
No significant difference was observed in the HRQoL scores between the treatment groups, but because there is no standard treatment method after the failure of platinum therapy, these data and the efficacy and safety results reported in the previous study further support lenvatinib + pembrolizide Compared with chemotherapy, resistance has overall favorable benefit/risk characteristics
.
8LEAP-005: Lenvatinib + Pembrolizumab highlights the potential for the treatment of gastrointestinal tumors LEAP-005 (NCT03797326) is a phase II, multi-cohort, non-randomized, open-label study designed to evaluate lenvatinib+ The efficacy and safety of pembrolizumab in patients with advanced solid tumors who have previously received treatment, this time ASCO announced the LEAP-005 gastric cancer cohort (abstract number: 4030), colorectal cancer cohort (abstract number: 3564) and The results of the cholangiocarcinoma cohort (abstract number: 4080)
.
Gastric cancer cohort: Among 31 gastric cancer patients who received lenvatinib + pembrolizumab, the ORR was 10%; 1 patient got CR (3%), 2 patients got PR (6%), and 12 patients ( 39%) were SD, DCR was 48%, median PFS was 2.
5 months, and median OS was 5.
9 months
.
It suggests that lenvatinib+pembrolizumab shows strong anti-tumor activity and controllable safety in patients with advanced gastric cancer who have previously received 2-line treatment
.
Based on this, the number of recruits for the gastric cancer cohort was expanded to 100 cases
.
Colorectal cancer cohort: Among 32 patients with colorectal cancer treated with lenvatinib + pembrolizumab, the ORR can reach 22%
.
It is suggested that in patients with advanced non-MSI-H (highly unstable microsatellites)/mismatch repair protein deficiency (dMMR) colorectal cancer who have received previous treatment, the combination regimen has strong anti-tumor activity and controllable safety
.
Based on this, the number of recruits for the colorectal cancer cohort was expanded to 100 cases
.
Cholangiocarcinoma cohort: Among the 31 cholangiocarcinoma patients treated with lenvatinib and pembrolizumab, 3 cases (10%) were PR and 18 cases (58%) were SD
.
The ORR was 10%, the DCR was 68%, and the median DOR was 5.
3 months
.
The median PFS was 6.
1 months
.
The median OS was 8.
6 months
.
It suggests that lenvatinib+pembrolizumab has good efficacy and safety in patients with advanced cholangiocarcinoma who have received first-line treatment
.
Based on these data, the number of recruits in the cholangiocarcinoma cohort was expanded to 100 cases
.
9 Targeting angiogenesis and cell growth factors: lenvatinib shows its talents in the field of NETs Abstract number: 4113 The plasma biomarker study of lenvatinib in patients with gastrointestinal pancreatic neuroendocrine tumors (NETs) revealed Ang2 And FGF2 are predictors of treatment response: results from the international phase II TALENT trial (GETNE1509)
.
The TALENT trial is a multicenter prospective phase II study designed to evaluate the treatment of G1/G2 advanced NETs derived from pancreas (panNETs) and gastrointestinal tract (giNETs) with lenvatinib.
ASCO announced the study's plasma biomarkers this time.
The result of the exploration of the object
.
In both cohorts, the plasma pro-angiogenic characteristics of patient samples revealed that high Ang2 and low FGF2 are predictive biomarkers of lenvatinib treatment response
.
In patients pretreated with anti-angiogenesis, Ang2 and VEGFR2 levels can significantly predict the treatment response of panNETs
.
Summary In addition to hepatocellular carcinoma (HCC), lenvatinib + pembrolizumab targets renal cell carcinoma, gastric cancer, endometrial cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, melanoma, cholangiocarcinoma, and urothelial carcinoma 13 tumor types such as colorectal cancer and colorectal cancer have layouts.
This ASCO conference presented the research progress of several of these tumor types, opening the way for multiple tumor types of lenvatinib + pembrolizumab.
Soil, provide more evidence-based support
.
In the future, it is expected that the joint program will bring more breakthroughs and benefit more cancer patients! Scan the QR code to download relevant abstracts* This article is only used to provide scientific information to medical professionals, and does not represent the views of this platform
