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The 2021 European Society of Medical Oncology Annual Meeting (ESMO 2021) will be held from September 16 to 21, local time
.
On September 13, ESMO has officially announced the meeting agenda and the topics and abstracts of related reports
.
This article summarizes the major researches that will be presented in the field of urinary tumors
.
Expert profile Professor Yang Rong is the chief physician, associate professor, and doctoral supervisor of Gulou Hospital, Nanjing University School of Medicine
.
Member of Urology Branch of Jiangsu Medical Association, Youth Member of Special Committee of Urinary and Male Reproductive System Tumors of Chinese Anti-Cancer Association, Object of Jiangsu Province 333 Project, Object of Funding of Six Talent Peaks of Jiangsu Province, Young Medical Talents of Jiangsu Province, and Nanjing City Winner of the Outstanding Youth Fund of the Health Bureau
.
Research direction: Research on the genesis and development mechanism of bladder cancer and gene therapy
.
Published more than 60 clinical and basic papers in international and domestic core journals, and won 3 National Natural Science Foundation of China
.
[Renal cell carcinoma] 1.
[LBA28] STAR study: a randomized multi-stage comparison of locally advanced and/or metastatic renal cell carcinoma (RCC) intermittent or continuous standard first-line treatment (sunitinib or pazopanib) Phase II/III trials of sunitinib and pazopanib are the standard first-line treatments for advanced renal cancer, but the best course of treatment is not yet clear.
The clinical practice continues until the patient develops disease progression or intolerable toxicity
.
The STAR study is a phase II/III randomized clinical trial supported by NIHR HTA in the United Kingdom.
Patients with advanced RCC will be randomly (1:1) assigned to the continuous treatment group (CCS) or the intermittent treatment group (DFIS)
.
The main goal of this study is to determine whether DFIS has non-inferiority in the 2-year overall survival (OS) rate and quality-adjusted life years (QALY) compared with CCS
.
This is a complicated experiment, and the study has been going on for nearly 10 years since its inception in 2012
.
After ten years of sharpening a sword, what answer will STAR research tell us? Let us wait and see
.
2.
[LBA29] Nivolumab combined with ipilimumab in the first-line treatment of patients with advanced renal cell carcinoma: a randomized phase II trial (PRISM) in the field of first-line treatment of advanced renal cancer, competition based on immune-based combination therapy Has entered the "white-hot", currently including Nivolumab + Ipilimumab, Pembrolizumab + Axitinib, Avelumab + Axitinib, Nivolumab + Cabozantinib, Pembrolizumab Clinical studies of multiple combinations such as monoclonal antibody + lenvatinib have achieved positive effects
.
Based on the pivotal Phase III CheckMate-214 study, nivolumab + ipilimumab can significantly reduce the risk of death by 37% of patients with intermediate and high-risk RCC (HR 0.
63, 99.
8%CI: 0.
44~0.
89; P＜0.
0001).
Long-term survival benefits, the program has been approved internationally
.
Although CheckMate-214 uses a low-dose ipilimumab regimen (1 mg/kg, once every 3 weeks), the toxicity of the double-immune regimen still increases to a certain extent
.
The phase II PRISM study aims to evaluate whether a further extension of the use cycle of ipilimumab (administered once every 12 weeks) can reduce side effects without affecting the efficacy
.
3.
[666P] KEYNOTE-427 study: Pembrolizumab (pembro) single-agent first-line treatment of patients with advanced renal clear cell carcinoma (ccRCC) 41-month follow-up results: Cohort A In recent years, multiple advanced RCC combined treatment studies The efficacy of anti-PD-1 and anti-PD-L1 monoclonal antibodies as first-line therapy has been evaluated, but the data on first-line immune monotherapy is still relatively limited
.
KEYNOTE-427 is a single-arm, open-label, non-randomized, multi-center (61 research centers), global (10 countries) phase II clinical trial
.
The study A cohort included 110 patients with advanced or metastatic ccRCC who received pembrolizumab monotherapy, 200 mg intravenously, once every 3 weeks
.
The KEYNOTE-427 study reported at the 2020 ASCO meeting confirmed the positive efficacy of pembrolizumab as a single agent in ccRCC patients
.
The objective response rate (ORR) was 36.
4% (95% CI, 27.
4-46.
1), 4 cases (3.
6%) had complete remission (CR), and 36 cases (32.
7%) had partial remission (PR)
.
This abstract published 41-month follow-up data.
The results showed that the median progression-free survival (PFS) of all patients was 7.
1 months (95% CI, 5.
6-11.
0), and the median OS was 40.
7 months (95 CI, 31.
1).
-Not reached); the 30-month PFS and OS rates were 19.
9% and 62.
6%, respectively
.
4.
[6530] KEYNOTE-564 study: a study comparing pembrolizumab (pembro) and placebo as an adjuvant treatment for patients with renal cell carcinoma (RCC)—patient report outcome (PRO) KEYNOTE-564 is a comparison of pembrolizumab A key phase III clinical trial of anti- or placebo adjuvant therapy for localized renal cancer
.
Delivered an oral report at the ASCO Conference in 2021, and the full text was recently published in NEJM Magazine
.
The results of a median follow-up of 24.
1 months showed that compared with placebo, the 2-year disease-free survival (DFS) rate of patients in the pembrolizumab group increased by 9.
2% (77.
3% vs 68.
1%), and the risk of recurrence or death was reduced It is 32% (HR=0.
68, 95%CI: 0.
53~0.
87, P=0.
002)
.
The oral report of this ESMO conference will report the PRO of the study.
Can pembrolizumab improve the quality of life while improving the survival outcome of DFS? 5.
[679P] NIVOSWITCH study: The efficacy of nivolumab maintenance therapy in patients with metastatic clear cell renal cell carcinoma (mRCC) after TKI induction: patient report outcome (PRO) In mRCC patients, the combination of TKI and ICI is The first-line standard of treatment at this stage
.
The NIVOSWITCH study explores whether the first-line maintenance regimen (ICI after TKI) can improve the prognosis of mRCC
.
The study design was that patients who achieved partial remission (PR) or stable disease (SD) after 12 weeks of TKI induction therapy were randomly divided into TKI continued treatment or nivolumab maintenance treatment at 1:1, starting from the time of randomization Evaluate ORR and PFS
.
The preliminary results of the NIVOSWITCH study were reported at the 2020 ASCO GU conference.
After first-line TKI induction therapy, switching to nivolumab therapy, ORR and mPFS are significantly lower than continuous TKI therapy
.
This abstract published the PRO of the study.
After a median follow-up of 26.
3 months (1.
3-45.
6), the 2-year OS of nivolumab treatment was 64%, and the TKI treatment was 66% (HR = 1.
12 [95% CI: 0.
43 2.
89]; P = 0.
82)
.
The data does not support the switch to nivolumab therapy after TKI induction therapy in mRCC
.
No PRO benefit detected
.
[Urothelial cancer] 6.
[LBA27] NORSE study: Erdatinib (ERDA) or ERDA combined with Cetrelimab (CET) in the treatment of locally advanced or metastatic urothelial cancer with fibroblast growth factor receptor mutation (FGFRa) (MUC) The first results analysis of the Phase II study in patients.
The NORSE study is a Phase 1b/2 study evaluating the combination of erdatinib and Cetrelimab in the treatment of mUC patients with FGFR mutations
.
The ESMO conference in 2020 reported the Phase Ib results of the study and determined that the recommended Phase II dose is erdatinib 8 mg + Cetrelimab 240 mg
.
The incidence of treatment-related adverse events (TRAE) grade 3-4 was 41%
.
Among the 11 evaluable patients, the ORR reached 55% and the disease control rate (DCR) reached 100%
.
7.
[LBA31] NABUCCO study: high-dose or low-dose preoperative nivolumab combined with ipilimumab for locally advanced urothelial cancer (cohort 2) NABUCCO study data were first published at ESMO 2019, NABUCCO study cohort 1 It is a dual-immune combination program in the high-risk phase III (cT3-4aN0M0 or lymph node positive) cisplatin intolerant patients with neoadjuvant therapy phase Ib exploration
.
The results of cohort 1 showed that the dual-immune combination (nivolumab + ipilimumab) neoadjuvant therapy had a pathological complete remission (pCR) rate of 46%, and PD-L1 positive patients had a pCR of 60%
.
This meeting will announce the data of cohort 2 nivolumab + ipilimumab neoadjuvant treatment at different doses
.
8.
[699P] IMvigor210 study: Atelizumab monotherapy in patients with untreated cisplatin-intolerant metastatic urothelial carcinoma: 5-year follow-up data and survival analysis (cohort 1) IMvigor210 is one item To explore the phase II study of atilizumab as a single agent in the treatment of patients with advanced urothelial carcinoma
.
The study cohort 1 included 119 patients with advanced UC who were newly treated but not suitable for cisplatin chemotherapy.
The data released by the 2019 ASCO conference showed that the overall ORR was 23%, the CR rate was 9%, and different PDL1 expression levels did not clearly affect the treatment Efficient
.
The median OS was 15.
9 months
.
The ESMO conference announced the 15.
8-year follow-up data of the IMvigor210 cohort.
The total population ORR was 23.
5% [16.
2, 32.
2], the median duration of response (DOR) was 59.
1 months (5 years), and PD-L1 IC0/1 tumor The patient's median DOR was 53.
5 months (IC2/3 median DOR has not yet been reached), and the results showed that atilizumab single-agent therapy brought long-term response and long-term survival
.
[Prostate cancer] 9.
[LBA24] COSMIC-021 study: Cabozantinib (C) combined with atelizumab (A) in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC): results of extended cohort 6 phase 1b COSMIC The -021 study aims to evaluate the application of multi-target TKI Cabozantinib combined with anti-PD-L1 atelizumab in patients with solid tumors
.
The primary study endpoint is ORR, the secondary study endpoint is safety, and the exploratory endpoint includes PFS and the correlation between biomarkers and prognosis
.
The results of the renal cancer cohort were reported at the ESMO conference in 2020.
The ORR of the 40mg Cabozantinib group and the 60mg Cabozantinib group were 53% and 58%, respectively; DCR were 94% and 92%, respectively; PFS were 19.
5 months and 15.
1 months, respectively
.
The COSMIC-021 study also includes many other research cohorts such as non-small cell lung cancer (NSCLC) and prostate cancer
.
The ESMO conference will report the results of patients in the mCRPC cohort
.
10.
[577O] PRINCE study: 177Lu-PSMA-617 combined with pembrolizumab in the treatment of metastatic castration resistant prostate cancer (mCRPC) Phase Ib study interim analysis 177Lu-PSMA-617 is a new type of radioligand therapy, Accurate treatment of cancer through the combination of therapeutic radioisotopes (radioactive particles) and targeted compounds (ligands)
.
The results of the key Phase III VISION study reported at the ASCO conference in 2021 and simultaneously published by NEJM showed that in patients with progressive PSMA-positive mCRPC, 177Lu-PSMA-617 combined with SOC can significantly improve patients’ rPFS and SOC compared with standard treatment (SOC).
OS
.
Median rPFS: 8.
7 months in 177Lu-PSMA-617+SOC group vs.
3.
4 months in SOC group (P＜0.
001), HR=0.
40 (99.
2%CI: 0.
29~0.
57); median OS: 177Lu-PSMA-617 +SOC group 15.
3 months vs.
SOC group 11.
3 months (P＜0.
001), HR=0.
62 (95%CI: 0.
52~0.
74)
.
Whether 177Lu-PSMA-617 combined with anti-PD-1 immunotherapy can further improve the efficacy, please look forward to the PRINCE study disclosed at the ESMO conference in 2021
.
Reference: https://cslide.
ctimeetingtech.
com/esmo2021/attendee/confcal_4/presentation/list?r=pt%7E33_34
.
On September 13, ESMO has officially announced the meeting agenda and the topics and abstracts of related reports
.
This article summarizes the major researches that will be presented in the field of urinary tumors
.
Expert profile Professor Yang Rong is the chief physician, associate professor, and doctoral supervisor of Gulou Hospital, Nanjing University School of Medicine
.
Member of Urology Branch of Jiangsu Medical Association, Youth Member of Special Committee of Urinary and Male Reproductive System Tumors of Chinese Anti-Cancer Association, Object of Jiangsu Province 333 Project, Object of Funding of Six Talent Peaks of Jiangsu Province, Young Medical Talents of Jiangsu Province, and Nanjing City Winner of the Outstanding Youth Fund of the Health Bureau
.
Research direction: Research on the genesis and development mechanism of bladder cancer and gene therapy
.
Published more than 60 clinical and basic papers in international and domestic core journals, and won 3 National Natural Science Foundation of China
.
[Renal cell carcinoma] 1.
[LBA28] STAR study: a randomized multi-stage comparison of locally advanced and/or metastatic renal cell carcinoma (RCC) intermittent or continuous standard first-line treatment (sunitinib or pazopanib) Phase II/III trials of sunitinib and pazopanib are the standard first-line treatments for advanced renal cancer, but the best course of treatment is not yet clear.
The clinical practice continues until the patient develops disease progression or intolerable toxicity
.
The STAR study is a phase II/III randomized clinical trial supported by NIHR HTA in the United Kingdom.
Patients with advanced RCC will be randomly (1:1) assigned to the continuous treatment group (CCS) or the intermittent treatment group (DFIS)
.
The main goal of this study is to determine whether DFIS has non-inferiority in the 2-year overall survival (OS) rate and quality-adjusted life years (QALY) compared with CCS
.
This is a complicated experiment, and the study has been going on for nearly 10 years since its inception in 2012
.
After ten years of sharpening a sword, what answer will STAR research tell us? Let us wait and see
.
2.
[LBA29] Nivolumab combined with ipilimumab in the first-line treatment of patients with advanced renal cell carcinoma: a randomized phase II trial (PRISM) in the field of first-line treatment of advanced renal cancer, competition based on immune-based combination therapy Has entered the "white-hot", currently including Nivolumab + Ipilimumab, Pembrolizumab + Axitinib, Avelumab + Axitinib, Nivolumab + Cabozantinib, Pembrolizumab Clinical studies of multiple combinations such as monoclonal antibody + lenvatinib have achieved positive effects
.
Based on the pivotal Phase III CheckMate-214 study, nivolumab + ipilimumab can significantly reduce the risk of death by 37% of patients with intermediate and high-risk RCC (HR 0.
63, 99.
8%CI: 0.
44~0.
89; P＜0.
0001).
Long-term survival benefits, the program has been approved internationally
.
Although CheckMate-214 uses a low-dose ipilimumab regimen (1 mg/kg, once every 3 weeks), the toxicity of the double-immune regimen still increases to a certain extent
.
The phase II PRISM study aims to evaluate whether a further extension of the use cycle of ipilimumab (administered once every 12 weeks) can reduce side effects without affecting the efficacy
.
3.
[666P] KEYNOTE-427 study: Pembrolizumab (pembro) single-agent first-line treatment of patients with advanced renal clear cell carcinoma (ccRCC) 41-month follow-up results: Cohort A In recent years, multiple advanced RCC combined treatment studies The efficacy of anti-PD-1 and anti-PD-L1 monoclonal antibodies as first-line therapy has been evaluated, but the data on first-line immune monotherapy is still relatively limited
.
KEYNOTE-427 is a single-arm, open-label, non-randomized, multi-center (61 research centers), global (10 countries) phase II clinical trial
.
The study A cohort included 110 patients with advanced or metastatic ccRCC who received pembrolizumab monotherapy, 200 mg intravenously, once every 3 weeks
.
The KEYNOTE-427 study reported at the 2020 ASCO meeting confirmed the positive efficacy of pembrolizumab as a single agent in ccRCC patients
.
The objective response rate (ORR) was 36.
4% (95% CI, 27.
4-46.
1), 4 cases (3.
6%) had complete remission (CR), and 36 cases (32.
7%) had partial remission (PR)
.
This abstract published 41-month follow-up data.
The results showed that the median progression-free survival (PFS) of all patients was 7.
1 months (95% CI, 5.
6-11.
0), and the median OS was 40.
7 months (95 CI, 31.
1).
-Not reached); the 30-month PFS and OS rates were 19.
9% and 62.
6%, respectively
.
4.
[6530] KEYNOTE-564 study: a study comparing pembrolizumab (pembro) and placebo as an adjuvant treatment for patients with renal cell carcinoma (RCC)—patient report outcome (PRO) KEYNOTE-564 is a comparison of pembrolizumab A key phase III clinical trial of anti- or placebo adjuvant therapy for localized renal cancer
.
Delivered an oral report at the ASCO Conference in 2021, and the full text was recently published in NEJM Magazine
.
The results of a median follow-up of 24.
1 months showed that compared with placebo, the 2-year disease-free survival (DFS) rate of patients in the pembrolizumab group increased by 9.
2% (77.
3% vs 68.
1%), and the risk of recurrence or death was reduced It is 32% (HR=0.
68, 95%CI: 0.
53~0.
87, P=0.
002)
.
The oral report of this ESMO conference will report the PRO of the study.
Can pembrolizumab improve the quality of life while improving the survival outcome of DFS? 5.
[679P] NIVOSWITCH study: The efficacy of nivolumab maintenance therapy in patients with metastatic clear cell renal cell carcinoma (mRCC) after TKI induction: patient report outcome (PRO) In mRCC patients, the combination of TKI and ICI is The first-line standard of treatment at this stage
.
The NIVOSWITCH study explores whether the first-line maintenance regimen (ICI after TKI) can improve the prognosis of mRCC
.
The study design was that patients who achieved partial remission (PR) or stable disease (SD) after 12 weeks of TKI induction therapy were randomly divided into TKI continued treatment or nivolumab maintenance treatment at 1:1, starting from the time of randomization Evaluate ORR and PFS
.
The preliminary results of the NIVOSWITCH study were reported at the 2020 ASCO GU conference.
After first-line TKI induction therapy, switching to nivolumab therapy, ORR and mPFS are significantly lower than continuous TKI therapy
.
This abstract published the PRO of the study.
After a median follow-up of 26.
3 months (1.
3-45.
6), the 2-year OS of nivolumab treatment was 64%, and the TKI treatment was 66% (HR = 1.
12 [95% CI: 0.
43 2.
89]; P = 0.
82)
.
The data does not support the switch to nivolumab therapy after TKI induction therapy in mRCC
.
No PRO benefit detected
.
[Urothelial cancer] 6.
[LBA27] NORSE study: Erdatinib (ERDA) or ERDA combined with Cetrelimab (CET) in the treatment of locally advanced or metastatic urothelial cancer with fibroblast growth factor receptor mutation (FGFRa) (MUC) The first results analysis of the Phase II study in patients.
The NORSE study is a Phase 1b/2 study evaluating the combination of erdatinib and Cetrelimab in the treatment of mUC patients with FGFR mutations
.
The ESMO conference in 2020 reported the Phase Ib results of the study and determined that the recommended Phase II dose is erdatinib 8 mg + Cetrelimab 240 mg
.
The incidence of treatment-related adverse events (TRAE) grade 3-4 was 41%
.
Among the 11 evaluable patients, the ORR reached 55% and the disease control rate (DCR) reached 100%
.
7.
[LBA31] NABUCCO study: high-dose or low-dose preoperative nivolumab combined with ipilimumab for locally advanced urothelial cancer (cohort 2) NABUCCO study data were first published at ESMO 2019, NABUCCO study cohort 1 It is a dual-immune combination program in the high-risk phase III (cT3-4aN0M0 or lymph node positive) cisplatin intolerant patients with neoadjuvant therapy phase Ib exploration
.
The results of cohort 1 showed that the dual-immune combination (nivolumab + ipilimumab) neoadjuvant therapy had a pathological complete remission (pCR) rate of 46%, and PD-L1 positive patients had a pCR of 60%
.
This meeting will announce the data of cohort 2 nivolumab + ipilimumab neoadjuvant treatment at different doses
.
8.
[699P] IMvigor210 study: Atelizumab monotherapy in patients with untreated cisplatin-intolerant metastatic urothelial carcinoma: 5-year follow-up data and survival analysis (cohort 1) IMvigor210 is one item To explore the phase II study of atilizumab as a single agent in the treatment of patients with advanced urothelial carcinoma
.
The study cohort 1 included 119 patients with advanced UC who were newly treated but not suitable for cisplatin chemotherapy.
The data released by the 2019 ASCO conference showed that the overall ORR was 23%, the CR rate was 9%, and different PDL1 expression levels did not clearly affect the treatment Efficient
.
The median OS was 15.
9 months
.
The ESMO conference announced the 15.
8-year follow-up data of the IMvigor210 cohort.
The total population ORR was 23.
5% [16.
2, 32.
2], the median duration of response (DOR) was 59.
1 months (5 years), and PD-L1 IC0/1 tumor The patient's median DOR was 53.
5 months (IC2/3 median DOR has not yet been reached), and the results showed that atilizumab single-agent therapy brought long-term response and long-term survival
.
[Prostate cancer] 9.
[LBA24] COSMIC-021 study: Cabozantinib (C) combined with atelizumab (A) in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC): results of extended cohort 6 phase 1b COSMIC The -021 study aims to evaluate the application of multi-target TKI Cabozantinib combined with anti-PD-L1 atelizumab in patients with solid tumors
.
The primary study endpoint is ORR, the secondary study endpoint is safety, and the exploratory endpoint includes PFS and the correlation between biomarkers and prognosis
.
The results of the renal cancer cohort were reported at the ESMO conference in 2020.
The ORR of the 40mg Cabozantinib group and the 60mg Cabozantinib group were 53% and 58%, respectively; DCR were 94% and 92%, respectively; PFS were 19.
5 months and 15.
1 months, respectively
.
The COSMIC-021 study also includes many other research cohorts such as non-small cell lung cancer (NSCLC) and prostate cancer
.
The ESMO conference will report the results of patients in the mCRPC cohort
.
10.
[577O] PRINCE study: 177Lu-PSMA-617 combined with pembrolizumab in the treatment of metastatic castration resistant prostate cancer (mCRPC) Phase Ib study interim analysis 177Lu-PSMA-617 is a new type of radioligand therapy, Accurate treatment of cancer through the combination of therapeutic radioisotopes (radioactive particles) and targeted compounds (ligands)
.
The results of the key Phase III VISION study reported at the ASCO conference in 2021 and simultaneously published by NEJM showed that in patients with progressive PSMA-positive mCRPC, 177Lu-PSMA-617 combined with SOC can significantly improve patients’ rPFS and SOC compared with standard treatment (SOC).
OS
.
Median rPFS: 8.
7 months in 177Lu-PSMA-617+SOC group vs.
3.
4 months in SOC group (P＜0.
001), HR=0.
40 (99.
2%CI: 0.
29~0.
57); median OS: 177Lu-PSMA-617 +SOC group 15.
3 months vs.
SOC group 11.
3 months (P＜0.
001), HR=0.
62 (95%CI: 0.
52~0.
74)
.
Whether 177Lu-PSMA-617 combined with anti-PD-1 immunotherapy can further improve the efficacy, please look forward to the PRINCE study disclosed at the ESMO conference in 2021
.
Reference: https://cslide.
ctimeetingtech.
com/esmo2021/attendee/confcal_4/presentation/list?r=pt%7E33_34
