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*It is only for medical professionals to read for reference.
Break the bottleneck in the treatment of advanced esophageal squamous cell carcinoma, and have more survival benefits.
Introduction The 2021 American Academy of Clinical Oncology (ASCO) will be held in the form of an online conference from June 4th to June 8th
.
In the abstract published on ASCO's official website, the preliminary results of the CheckMate648 study on the first-line treatment of advanced esophageal squamous cell carcinoma by Professor Ian Chau's team from Royal Marsden Hospital in the UK are listed
.
So, what are the specific contents of the research results? What enlightenment does it bring to the clinic? Abstract number: LBA4001 First-line treatment of advanced esophageal squamous cell carcinoma: double immunity VS chemotherapy and immune + chemotherapy VS chemotherapy? Globally, esophageal cancer can cause more than 500,000 deaths each year, of which esophageal squamous cell carcinoma (ESCC) patients account for 85%
.
For patients with metastatic or advanced ESCC, the overall survival (OS) benefit of standard first-line chemotherapy has reached the bottleneck (median OS<1 year)
.
According to the ATTRACTION-3 study, for patients with advanced ESCC after treatment, nivolumab (NIVO) brings greater OS benefits to patients than chemotherapy
.
The CheckMate648 study is the first global open-label, randomized phase III clinical study to evaluate the efficacy and safety of double immunity, immune plus chemotherapy, and chemotherapy in patients with advanced ESCC.
Here, its preliminary results are reported
.
CheckMate648 study design CheckMate648 study data statistical method 1 Baseline situation as of January 18, 2021, in the minimum follow-up time of 12.
9 months, after randomization, the NIVO + chemotherapy group, NIVO + IPI group, and chemotherapy group were enrolled separately There were 321, 325 and 324 patients
.
255% of randomized patients at baseline received follow-up treatment.
The median duration of treatment in the NIVO + chemotherapy group, NIVO + IPI group, and chemotherapy group were 5.
7 months, 2.
8 months, and 3.
4 months, respectively.
The three groups were caused by various reasons.
The rates of treatment interruption were 92%, 93%, and 99%, respectively
.
55% of randomized patients received follow-up treatment, most of which were chemotherapy
.
In the treatment group and chemotherapy group including NIVO, 5% and 16% of patients received subsequent immunotherapy, respectively
.
Treatment continuity 3 NIVO + chemotherapy vs.
OS results of chemotherapy: NIVO + chemotherapy is better, and it is more dominant in the population with tumor cell PD-L1 expression ≥ 1%.
Tumor cell PD-L1 expression ≥ 1% and in all randomized populations, Compared with chemotherapy, NIVO + chemotherapy can reduce the patient's death risk by 46% and 26%, and the median overall survival (OS) time is prolonged by 6.
3 months and 2.
5 months, respectively
.
PD-L1 expression ≥ 1% and OS results of all randomized populations are in almost all subgroups.
The benefit of OS is more obvious in the NIVO + chemotherapy group than the chemotherapy group
.
OS subgroup analysis results 4 NIVO + chemotherapy vs.
PFS results of chemotherapy: the addition of NIVO helps PFS benefit.
Among the population with tumor cell PD-L1 expression ≥1%, the use of NIVO can increase the risk ratio of disease progression free survival (PFS) 0.
53 (HR) (95%CI 0.
41-0.
69), and in all randomized populations, the value of HR increase is 0.
69 (95%CI 0.
58-0.
83)
.
PFS benefit status 5 NIVO+ chemotherapy vs chemotherapy: the former has longer duration of remission and higher ORR.
Among all randomized populations with PD-L1 expression ≥1%, NIVO+ chemotherapy vs chemotherapy duration of response (DoR) was 8.
4, respectively Month vs.
5.
7 months and 8.
2 months vs.
7.
1 months, the objective response rate (ORR) of NIVO+ chemotherapy vs chemotherapy was 53% vs 20% and 47% vs 27%, respectively
.
NIVO+chemotherapy VS chemotherapy treatment remission status 6 NIVO+IPI VS chemotherapy OS results: all populations and those with PD-L1 expression ≥1%, NIVO+IPI is better in tumor cells with PD-L1 expression ≥1% and all randomized populations Compared with chemotherapy, NIVO+IPI can reduce the risk of death by 36% and 22%, and prolong the median OS by 4.
6 months and 2.
1 months, respectively
.
The OS results of NIVO+IPI VS chemotherapy were in almost all subgroups, and the benefit of OS was more obvious in the NIVO+IPI group than the chemotherapy group
.
7 PFS results of NIVO+IPI VS chemotherapy: The addition of NIVO helps PFS benefit.
In people with tumor cell PD-L1 expression ≥1%, the addition of NIVO can directly increase the PFS HR value of 0.
83 (95% CI 0.
64-1.
07).
In all random populations, the PFS HR value increased to 1.
01 (95% CI 0.
85-1.
21)
.
8NIVO+IPI vs chemotherapy: The former has longer duration of remission and higher ORR.
Among all randomized populations with PD-L1 expression ≥1%, NIVO+IPI vs chemotherapy DoR was 11.
8 months vs.
5.
7 months and respectively.
11.
1 months vs 7.
1 months, the ORR of NIVO+IPI vs chemotherapy was 35% vs 20% and 28% vs 27%, respectively
.
NIVO+IPI vs chemotherapy treatment remission status 9 Treatment-related adverse reactions Common treatment-related adverse reactions (TRAEs) (≥10%), nausea, decreased appetite, and stomach pain in the NIVO+ chemotherapy group and chemotherapy group, and skin rash in the NIVO+IPI group Etc.
, the vast majority of immune-related adverse reactions are grade 1 or 2, and there is no new safety signal
.
TRAEs immune-related TRAEs summary: NIVO is the first PD-1 inhibitor that proved to be more beneficial than chemotherapy or IPI combined with chemotherapy in patients with advanced ESCC without treatment: PD-L1 expression on tumor cells ≥1% and among all randomized populations, NIVO+ chemotherapy and NIVO+IPI have statistically significant and clinically significant OS benefits compared to chemotherapy; patients in the NIVO+ chemotherapy group have clinically significant PFS benefits and higher ORR ; The treatment plan that includes NIVO can bring the patient longer treatment relief time
.
It is worth noting that no new safety signals were found in the NIVO+chemotherapy group and NIVO+IPI group
.
In summary, both NIVO+chemotherapy and NIVO+IPI can be used as potential first-line treatment options for advanced ESCC
.
Break the bottleneck in the treatment of advanced esophageal squamous cell carcinoma, and have more survival benefits.
Introduction The 2021 American Academy of Clinical Oncology (ASCO) will be held in the form of an online conference from June 4th to June 8th
.
In the abstract published on ASCO's official website, the preliminary results of the CheckMate648 study on the first-line treatment of advanced esophageal squamous cell carcinoma by Professor Ian Chau's team from Royal Marsden Hospital in the UK are listed
.
So, what are the specific contents of the research results? What enlightenment does it bring to the clinic? Abstract number: LBA4001 First-line treatment of advanced esophageal squamous cell carcinoma: double immunity VS chemotherapy and immune + chemotherapy VS chemotherapy? Globally, esophageal cancer can cause more than 500,000 deaths each year, of which esophageal squamous cell carcinoma (ESCC) patients account for 85%
.
For patients with metastatic or advanced ESCC, the overall survival (OS) benefit of standard first-line chemotherapy has reached the bottleneck (median OS<1 year)
.
According to the ATTRACTION-3 study, for patients with advanced ESCC after treatment, nivolumab (NIVO) brings greater OS benefits to patients than chemotherapy
.
The CheckMate648 study is the first global open-label, randomized phase III clinical study to evaluate the efficacy and safety of double immunity, immune plus chemotherapy, and chemotherapy in patients with advanced ESCC.
Here, its preliminary results are reported
.
CheckMate648 study design CheckMate648 study data statistical method 1 Baseline situation as of January 18, 2021, in the minimum follow-up time of 12.
9 months, after randomization, the NIVO + chemotherapy group, NIVO + IPI group, and chemotherapy group were enrolled separately There were 321, 325 and 324 patients
.
255% of randomized patients at baseline received follow-up treatment.
The median duration of treatment in the NIVO + chemotherapy group, NIVO + IPI group, and chemotherapy group were 5.
7 months, 2.
8 months, and 3.
4 months, respectively.
The three groups were caused by various reasons.
The rates of treatment interruption were 92%, 93%, and 99%, respectively
.
55% of randomized patients received follow-up treatment, most of which were chemotherapy
.
In the treatment group and chemotherapy group including NIVO, 5% and 16% of patients received subsequent immunotherapy, respectively
.
Treatment continuity 3 NIVO + chemotherapy vs.
OS results of chemotherapy: NIVO + chemotherapy is better, and it is more dominant in the population with tumor cell PD-L1 expression ≥ 1%.
Tumor cell PD-L1 expression ≥ 1% and in all randomized populations, Compared with chemotherapy, NIVO + chemotherapy can reduce the patient's death risk by 46% and 26%, and the median overall survival (OS) time is prolonged by 6.
3 months and 2.
5 months, respectively
.
PD-L1 expression ≥ 1% and OS results of all randomized populations are in almost all subgroups.
The benefit of OS is more obvious in the NIVO + chemotherapy group than the chemotherapy group
.
OS subgroup analysis results 4 NIVO + chemotherapy vs.
PFS results of chemotherapy: the addition of NIVO helps PFS benefit.
Among the population with tumor cell PD-L1 expression ≥1%, the use of NIVO can increase the risk ratio of disease progression free survival (PFS) 0.
53 (HR) (95%CI 0.
41-0.
69), and in all randomized populations, the value of HR increase is 0.
69 (95%CI 0.
58-0.
83)
.
PFS benefit status 5 NIVO+ chemotherapy vs chemotherapy: the former has longer duration of remission and higher ORR.
Among all randomized populations with PD-L1 expression ≥1%, NIVO+ chemotherapy vs chemotherapy duration of response (DoR) was 8.
4, respectively Month vs.
5.
7 months and 8.
2 months vs.
7.
1 months, the objective response rate (ORR) of NIVO+ chemotherapy vs chemotherapy was 53% vs 20% and 47% vs 27%, respectively
.
NIVO+chemotherapy VS chemotherapy treatment remission status 6 NIVO+IPI VS chemotherapy OS results: all populations and those with PD-L1 expression ≥1%, NIVO+IPI is better in tumor cells with PD-L1 expression ≥1% and all randomized populations Compared with chemotherapy, NIVO+IPI can reduce the risk of death by 36% and 22%, and prolong the median OS by 4.
6 months and 2.
1 months, respectively
.
The OS results of NIVO+IPI VS chemotherapy were in almost all subgroups, and the benefit of OS was more obvious in the NIVO+IPI group than the chemotherapy group
.
7 PFS results of NIVO+IPI VS chemotherapy: The addition of NIVO helps PFS benefit.
In people with tumor cell PD-L1 expression ≥1%, the addition of NIVO can directly increase the PFS HR value of 0.
83 (95% CI 0.
64-1.
07).
In all random populations, the PFS HR value increased to 1.
01 (95% CI 0.
85-1.
21)
.
8NIVO+IPI vs chemotherapy: The former has longer duration of remission and higher ORR.
Among all randomized populations with PD-L1 expression ≥1%, NIVO+IPI vs chemotherapy DoR was 11.
8 months vs.
5.
7 months and respectively.
11.
1 months vs 7.
1 months, the ORR of NIVO+IPI vs chemotherapy was 35% vs 20% and 28% vs 27%, respectively
.
NIVO+IPI vs chemotherapy treatment remission status 9 Treatment-related adverse reactions Common treatment-related adverse reactions (TRAEs) (≥10%), nausea, decreased appetite, and stomach pain in the NIVO+ chemotherapy group and chemotherapy group, and skin rash in the NIVO+IPI group Etc.
, the vast majority of immune-related adverse reactions are grade 1 or 2, and there is no new safety signal
.
TRAEs immune-related TRAEs summary: NIVO is the first PD-1 inhibitor that proved to be more beneficial than chemotherapy or IPI combined with chemotherapy in patients with advanced ESCC without treatment: PD-L1 expression on tumor cells ≥1% and among all randomized populations, NIVO+ chemotherapy and NIVO+IPI have statistically significant and clinically significant OS benefits compared to chemotherapy; patients in the NIVO+ chemotherapy group have clinically significant PFS benefits and higher ORR ; The treatment plan that includes NIVO can bring the patient longer treatment relief time
.
It is worth noting that no new safety signals were found in the NIVO+chemotherapy group and NIVO+IPI group
.
In summary, both NIVO+chemotherapy and NIVO+IPI can be used as potential first-line treatment options for advanced ESCC
.
