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The 2022 European Lung Cancer Conference (ELCC) will be held from March 30 to April 2 local time, and a number of studies led by Chinese experts have been selected for this event
.
Small cell lung cancer (SCLC) is a less common pathological subtype of lung cancer, and its prognosis is generally poor
.
Currently, the recommended treatment for extensive-stage small cell lung cancer (ES-SCLC) in NCCN guidelines is platinum combined with etoposide (EP)
.
In recent years, with the popularity of immunotherapy, researches exploring the application of immunotherapy in SCLC have received more and more attention, such as the CASPIAN study and the CANTABRICO study
.
In this meeting, the CANTABRICO study announced the safety and efficacy analysis results of immunotherapy combined with EP regimen, and the CASPIAN study announced the clinical and molecular characteristics of long-term survivors
.
CANTABRICO study published the first-line treatment results of durvalumab combined with EP regimen Research Background Most SCLC patients have developed to extensive stage at the time of diagnosis, and ES-SCLC patients usually have a poor prognosis
.
The previous CASPIAN trial showed that durvalumab combined with EP regimen as first-line treatment significantly improved overall survival (OS) in ES-SCLC patients compared with control patients
.
This study (CANTABRICO, NCT04712903) will evaluate the safety and efficacy of durvalumab combined with platinum + etoposide (EP) in ES-SCLC populations in the real world
.
Methods This is a phase IIIb, single-arm, multicenter study of 101 patients with ES-SCLC aged ≥18 years, treatment-naïve, ECOG PS 0-2, and at least one measurable lesion
.
All patients received 4-6 cycles of durvalumab combined with EP first-line therapy (durvalumab 1500 mg, d1; cisplatin or carboplatin, d1; etoposide, d1-3; q3w), Thereafter, durvalumab was administered every 4 weeks until disease progression (PD) or intolerable toxicity
.
The primary endpoint of the study is safety, and secondary endpoints include objective response rate (ORR), etc.
The detailed design is shown in Figure 1
.
Figure 1 Study Design Study Results Patient Baseline and Treatment Status The median patient age was 65 years, 67% of patients were male, 94% of patients had ECOG 0-1, 33% of patients had liver metastases, and 11% had brain metastases transfer
.
At data cutoff on February 28, 2022, 22 patients were still receiving durvalumab
.
84% of patients completed ≥4 cycles of chemotherapy, 40% completed ≥5 cycles of chemotherapy, 33% completed 6 cycles of chemotherapy, and the median number of cycles of durvalumab was 8
.
The ORR of patients with clinical benefit was 52%, 4 patients achieved complete remission, 48 patients achieved partial response, and 33 patients had stable disease, with a clinical benefit rate of 84%
.
The researchers compared the disease remission in this study with that of CASPAIN.
The clinical benefit rates of the two studies were similar, and other comparisons are shown in Table 1
.
Table 1 Disease remission of patients and safety analysis compared with CASPAIN study There were 63 cases of grade 3-4 adverse events and 7 cases of grade 5 adverse events in all patients; 21 cases of immune-related adverse events occurred in all patients, of which 6 cases were 3 - Grade 5 immune-related adverse events
.
Etoposide treatment was discontinued due to adverse events in 10 patients, platinum therapy was discontinued due to adverse events in 2 patients, durvalumab treatment was delayed due to adverse events in 89 patients, and duvalumab was discontinued due to adverse events in 8 patients.
4 patients died in limumab treatment
.
CONCLUSIONS This study showed that increasing the number of cycles of EP chemotherapy had no adverse effect, as more than 40% of patients tolerated more than 4 cycles of chemotherapy and 32% tolerated 6 cycles of chemotherapy
.
Only 1 patient discontinued chemotherapy due to toxicity after cycle 5, and the most common adverse event leading to chemotherapy dose adjustment was chemotherapy-induced hematologic toxicity
.
The clinical benefit profile of this study was similar to that of the CASPAIN trial
.
Clinical and Molecular Characteristics of Long-Term Surviving Patients in the CASPIAN Study Background The Phase III study of the CASPIAN trial showed that first-line durvalumab combined with EP chemotherapy significantly improved OS compared with EP chemotherapy, with a median follow-up > 3 This benefit persisted after one year (HR 0.
71; 95% CI 0.
60-0.
86, nominal p=0.
0003)
.
Here, the investigators present the clinical and molecular characteristics of long-term survivors in the CASPIAN trial
.
Research methods 805 ES-SCLC patients were randomized to receive durvalumab + EP, durvalumab + Tremelimumab + EP or EP in a 1:1:1 ratio
.
The investigators assessed the clinical characteristics of patients with long-term survival (LTS; n = 94) in a post hoc analysis, defined as those after data cutoff on March 22, 2021 (median follow-up, 39.
4 months) patients who are still alive
.
With OS ≥18 months as the cutoff, we assessed PD-L1 expression and tissue tumor mutational burden (tTMB) in biomarker-evaluable populations (BEPs)
.
RESULTS: There were 44 (16%), 37 (14%), and 13 (5%) LTS patients in the durvalumab+EP, durvalumab+Tremelimumab+EP, and EP groups, respectively
.
In terms of baseline characteristics, LTS patients had a lower incidence of brain/liver metastases compared with all treated patients (ITT) (Table 2)
.
Compared with ITT patients, the median treatment dose of immunotherapy + EP regimen was higher in LTS patients, and the proportion of patients who received ≥4 cycles of EP chemotherapy was also higher
.
At the time of data cutoff, 46 LTS patients were still receiving durvalumab
.
In the durvalumab + EP treatment group, ORR was 89% for LTS patients and 79% for ITT patients; 24-month PFS was as high as 65% for LTS patients and 11% for ITT patients
.
In the durvalumab + tremelimumab + EP treatment group, ORR was 92% for LTS patients and 74% for ITT patients; 24-month PFS was as high as 67% for LTS patients and 12% for ITT patients
.
The incidence of serious adverse events in LTS patients was similar to that in ITT patients (Table 2)
.
Only in the durvalumab + Tremelimumab + EP group, the proportion of patients with PD-L1 ≥ 1% in the LTS population with OS ≥ 18 months was higher than that in the ITT population with OS < 18 months, and there was no significant difference in the other two groups.
differences (Table 2)
.
Table 2 Patient baseline and outcome table Study conclusions The number of LTS patients in the durvalumab + EP group was more than 3 times that of the EP group
.
Although some LTS patients had brain/liver metastases at baseline, LTS patients were more likely to have favorable prognostic characteristics compared with ITT patients
.
Notably, the majority of LTS patients completed EP treatment compared with ITT patients, and in the immunotherapy + EP group, LTS patients had significantly higher overall treatment doses, and these patients also achieved higher ORRs and longer durations.
PFS
.
No cumulative toxicity based on serious adverse events was found
.
Reference 1.
D.
Isla, E.
Arriola, MR Garcia Campelo, et al.
Phase IIIb study of durvalumab plus platinumeetoposide in first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): Treatment patterns of chemotherapy combination phase with durvalumab.
ELCC 2022 142P.
2.
N.
Reinmuth, JW Goldman, MC Garassino, et al.
Durvalumab (D) ± tremelimumab (T) + platinum-etoposide(EP) in 1L extensive-stage (ES) SCLC: Characteristics of longterm survivors in the CASPIAN study.
ELCC 2022 141O.
Editor: Youshi Reviewer: Youshi Typesetting: XY Execution: XY
.
Small cell lung cancer (SCLC) is a less common pathological subtype of lung cancer, and its prognosis is generally poor
.
Currently, the recommended treatment for extensive-stage small cell lung cancer (ES-SCLC) in NCCN guidelines is platinum combined with etoposide (EP)
.
In recent years, with the popularity of immunotherapy, researches exploring the application of immunotherapy in SCLC have received more and more attention, such as the CASPIAN study and the CANTABRICO study
.
In this meeting, the CANTABRICO study announced the safety and efficacy analysis results of immunotherapy combined with EP regimen, and the CASPIAN study announced the clinical and molecular characteristics of long-term survivors
.
CANTABRICO study published the first-line treatment results of durvalumab combined with EP regimen Research Background Most SCLC patients have developed to extensive stage at the time of diagnosis, and ES-SCLC patients usually have a poor prognosis
.
The previous CASPIAN trial showed that durvalumab combined with EP regimen as first-line treatment significantly improved overall survival (OS) in ES-SCLC patients compared with control patients
.
This study (CANTABRICO, NCT04712903) will evaluate the safety and efficacy of durvalumab combined with platinum + etoposide (EP) in ES-SCLC populations in the real world
.
Methods This is a phase IIIb, single-arm, multicenter study of 101 patients with ES-SCLC aged ≥18 years, treatment-naïve, ECOG PS 0-2, and at least one measurable lesion
.
All patients received 4-6 cycles of durvalumab combined with EP first-line therapy (durvalumab 1500 mg, d1; cisplatin or carboplatin, d1; etoposide, d1-3; q3w), Thereafter, durvalumab was administered every 4 weeks until disease progression (PD) or intolerable toxicity
.
The primary endpoint of the study is safety, and secondary endpoints include objective response rate (ORR), etc.
The detailed design is shown in Figure 1
.
Figure 1 Study Design Study Results Patient Baseline and Treatment Status The median patient age was 65 years, 67% of patients were male, 94% of patients had ECOG 0-1, 33% of patients had liver metastases, and 11% had brain metastases transfer
.
At data cutoff on February 28, 2022, 22 patients were still receiving durvalumab
.
84% of patients completed ≥4 cycles of chemotherapy, 40% completed ≥5 cycles of chemotherapy, 33% completed 6 cycles of chemotherapy, and the median number of cycles of durvalumab was 8
.
The ORR of patients with clinical benefit was 52%, 4 patients achieved complete remission, 48 patients achieved partial response, and 33 patients had stable disease, with a clinical benefit rate of 84%
.
The researchers compared the disease remission in this study with that of CASPAIN.
The clinical benefit rates of the two studies were similar, and other comparisons are shown in Table 1
.
Table 1 Disease remission of patients and safety analysis compared with CASPAIN study There were 63 cases of grade 3-4 adverse events and 7 cases of grade 5 adverse events in all patients; 21 cases of immune-related adverse events occurred in all patients, of which 6 cases were 3 - Grade 5 immune-related adverse events
.
Etoposide treatment was discontinued due to adverse events in 10 patients, platinum therapy was discontinued due to adverse events in 2 patients, durvalumab treatment was delayed due to adverse events in 89 patients, and duvalumab was discontinued due to adverse events in 8 patients.
4 patients died in limumab treatment
.
CONCLUSIONS This study showed that increasing the number of cycles of EP chemotherapy had no adverse effect, as more than 40% of patients tolerated more than 4 cycles of chemotherapy and 32% tolerated 6 cycles of chemotherapy
.
Only 1 patient discontinued chemotherapy due to toxicity after cycle 5, and the most common adverse event leading to chemotherapy dose adjustment was chemotherapy-induced hematologic toxicity
.
The clinical benefit profile of this study was similar to that of the CASPAIN trial
.
Clinical and Molecular Characteristics of Long-Term Surviving Patients in the CASPIAN Study Background The Phase III study of the CASPIAN trial showed that first-line durvalumab combined with EP chemotherapy significantly improved OS compared with EP chemotherapy, with a median follow-up > 3 This benefit persisted after one year (HR 0.
71; 95% CI 0.
60-0.
86, nominal p=0.
0003)
.
Here, the investigators present the clinical and molecular characteristics of long-term survivors in the CASPIAN trial
.
Research methods 805 ES-SCLC patients were randomized to receive durvalumab + EP, durvalumab + Tremelimumab + EP or EP in a 1:1:1 ratio
.
The investigators assessed the clinical characteristics of patients with long-term survival (LTS; n = 94) in a post hoc analysis, defined as those after data cutoff on March 22, 2021 (median follow-up, 39.
4 months) patients who are still alive
.
With OS ≥18 months as the cutoff, we assessed PD-L1 expression and tissue tumor mutational burden (tTMB) in biomarker-evaluable populations (BEPs)
.
RESULTS: There were 44 (16%), 37 (14%), and 13 (5%) LTS patients in the durvalumab+EP, durvalumab+Tremelimumab+EP, and EP groups, respectively
.
In terms of baseline characteristics, LTS patients had a lower incidence of brain/liver metastases compared with all treated patients (ITT) (Table 2)
.
Compared with ITT patients, the median treatment dose of immunotherapy + EP regimen was higher in LTS patients, and the proportion of patients who received ≥4 cycles of EP chemotherapy was also higher
.
At the time of data cutoff, 46 LTS patients were still receiving durvalumab
.
In the durvalumab + EP treatment group, ORR was 89% for LTS patients and 79% for ITT patients; 24-month PFS was as high as 65% for LTS patients and 11% for ITT patients
.
In the durvalumab + tremelimumab + EP treatment group, ORR was 92% for LTS patients and 74% for ITT patients; 24-month PFS was as high as 67% for LTS patients and 12% for ITT patients
.
The incidence of serious adverse events in LTS patients was similar to that in ITT patients (Table 2)
.
Only in the durvalumab + Tremelimumab + EP group, the proportion of patients with PD-L1 ≥ 1% in the LTS population with OS ≥ 18 months was higher than that in the ITT population with OS < 18 months, and there was no significant difference in the other two groups.
differences (Table 2)
.
Table 2 Patient baseline and outcome table Study conclusions The number of LTS patients in the durvalumab + EP group was more than 3 times that of the EP group
.
Although some LTS patients had brain/liver metastases at baseline, LTS patients were more likely to have favorable prognostic characteristics compared with ITT patients
.
Notably, the majority of LTS patients completed EP treatment compared with ITT patients, and in the immunotherapy + EP group, LTS patients had significantly higher overall treatment doses, and these patients also achieved higher ORRs and longer durations.
PFS
.
No cumulative toxicity based on serious adverse events was found
.
Reference 1.
D.
Isla, E.
Arriola, MR Garcia Campelo, et al.
Phase IIIb study of durvalumab plus platinumeetoposide in first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): Treatment patterns of chemotherapy combination phase with durvalumab.
ELCC 2022 142P.
2.
N.
Reinmuth, JW Goldman, MC Garassino, et al.
Durvalumab (D) ± tremelimumab (T) + platinum-etoposide(EP) in 1L extensive-stage (ES) SCLC: Characteristics of longterm survivors in the CASPIAN study.
ELCC 2022 141O.
Editor: Youshi Reviewer: Youshi Typesetting: XY Execution: XY
