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*Only for medical professionals to read and refer to the latest data of multiple studies on EGFR 20ins at the 2021ASCO Conference! EGFR mutation is a common mutated gene in non-small cell lung cancer (NSCLC) patients.
In Asian population, this value is about 40% to 50%.
Among them, EGFR exon 20 insertion mutations (EGFR 20ins) account for about 9% of all NSCLC patients.
The prognosis of these patients using EGFR-TKI is poor, and the standard treatment is conventional cytotoxic chemotherapy.
However, in recent years, many researches have made breakthroughs in addressing the EGFR 20ins mutation problem, and many drugs have begun to exert their strength.
Recently, the EGFR/c-Met bispecific antibody Amivantamab was approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of EGFR Exon 20ins, breaking the clinical diagnosis and treatment dilemma for many years.
What's more gratifying is that the 2021 American Society of Clinical Oncology (ASCO) annual meeting will also announce a variety of new EGFR Exon 20ins drugs.
The medical oncology channel is hereby compiled for readers to view! Amivantamab received accelerated FDA approval, EGFR Exon 20ins is no longer "no drug available" On May 21, the FDA accelerated the approval of Amivantamab for the treatment of patients with metastatic EGFR 20ins metastatic NSCLC who have progressed after platinum-based chemotherapy.
This is the first approved by the FDA Drugs that target such mutations.
The FDA accelerated approval is based on data from the Amivantamab monotherapy cohort in the Phase I CHRYSALIS study.
The CHRYSALIS study is a multi-center, open-label, multi-cohort trial that evaluated the efficacy and safety data of Amivantamab as a single agent and the combined EGFR T790M inhibitor Lazertinib in the treatment of advanced NSCLC in adults.
The study included 81 patients with locally advanced or metastatic NSCLC with EGFR 20ins that had progressed during or after platinum-based chemotherapy.
The results showed that the objective response rate (ORR) reached 40%, and the median duration of response (DOR) was 11.
1 months.
In the abstract published on the official website of the ASCO conference in 2021, the latest results of the CHRYSALIS study were reported.
CHRYSALIS research update, Amivantamab's OS and PFS completely outperform the real world treatment plan.
The ASCO conference abstract released the data of the external control (EC) group (Abstract No.
9052), in patients with advanced NSCLC EGFR 20ins who progressed after platinum chemotherapy , Comparing Amivantamab and real-world treatment options, more comprehensively demonstrated the efficacy of Amivantamab for such patients.
The researchers obtained real-world data from three companies in the United States (Flatiron, COTA, and ConcertAI).
After the data set was deduplicated, 126 patients were included in the EC group, and the criteria for inclusion were: EGFR 20ins advanced NSCLC after ≥1 line platinum treatment.
The population treated with Amivantamab (N=81) included patients who received the recommended phase II dose (Sabari WCLC 2020 Abs#3031) for EGFR 20ins advanced NSCLC postplatinum patients.
The most common treatments after platinum dual chemotherapy in the EC group are checkpoint inhibitors (CPI; 25%), single-agent, non-platinum chemotherapy (25%), and EGFR tyrosine kinase inhibitors (TKIs; 16%).
The proportion of Asian patients in the Amivantamab group was higher (56% vs 9%), and the number of previous treatment lines was higher (median 2 to 1).
The median overall survival (OS) of the Amivantamab group was 22.
8 months, and that of the EC group was 13.
1 months (HR 0.
53; 95% CI 0.
33~0.
86). The progression-free survival (PFS) in the Amivantamab group was longer (8.
3 months vs 2.
9 months; HR 0.
46; 95% CI 0.
33~0.
63).
Compared with the EC group, the Amivantamab group has a longer interval between next treatments (14.
8 months vs 4.
8 months; HR 0.
42; 95%CI 0.
29~0.
6).
The ORR of Amivantamab patients was 40%, and that of EC patients was 10% (OR 4.
44; 95% CI 2.
42~8.
14).
A number of studies on EGFR20ins competed, and patients with brain metastases had a remarkable effect.
1 After the failure of platinum-containing double drugs, EGFR 20ins patients with advanced NSCLC TAK- 788 treatment ORR is 28%, and the EXCLAIM cohort has good safety (Abstract No.
9014) Mobocertinib (TAK-788) is an oral drug targeting EGFR 20ins.
It has obtained breakthrough therapy designation in China and the United States, and has progressed in the treatment of platinum chemotherapy.
Patients with advanced NSCLC after EGFR 20ins.
The NCT02716116 study is an open-label multicenter study, consisting of a dose-escalation cohort, an expanded cohort, and the subsequent further expansion of the 20ins group (EXCLAIM) cohort.
The included patients were locally advanced or metastatic EGFR 20ins NSCLC patients who had received at least first-line treatment and received TAK-788 160 mg once a day.
The primary endpoint was ORR assessed by the Independent Review Committee (IRC).
The ASCO conference reported the efficacy and safety data of 114 platinum-based pretreatment patients (PPP) and 96 patients in the EXCLAIM cohort.
As of the data cutoff date of November 1, 2020, among the patients in the PPP cohort (n=114), 66% were women, 60% were Asian patients, and 59% had previously received ≥2 lines of systemic systemic therapy.
The results of the study showed that the ORR assessed by IRC was 28%, including 1 case of complete remission (CR); disease control rate (DCR) was 78% (95% CI 69~85); median duration of response (DOR) was 17.
5 months (see Table 1).
Table 1 Results of the NCT02716116 study in the EXCLAIM cohort, 33/96 cases (34%) of brain metastases at baseline examination; in 40% of patients and 73% of patients with brain metastases, IRC evaluated the disease progression (PD) first This part is the brain.
2DZD9008 Two studies have determined that RP2D has an ORR of up to 48.
4%! (Abstract No.
9008) DZD9008 is a selective and irreversible EGFR 20ins inhibitor, currently undergoing two phase I/II studies (NCT03974022 and CTR20192097).
The purpose of the two studies was to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of DZD9008 in EGFR or HER2-positive NSCLC patients.
Both studies included dose escalation and expansion of the cohort.
Combined analysis to determine the recommended phase II dose (RP2D).
From July 9, 2019 to February 5, 2021, 97 patients with EGFR or HER2 mutation-positive NSCLC took DZD9008 (dose range: 50mg to 400mg, once a day).
Among them, 59 patients with EGFR 20ins NSCLC received DZD9008 400mg (MTD) once a day and were well tolerated.
Dose limiting toxicity is diarrhea and arrhythmia.
The most common adverse reactions were diarrhea (Grade 3, 5.
2%) and rash (Grade 3, 1%).
The median number of treatment lines in the past was 2 (range 1-10), 92.
9% (52/56) of those who had received chemotherapy in the past; 44.
6% (25/56) of those who had received TKI treatment in the past, of which 1 case had received poziotinib Treatment; 42.
9% (24/56) of patients with brain metastases. Some patients experienced remission at dose levels ≥ 100 mg.
The RP2D dose was 300 mg/d, ORR was 48.
4% (15/31), and DCR was 90.
3% (28/31).
Two patients who had received JNJ-61186372 treatment experienced remission.
Anti-tumor activity has been observed in different EGFR Exon 20ins subtypes.
As of the data cutoff date, the average treatment time was 100 days (range 1-422).
The longest remission lasted more than 6 months, and 18 of the 22 responders were still responding.
DZD9008 shows good safety and good anti-tumor efficacy in the treatment of EGFR Exon 20ins NSCLC.
3 EGFR or HER2 20ins NSCLC intracranial metastasis is a new breakthrough! Bozitinib has a complete intracranial remission of 8.
3%! (Abstract No.
: 9093) EGFR 20ins NSCLC is related to the high incidence and poor survival rate of central nervous system (CNS) metastasis.
Poziotinib is a potent and irreversible tyrosine kinase inhibitor (TKI).
Preclinical data shows that poziotinib has good CNS penetration ability.
The ASCO conference announced the Cohort, multicenter phase II study ZENITH20 (NCT03318939) data on the intracranial remission efficacy of bozitinib in patients with 20ins NSCLC.
The ZENITH20 study included treated and newly-treated patients with advanced/metastatic EGFR or HER2 20ins NSCLC into three cohorts: cohort 1 (C1) had received anti-EGFR drug therapy in the past (n=115); cohort 2 (C2) Previously received anti-HER2 therapy (n=90) and cohort 3 (C3) did not receive systemic therapy (n=79).
All patients with stable CNS metastases at baseline were included.
The median age of the three cohorts was 60.
5 years. The median follow-up time of all patients with C1, C2 and C3 were 7.
3, 8.
3 and 9.
2 months, respectively.
Among NSCLC patients with baseline CNS lesions (n=36), the analysis showed that the patient-based ORR was 22.
2% (8/36) and the DCR was 88.
9% (32/36).
One patient in each cohort achieved complete intracranial remission.
The stable disease rate in the three cohorts was 80.
6%, and the C2 was 92.
9%.
C1 and C3 each had disease progression (PD) in 2 patients, and C2 had no CNS progression (see Table 2).
Table 2 Latest data from the ZENITH20 study.
Among patients with EGFR or HER2 20ins in the ZENITH20 cohort 1-3, bozitinib showed clinically significant CNS activity.
Most patients had no CNS progression, and 8.
3% (3/36) patients achieved complete intracranial remission.
4 The new TKI CLN-081 made the tumor regressed significantly, and 40% of the patients achieved PR! (Abstract No.
9077) CLN-081 is a new type of oral EGFR-TKI.
The adverse reactions of EGFR 20ins drugs in wild-type EGFR are common and difficult to control.
This suggests that CLN-081 may be more beneficial for such patients New treatment options.
The ASCO conference announced the interim results of a multicenter Phase I/IIa trial to evaluate the role of CLN-081 in advanced EGFR ins20 NSCLC (NCT04036682).
The study included patients with EGFR20 ins who had previously received platinum drug therapy.
As of November 10, 2020, 37 patients received CLN-081 at doses of 30 mg (n=8), 45 mg (n=1), 65 mg (n=12), 100 mg (n=13) and 150 mg (n=3) twice daily.
Among the 25 patients with evaluable efficacy (RECIST 1.
1), 10 (40%) achieved PR (6 confirmed, 2 pending, 2 undiagnosed), 14 (56%) had stable disease (SD), 1 Example (4%) PD. Of the 4 patients who received EGFR 20 ins inhibitors, 2 achieved PR and 2 SD.
Among the patients with SD or PR as the best response, 83% (20/24) experienced tumor shrinkage.
5SUMMIT basket test results are out! Lenatinib in the treatment of EGFR18 exon mutation brain metastasis NSCLC patients with OS for up to 17.
9 months! (Abstract No.
9068) Exon 18 is a rare mutation site in EGFR.
The phase II SUMMIT basket trial (NCT01953926) confirmed the efficacy of lenatinib in patients with NSCLC patients with EGFR exon 18 mutations, and it is also active in HER2+ metastatic breast cancer with CNS metastasis.
This ASCO conference reported the results of a subgroup of the SUMMIT study, which analyzed the efficacy data of lenatinib monotherapy in patients with EGFR exon 18 mutation NSCLC and NSCLC patients with CNS metastasis.
The included patients received lenatinib monotherapy (240 mg per day).
Patients with stable and asymptomatic CNS metastases were included in the study, allowing previous treatment with EGFR-TKI, chemotherapy, and checkpoint inhibitors.
Baseline characteristics of 11 stroke patients with EGFR exon 18 mutation NSCLC: median age 67 years (range 56-83 years); ECOG PS score 0/1 (45%/55%).
Previous treatment lines: 2 (range 1-3): EGFR-TKIs (91%); chemotherapy (55%); checkpoint inhibitors (27%).
3/11 patients had baseline CNS metastases and received radiotherapy 8-22 months before study registration.
The best CNS response of these 3 patients was SD, individual PFS was 1.
9 (censored), 6.
9, and 9.
1 months, and OS was 2.
6 (censored), 17.
7 (censored), and 17.
9 months.
The curative effect is summarized in Table 3.
Table 3 TKI pretreatment of EGFR exon 18 mutation NSCLC patients in the NCT01953926 subgroup The activity of lenatinib single agent was observed in TKI pretreatment EGFR exon 18 mutation NSCLC patients, although there were only 3 patients with CNS metastasis , The sample size is small, but the results of the study still show that lenatinib may be a systemic treatment option for NSCLC patients.
In Asian population, this value is about 40% to 50%.
Among them, EGFR exon 20 insertion mutations (EGFR 20ins) account for about 9% of all NSCLC patients.
The prognosis of these patients using EGFR-TKI is poor, and the standard treatment is conventional cytotoxic chemotherapy.
However, in recent years, many researches have made breakthroughs in addressing the EGFR 20ins mutation problem, and many drugs have begun to exert their strength.
Recently, the EGFR/c-Met bispecific antibody Amivantamab was approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of EGFR Exon 20ins, breaking the clinical diagnosis and treatment dilemma for many years.
What's more gratifying is that the 2021 American Society of Clinical Oncology (ASCO) annual meeting will also announce a variety of new EGFR Exon 20ins drugs.
The medical oncology channel is hereby compiled for readers to view! Amivantamab received accelerated FDA approval, EGFR Exon 20ins is no longer "no drug available" On May 21, the FDA accelerated the approval of Amivantamab for the treatment of patients with metastatic EGFR 20ins metastatic NSCLC who have progressed after platinum-based chemotherapy.
This is the first approved by the FDA Drugs that target such mutations.
The FDA accelerated approval is based on data from the Amivantamab monotherapy cohort in the Phase I CHRYSALIS study.
The CHRYSALIS study is a multi-center, open-label, multi-cohort trial that evaluated the efficacy and safety data of Amivantamab as a single agent and the combined EGFR T790M inhibitor Lazertinib in the treatment of advanced NSCLC in adults.
The study included 81 patients with locally advanced or metastatic NSCLC with EGFR 20ins that had progressed during or after platinum-based chemotherapy.
The results showed that the objective response rate (ORR) reached 40%, and the median duration of response (DOR) was 11.
1 months.
In the abstract published on the official website of the ASCO conference in 2021, the latest results of the CHRYSALIS study were reported.
CHRYSALIS research update, Amivantamab's OS and PFS completely outperform the real world treatment plan.
The ASCO conference abstract released the data of the external control (EC) group (Abstract No.
9052), in patients with advanced NSCLC EGFR 20ins who progressed after platinum chemotherapy , Comparing Amivantamab and real-world treatment options, more comprehensively demonstrated the efficacy of Amivantamab for such patients.
The researchers obtained real-world data from three companies in the United States (Flatiron, COTA, and ConcertAI).
After the data set was deduplicated, 126 patients were included in the EC group, and the criteria for inclusion were: EGFR 20ins advanced NSCLC after ≥1 line platinum treatment.
The population treated with Amivantamab (N=81) included patients who received the recommended phase II dose (Sabari WCLC 2020 Abs#3031) for EGFR 20ins advanced NSCLC postplatinum patients.
The most common treatments after platinum dual chemotherapy in the EC group are checkpoint inhibitors (CPI; 25%), single-agent, non-platinum chemotherapy (25%), and EGFR tyrosine kinase inhibitors (TKIs; 16%).
The proportion of Asian patients in the Amivantamab group was higher (56% vs 9%), and the number of previous treatment lines was higher (median 2 to 1).
The median overall survival (OS) of the Amivantamab group was 22.
8 months, and that of the EC group was 13.
1 months (HR 0.
53; 95% CI 0.
33~0.
86). The progression-free survival (PFS) in the Amivantamab group was longer (8.
3 months vs 2.
9 months; HR 0.
46; 95% CI 0.
33~0.
63).
Compared with the EC group, the Amivantamab group has a longer interval between next treatments (14.
8 months vs 4.
8 months; HR 0.
42; 95%CI 0.
29~0.
6).
The ORR of Amivantamab patients was 40%, and that of EC patients was 10% (OR 4.
44; 95% CI 2.
42~8.
14).
A number of studies on EGFR20ins competed, and patients with brain metastases had a remarkable effect.
1 After the failure of platinum-containing double drugs, EGFR 20ins patients with advanced NSCLC TAK- 788 treatment ORR is 28%, and the EXCLAIM cohort has good safety (Abstract No.
9014) Mobocertinib (TAK-788) is an oral drug targeting EGFR 20ins.
It has obtained breakthrough therapy designation in China and the United States, and has progressed in the treatment of platinum chemotherapy.
Patients with advanced NSCLC after EGFR 20ins.
The NCT02716116 study is an open-label multicenter study, consisting of a dose-escalation cohort, an expanded cohort, and the subsequent further expansion of the 20ins group (EXCLAIM) cohort.
The included patients were locally advanced or metastatic EGFR 20ins NSCLC patients who had received at least first-line treatment and received TAK-788 160 mg once a day.
The primary endpoint was ORR assessed by the Independent Review Committee (IRC).
The ASCO conference reported the efficacy and safety data of 114 platinum-based pretreatment patients (PPP) and 96 patients in the EXCLAIM cohort.
As of the data cutoff date of November 1, 2020, among the patients in the PPP cohort (n=114), 66% were women, 60% were Asian patients, and 59% had previously received ≥2 lines of systemic systemic therapy.
The results of the study showed that the ORR assessed by IRC was 28%, including 1 case of complete remission (CR); disease control rate (DCR) was 78% (95% CI 69~85); median duration of response (DOR) was 17.
5 months (see Table 1).
Table 1 Results of the NCT02716116 study in the EXCLAIM cohort, 33/96 cases (34%) of brain metastases at baseline examination; in 40% of patients and 73% of patients with brain metastases, IRC evaluated the disease progression (PD) first This part is the brain.
2DZD9008 Two studies have determined that RP2D has an ORR of up to 48.
4%! (Abstract No.
9008) DZD9008 is a selective and irreversible EGFR 20ins inhibitor, currently undergoing two phase I/II studies (NCT03974022 and CTR20192097).
The purpose of the two studies was to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of DZD9008 in EGFR or HER2-positive NSCLC patients.
Both studies included dose escalation and expansion of the cohort.
Combined analysis to determine the recommended phase II dose (RP2D).
From July 9, 2019 to February 5, 2021, 97 patients with EGFR or HER2 mutation-positive NSCLC took DZD9008 (dose range: 50mg to 400mg, once a day).
Among them, 59 patients with EGFR 20ins NSCLC received DZD9008 400mg (MTD) once a day and were well tolerated.
Dose limiting toxicity is diarrhea and arrhythmia.
The most common adverse reactions were diarrhea (Grade 3, 5.
2%) and rash (Grade 3, 1%).
The median number of treatment lines in the past was 2 (range 1-10), 92.
9% (52/56) of those who had received chemotherapy in the past; 44.
6% (25/56) of those who had received TKI treatment in the past, of which 1 case had received poziotinib Treatment; 42.
9% (24/56) of patients with brain metastases. Some patients experienced remission at dose levels ≥ 100 mg.
The RP2D dose was 300 mg/d, ORR was 48.
4% (15/31), and DCR was 90.
3% (28/31).
Two patients who had received JNJ-61186372 treatment experienced remission.
Anti-tumor activity has been observed in different EGFR Exon 20ins subtypes.
As of the data cutoff date, the average treatment time was 100 days (range 1-422).
The longest remission lasted more than 6 months, and 18 of the 22 responders were still responding.
DZD9008 shows good safety and good anti-tumor efficacy in the treatment of EGFR Exon 20ins NSCLC.
3 EGFR or HER2 20ins NSCLC intracranial metastasis is a new breakthrough! Bozitinib has a complete intracranial remission of 8.
3%! (Abstract No.
: 9093) EGFR 20ins NSCLC is related to the high incidence and poor survival rate of central nervous system (CNS) metastasis.
Poziotinib is a potent and irreversible tyrosine kinase inhibitor (TKI).
Preclinical data shows that poziotinib has good CNS penetration ability.
The ASCO conference announced the Cohort, multicenter phase II study ZENITH20 (NCT03318939) data on the intracranial remission efficacy of bozitinib in patients with 20ins NSCLC.
The ZENITH20 study included treated and newly-treated patients with advanced/metastatic EGFR or HER2 20ins NSCLC into three cohorts: cohort 1 (C1) had received anti-EGFR drug therapy in the past (n=115); cohort 2 (C2) Previously received anti-HER2 therapy (n=90) and cohort 3 (C3) did not receive systemic therapy (n=79).
All patients with stable CNS metastases at baseline were included.
The median age of the three cohorts was 60.
5 years. The median follow-up time of all patients with C1, C2 and C3 were 7.
3, 8.
3 and 9.
2 months, respectively.
Among NSCLC patients with baseline CNS lesions (n=36), the analysis showed that the patient-based ORR was 22.
2% (8/36) and the DCR was 88.
9% (32/36).
One patient in each cohort achieved complete intracranial remission.
The stable disease rate in the three cohorts was 80.
6%, and the C2 was 92.
9%.
C1 and C3 each had disease progression (PD) in 2 patients, and C2 had no CNS progression (see Table 2).
Table 2 Latest data from the ZENITH20 study.
Among patients with EGFR or HER2 20ins in the ZENITH20 cohort 1-3, bozitinib showed clinically significant CNS activity.
Most patients had no CNS progression, and 8.
3% (3/36) patients achieved complete intracranial remission.
4 The new TKI CLN-081 made the tumor regressed significantly, and 40% of the patients achieved PR! (Abstract No.
9077) CLN-081 is a new type of oral EGFR-TKI.
The adverse reactions of EGFR 20ins drugs in wild-type EGFR are common and difficult to control.
This suggests that CLN-081 may be more beneficial for such patients New treatment options.
The ASCO conference announced the interim results of a multicenter Phase I/IIa trial to evaluate the role of CLN-081 in advanced EGFR ins20 NSCLC (NCT04036682).
The study included patients with EGFR20 ins who had previously received platinum drug therapy.
As of November 10, 2020, 37 patients received CLN-081 at doses of 30 mg (n=8), 45 mg (n=1), 65 mg (n=12), 100 mg (n=13) and 150 mg (n=3) twice daily.
Among the 25 patients with evaluable efficacy (RECIST 1.
1), 10 (40%) achieved PR (6 confirmed, 2 pending, 2 undiagnosed), 14 (56%) had stable disease (SD), 1 Example (4%) PD. Of the 4 patients who received EGFR 20 ins inhibitors, 2 achieved PR and 2 SD.
Among the patients with SD or PR as the best response, 83% (20/24) experienced tumor shrinkage.
5SUMMIT basket test results are out! Lenatinib in the treatment of EGFR18 exon mutation brain metastasis NSCLC patients with OS for up to 17.
9 months! (Abstract No.
9068) Exon 18 is a rare mutation site in EGFR.
The phase II SUMMIT basket trial (NCT01953926) confirmed the efficacy of lenatinib in patients with NSCLC patients with EGFR exon 18 mutations, and it is also active in HER2+ metastatic breast cancer with CNS metastasis.
This ASCO conference reported the results of a subgroup of the SUMMIT study, which analyzed the efficacy data of lenatinib monotherapy in patients with EGFR exon 18 mutation NSCLC and NSCLC patients with CNS metastasis.
The included patients received lenatinib monotherapy (240 mg per day).
Patients with stable and asymptomatic CNS metastases were included in the study, allowing previous treatment with EGFR-TKI, chemotherapy, and checkpoint inhibitors.
Baseline characteristics of 11 stroke patients with EGFR exon 18 mutation NSCLC: median age 67 years (range 56-83 years); ECOG PS score 0/1 (45%/55%).
Previous treatment lines: 2 (range 1-3): EGFR-TKIs (91%); chemotherapy (55%); checkpoint inhibitors (27%).
3/11 patients had baseline CNS metastases and received radiotherapy 8-22 months before study registration.
The best CNS response of these 3 patients was SD, individual PFS was 1.
9 (censored), 6.
9, and 9.
1 months, and OS was 2.
6 (censored), 17.
7 (censored), and 17.
9 months.
The curative effect is summarized in Table 3.
Table 3 TKI pretreatment of EGFR exon 18 mutation NSCLC patients in the NCT01953926 subgroup The activity of lenatinib single agent was observed in TKI pretreatment EGFR exon 18 mutation NSCLC patients, although there were only 3 patients with CNS metastasis , The sample size is small, but the results of the study still show that lenatinib may be a systemic treatment option for NSCLC patients.
