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When it comes to epidermal growth factor receptor (EGFR), we think of the driver gene for non-small cell lung cancer (NSCLC)
.
The most common types of EGFR mutations, exon 19 deletion (19del) and exon 21 point mutation (21L858R), are sensitive mutations
.
The relatively rare exon 20 insertion mutation (20ins) is a drug-resistant mutation, and conventional targeted drugs against EGFR-sensitive mutations are not sensitive to this mutation
.
For advanced non-small cell lung cancer with EGFR 20ins mutation, chemotherapy is still the first-line standard treatment
.
In recent years, researchers are also exploring precision therapies for people with EGFR 20ins mutations, such as Amivantamab
.
What is Amivantamab? Amivantamab, a bispecific antibody that simultaneously targets both EGFR and MET receptors, has been shown to overcome primary drug resistance in EGFR 20ins mutant non-small cell lung cancer
.
Like other new drugs, the clinical study of Amivantamab was first attempted as a second-line treatment after failure of first-line standard chemotherapy
.
The CHRYSALIS (NCT02609776) study is an open-label, dose-escalation phase I clinical trial
.
This study preliminarily confirmed that Amivantamab has good safety and durable efficacy in EGFR 20ins-mutated non-small cell lung cancer after failure of first-line chemotherapy
.
The objective response rate (ORR) of the later-line Amivantamab treatment was 40%; the median duration of response (DOR) was 11.
1 months, and the median progression-free survival (PFS) was also 8.
3 months [1]
.
Amivantamab is now the first drug approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of patients with advanced non-small cell lung cancer with EGFR 20ins mutations who have failed platinum-based chemotherapy
.
Phase I clinical studies mainly evaluate drug safety, while efficacy is secondary
.
Although the preliminary efficacy of Amivantamab shown by the CHRYSALIS study is good, it is difficult to say whether it is better than other treatments due to the lack of control
.
Are there any "first aid measures" to remedy the shortcomings of the efficacy data of this study? Recently, some researchers have configured an "external control" for the CHRYSALIS study, which is derived from real-world physician selection data [2]
.
In this way, it is possible to compare the pros and cons of the new amivantamab drug and existing treatment strategies for the EGFR 20ins mutant population after progression on platinum-based chemotherapy
.
In the real world, how should treatment options be selected after platinum-containing therapy fails? Before the emergence of Amivantamab, patients with EGFR 20ins mutation progressed after receiving platinum-containing chemotherapy.
How to choose the follow-up regimen? According to statistics, physicians in the real world recommended different late-line treatment regimens for patients (Table 1), which included: chemotherapy regimens without platinum (25%); immunotherapy with or without anti-angiogenic therapy (24%) ); other regimens of platinum-containing chemotherapy (16%); combined or not combined with anti-angiogenic targeted therapy (16%),
etc.
These choices are based on the doctor's experience and judgment on the individualized situation of the patient, but the "individualization" here actually reflects the lack of standard treatment strategies to some extent
.
Table 1.
Real-world treatment options for patients with EGFR 20ins who fail platinum-based chemotherapy Does Amivantamab outperform existing real-world strategies in terms of efficacy? We also evaluated the main efficacy indicators from objective response rate (ORR), progression-free survival (PFS), time to last-line therapy (TTNT), and overall survival (OS)
.
Statistically, it is not difficult to see that Amivantamab outperformed existing real-world treatments (Table 2)
.
For patients with advanced non-small cell lung cancer with EGFR 20ins mutation who progressed on platinum-based chemotherapy, Amivantamab can still achieve objective response in 40% of patients, compared with less than 20% of other strategies
.
Table 2.
Comparison of Primary Efficacy Data The median progression-free survival in this cohort receiving amivantamab was 8.
3 months, significantly better than the real-world strategy of 2.
9 months (Figure 1)
.
At 1 year of amivantamab treatment, more than 30% of patients were still in the non-progressive state
.
Figure 1.
Progression-Free Survival Curve[2] On the time-to-last-line therapy (TTNT) metric, which reflects time to clinical benefit, Amivantamab was more than one year (14.
8 months), compared with only 4.
8 months for the real-world strategy months (Figure 2)
.
It is worth mentioning that the clinical benefit of Amivantamab may be durable, and nearly half of the patients still continue to receive the drug after one and a half years of treatment
.
Figure 2.
Time-to-last-line therapy (TTNT) curve[2] Overall survival is the "gold standard" for reflecting patient prognosis
.
Although follow-up in the CHRYSALIS study is limited, available data suggest that amivantamab is superior to real-world therapy (median overall survival: 22.
8 months vs 12.
8 months) (Figure 3)
.
Figure 3.
Overall survival curve[2]Summary and outlook Real-world data show that current EGFR 20ins-mutated non-small cell lung cancer has limited treatment options after failure of platinum-based chemotherapy, and there is no standardized treatment recommendation
.
Results compared with real-world strategies suggest that amivantamab is more likely to become the standard of care in this population
.
Amivantamab is a representative of a new type of targeted drug for tumors.
Its unique mechanism of action brings a new treatment option to the population with EGFR 20ins mutation
.
We also look forward to evidence from studies of amivantamab for first-line treatment of EGFRS20ins mutant tumors
.
There is now a phase II clinical trial using the drug Amivantamab
.
The drug has been FDA-approved in the United States for lung cancer patients with EGFRS20ins, and now recruited patients can use the drug for free
.
To participate in this clinical study, you can search and download the Cancer App, click on clinical trial registration, or click on "Global Clinical Trials" to apply for registration
.
Click below to learn more about clinical trial project references: (swipe up and down to view) 1.
Keunchil Park, et al.
Amivantamab in EGFR Exon 20 Insertion–Mutated Non–Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study.
Journal of Clinical Oncology.
2021;39(30):3391-3402.
DOI: 10.
1200/JCO.
21.
00662.
2.
Anna Minchom, et al.
Amivantamab compared with real-world therapies in patients with advanced non- small cell lung cancer harboring EGFR exon 20 insertion mutations who progressed after platinum-based chemotherapy.
Lung Cancer.
2022; published online.
DOI: 10.
1016/j.
lungcan.
2022.
03.
005.
Call for Papers, Issue 2 [Participation Method] Scan the QR code of the poster below to learn about the event details and add @cancer degree official WeChat to participate in the review of anti-cancer dry goods<< swipe left and right to see more>>
.
The most common types of EGFR mutations, exon 19 deletion (19del) and exon 21 point mutation (21L858R), are sensitive mutations
.
The relatively rare exon 20 insertion mutation (20ins) is a drug-resistant mutation, and conventional targeted drugs against EGFR-sensitive mutations are not sensitive to this mutation
.
For advanced non-small cell lung cancer with EGFR 20ins mutation, chemotherapy is still the first-line standard treatment
.
In recent years, researchers are also exploring precision therapies for people with EGFR 20ins mutations, such as Amivantamab
.
What is Amivantamab? Amivantamab, a bispecific antibody that simultaneously targets both EGFR and MET receptors, has been shown to overcome primary drug resistance in EGFR 20ins mutant non-small cell lung cancer
.
Like other new drugs, the clinical study of Amivantamab was first attempted as a second-line treatment after failure of first-line standard chemotherapy
.
The CHRYSALIS (NCT02609776) study is an open-label, dose-escalation phase I clinical trial
.
This study preliminarily confirmed that Amivantamab has good safety and durable efficacy in EGFR 20ins-mutated non-small cell lung cancer after failure of first-line chemotherapy
.
The objective response rate (ORR) of the later-line Amivantamab treatment was 40%; the median duration of response (DOR) was 11.
1 months, and the median progression-free survival (PFS) was also 8.
3 months [1]
.
Amivantamab is now the first drug approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of patients with advanced non-small cell lung cancer with EGFR 20ins mutations who have failed platinum-based chemotherapy
.
Phase I clinical studies mainly evaluate drug safety, while efficacy is secondary
.
Although the preliminary efficacy of Amivantamab shown by the CHRYSALIS study is good, it is difficult to say whether it is better than other treatments due to the lack of control
.
Are there any "first aid measures" to remedy the shortcomings of the efficacy data of this study? Recently, some researchers have configured an "external control" for the CHRYSALIS study, which is derived from real-world physician selection data [2]
.
In this way, it is possible to compare the pros and cons of the new amivantamab drug and existing treatment strategies for the EGFR 20ins mutant population after progression on platinum-based chemotherapy
.
In the real world, how should treatment options be selected after platinum-containing therapy fails? Before the emergence of Amivantamab, patients with EGFR 20ins mutation progressed after receiving platinum-containing chemotherapy.
How to choose the follow-up regimen? According to statistics, physicians in the real world recommended different late-line treatment regimens for patients (Table 1), which included: chemotherapy regimens without platinum (25%); immunotherapy with or without anti-angiogenic therapy (24%) ); other regimens of platinum-containing chemotherapy (16%); combined or not combined with anti-angiogenic targeted therapy (16%),
etc.
These choices are based on the doctor's experience and judgment on the individualized situation of the patient, but the "individualization" here actually reflects the lack of standard treatment strategies to some extent
.
Table 1.
Real-world treatment options for patients with EGFR 20ins who fail platinum-based chemotherapy Does Amivantamab outperform existing real-world strategies in terms of efficacy? We also evaluated the main efficacy indicators from objective response rate (ORR), progression-free survival (PFS), time to last-line therapy (TTNT), and overall survival (OS)
.
Statistically, it is not difficult to see that Amivantamab outperformed existing real-world treatments (Table 2)
.
For patients with advanced non-small cell lung cancer with EGFR 20ins mutation who progressed on platinum-based chemotherapy, Amivantamab can still achieve objective response in 40% of patients, compared with less than 20% of other strategies
.
Table 2.
Comparison of Primary Efficacy Data The median progression-free survival in this cohort receiving amivantamab was 8.
3 months, significantly better than the real-world strategy of 2.
9 months (Figure 1)
.
At 1 year of amivantamab treatment, more than 30% of patients were still in the non-progressive state
.
Figure 1.
Progression-Free Survival Curve[2] On the time-to-last-line therapy (TTNT) metric, which reflects time to clinical benefit, Amivantamab was more than one year (14.
8 months), compared with only 4.
8 months for the real-world strategy months (Figure 2)
.
It is worth mentioning that the clinical benefit of Amivantamab may be durable, and nearly half of the patients still continue to receive the drug after one and a half years of treatment
.
Figure 2.
Time-to-last-line therapy (TTNT) curve[2] Overall survival is the "gold standard" for reflecting patient prognosis
.
Although follow-up in the CHRYSALIS study is limited, available data suggest that amivantamab is superior to real-world therapy (median overall survival: 22.
8 months vs 12.
8 months) (Figure 3)
.
Figure 3.
Overall survival curve[2]Summary and outlook Real-world data show that current EGFR 20ins-mutated non-small cell lung cancer has limited treatment options after failure of platinum-based chemotherapy, and there is no standardized treatment recommendation
.
Results compared with real-world strategies suggest that amivantamab is more likely to become the standard of care in this population
.
Amivantamab is a representative of a new type of targeted drug for tumors.
Its unique mechanism of action brings a new treatment option to the population with EGFR 20ins mutation
.
We also look forward to evidence from studies of amivantamab for first-line treatment of EGFRS20ins mutant tumors
.
There is now a phase II clinical trial using the drug Amivantamab
.
The drug has been FDA-approved in the United States for lung cancer patients with EGFRS20ins, and now recruited patients can use the drug for free
.
To participate in this clinical study, you can search and download the Cancer App, click on clinical trial registration, or click on "Global Clinical Trials" to apply for registration
.
Click below to learn more about clinical trial project references: (swipe up and down to view) 1.
Keunchil Park, et al.
Amivantamab in EGFR Exon 20 Insertion–Mutated Non–Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study.
Journal of Clinical Oncology.
2021;39(30):3391-3402.
DOI: 10.
1200/JCO.
21.
00662.
2.
Anna Minchom, et al.
Amivantamab compared with real-world therapies in patients with advanced non- small cell lung cancer harboring EGFR exon 20 insertion mutations who progressed after platinum-based chemotherapy.
Lung Cancer.
2022; published online.
DOI: 10.
1016/j.
lungcan.
2022.
03.
005.
Call for Papers, Issue 2 [Participation Method] Scan the QR code of the poster below to learn about the event details and add @cancer degree official WeChat to participate in the review of anti-cancer dry goods<< swipe left and right to see more>>
