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Lung cancer is the most common malignant tumor, and currently has the highest morbidity and mortality.
The 2020 Global Cancer Burden Report issued by the International Agency for Research on Cancer (IARC) of the World Health Organization shows that there are 9.
96 million cancer deaths worldwide in 2020, of which 1.
8 million are lung cancer deaths, far exceeding other types of cancer.
There are two main pathological types of lung cancer: small cell lung cancer (SCLC), accounting for 15%; non-small cell lung cancer (NSCLC), accounting for 85%.
In recent years, immunotherapy, represented by PD-1/PD-L1 inhibitors, has led the transformation of advanced lung cancer treatment with its long-lasting efficacy, greatly improved the survival benefits of patients, and brought us new hope.
This article will share with you the latest 5-year survival follow-up data of pembrolizumab (commonly known as K drug), the star drug for the treatment of lung cancer.
The large PK data of pembrolizumab and chemotherapeutics comes from the KEYNOTE-024 study, which was recently published in the Journal of Clinical Oncology1.
The study conducted parallel controlled trials on both K drug and chemotherapy regimens at the same time to compare the efficacy and safety of the two regimens in the first-line treatment of non-small cell lung cancer patients with PD-L1 TPS ≥50% and EGFR/ALK mutation negative.
A total of 305 patients were enrolled in the study, and they were randomly divided into the K-drug monotherapy group and the chemotherapy group at 1:1.
Patients in the chemotherapy group can be crossed to the K drug group for follow-up treatment after their disease progresses.
The primary endpoint of the study is progression-free survival (PFS), and the secondary endpoints are overall survival (OS), objective response rate (ORR), and safety.
The study data is as of June 1, 2020, and the median follow-up time is 59.
9 months.Compared with chemotherapy, K drug showed a better overall survival benefit (Figure 1A) The median overall survival of K drug group and chemotherapy group were 26.
3 and 13.
4 months, respectively.
The overall survival nearly doubled, and the extended time exceeded For a year.
The three-year overall survival rates were 43.
7% and 23.
7%, the four-year overall survival rates were 35.
8% and 19.
8%, and the five-year overall survival rates were 31.
9% and 16.
3%, respectively.
Compared with chemotherapy, drug K showed a better progression-free survival benefit (Figure 1B).
The median progression-free survival of drug K group and chemotherapy group were 7.
7 and 5.
5 months, respectively, which was an extension of 40%.
The five-year progression-free survival rates of the two groups were 12.
8% and not reached respectively.
“Not reached” means that no patient in the chemotherapy group survived the 5-year follow-up time.
The three-year progression-free survival rates of the two groups were 22.
8% and 4.
1% (a difference of 5 times), and the four-year progression-free survival rates were 16.
4% and 1.
4% (correlated 11 times), respectively.
The data of the K drug group was absolutely superior Overwhelm the chemotherapy group.
Figure 1 In the KEYNOTE-024 study, the overall survival data (A) of patients receiving the treatment of the K drug group and the chemotherapy group (A) compared with the progression-free survival (B) data of chemotherapy, the K drug is more effective, and the duration of remission is particularly prolonged (Figure 2) The objective response rate of the K drug group was 46.
1%, of which the complete response (CR) rate was 4.
5%, and the partial response (PR) rate was 41.
6%.
The objective response rate in the chemotherapy group was only 31.
1%, and none of the patients had a complete response.
The median duration of remission (DoR) of the two groups were 29.
1 and 6.
3 months, respectively, which means that the duration of remission for patients who received K drug was 4.
6 times that of chemotherapy, and the K drug group had obvious advantages.
Figure 2 Long-term follow-up of ORR and DoR data of KEYNOTE-024 study, no new adverse reactions were observed for K drug (Figure 3) Common adverse reactions of K drug include fatigue, itching, diarrhea, etc.
There were no new adverse reactions during the long-term follow-up.
The incidence of grade 3 to 5 treatment-related adverse events in the K drug group and the chemotherapy group were 31.
2% and 53.
3%, respectively; the incidence of serious treatment-related adverse events was 22.
7% and 20.
7%, respectively; the incidence of grade 3 to 5 immune-mediated adverse events The incidence of events and infusion reactions was 13.
6% and 0.
7% in the two groups, respectively.
The overall side effects of K drugs are less than those of chemotherapy, which allows many patients to benefit from survival and improve their quality of life.
Figure 3 Adverse event data of patients in the KEYNOTE-024 study K drug wins chemotherapy K drug group and the big PK of chemotherapy group, whether it is progression-free survival, overall survival, objective remission rate, or safety, K drug group wins Chemotherapy group.
Among the multiple clinical studies of immunotherapy, the most attractive is the "survival tailing effect" in the late follow-up period of immunotherapy, which is also an important feature that distinguishes it from traditional therapies.
Once immunotherapy takes effect, some patients will be able to achieve clinical cure, that is, long-term no recurrence, no progression, and long-term survival.
The 5-year follow-up data of the KEYNOTE-024 study once again confirmed this point.
The use of PD-1 inhibitors is more effective than chemotherapy, has a longer survival period, and has fewer side effects.
In view of the outstanding efficacy of pembrolizumab single agent in untreated, EGFR/ALK-negative, PD-L1 TPS ≥50% metastatic non-small cell lung cancer, it can be used as the standard of first-line treatment for such patients.
Download the Cancer Degree APP to learn more about immunotherapy.
Reference 1.
Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non--Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50% | Journal of Clinical Oncology.
https://ascopubs.
org/doi/full/10.
1200 /JCO.
21.
00174.
Click below to learn more about the past review of clinical trial projects.
Slide to view more past content
The 2020 Global Cancer Burden Report issued by the International Agency for Research on Cancer (IARC) of the World Health Organization shows that there are 9.
96 million cancer deaths worldwide in 2020, of which 1.
8 million are lung cancer deaths, far exceeding other types of cancer.
There are two main pathological types of lung cancer: small cell lung cancer (SCLC), accounting for 15%; non-small cell lung cancer (NSCLC), accounting for 85%.
In recent years, immunotherapy, represented by PD-1/PD-L1 inhibitors, has led the transformation of advanced lung cancer treatment with its long-lasting efficacy, greatly improved the survival benefits of patients, and brought us new hope.
This article will share with you the latest 5-year survival follow-up data of pembrolizumab (commonly known as K drug), the star drug for the treatment of lung cancer.
The large PK data of pembrolizumab and chemotherapeutics comes from the KEYNOTE-024 study, which was recently published in the Journal of Clinical Oncology1.
The study conducted parallel controlled trials on both K drug and chemotherapy regimens at the same time to compare the efficacy and safety of the two regimens in the first-line treatment of non-small cell lung cancer patients with PD-L1 TPS ≥50% and EGFR/ALK mutation negative.
A total of 305 patients were enrolled in the study, and they were randomly divided into the K-drug monotherapy group and the chemotherapy group at 1:1.
Patients in the chemotherapy group can be crossed to the K drug group for follow-up treatment after their disease progresses.
The primary endpoint of the study is progression-free survival (PFS), and the secondary endpoints are overall survival (OS), objective response rate (ORR), and safety.
The study data is as of June 1, 2020, and the median follow-up time is 59.
9 months.Compared with chemotherapy, K drug showed a better overall survival benefit (Figure 1A) The median overall survival of K drug group and chemotherapy group were 26.
3 and 13.
4 months, respectively.
The overall survival nearly doubled, and the extended time exceeded For a year.
The three-year overall survival rates were 43.
7% and 23.
7%, the four-year overall survival rates were 35.
8% and 19.
8%, and the five-year overall survival rates were 31.
9% and 16.
3%, respectively.
Compared with chemotherapy, drug K showed a better progression-free survival benefit (Figure 1B).
The median progression-free survival of drug K group and chemotherapy group were 7.
7 and 5.
5 months, respectively, which was an extension of 40%.
The five-year progression-free survival rates of the two groups were 12.
8% and not reached respectively.
“Not reached” means that no patient in the chemotherapy group survived the 5-year follow-up time.
The three-year progression-free survival rates of the two groups were 22.
8% and 4.
1% (a difference of 5 times), and the four-year progression-free survival rates were 16.
4% and 1.
4% (correlated 11 times), respectively.
The data of the K drug group was absolutely superior Overwhelm the chemotherapy group.
Figure 1 In the KEYNOTE-024 study, the overall survival data (A) of patients receiving the treatment of the K drug group and the chemotherapy group (A) compared with the progression-free survival (B) data of chemotherapy, the K drug is more effective, and the duration of remission is particularly prolonged (Figure 2) The objective response rate of the K drug group was 46.
1%, of which the complete response (CR) rate was 4.
5%, and the partial response (PR) rate was 41.
6%.
The objective response rate in the chemotherapy group was only 31.
1%, and none of the patients had a complete response.
The median duration of remission (DoR) of the two groups were 29.
1 and 6.
3 months, respectively, which means that the duration of remission for patients who received K drug was 4.
6 times that of chemotherapy, and the K drug group had obvious advantages.
Figure 2 Long-term follow-up of ORR and DoR data of KEYNOTE-024 study, no new adverse reactions were observed for K drug (Figure 3) Common adverse reactions of K drug include fatigue, itching, diarrhea, etc.
There were no new adverse reactions during the long-term follow-up.
The incidence of grade 3 to 5 treatment-related adverse events in the K drug group and the chemotherapy group were 31.
2% and 53.
3%, respectively; the incidence of serious treatment-related adverse events was 22.
7% and 20.
7%, respectively; the incidence of grade 3 to 5 immune-mediated adverse events The incidence of events and infusion reactions was 13.
6% and 0.
7% in the two groups, respectively.
The overall side effects of K drugs are less than those of chemotherapy, which allows many patients to benefit from survival and improve their quality of life.
Figure 3 Adverse event data of patients in the KEYNOTE-024 study K drug wins chemotherapy K drug group and the big PK of chemotherapy group, whether it is progression-free survival, overall survival, objective remission rate, or safety, K drug group wins Chemotherapy group.
Among the multiple clinical studies of immunotherapy, the most attractive is the "survival tailing effect" in the late follow-up period of immunotherapy, which is also an important feature that distinguishes it from traditional therapies.
Once immunotherapy takes effect, some patients will be able to achieve clinical cure, that is, long-term no recurrence, no progression, and long-term survival.
The 5-year follow-up data of the KEYNOTE-024 study once again confirmed this point.
The use of PD-1 inhibitors is more effective than chemotherapy, has a longer survival period, and has fewer side effects.
In view of the outstanding efficacy of pembrolizumab single agent in untreated, EGFR/ALK-negative, PD-L1 TPS ≥50% metastatic non-small cell lung cancer, it can be used as the standard of first-line treatment for such patients.
Download the Cancer Degree APP to learn more about immunotherapy.
Reference 1.
Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non--Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50% | Journal of Clinical Oncology.
https://ascopubs.
org/doi/full/10.
1200 /JCO.
21.
00174.
Click below to learn more about the past review of clinical trial projects.
Slide to view more past content
