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▎The content team editor of WuXi AppTec today, the US FDA announced that it has approved Bristol-Myers Squibb (BMS)'s blockbuster PD-1 inhibitor Opdivo (nivolumab) in combination with chemotherapy as a treatment for advanced or metastatic gastric cancer and gastroesophageal combination First-line therapy for GEJ cancer and esophageal adenocarcinoma.
The press release stated that this is the first first-line immunotherapy approved by the FDA for the treatment of gastric cancer.
Stomach cancer is the fifth most common cancer in the world and the third leading cause of cancer death.
In China, gastric cancer is the second most common type of cancer after lung cancer.
Its incidences and deaths accounted for 44% and 50% of the world's total.
80% of Chinese gastric cancer patients are already at an advanced stage when they are diagnosed.
For most patients with advanced gastric cancer, chemotherapy has remained the first choice of first-line treatment in the past few decades.
However, the therapeutic effect of chemotherapy is limited, and the 5-year survival rate for patients with advanced or metastatic gastric cancer is only 5%.
Opdivo developed by Bristol-Myers Squibb is a monoclonal antibody that targets PD-1.
It enhances the anti-cancer immune response of T lymphocytes by inhibiting the signal pathway mediated by PD-1 immune checkpoint protein, thereby inhibiting tumor growth.
Since it was first approved by the FDA in 2014, it has been approved by more than 65 countries and regions in the world to treat a variety of cancer types including melanoma and non-small cell lung cancer.
This approval is supported by a randomized, open-label Phase 3 clinical trial, CheckMate-649.
A total of 1,581 untreated patients with advanced or metastatic gastric cancer, GEJ cancer, and esophageal adenocarcinoma participated in the trial.
The results of the trial showed that the combination therapy of Opdivo and chemotherapy significantly improved the overall survival (OS) of patients.
The median survival time of patients in the Opdivo combination therapy group was 13.
8 months, and that in the chemotherapy group was 11.
6 months.
In patients whose tumors express PD-L1 (CPS>5), the Opdivo combination therapy has a better effect, with a median OS of 14.
4 months in patients and 11.
1 months in the chemotherapy control group.
Opdivo combination therapy reduced the risk of death by 29% (HR=0.
71, 98.
4% CI, 0.
59-0.
86, p<0.
0001).
▲Survival data of CheckMate-649 (picture source: BMS official website) "The first-line therapy approved today (compared with standard treatment) provides survival benefit for patients with advanced or metastatic gastric cancer for the first time in more than a decade.
" FDA Center of Excellence on Oncology Director Dr.
Richard Pazdur said, “The FDA is committed to bringing more safe and effective treatment options like Opdivo to patients with advanced cancer.
” In China, Opdivo was approved by the China National Medical Products Administration in March last year.
It is used to treat patients with advanced or recurrent gastric or gastroesophageal junction adenocarcinoma who have received two or more systemic treatments in the past.
Last week, Bristol-Myers Squibb announced the main results of the CheckMate-649 China subgroup.
The results showed that in the Chinese population, compared with chemotherapy alone, Odivo (Navulimab) combined with chemotherapy has achieved clinically significant results in the first-line treatment of unresectable advanced or metastatic gastric cancer and gastroesophageal junction cancer.
Survival and progression-free survival (PFS) benefit.
The analysis results of the Chinese subgroup are consistent with the results of the global population as a whole.
In addition to Opdivo, at the American Society of Clinical Oncology-Gastrointestinal Cancer Symposium at the beginning of this year, BeiGene and Zymeworks jointly developed HER2 targeting bispecific antibody zanidatamab, Five Prime Therapeutics (recently acquired by Amgen) ) The FGFR2b monoclonal antibody bemarituzumab jointly developed with Zai Lab and the blockbuster PD-1 inhibitor Keytruda combination therapy have achieved positive results in first-line clinical trials for the treatment of gastric cancer.
We expect that with the continuous progress of targeted therapy and immunotherapy, patients with gastric cancer will be able to obtain more and better treatment options and prolong their lives.
Related reading: Where is the treatment of advanced gastric cancer heading? The "Nature" sub-published reference materials for precision treatment blueprints: [1] FDA Approves First Immunotherapy for Initial Treatment of Gastric Cancer.
Retrieved April 16, 2021, from approves-first-immunotherapy-for-initial-treatment-of-gastric-cancer-301270710.
html Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
The press release stated that this is the first first-line immunotherapy approved by the FDA for the treatment of gastric cancer.
Stomach cancer is the fifth most common cancer in the world and the third leading cause of cancer death.
In China, gastric cancer is the second most common type of cancer after lung cancer.
Its incidences and deaths accounted for 44% and 50% of the world's total.
80% of Chinese gastric cancer patients are already at an advanced stage when they are diagnosed.
For most patients with advanced gastric cancer, chemotherapy has remained the first choice of first-line treatment in the past few decades.
However, the therapeutic effect of chemotherapy is limited, and the 5-year survival rate for patients with advanced or metastatic gastric cancer is only 5%.
Opdivo developed by Bristol-Myers Squibb is a monoclonal antibody that targets PD-1.
It enhances the anti-cancer immune response of T lymphocytes by inhibiting the signal pathway mediated by PD-1 immune checkpoint protein, thereby inhibiting tumor growth.
Since it was first approved by the FDA in 2014, it has been approved by more than 65 countries and regions in the world to treat a variety of cancer types including melanoma and non-small cell lung cancer.
This approval is supported by a randomized, open-label Phase 3 clinical trial, CheckMate-649.
A total of 1,581 untreated patients with advanced or metastatic gastric cancer, GEJ cancer, and esophageal adenocarcinoma participated in the trial.
The results of the trial showed that the combination therapy of Opdivo and chemotherapy significantly improved the overall survival (OS) of patients.
The median survival time of patients in the Opdivo combination therapy group was 13.
8 months, and that in the chemotherapy group was 11.
6 months.
In patients whose tumors express PD-L1 (CPS>5), the Opdivo combination therapy has a better effect, with a median OS of 14.
4 months in patients and 11.
1 months in the chemotherapy control group.
Opdivo combination therapy reduced the risk of death by 29% (HR=0.
71, 98.
4% CI, 0.
59-0.
86, p<0.
0001).
▲Survival data of CheckMate-649 (picture source: BMS official website) "The first-line therapy approved today (compared with standard treatment) provides survival benefit for patients with advanced or metastatic gastric cancer for the first time in more than a decade.
" FDA Center of Excellence on Oncology Director Dr.
Richard Pazdur said, “The FDA is committed to bringing more safe and effective treatment options like Opdivo to patients with advanced cancer.
” In China, Opdivo was approved by the China National Medical Products Administration in March last year.
It is used to treat patients with advanced or recurrent gastric or gastroesophageal junction adenocarcinoma who have received two or more systemic treatments in the past.
Last week, Bristol-Myers Squibb announced the main results of the CheckMate-649 China subgroup.
The results showed that in the Chinese population, compared with chemotherapy alone, Odivo (Navulimab) combined with chemotherapy has achieved clinically significant results in the first-line treatment of unresectable advanced or metastatic gastric cancer and gastroesophageal junction cancer.
Survival and progression-free survival (PFS) benefit.
The analysis results of the Chinese subgroup are consistent with the results of the global population as a whole.
In addition to Opdivo, at the American Society of Clinical Oncology-Gastrointestinal Cancer Symposium at the beginning of this year, BeiGene and Zymeworks jointly developed HER2 targeting bispecific antibody zanidatamab, Five Prime Therapeutics (recently acquired by Amgen) ) The FGFR2b monoclonal antibody bemarituzumab jointly developed with Zai Lab and the blockbuster PD-1 inhibitor Keytruda combination therapy have achieved positive results in first-line clinical trials for the treatment of gastric cancer.
We expect that with the continuous progress of targeted therapy and immunotherapy, patients with gastric cancer will be able to obtain more and better treatment options and prolong their lives.
Related reading: Where is the treatment of advanced gastric cancer heading? The "Nature" sub-published reference materials for precision treatment blueprints: [1] FDA Approves First Immunotherapy for Initial Treatment of Gastric Cancer.
Retrieved April 16, 2021, from approves-first-immunotherapy-for-initial-treatment-of-gastric-cancer-301270710.
html Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
