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▎Editor of WuXi AppTec's content team today, Novocure announced that its Tumor Treating Fields (TTF) has made positive progress in a pivotal phase 3 clinical trial for the treatment of patients with non-small cell lung cancer.
The Independent Data Monitoring Committee (DMC) recommended that this clinical trial continue after an interim analysis of the data of 210 patients.
At the same time, DMC stated that it may not be necessary to accumulate 534 patients in the control group of this clinical trial and follow them for 18 months.
It is recommended to reduce the number of people in the control group to 276 and the follow-up time to 12 months.
DMC believes that the number of these patients and the follow-up time can provide sufficient data to show the role of TTF.
Mr.
Asaf Danziger, CEO of Novocure, said that this proposed change to the clinical trial may speed up the trial progress by more than a year.
Tumor treatment electric field is a low-intensity alternating electric field, which can affect the movement of specific cell components during cell mitosis and disrupt mitosis.
Due to the unique shape and characteristics of tumor cells during mitosis, by adjusting the alternating frequency of the tumor treatment electric field, it can perturb the division of tumor cells in a targeted manner.
▲The mechanism of tumor electric field therapy (picture source: Novocure's official website) This innovative treatment method has been approved by the US FDA and used in combination with chemotherapy for the first-line treatment of unresectable locally advanced or metastatic malignant pleural mesothelioma.
In China, Zai Lab has the development rights of tumor electric field therapy in Greater China.
This innovative treatment model was also approved by the National Medical Products Administration of China last year, becoming the first approved treatment for glioblastoma in mainland China in 15 years.
This pivotal Phase 3 clinical trial aims to evaluate the combination of tumor electric field therapy with immune checkpoint inhibitors or docetaxel, compared with immune checkpoint inhibitors or docetaxel monotherapy, in treatment level 4 ( stage 4) The effect in patients with non-small cell lung cancer.
These patients have been treated with platinum-containing chemotherapy and the disease continues to progress.
Lung cancer is one of the leading causes of cancer deaths in the world, and it is also the type of cancer with the highest incidence and the highest number of deaths in China.
Therefore, if the tumor electric field therapy obtains positive results in this trial, it is expected to benefit a large number of lung cancer patients.
"Combination therapy is the cornerstone of cancer treatment.
We believe that combining electric field therapy with other treatments can provide patients with better treatment outcomes.
" said Mr.
William Doyle, Executive Chairman of Novocure.
Reference: [1] Novocure Announces Update on Phase 3 Pivotal LUNAR Trial of Tumor Treating Fields in Non-Small Cell Lung Cancer.
Retrieved April 13, 2021, fromen 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 Independent Data Monitoring Committee (DMC) recommended that this clinical trial continue after an interim analysis of the data of 210 patients.
At the same time, DMC stated that it may not be necessary to accumulate 534 patients in the control group of this clinical trial and follow them for 18 months.
It is recommended to reduce the number of people in the control group to 276 and the follow-up time to 12 months.
DMC believes that the number of these patients and the follow-up time can provide sufficient data to show the role of TTF.
Mr.
Asaf Danziger, CEO of Novocure, said that this proposed change to the clinical trial may speed up the trial progress by more than a year.
Tumor treatment electric field is a low-intensity alternating electric field, which can affect the movement of specific cell components during cell mitosis and disrupt mitosis.
Due to the unique shape and characteristics of tumor cells during mitosis, by adjusting the alternating frequency of the tumor treatment electric field, it can perturb the division of tumor cells in a targeted manner.
▲The mechanism of tumor electric field therapy (picture source: Novocure's official website) This innovative treatment method has been approved by the US FDA and used in combination with chemotherapy for the first-line treatment of unresectable locally advanced or metastatic malignant pleural mesothelioma.
In China, Zai Lab has the development rights of tumor electric field therapy in Greater China.
This innovative treatment model was also approved by the National Medical Products Administration of China last year, becoming the first approved treatment for glioblastoma in mainland China in 15 years.
This pivotal Phase 3 clinical trial aims to evaluate the combination of tumor electric field therapy with immune checkpoint inhibitors or docetaxel, compared with immune checkpoint inhibitors or docetaxel monotherapy, in treatment level 4 ( stage 4) The effect in patients with non-small cell lung cancer.
These patients have been treated with platinum-containing chemotherapy and the disease continues to progress.
Lung cancer is one of the leading causes of cancer deaths in the world, and it is also the type of cancer with the highest incidence and the highest number of deaths in China.
Therefore, if the tumor electric field therapy obtains positive results in this trial, it is expected to benefit a large number of lung cancer patients.
"Combination therapy is the cornerstone of cancer treatment.
We believe that combining electric field therapy with other treatments can provide patients with better treatment outcomes.
" said Mr.
William Doyle, Executive Chairman of Novocure.
Reference: [1] Novocure Announces Update on Phase 3 Pivotal LUNAR Trial of Tumor Treating Fields in Non-Small Cell Lung Cancer.
Retrieved April 13, 2021, fromen 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.