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ASCO 2017: BCMA-Specific CAR T-Cell Therapy Sends Relapsed

ASCO 2017: BCMA-Specific CAR T-Cell Therapy Sends Relapsed/Refractory Numerous Myeloma Into Lasting Remission in an Early Trial

Posted: 6/Five/2017 11:33:55 AM

Last Updated: 6/Five/2017 11:33:55 AM

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Key Points

• Overall, the objective response rate was 100%, and thirty three patients (94%) had an evident clinical remission of myeloma (accomplish response, very good partial response, or partial response) within two months of receiving CAR T cells.
• After following the group for a period of more than four months, of the nineteen patients, fourteen have reached stringent finish response criteria, one patient has reached partial response, and four patients have achieved very good partial remission criteria in efficacy.
• Cytokine-release syndrome, a common and potentially dangerous side effect of CAR T-cell therapy, occurred in 85% of patients, but it was transient. No patients experienced neurologic side effects, another common and serious complication of CAR T-cell therapy.

In an early clinical trial, thirty three out of thirty five (94%) patients had clinical remission of numerous myeloma upon receiving immunotherapy with chimeric antigen receptor (CAR) T cells targeting B-cell maturation protein, or BCMA. Most patients had only mild side effects. The examine was introduced by Fan et al today at the two thousand seventeen ASCO Annual Meeting (Abstract LBA3001).

«Albeit latest advances in chemotherapy have prolonged life expectancy in numerous myeloma, this cancer remains incurable,» said investigate author Wanhong Zhao, MD, PhD, an Associate Director of Hematology at The 2nd Affiliated Hospital of Xi`an Jiaotong University in Xi`an, China. «It shows up that with this novel immunotherapy there may be a chance for cure in numerous myeloma, but we will need to go after patients much longer to confirm that.»

CAR T-cell therapy is custom-made for each patient. The patient`s own T cells are collected, genetically reprogrammed in a lab, and injected back into the patient. The reprogramming involves inserting an artificially designed gene into the T-cell genome, which helps the genetically reprogrammed cells find and ruin cancer cells via the assets.

Over the past few years, CAR T-cell therapy targeting a B-cell biomarker called CD19 proved very effective in initial trials for acute lymphoblastic leukemia and some types of lymphoma, but until now, there has been little success with CAR T-cell therapies targeting other biomarkers in other types of cancer. This is one of the very first clinical trials of CAR T cells targeting BCMA, which was discovered to play a role in the progression of numerous myeloma in 2004.

The authors reported results from the very first thirty five patients with relapsed or refractory numerous myeloma enrolled in this ongoing phase I clinical trial in China. Very first signs of treatment efficacy appeared as early as ten days after initial injection of CAR T cells (patients received three split doses of cells over a week). Overall, the objective response rate was 100%, and thirty three patients (94%) had an evident clinical remission of myeloma (finish response, very good partial response, or partial response) within two months of receiving CAR T cells.

To date, nineteen patients have been followed for more than four months, a preset time for utter efficacy assessment by the International Myeloma Working Group consensus. Of the nineteen patients, fourteen have reached stringent accomplish response criteria, one patient has reached partial response, and four patients have achieved very good partial remission criteria in efficacy.

There has been only a single case of disease progression after very good partial remission; an extramedullary lesion of this patient reappeared three months after disappearing on CT scans. There has not been a single case of relapse among patients who reached stringent finish response criteria. The five patients who have been followed for over one year (12 to fourteen months) all remain in stringent finish response status and are free of minimal residual disease as well.

Cytokine-release syndrome, a common and potentially dangerous side effect of CAR T-cell therapy, occurred in 85% of patients, but it was transient. In the majority of patients, symptoms were mild and manageable. Cytokine-release syndrome is associated with symptoms such as fever, low blood pressure, difficulty breathing, and problems with numerous organs. Only two patients on this investigate experienced severe cytokine-release syndrome (grade Trio), but they recovered upon receiving tocilizumab (Actemra), an inflammation-reducing agent . No patients experienced neurologic side effects, another common and serious complication from CAR T-cell therapy.

The researchers plan to enroll a total of one hundred patients in this clinical trial at four participating hospitals in China. «In early 2018, we also plan to launch a similar clinical trial in the United States. Looking ahead, we would like to explore whether BCMA CAR T-cell therapy benefits patients who are freshly diagnosed with numerous myeloma,» said Dr. Zhao.

«While it`s still early, these data are a strong sign that CAR T-cell therapy can send numerous myeloma into remission. It`s infrequent to see such high response rates, especially for a hard-to-treat cancer. This serves as proof that immunotherapy and precision medicine research pays off. We hope that future research builds on this success in numerous myeloma and other cancers,» said ASCO Accomplished Michael S. Sabel, MD, FACS.

This probe was funded by Legend Biotech Co.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.

ASCO 2017: BCMA-Specific CAR T-Cell Therapy Sends Relapsed

ASCO 2017: BCMA-Specific CAR T-Cell Therapy Sends Relapsed/Refractory Numerous Myeloma Into Lasting Remission in an Early Trial

Posted: 6/Five/2017 11:33:55 AM

Last Updated: 6/Five/2017 11:33:55 AM

Tweet this page

Key Points

• Overall, the objective response rate was 100%, and thirty three patients (94%) had an evident clinical remission of myeloma (finish response, very good partial response, or partial response) within two months of receiving CAR T cells.
• After following the group for a period of more than four months, of the nineteen patients, fourteen have reached stringent finish response criteria, one patient has reached partial response, and four patients have achieved very good partial remission criteria in efficacy.
• Cytokine-release syndrome, a common and potentially dangerous side effect of CAR T-cell therapy, occurred in 85% of patients, but it was transient. No patients experienced neurologic side effects, another common and serious complication of CAR T-cell therapy.

In an early clinical trial, thirty three out of thirty five (94%) patients had clinical remission of numerous myeloma upon receiving immunotherapy with chimeric antigen receptor (CAR) T cells targeting B-cell maturation protein, or BCMA. Most patients had only mild side effects. The investigate was introduced by Fan et al today at the two thousand seventeen ASCO Annual Meeting (Abstract LBA3001).

«Albeit latest advances in chemotherapy have prolonged life expectancy in numerous myeloma, this cancer remains incurable,» said probe author Wanhong Zhao, MD, PhD, an Associate Director of Hematology at The 2nd Affiliated Hospital of Xi`an Jiaotong University in Xi`an, China. «It emerges that with this novel immunotherapy there may be a chance for cure in numerous myeloma, but we will need to go after patients much longer to confirm that.»

CAR T-cell therapy is custom-made for each patient. The patient`s own T cells are collected, genetically reprogrammed in a lab, and injected back into the patient. The reprogramming involves inserting an artificially designed gene into the T-cell genome, which helps the genetically reprogrammed cells find and demolish cancer cells across the figure.

Over the past few years, CAR T-cell therapy targeting a B-cell biomarker called CD19 proved very effective in initial trials for acute lymphoblastic leukemia and some types of lymphoma, but until now, there has been little success with CAR T-cell therapies targeting other biomarkers in other types of cancer. This is one of the very first clinical trials of CAR T cells targeting BCMA, which was discovered to play a role in the progression of numerous myeloma in 2004.

The authors reported results from the very first thirty five patients with relapsed or refractory numerous myeloma enrolled in this ongoing phase I clinical trial in China. Very first signs of treatment efficacy appeared as early as ten days after initial injection of CAR T cells (patients received three split doses of cells over a week). Overall, the objective response rate was 100%, and thirty three patients (94%) had an evident clinical remission of myeloma (accomplish response, very good partial response, or partial response) within two months of receiving CAR T cells.

To date, nineteen patients have been followed for more than four months, a preset time for utter efficacy assessment by the International Myeloma Working Group consensus. Of the nineteen patients, fourteen have reached stringent finish response criteria, one patient has reached partial response, and four patients have achieved very good partial remission criteria in efficacy.

There has been only a single case of disease progression after very good partial remission; an extramedullary lesion of this patient reappeared three months after disappearing on CT scans. There has not been a single case of relapse among patients who reached stringent accomplish response criteria. The five patients who have been followed for over one year (12 to fourteen months) all remain in stringent finish response status and are free of minimal residual disease as well.

Cytokine-release syndrome, a common and potentially dangerous side effect of CAR T-cell therapy, occurred in 85% of patients, but it was transient. In the majority of patients, symptoms were mild and manageable. Cytokine-release syndrome is associated with symptoms such as fever, low blood pressure, difficulty breathing, and problems with numerous organs. Only two patients on this probe experienced severe cytokine-release syndrome (grade Three), but they recovered upon receiving tocilizumab (Actemra), an inflammation-reducing agent . No patients experienced neurologic side effects, another common and serious complication from CAR T-cell therapy.

The researchers plan to enroll a total of one hundred patients in this clinical trial at four participating hospitals in China. «In early 2018, we also plan to launch a similar clinical trial in the United States. Looking ahead, we would like to explore whether BCMA CAR T-cell therapy benefits patients who are freshly diagnosed with numerous myeloma,» said Dr. Zhao.

«While it`s still early, these data are a strong sign that CAR T-cell therapy can send numerous myeloma into remission. It`s uncommon to see such high response rates, especially for a hard-to-treat cancer. This serves as proof that immunotherapy and precision medicine research pays off. We hope that future research builds on this success in numerous myeloma and other cancers,» said ASCO Accomplished Michael S. Sabel, MD, FACS.

This explore was funded by Legend Biotech Co.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.

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