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ASCO's Cancer Advance of the Year, FDA Approval in NETs, and More

Gina Columbus
Published: Saturday, Feb 03, 2018



Today-

ASCO announces its 2018 Cancer Advance of the Year, an FDA approval in neuroendocrine tumors, a European regulatory upate in multiple myeloma, and promising phase III findings in a follicular lymphoma trial.

Welcome to OncLive News Network! I'm Gina Columbus.

ASCO has announced chimeric antigen receptor T-cell therapy as its Advance of the Year as part of Clinical Cancer Advances 2018: ASCO's Annual Report on Progress Against Cancer.

The annual update on oncology treatment highlights the most impactful clinical cancer research and policy developments over the past year.

The organization said that CAR T-cell treatment is poised to transform the outlook for children and adults with certain otherwise incurable cancers. Additionally, in a press release, ASCO President Bruce E. Johnson, MD, said that the emergence of CAR T-cell therapy is the payoff for decades of investment by the National Institutes of Health, academic medical centers, and the pharma/biotech industry in the basic sciences of immunology, cancer biology, and genetics.

The FDA approved a pair of CAR T-cell therapies in 2017: tisagenlecleucel for the treatment of children and young adults aged up to 25 with relapsed/refractory B-cell precursor acute lymphoblastic leukemia and axicabtagene ciloleucel for adults with relapsed/refractory diffuse large B-cell lymphoma. Axi-cel is also indicated for primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma.

Tisagenlecleucel, developed by the University of Pennsylvania and Novartis, was the first CAR T-cell therapy approved by the FDA.

Tisagenlecleucel was approved based on results from the phase II, single-arm, international ELIANA trial of 63 patients who received a single dose of tisagenlecleucel. The overall remission rate was 82.5% in treated patients.

Axi-cel was approved by the FDA based on single-arm findings of the ZUMA-1 study. Those with DLBCL had an ORR of 82% and a complete response rate of 49%. After 8.7 months of follow-up, the ORR in the DLBCL group was 36%, which included a CR rate of 31%. In the PMBCL/TFL group, the ORR was 83% and the CR rate was 71%. The 8.7-month ORR rate was 67%, with a CR rate of 63%.

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The FDA has granted an approval to Lutathera for the treatment of patients with gastroenteropancreatic neuroendocrine tumors.

The approval is based on results of the phase III NETTER-1 trial, which compared Lutathera with high-dose octreotide LAR for patients with grade 1 or 2 metastatic midgut NETs. In this study, there was a 79% reduction in the risk of progression or death with Lutathera compared with octreotide.

The overall response rate with Lutathera was 13% versus 4% with octreotide. Additionally, the median PFS had not been reached in the Lutathera arm compared with 8.5 months in the high-dose octreotide arm. At the interim analysis of OS, there was a 48% reduction in the risk of death seen with Lutathera versus octreotide.

Previously, the FDA had granted a priority review designation to the NDA for Lutathera in June 2016, and had been scheduled to make its final decision by December 28, 2016. However, on December 21, 2016, Advanced Accelerator Applications, the manufacturer of Lutathera, reported that the FDA had issued a complete response letter informing the company that the new drug application for the agent would need to be resubmitted.

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The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive recommendation for a label variation of carfilzomib in patients with relapsed/refractory multiple myeloma.

If approved by the EMA, the adjusted label will include updated overall survival data from the phase III ENDEAVOR trial. In results from the study, carfilzomib reduced the risk of death by 21% compared with bortezomib in patients with relapsed/refractory multiple myeloma.

Carfilzomib in combination with dexamethasone extended OS by 7.6 months versus bortezomib and dexamethasone. The OS benefit was consistent for both patients who received previous bortezomib and those who did not.

Carfilzomib is currently approved in the European Union for use in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 1 prior therapy.

Earlier this month, the FDA approved a request from Amgen, the developer of carfilzomib, to update the US label based on these findings.

******************************

Phase III findings of the REFLECTIONS B3281006 trial demonstrated that the rituximab biosimilar PF-05280586 met its primary endpoint for overall response rate in patients with follicular lymphoma.

Pfizer, the company that is manufacturing the biomsimilar, announced that the monoclonal antibody had equivalence in ORR compared with rituximab for the first-line treatment of patients with CD20-positive, low tumor burden FL.

PF-05280586 is an investigational compound that has not received regulatory approval in any country. Its intended use is for the treatment of patients with certain types of CD20-positive non-Hodgkin lymphoma and CD20-positive chronic lymphocytic leukemia.

Rituximab has several approved indications, including non-Hodgkin lymphoma, CLL, and rheumatoid arthritis.

**************************************

This week, we sat down with Dr Stephen M. Ansell of Mayo Clinic to discuss the significance of the ECHELON-1 trial in Hodgkin lymphoma.

That's all for today.

Thank you for watching OncLive News Network! I'm Gina Columbus.
 
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Today-

ASCO announces its 2018 Cancer Advance of the Year, an FDA approval in neuroendocrine tumors, a European regulatory upate in multiple myeloma, and promising phase III findings in a follicular lymphoma trial.

Welcome to OncLive News Network! I'm Gina Columbus.

ASCO has announced chimeric antigen receptor T-cell therapy as its Advance of the Year as part of Clinical Cancer Advances 2018: ASCO's Annual Report on Progress Against Cancer.

The annual update on oncology treatment highlights the most impactful clinical cancer research and policy developments over the past year.

The organization said that CAR T-cell treatment is poised to transform the outlook for children and adults with certain otherwise incurable cancers. Additionally, in a press release, ASCO President Bruce E. Johnson, MD, said that the emergence of CAR T-cell therapy is the payoff for decades of investment by the National Institutes of Health, academic medical centers, and the pharma/biotech industry in the basic sciences of immunology, cancer biology, and genetics.

The FDA approved a pair of CAR T-cell therapies in 2017: tisagenlecleucel for the treatment of children and young adults aged up to 25 with relapsed/refractory B-cell precursor acute lymphoblastic leukemia and axicabtagene ciloleucel for adults with relapsed/refractory diffuse large B-cell lymphoma. Axi-cel is also indicated for primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma.

Tisagenlecleucel, developed by the University of Pennsylvania and Novartis, was the first CAR T-cell therapy approved by the FDA.

Tisagenlecleucel was approved based on results from the phase II, single-arm, international ELIANA trial of 63 patients who received a single dose of tisagenlecleucel. The overall remission rate was 82.5% in treated patients.

Axi-cel was approved by the FDA based on single-arm findings of the ZUMA-1 study. Those with DLBCL had an ORR of 82% and a complete response rate of 49%. After 8.7 months of follow-up, the ORR in the DLBCL group was 36%, which included a CR rate of 31%. In the PMBCL/TFL group, the ORR was 83% and the CR rate was 71%. The 8.7-month ORR rate was 67%, with a CR rate of 63%.

*****************************************

The FDA has granted an approval to Lutathera for the treatment of patients with gastroenteropancreatic neuroendocrine tumors.

The approval is based on results of the phase III NETTER-1 trial, which compared Lutathera with high-dose octreotide LAR for patients with grade 1 or 2 metastatic midgut NETs. In this study, there was a 79% reduction in the risk of progression or death with Lutathera compared with octreotide.

The overall response rate with Lutathera was 13% versus 4% with octreotide. Additionally, the median PFS had not been reached in the Lutathera arm compared with 8.5 months in the high-dose octreotide arm. At the interim analysis of OS, there was a 48% reduction in the risk of death seen with Lutathera versus octreotide.

Previously, the FDA had granted a priority review designation to the NDA for Lutathera in June 2016, and had been scheduled to make its final decision by December 28, 2016. However, on December 21, 2016, Advanced Accelerator Applications, the manufacturer of Lutathera, reported that the FDA had issued a complete response letter informing the company that the new drug application for the agent would need to be resubmitted.

*************************************

The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive recommendation for a label variation of carfilzomib in patients with relapsed/refractory multiple myeloma.

If approved by the EMA, the adjusted label will include updated overall survival data from the phase III ENDEAVOR trial. In results from the study, carfilzomib reduced the risk of death by 21% compared with bortezomib in patients with relapsed/refractory multiple myeloma.

Carfilzomib in combination with dexamethasone extended OS by 7.6 months versus bortezomib and dexamethasone. The OS benefit was consistent for both patients who received previous bortezomib and those who did not.

Carfilzomib is currently approved in the European Union for use in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 1 prior therapy.

Earlier this month, the FDA approved a request from Amgen, the developer of carfilzomib, to update the US label based on these findings.

******************************

Phase III findings of the REFLECTIONS B3281006 trial demonstrated that the rituximab biosimilar PF-05280586 met its primary endpoint for overall response rate in patients with follicular lymphoma.

Pfizer, the company that is manufacturing the biomsimilar, announced that the monoclonal antibody had equivalence in ORR compared with rituximab for the first-line treatment of patients with CD20-positive, low tumor burden FL.

PF-05280586 is an investigational compound that has not received regulatory approval in any country. Its intended use is for the treatment of patients with certain types of CD20-positive non-Hodgkin lymphoma and CD20-positive chronic lymphocytic leukemia.

Rituximab has several approved indications, including non-Hodgkin lymphoma, CLL, and rheumatoid arthritis.

**************************************

This week, we sat down with Dr Stephen M. Ansell of Mayo Clinic to discuss the significance of the ECHELON-1 trial in Hodgkin lymphoma.

That's all for today.

Thank you for watching OncLive News Network! I'm Gina Columbus.
 
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