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FDA Approval in Multiple Myeloma, Priority Reviews in DLBCL and Myeloma, and More

Gina Columbus
Published: Monday, Jan 29, 2018



Today-

An FDA approval in multiple myeloma, priority review designations in diffuse large B-cell lymphoma and multiple myeloma, a European approval in cutaneous T-cell lymphoma, and an acquisition of a major CAR T-cell therapy developer.

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

The FDA has approved a supplemental new drug application that adds overall survival data from the phase III ENDEAVOR trial to the label for carfilzomib. The indication is for patients with relapsed or refractory multiple myeloma.

Results from the primary ENDEAVOR OS analysis, which were published in the Lancet Oncology, showed that carfilzomib reduced the risk of death by 21% versus bortezomib in patients with relapsed/refractory disease.

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

The agent is currently approved in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy. Carfilzomib is also approved as a monotherapy for relapsed/refractory myeloma patients who have received 1 or more lines of therapy.

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The FDA has granted a priority review to a supplemental biologics license application for tisagenlecleucel as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma who are ineligible for or relapse after autologous stem cell transplant.

The application is based on the phase II JULIET study, in which the CD19-directed CAR T-cell therapy reached an overall response rate of 53.1% in adult patients with relapsed/refractory disease.

The European Medicines Agency also granted an accelerated assessment to a marketing authorization application for tisagenlecleucel for the same DLBCL indication based on the JULIET findings. The European application also includes an indication for the treatment of children and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia.

The FDA previously approved tisagenlecleucel in August 2017 for use in patients with ALL.

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In multiple myeloma, the FDA granted a priority review designation to daratumumab in combination with bortezomib, melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

The designation was based on findings from the phase III ALCYONE study, in which daratumumab plus VMP elicited an 18-month progression-free survival rate of 71.6% versus 50.2% for VMP alone, representing a 50% reduction in the risk of progression or death.

The median PFS was 18.1 months in the VMP arm and was not yet reached for those treated with the daratumumab regimen. At the 12-month assessment, 87% of patients remained alive and progression-free in the daratumumab group versus 76% for VMP.

The objective response rate with the daratumumab regimen was 90.9% versus 73.9% in the control arm, which included a complete response or better for 42.6% of patients in the daratumumab arm compared with 24.4% in the VMP alone group.

The FDA will decide on the application for daratumumab plus VMP by May 21, 2018, as part of the Prescription Drug User Fee Act.

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The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of brentuximab vedotin in adults with CD30-positive cutaneous T-cell lymphoma following at least 1 prior systemic therapy.

If approved by the European Commission, brentuximab vedotin would be available for use in the 28-member European Union along with Norway, Liechtenstein, and Iceland.

The CHMP reviewed findings from the international, open-label, phase III ALCANZA trial, which showed that brentuximab vedotin induced responses lasting at least 4 months in 56.3% of patients versus 12.5% in patients receiving physician's choice of standard therapies.

The median progression-free survival was 16.7 months with brentuximab vedotin versus 3.5 months with physician's choice. The objective response rate was 67% versus 20%, with complete response rates of 16% versus 2%, in the brentuximab vedotin and control arms, respectively.

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

Celgene has announced plans to acquire Juno Therapeutics, which is the developer of the CAR T-cell therapy lisocabtagene maraleucel, known as JCAR017, for $87 per share, totaling approximately $9 billion. The decision was approved by both companies and is expected to complete within the first quarter of 2018.

Juno and Celgene both anticipate a regulatory submission and subsequent approval in 2019 for liso-cel as a treatment for patients with relapsed and/or refractory diffuse large B-cell lymphoma. Although not yet submitted, the companies believe liso-cel has the potential to be a "best-in-class" CAR T-cell therapy, allowing it to achieve $3 billion in peak sales.

In data from the TRANSCEND trial, which were presented at the 2017 ASH Annual Meeting, liso-cel induced an 81% objective response rate with a 63% complete remission rate in patients with relapsed/refractory DLBCL. At the 3-month assessment for the dose being used in an ongoing pivotal trial for liso-cel, the ORR was 74% with a CR rate of 68%. By month 6, the ORR and CR rates were both 50% in this group.

As part of the acquisition, Celgene reaffirmed its goal of $19 to $20 billion in product sales by 2020. In addition to liso-cel, Juno is also developing JCARH125, a CAR T-cell therapy targeted against B-cell maturation antigen for multiple myeloma.

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

This week, we sat down with Dr Judd Moul of Duke University School of Medicine to discuss the changing landscape of treatment for patients with nonmetastatic castration-resistant prostate cancer.

That's all for today.

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

An FDA approval in multiple myeloma, priority review designations in diffuse large B-cell lymphoma and multiple myeloma, a European approval in cutaneous T-cell lymphoma, and an acquisition of a major CAR T-cell therapy developer.

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

The FDA has approved a supplemental new drug application that adds overall survival data from the phase III ENDEAVOR trial to the label for carfilzomib. The indication is for patients with relapsed or refractory multiple myeloma.

Results from the primary ENDEAVOR OS analysis, which were published in the Lancet Oncology, showed that carfilzomib reduced the risk of death by 21% versus bortezomib in patients with relapsed/refractory disease.

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

The agent is currently approved in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy. Carfilzomib is also approved as a monotherapy for relapsed/refractory myeloma patients who have received 1 or more lines of therapy.

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

The FDA has granted a priority review to a supplemental biologics license application for tisagenlecleucel as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma who are ineligible for or relapse after autologous stem cell transplant.

The application is based on the phase II JULIET study, in which the CD19-directed CAR T-cell therapy reached an overall response rate of 53.1% in adult patients with relapsed/refractory disease.

The European Medicines Agency also granted an accelerated assessment to a marketing authorization application for tisagenlecleucel for the same DLBCL indication based on the JULIET findings. The European application also includes an indication for the treatment of children and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia.

The FDA previously approved tisagenlecleucel in August 2017 for use in patients with ALL.

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

In multiple myeloma, the FDA granted a priority review designation to daratumumab in combination with bortezomib, melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

The designation was based on findings from the phase III ALCYONE study, in which daratumumab plus VMP elicited an 18-month progression-free survival rate of 71.6% versus 50.2% for VMP alone, representing a 50% reduction in the risk of progression or death.

The median PFS was 18.1 months in the VMP arm and was not yet reached for those treated with the daratumumab regimen. At the 12-month assessment, 87% of patients remained alive and progression-free in the daratumumab group versus 76% for VMP.

The objective response rate with the daratumumab regimen was 90.9% versus 73.9% in the control arm, which included a complete response or better for 42.6% of patients in the daratumumab arm compared with 24.4% in the VMP alone group.

The FDA will decide on the application for daratumumab plus VMP by May 21, 2018, as part of the Prescription Drug User Fee Act.

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

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of brentuximab vedotin in adults with CD30-positive cutaneous T-cell lymphoma following at least 1 prior systemic therapy.

If approved by the European Commission, brentuximab vedotin would be available for use in the 28-member European Union along with Norway, Liechtenstein, and Iceland.

The CHMP reviewed findings from the international, open-label, phase III ALCANZA trial, which showed that brentuximab vedotin induced responses lasting at least 4 months in 56.3% of patients versus 12.5% in patients receiving physician's choice of standard therapies.

The median progression-free survival was 16.7 months with brentuximab vedotin versus 3.5 months with physician's choice. The objective response rate was 67% versus 20%, with complete response rates of 16% versus 2%, in the brentuximab vedotin and control arms, respectively.

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

Celgene has announced plans to acquire Juno Therapeutics, which is the developer of the CAR T-cell therapy lisocabtagene maraleucel, known as JCAR017, for $87 per share, totaling approximately $9 billion. The decision was approved by both companies and is expected to complete within the first quarter of 2018.

Juno and Celgene both anticipate a regulatory submission and subsequent approval in 2019 for liso-cel as a treatment for patients with relapsed and/or refractory diffuse large B-cell lymphoma. Although not yet submitted, the companies believe liso-cel has the potential to be a "best-in-class" CAR T-cell therapy, allowing it to achieve $3 billion in peak sales.

In data from the TRANSCEND trial, which were presented at the 2017 ASH Annual Meeting, liso-cel induced an 81% objective response rate with a 63% complete remission rate in patients with relapsed/refractory DLBCL. At the 3-month assessment for the dose being used in an ongoing pivotal trial for liso-cel, the ORR was 74% with a CR rate of 68%. By month 6, the ORR and CR rates were both 50% in this group.

As part of the acquisition, Celgene reaffirmed its goal of $19 to $20 billion in product sales by 2020. In addition to liso-cel, Juno is also developing JCARH125, a CAR T-cell therapy targeted against B-cell maturation antigen for multiple myeloma.

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

This week, we sat down with Dr Judd Moul of Duke University School of Medicine to discuss the changing landscape of treatment for patients with nonmetastatic castration-resistant prostate cancer.

That's all for today.

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