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FDA Approval in Waldenstrom Macroglobulinemia, Priority Review and sNDA in Multiple Myeloma, and More

Gina Columbus
Published: Friday, Aug 31, 2018



Today-

An FDA approval in Waldenstrom macroglobulinemia, a priority review in multiple myeloma, a new drug application submitted in myeloma, European approvals of chimeric antigen receptor T-cell therapies, and a US Preventative Task Force screening recommendation in cervical cancer.

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

The FDA has approved ibrutinib for use in combination with rituximab as a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia.

The decision is based on data from the phase III iNNOVATE trial, in which the ibrutinib/rituximab combination lowered the risk of disease progression or death by 80% versus rituximab alone in patients.

At a median follow-up of 26.5 months, the median progression-free survival was not reached with the ibrutinib combination and was 20.3 months with rituximab alone. The 30-month PFS rates were 82% versus 28%, respectively.

The OS rate at 30 months was 94% versus 92% in the combination versus control arms, respectively. In the overall population, the ORR was 92% with the ibrutinib combination versus 47% with rituximab alone, and the major response was 72% versus 32%, respectively.

The combination may be considered a first- and second-line option for appropriate people diagnosed and living with Waldenström macroglobulinemia.

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The FDA has granted a priority review to a supplemental biologics license application for elotuzumab in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, which includes lenalidomide and a proteasome inhibitor.

The application was submitted based on the phase II ELOQUENT-3 trial, in which the addition of elotuzumab to pomalidomide and dexamethasone reduced the risk of disease progression or death by 46% versus pomalidomide and dexamethasone alone for patients with relapsed/refractory disease.

Results also showed that the median progression-free survival was 10.3 months with the elotuzumab regimen compared with 4.7 months with pomalidomide and dexamethasone. The PFS benefit associated with the elotuzumab regimen was similar, regardless of whether patients had received 2 to 3 prior lines of treatment or more than 4 lines of treatment.

Additionally, the objective response rate was 53% with elotuzumab versus 26% in the control arm. The rate of very good partial response or better was 20% versus 9%, with and without elotuzumab, respectively.

Under the Prescription Drug User Fee Act, the FDA is scheduled to decide on the application by December 27, 2018.

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Also in multiple myeloma, a supplemental new drug application was submitted to the FDA for a once-weekly dosing option of carfilzomib to use in combination with dexamethasone for patients with relapsed/refractory disease.

The sNDA is based on findings from the phase III ARROW study, in which carfilzomib administered once weekly at 70 mg per square meter with dexamethasone led to a prolonged progression-free survival versus the standard twice-weekly schedule in patients with relapsed/refractory multiple myeloma.

The findings showed a median PFS of 11.2 months with once weekly carfilzomib and dexamethasone compared with 7.6 months for the standard twice-weekly schedule of carfilzomib.

The overall response rate in patients in the once-weekly arm was 62.9% versus 40.8% in the twice-weekly arm. Additionally, 7% of patients in the once-weekly arm achieved a complete response or better versus 2% of patients who achieved a CR in the twice-weekly arm. ORR was a secondary endpoint, in addition to overall survival, and safety and tolerability.

The maximum tolerated dose of carfilzomib at 70 mg per square meter when given in combination with dexamethasone was established in the phase I/II CHAMPION-1 study, which was the first trial to explore the once-weekly schedule.

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

The first CAR-T cell therapies were recently approved for use in the European Union.

First, tisagenlecleucel was approved for the treatment of either adult patients with diffuse large B-cell lymphoma that is relapsed or refractory after 2 or more lines of systemic therapy, or patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse posttransplant, or in second or later relapse.

The approval in DLBCL was based on data from the phase II JULIET study, which showed that at a median follow-up of 14.1 months, tisagenlecleucel achieved an objective response rate of 52% in adult patients with relapsed/refractory DLBCL.

The ALL approval was based on data from the phase II ELIANA trial, which showed that at a median follow-up of 13.1 months, tisagenlecleucel induced an ORR of 81% in children and young adults with relapsed/refractory B-cell ALL.

Secondly, the European Commission approved axicabtagene ciloleucel as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma following at least 2 lines of systemic therapy.

The decision is based on data from the single-arm phase II ZUMA-1 trial. Results showed that axi-cel had an objective response rate of 82% and a complete remission rate of 54%. After 8.7 months of follow-up, 39% of patients remained in CR. The median duration of response in those with a CR was not reached at the time of the assessment. Moreover, the FDA label for the medication in the United States lists the ORR as 72% and the CR rate as 51%.

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

The US Preventive Services Task Force issued new guidelines recommending that women aged 30 to 65 years at average risk for cervical cancer can choose to receive a Pap smear alone every 3 years or screening with the high-risk human papillomavirus test alone or cotesting every 5 years.

Moreover, women aged 21 to 29 years should receive a Pap test every 3 years. This new guideline updates recommendations issued in 2012. This the first time the USPSTF has recommended hrHPV screening alone.

The USPSTF concluded that there are no clinically important differences between liquid-based cytology and conventional cytology.

These recommendations are intended for asymptomatic women regardless of sexual history or HPV vaccination status. As in the previous guideline, the Task Force recommends against screening for average-risk women younger than 21 years, older than 65 years who have had adequate prior screening, or women who have had a hysterectomy with removal of the cervix and do not have a history of high-grade precancerous lesions.

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

This week, we sat down with Dr Joyce A. O’Shaughnessy, of Baylor University Medical Center, to discuss the factors in selecting a CDK4/6 inhibitor in hormone receptor-positive breast 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 Waldenstrom macroglobulinemia, a priority review in multiple myeloma, a new drug application submitted in myeloma, European approvals of chimeric antigen receptor T-cell therapies, and a US Preventative Task Force screening recommendation in cervical cancer.

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

The FDA has approved ibrutinib for use in combination with rituximab as a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia.

The decision is based on data from the phase III iNNOVATE trial, in which the ibrutinib/rituximab combination lowered the risk of disease progression or death by 80% versus rituximab alone in patients.

At a median follow-up of 26.5 months, the median progression-free survival was not reached with the ibrutinib combination and was 20.3 months with rituximab alone. The 30-month PFS rates were 82% versus 28%, respectively.

The OS rate at 30 months was 94% versus 92% in the combination versus control arms, respectively. In the overall population, the ORR was 92% with the ibrutinib combination versus 47% with rituximab alone, and the major response was 72% versus 32%, respectively.

The combination may be considered a first- and second-line option for appropriate people diagnosed and living with Waldenström macroglobulinemia.

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

The FDA has granted a priority review to a supplemental biologics license application for elotuzumab in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, which includes lenalidomide and a proteasome inhibitor.

The application was submitted based on the phase II ELOQUENT-3 trial, in which the addition of elotuzumab to pomalidomide and dexamethasone reduced the risk of disease progression or death by 46% versus pomalidomide and dexamethasone alone for patients with relapsed/refractory disease.

Results also showed that the median progression-free survival was 10.3 months with the elotuzumab regimen compared with 4.7 months with pomalidomide and dexamethasone. The PFS benefit associated with the elotuzumab regimen was similar, regardless of whether patients had received 2 to 3 prior lines of treatment or more than 4 lines of treatment.

Additionally, the objective response rate was 53% with elotuzumab versus 26% in the control arm. The rate of very good partial response or better was 20% versus 9%, with and without elotuzumab, respectively.

Under the Prescription Drug User Fee Act, the FDA is scheduled to decide on the application by December 27, 2018.

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

Also in multiple myeloma, a supplemental new drug application was submitted to the FDA for a once-weekly dosing option of carfilzomib to use in combination with dexamethasone for patients with relapsed/refractory disease.

The sNDA is based on findings from the phase III ARROW study, in which carfilzomib administered once weekly at 70 mg per square meter with dexamethasone led to a prolonged progression-free survival versus the standard twice-weekly schedule in patients with relapsed/refractory multiple myeloma.

The findings showed a median PFS of 11.2 months with once weekly carfilzomib and dexamethasone compared with 7.6 months for the standard twice-weekly schedule of carfilzomib.

The overall response rate in patients in the once-weekly arm was 62.9% versus 40.8% in the twice-weekly arm. Additionally, 7% of patients in the once-weekly arm achieved a complete response or better versus 2% of patients who achieved a CR in the twice-weekly arm. ORR was a secondary endpoint, in addition to overall survival, and safety and tolerability.

The maximum tolerated dose of carfilzomib at 70 mg per square meter when given in combination with dexamethasone was established in the phase I/II CHAMPION-1 study, which was the first trial to explore the once-weekly schedule.

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

The first CAR-T cell therapies were recently approved for use in the European Union.

First, tisagenlecleucel was approved for the treatment of either adult patients with diffuse large B-cell lymphoma that is relapsed or refractory after 2 or more lines of systemic therapy, or patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse posttransplant, or in second or later relapse.

The approval in DLBCL was based on data from the phase II JULIET study, which showed that at a median follow-up of 14.1 months, tisagenlecleucel achieved an objective response rate of 52% in adult patients with relapsed/refractory DLBCL.

The ALL approval was based on data from the phase II ELIANA trial, which showed that at a median follow-up of 13.1 months, tisagenlecleucel induced an ORR of 81% in children and young adults with relapsed/refractory B-cell ALL.

Secondly, the European Commission approved axicabtagene ciloleucel as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma following at least 2 lines of systemic therapy.

The decision is based on data from the single-arm phase II ZUMA-1 trial. Results showed that axi-cel had an objective response rate of 82% and a complete remission rate of 54%. After 8.7 months of follow-up, 39% of patients remained in CR. The median duration of response in those with a CR was not reached at the time of the assessment. Moreover, the FDA label for the medication in the United States lists the ORR as 72% and the CR rate as 51%.

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

The US Preventive Services Task Force issued new guidelines recommending that women aged 30 to 65 years at average risk for cervical cancer can choose to receive a Pap smear alone every 3 years or screening with the high-risk human papillomavirus test alone or cotesting every 5 years.

Moreover, women aged 21 to 29 years should receive a Pap test every 3 years. This new guideline updates recommendations issued in 2012. This the first time the USPSTF has recommended hrHPV screening alone.

The USPSTF concluded that there are no clinically important differences between liquid-based cytology and conventional cytology.

These recommendations are intended for asymptomatic women regardless of sexual history or HPV vaccination status. As in the previous guideline, the Task Force recommends against screening for average-risk women younger than 21 years, older than 65 years who have had adequate prior screening, or women who have had a hysterectomy with removal of the cervix and do not have a history of high-grade precancerous lesions.

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

This week, we sat down with Dr Joyce A. O’Shaughnessy, of Baylor University Medical Center, to discuss the factors in selecting a CDK4/6 inhibitor in hormone receptor-positive breast cancer.

That’s all for today.

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