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FDA Approvals in NHL and CINV, Priority Reviews in Melanoma and Breast Cancer, and More

Gina Columbus
Published: Friday, Oct 27, 2017



Today-

FDA approvals of a CAR T-cell therapy in non-Hodgkin lymphoma and an agent to treat delayed chemotherapy-induced nausea and vomiting, priority review designations in melanoma and breast cancer, a breakthrough therapy designation in melanoma, and impressive findings in a multiple myeloma trial.

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

The FDA has approved the CD19-directed chimeric antigen receptor T-cell therapy axicabtagene ciloleucel, known by the trade name Yescarta, as a treatment for adults with relapsed or refractory non-Hodgkin lymphoma. Axi-cel is the second CAR T-cell therapy approved by the FDA, with the first approval arriving in late August for patients with acute lymphoblastic leukemia.

The approval, which is based on complete remission rates in the phase II ZUMA-1 trial, is specifically for those with large B-cell lymphoma following 2 prior therapies, including for those with diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma.

In the ZUMA-1 study, axi-cel demonstrated an objective response rate of 82% and a CR 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. Axi-cel’s label for the medication lists the ORR as 72% and the CR rate as 51%.

The manufacturer Kite Pharma, which was recently acquired by Gilead, plans to market axi-cel at a list price of $373,000.

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The FDA has approved intravenous rolapitant for use in combination with other antiemetic agents to treat delayed chemotherapy-induced nausea and vomiting in adults.

The IV approval was based on a bioequivalence trial that showed the comparability of the IV formulation with a previously approved oral formulation. Other than infusion-site reactions with IV rolapitant, the safety profile in the study was consistent to previous trial findings with the oral formulation.

Delayed nausea and vomiting occurs between 25 and 120 hours after chemotherapy. The FDA previously approved oral rolapitant for this indication in September 2015, a decision that was based on 3 phase III clinical trials.

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The FDA has granted a priority review to a supplemental biologics license application for nivolumab to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.

The decision is based on results from the CheckMate-238 trial, in which nivolumab significantly improved relapse-free survival versus standard ipilimumab in patients with resected stage IIIB/C and IV melanoma. Previously, the FDA granted a breakthrough designation for nivolumab in this setting.

In the study, results showed that at a minimum follow-up of 18 months, the 12-month RFS rate was 70.5% in the nivolumab group versus 60.8% in the ipilimumab group.

Among the patients with PD-L1 expression less than 5%, the 12-month RFS rate was 64.3% in the nivolumab group and 53.7% in the ipilimumab group. Among those with PD-L1 expression at more than 5%, the 12-month RFS rate was 81.9% in the nivolumab arm and 73.8% in the ipilimumab arm.

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In breast cancer, the FDA has granted a priority review to a supplemental new drug application for olaparib for the treatment of patients with germline BRCA-positive, HER2-negative metastatic disease who have previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic settings.

The application is based on findings from the phase III OlympiAD trial, which showed that the PARP inhibitor olaparib reduced the risk of disease progression or death by 42% and improved progression-free survival by 2.8 months versus standard chemotherapy in previously treated patients with BRCA-positive, HER2-negative disease.

Additionally, the median progression-free survival was 7.0 months in the olaparib arm versus 4.2 months with standard chemotherapy. At 12 months, 25.9% of the patients in the olaparib group and 15.0% of the patients in the standard-therapy group were free from progression or death.

A Prescription Drug User Fee Act date for a final FDA decision is set for early next year.

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In melanoma, the FDA has awarded the adjuvant combination of dabrafenib and trametinib a breakthrough therapy designation for the treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection.

If approved, the combination would be the first adjuvant treatment specifically aimed at this patient population.

Novartis, the manufacturer of the regimen, submitted phase III results to the FDA from COMBI-AD, a double-blind, placebo-controlled trial of patients with completely resected, stage III melanoma with BRAF V600E or V600K mutations.

Results showed that the combination therapy reduced the risk of disease recurrence or death by 53% versus placebo. The estimated 3-year relapse-free survival rate was 58% for the combination versus 39% for placebo. Median RFS was not reached in the combination arm versus 16.6 months with placebo.

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

Phase III results from the ARROW trial demonstrated that higher-dose, once-weekly treatment with carfilzomib demonstrated superior efficacy for patients with relapsed/refractory multiple myeloma versus a lower-dose, twice-weekly regimen.

Progression-free survival was 3.6 months longer for patients assigned to once-weekly carfilzomib at 70 mg/m2 with dexamethasone compared with those assigned to a twice-weekly 27 mg/m2 dose with dexamethasone.

The most frequently reported treatment-emergent adverse events in either treatment arm were anemia, diarrhea, fatigue, hypertension, insomnia, and pyrexia.

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

This week, we sat down with Dr Daniel George of Duke Cancer Institute to discuss the CheckMate-214 findings of nivolumab combined with ipilimumab in metastatic renal cell carcinoma.

That’s all for today.

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

FDA approvals of a CAR T-cell therapy in non-Hodgkin lymphoma and an agent to treat delayed chemotherapy-induced nausea and vomiting, priority review designations in melanoma and breast cancer, a breakthrough therapy designation in melanoma, and impressive findings in a multiple myeloma trial.

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

The FDA has approved the CD19-directed chimeric antigen receptor T-cell therapy axicabtagene ciloleucel, known by the trade name Yescarta, as a treatment for adults with relapsed or refractory non-Hodgkin lymphoma. Axi-cel is the second CAR T-cell therapy approved by the FDA, with the first approval arriving in late August for patients with acute lymphoblastic leukemia.

The approval, which is based on complete remission rates in the phase II ZUMA-1 trial, is specifically for those with large B-cell lymphoma following 2 prior therapies, including for those with diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma.

In the ZUMA-1 study, axi-cel demonstrated an objective response rate of 82% and a CR 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. Axi-cel’s label for the medication lists the ORR as 72% and the CR rate as 51%.

The manufacturer Kite Pharma, which was recently acquired by Gilead, plans to market axi-cel at a list price of $373,000.

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

The FDA has approved intravenous rolapitant for use in combination with other antiemetic agents to treat delayed chemotherapy-induced nausea and vomiting in adults.

The IV approval was based on a bioequivalence trial that showed the comparability of the IV formulation with a previously approved oral formulation. Other than infusion-site reactions with IV rolapitant, the safety profile in the study was consistent to previous trial findings with the oral formulation.

Delayed nausea and vomiting occurs between 25 and 120 hours after chemotherapy. The FDA previously approved oral rolapitant for this indication in September 2015, a decision that was based on 3 phase III clinical trials.

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

The FDA has granted a priority review to a supplemental biologics license application for nivolumab to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.

The decision is based on results from the CheckMate-238 trial, in which nivolumab significantly improved relapse-free survival versus standard ipilimumab in patients with resected stage IIIB/C and IV melanoma. Previously, the FDA granted a breakthrough designation for nivolumab in this setting.

In the study, results showed that at a minimum follow-up of 18 months, the 12-month RFS rate was 70.5% in the nivolumab group versus 60.8% in the ipilimumab group.

Among the patients with PD-L1 expression less than 5%, the 12-month RFS rate was 64.3% in the nivolumab group and 53.7% in the ipilimumab group. Among those with PD-L1 expression at more than 5%, the 12-month RFS rate was 81.9% in the nivolumab arm and 73.8% in the ipilimumab arm.

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

In breast cancer, the FDA has granted a priority review to a supplemental new drug application for olaparib for the treatment of patients with germline BRCA-positive, HER2-negative metastatic disease who have previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic settings.

The application is based on findings from the phase III OlympiAD trial, which showed that the PARP inhibitor olaparib reduced the risk of disease progression or death by 42% and improved progression-free survival by 2.8 months versus standard chemotherapy in previously treated patients with BRCA-positive, HER2-negative disease.

Additionally, the median progression-free survival was 7.0 months in the olaparib arm versus 4.2 months with standard chemotherapy. At 12 months, 25.9% of the patients in the olaparib group and 15.0% of the patients in the standard-therapy group were free from progression or death.

A Prescription Drug User Fee Act date for a final FDA decision is set for early next year.

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

In melanoma, the FDA has awarded the adjuvant combination of dabrafenib and trametinib a breakthrough therapy designation for the treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection.

If approved, the combination would be the first adjuvant treatment specifically aimed at this patient population.

Novartis, the manufacturer of the regimen, submitted phase III results to the FDA from COMBI-AD, a double-blind, placebo-controlled trial of patients with completely resected, stage III melanoma with BRAF V600E or V600K mutations.

Results showed that the combination therapy reduced the risk of disease recurrence or death by 53% versus placebo. The estimated 3-year relapse-free survival rate was 58% for the combination versus 39% for placebo. Median RFS was not reached in the combination arm versus 16.6 months with placebo.

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

Phase III results from the ARROW trial demonstrated that higher-dose, once-weekly treatment with carfilzomib demonstrated superior efficacy for patients with relapsed/refractory multiple myeloma versus a lower-dose, twice-weekly regimen.

Progression-free survival was 3.6 months longer for patients assigned to once-weekly carfilzomib at 70 mg/m2 with dexamethasone compared with those assigned to a twice-weekly 27 mg/m2 dose with dexamethasone.

The most frequently reported treatment-emergent adverse events in either treatment arm were anemia, diarrhea, fatigue, hypertension, insomnia, and pyrexia.

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

This week, we sat down with Dr Daniel George of Duke Cancer Institute to discuss the CheckMate-214 findings of nivolumab combined with ipilimumab in metastatic renal cell carcinoma.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
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Community Practice Connections™: Personalized Sequencing in Castration-Resistant Prostate Cancer: Bridging the Latest Evidence to the Bedside in Clinical ManagementAug 25, 20181.5
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