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FDA Approvals in Prostate Cancer and NSCLC, Priority Review in AML, ODAC Review in ALL, and More

Gina Columbus
Published: Friday, Feb 23, 2018



Today-

FDA approvals in prostate cancer and lung cancer, a priority review designation in AML, an ODAC review in ALL, and disappointing findings in a lung cancer trial.

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

The FDA has approved apalutamide, known by the trade name Erleada, for the treatment of patients with nonmetastatic castration-resistant prostate cancer. The drug is now the first FDA-approved treatment in this setting.

The decision is based on the phase III SPARTAN trial, in which apalutamide reduced the risk of metastasis or death by 72% compared with placebo in patients with nonmetastatic CRPC. The median metastasis-free survival was 40.5 months in the apalutamide arm versus 16.2 months in the placebo arm.

At a median follow-up of 20.3 months, 61% of those on the apalutamide arm remained on treatment compared with 30% of the placebo group. Additionally, an interim OS analysis revealed a trend favoring apalutamide.

The time between randomization to first treatment for metastatic CRPC and subsequent progression was longer for patients who were initially randomized to apalutamide.

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In non-small cell lung cancer, the FDA approved durvalumab for the treatment of patients with locally advanced, unresectable stage III disease who have not progressed following chemoradiotherapy.

This marks the first treatment approved for stage III unresectable NSCLC to reduce the risk of the cancer progressing when disease has not worsened after chemoradiation.

The regulatory decision is based on results of the phase III PACIFIC trial, in which the PD-L1 inhibitor durvalumab improved median progression-free survival by 11.2 months versus placebo. The 12-month progression-free survival rate was 55.9% versus 35.3%, and the 18-month PFS rate was 44.2% versus 27.0%, again favoring the durvalumab arm.

The PFS benefit associated with durvalumab was found to be consistent across all prespecified subgroups, and also held irrespective of PD-L1 expression before chemoradiotherapy.

Objective response rate was also significantly higher with durvalumab at 28.4% versus 16.0%. Of the patients who had a response to durvalumab, 72.8% had an ongoing response at both 12 and 18 months as compared with 56.1% and 46.8%, respectively, in the placebo arm.

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The FDA has granted a priority review designation to ivosidenib for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia.

The new drug application was based on findings from a phase I trial that was presented at the 2017 ASH Annual Meeting. In the single-arm trial, patients treated with the FDA-submitted 500 mg daily dose of ivosidenib had a complete response or CR with partial hematologic recovery rate of 30.4%, which lasted for a median duration of 8.2 months. Of those in CR, 28% were negative for minimal residual disease.

In addition to the new drug application, a premarket approval application was also submitted to the FDA for a companion diagnostic to detect IDH1 mutations, which occur in 6% to 10% of patients with AML. The assay, which is Abbott's m2000 RealTime System, is designed to automatically prepares samples and analyze batches for nucleic acid amplification and detection.

Under the Prescription Drug User Fee Act, the FDA will decide on the application for ivosidenib by August 21, 2018.

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The FDA's Oncologic Drugs Advisory Committee is expected to review a supplemental biologics license application for the use of blinatumomab for the treatment of patients with minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia on March 7, 2018.

A Prescription Drug User Fee Act target action date for the application is set for March 29. This is the first sBLA submitted for an MRD-positive indication.

Amgen, the manufacturer of blinatumomab, filed the application based on data from the phase II BLAST trial. In the results, 78% of evaluable patients had a complete MRD response after 1 cycle of treatment with blinatumomab. Two more patients achieved a complete MRD response after cycle 2. Among 5 patients with Philadelphia chromosome-positive disease who had MRD evaluations, 3 had an MRD response during cycle 1.

Investigators also found that complete MRD response was associated with significantly improved survival. Compared with nonresponders, patients who had complete MRD response had superior relapse-free survival at 23.6 vs 5.7 months and overall survival at 38.9 vs 12.5 months. Among the entire study population, the median OS was 36.5 months.

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The PD-L1 inhibitor avelumab missed the primary endpoint of improving overall survival in pretreated patients with non-small cell lung cancer, according to findings from the phase III JAVELIN Lung 200 Trial.

The PD-L1 inhibitor did not improve OS for patients with PD-L1-positive unresectable, recurrent or metastatic NSCLC compared with docetaxel in patients who had progressed on platinum-containing doublet chemotherapy. The results were announced by Merck KGaA and Pfizer, the co-developers of avelumab.

The proportion of patients in the chemotherapy arm crossing over to immune checkpoint inhibitors outside the study was higher than previously reported in post-platinum immunotherapy clinical trials, which the companies say may have confounded the outcome. More than one-quarter of patients in the docetaxel arm received subsequent checkpoint inhibitor therapy versus 5.7% in the avelumab arm.

Investigators noted improvements in OS versus the control arm in the 40% of patients with moderate-to-high PD-L1 expression and the 30% of the cohort with high PD-L1 expression.

The developers plan to release more detailed findings from JAVELIN Lung 200 at a future medical meeting and discuss the data with regulatory agencies.

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

This week, we sat down with Dr Josep Llovet, of Mount Sinai School of Medicine, to discuss the results of the CELESTIAL trial of second-line cabozantinib in hepatocellular carcinoma.

That's all for today.

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

FDA approvals in prostate cancer and lung cancer, a priority review designation in AML, an ODAC review in ALL, and disappointing findings in a lung cancer trial.

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

The FDA has approved apalutamide, known by the trade name Erleada, for the treatment of patients with nonmetastatic castration-resistant prostate cancer. The drug is now the first FDA-approved treatment in this setting.

The decision is based on the phase III SPARTAN trial, in which apalutamide reduced the risk of metastasis or death by 72% compared with placebo in patients with nonmetastatic CRPC. The median metastasis-free survival was 40.5 months in the apalutamide arm versus 16.2 months in the placebo arm.

At a median follow-up of 20.3 months, 61% of those on the apalutamide arm remained on treatment compared with 30% of the placebo group. Additionally, an interim OS analysis revealed a trend favoring apalutamide.

The time between randomization to first treatment for metastatic CRPC and subsequent progression was longer for patients who were initially randomized to apalutamide.

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

In non-small cell lung cancer, the FDA approved durvalumab for the treatment of patients with locally advanced, unresectable stage III disease who have not progressed following chemoradiotherapy.

This marks the first treatment approved for stage III unresectable NSCLC to reduce the risk of the cancer progressing when disease has not worsened after chemoradiation.

The regulatory decision is based on results of the phase III PACIFIC trial, in which the PD-L1 inhibitor durvalumab improved median progression-free survival by 11.2 months versus placebo. The 12-month progression-free survival rate was 55.9% versus 35.3%, and the 18-month PFS rate was 44.2% versus 27.0%, again favoring the durvalumab arm.

The PFS benefit associated with durvalumab was found to be consistent across all prespecified subgroups, and also held irrespective of PD-L1 expression before chemoradiotherapy.

Objective response rate was also significantly higher with durvalumab at 28.4% versus 16.0%. Of the patients who had a response to durvalumab, 72.8% had an ongoing response at both 12 and 18 months as compared with 56.1% and 46.8%, respectively, in the placebo arm.

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

The FDA has granted a priority review designation to ivosidenib for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia.

The new drug application was based on findings from a phase I trial that was presented at the 2017 ASH Annual Meeting. In the single-arm trial, patients treated with the FDA-submitted 500 mg daily dose of ivosidenib had a complete response or CR with partial hematologic recovery rate of 30.4%, which lasted for a median duration of 8.2 months. Of those in CR, 28% were negative for minimal residual disease.

In addition to the new drug application, a premarket approval application was also submitted to the FDA for a companion diagnostic to detect IDH1 mutations, which occur in 6% to 10% of patients with AML. The assay, which is Abbott's m2000 RealTime System, is designed to automatically prepares samples and analyze batches for nucleic acid amplification and detection.

Under the Prescription Drug User Fee Act, the FDA will decide on the application for ivosidenib by August 21, 2018.

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

The FDA's Oncologic Drugs Advisory Committee is expected to review a supplemental biologics license application for the use of blinatumomab for the treatment of patients with minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia on March 7, 2018.

A Prescription Drug User Fee Act target action date for the application is set for March 29. This is the first sBLA submitted for an MRD-positive indication.

Amgen, the manufacturer of blinatumomab, filed the application based on data from the phase II BLAST trial. In the results, 78% of evaluable patients had a complete MRD response after 1 cycle of treatment with blinatumomab. Two more patients achieved a complete MRD response after cycle 2. Among 5 patients with Philadelphia chromosome-positive disease who had MRD evaluations, 3 had an MRD response during cycle 1.

Investigators also found that complete MRD response was associated with significantly improved survival. Compared with nonresponders, patients who had complete MRD response had superior relapse-free survival at 23.6 vs 5.7 months and overall survival at 38.9 vs 12.5 months. Among the entire study population, the median OS was 36.5 months.

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

The PD-L1 inhibitor avelumab missed the primary endpoint of improving overall survival in pretreated patients with non-small cell lung cancer, according to findings from the phase III JAVELIN Lung 200 Trial.

The PD-L1 inhibitor did not improve OS for patients with PD-L1-positive unresectable, recurrent or metastatic NSCLC compared with docetaxel in patients who had progressed on platinum-containing doublet chemotherapy. The results were announced by Merck KGaA and Pfizer, the co-developers of avelumab.

The proportion of patients in the chemotherapy arm crossing over to immune checkpoint inhibitors outside the study was higher than previously reported in post-platinum immunotherapy clinical trials, which the companies say may have confounded the outcome. More than one-quarter of patients in the docetaxel arm received subsequent checkpoint inhibitor therapy versus 5.7% in the avelumab arm.

Investigators noted improvements in OS versus the control arm in the 40% of patients with moderate-to-high PD-L1 expression and the 30% of the cohort with high PD-L1 expression.

The developers plan to release more detailed findings from JAVELIN Lung 200 at a future medical meeting and discuss the data with regulatory agencies.

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

This week, we sat down with Dr Josep Llovet, of Mount Sinai School of Medicine, to discuss the results of the CELESTIAL trial of second-line cabozantinib in hepatocellular carcinoma.

That's all for today.

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