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Priority Review Designation in Cervical Cancer, ODAC Recommendation in ALL, and More

Gina Columbus
Published: Monday, Mar 19, 2018



Today-

A priority review designation in cervical cancer, an ODAC recommendation in acute lymphoblastic leukemia, a clinical hold in cervical and head and neck cancer, and an addition to the NCCN Prostate Cancer Guidelines.

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

The FDA has granted a priority review to a supplemental biologics license application for pembrolizumab for the treatment of advanced cervical cancer with disease progression on or after chemotherapy. This is the first time the FDA has given a priority review to an anti–PD-1 therapy in this disease.

Merck, the developer of pembrolizumab, filed the application based on results from the phase II KEYNOTE-158 trial. The ongoing global, open-label, nonrandomized, multicohort, multicenter study is evaluating pembrolizumab in patients with multiple types of advanced solid tumors who have progressed on standard therapy.

Preliminary data showed that the objective response rate was 12% among the first 82 patients in the advanced cervical squamous cell cancer cohort, with 3 complete responses and 7 partial responses. All 10 responses were ongoing at the data cutoff, 17 patients had stable disease, and 44 had progressive disease.

The ORR was 14% among 71 patients with PD-L1–positive tumors, with 3 complete responses and 7 partial responses. None of the 9 PD-L1–negative patients responded to treatment.

Under the Prescription Drug User Fee Act, the FDA must decide on the approval on or before June 28, 2018.

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In acute lymphoblastic leukemia, blinatumomab received an 8 to 4 vote from the FDA’s Oncologic Drugs Advisory Committee in favor of an indication for the treatment of minimal residual disease-positive B-cell precursor disease.

The FDA will now make its final decision on the blinatumomab indication, with an action date set under the Prescription Drug User Fee Act of March 29, 2018.

At the meeting, ODAC sought to determine whether more than 0.1% MRD was a valid cutoff describing a subpopulation of patients with ALL in complete remission who have a need for pre-emptive therapy. Following that, ODAC voted to determine whether, in the greater than 0.1% MRD-positive population, the benefits of blinatumomab outweighed the risks.

Data were submitted were from the phase II BLAST study. BLAST was a single-arm trial of up to 4 cycles of blinatumomab for treatment of patients with B-cell precursor ALL in complete remissiom or CR with partial platelet recovery and MRD greater than 0.1%.

Of 116 patients who received at least 1 dose of blinatumomab, the FDA identified 87 in CR with hematologic recovery and baseline MRD of more than 0.1%, including 61 patients in CR1, 25 in CR2 and 1 in CR3. Sixty-nine patients achieved a complete MRD response within the first cycle.

Although the panel voted to recommend approval, there was no consensus on the appropriate MRD cutoff for treatment intervention.

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

The FDA has put a clinical hold on a phase I/II study of axalimogene filolisbac, also known as AXAL, plus durvalumab for the treatment of patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck squamous cell carcinoma.

AXAL is a targeted Listeria monocytogenes-based immunotherapy that attacks HPV-associated cancers. The FDA cited a safety report regarding a patient who died February 27, 2018, of respiratory failure following the sixth combination cycle in the trial.

Preliminary results from the phase I/II trial put on hold included 11 patients enrolled in phase I of the 2-stage study, at the time of presentation. One patient with cervical cancer achieved a complete response, which remained ongoing after 12 months of follow-up. Another patient with cervical cancer achieved a partial response with subsequent disease progression.

Additionally, 2 patients with HNSCC had stable disease. Treatment-related adverse events were reported in 91% of patients, though most were either grade 1/2 events such as chills, fever, nausea and hypotension. Three patients experienced grade 3 TRAEs, and 1 patient experienced a grade 4 event.

Enrollment and dosing in all other clinical programs by Advaxis, the manufacturer of AXAL, are unaffected.

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

The NCCN now lists apalutamide as a category 1 recommendation for the treatment of patients with nonmetastatic castration-resistant prostate cancer.

In treatment guidelines issued March 8, 2018, the NCCN included the next-generation androgen receptor inhibitor as a treatment option for patients with M0 disease, especially in those for whom prostate-specific antigen doubling time is less than 10 months.

The FDA approved apalutamide in February 2018 for the treatment of patients with nonmetastatic CRPC. The decision was based on results from the international, placebo-controlled randomized, phase III SPARTAN trial in which apalutamide reduced the risk of metastasis or death by 72% 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.

The median time to metastasis was 40.5 months in the apalutamide arm compared with 16.6 months for placebo and the median progression-free survival was 40.5 months compared with 14.7 months for placebo.

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

This week, we sat down with Dr Andrew Chi, of NYU Langone Health, to discuss the efficacy of checkpoint inhibition in glioblastoma.

That’s all for today.

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

A priority review designation in cervical cancer, an ODAC recommendation in acute lymphoblastic leukemia, a clinical hold in cervical and head and neck cancer, and an addition to the NCCN Prostate Cancer Guidelines.

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

The FDA has granted a priority review to a supplemental biologics license application for pembrolizumab for the treatment of advanced cervical cancer with disease progression on or after chemotherapy. This is the first time the FDA has given a priority review to an anti–PD-1 therapy in this disease.

Merck, the developer of pembrolizumab, filed the application based on results from the phase II KEYNOTE-158 trial. The ongoing global, open-label, nonrandomized, multicohort, multicenter study is evaluating pembrolizumab in patients with multiple types of advanced solid tumors who have progressed on standard therapy.

Preliminary data showed that the objective response rate was 12% among the first 82 patients in the advanced cervical squamous cell cancer cohort, with 3 complete responses and 7 partial responses. All 10 responses were ongoing at the data cutoff, 17 patients had stable disease, and 44 had progressive disease.

The ORR was 14% among 71 patients with PD-L1–positive tumors, with 3 complete responses and 7 partial responses. None of the 9 PD-L1–negative patients responded to treatment.

Under the Prescription Drug User Fee Act, the FDA must decide on the approval on or before June 28, 2018.

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

In acute lymphoblastic leukemia, blinatumomab received an 8 to 4 vote from the FDA’s Oncologic Drugs Advisory Committee in favor of an indication for the treatment of minimal residual disease-positive B-cell precursor disease.

The FDA will now make its final decision on the blinatumomab indication, with an action date set under the Prescription Drug User Fee Act of March 29, 2018.

At the meeting, ODAC sought to determine whether more than 0.1% MRD was a valid cutoff describing a subpopulation of patients with ALL in complete remission who have a need for pre-emptive therapy. Following that, ODAC voted to determine whether, in the greater than 0.1% MRD-positive population, the benefits of blinatumomab outweighed the risks.

Data were submitted were from the phase II BLAST study. BLAST was a single-arm trial of up to 4 cycles of blinatumomab for treatment of patients with B-cell precursor ALL in complete remissiom or CR with partial platelet recovery and MRD greater than 0.1%.

Of 116 patients who received at least 1 dose of blinatumomab, the FDA identified 87 in CR with hematologic recovery and baseline MRD of more than 0.1%, including 61 patients in CR1, 25 in CR2 and 1 in CR3. Sixty-nine patients achieved a complete MRD response within the first cycle.

Although the panel voted to recommend approval, there was no consensus on the appropriate MRD cutoff for treatment intervention.

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

The FDA has put a clinical hold on a phase I/II study of axalimogene filolisbac, also known as AXAL, plus durvalumab for the treatment of patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck squamous cell carcinoma.

AXAL is a targeted Listeria monocytogenes-based immunotherapy that attacks HPV-associated cancers. The FDA cited a safety report regarding a patient who died February 27, 2018, of respiratory failure following the sixth combination cycle in the trial.

Preliminary results from the phase I/II trial put on hold included 11 patients enrolled in phase I of the 2-stage study, at the time of presentation. One patient with cervical cancer achieved a complete response, which remained ongoing after 12 months of follow-up. Another patient with cervical cancer achieved a partial response with subsequent disease progression.

Additionally, 2 patients with HNSCC had stable disease. Treatment-related adverse events were reported in 91% of patients, though most were either grade 1/2 events such as chills, fever, nausea and hypotension. Three patients experienced grade 3 TRAEs, and 1 patient experienced a grade 4 event.

Enrollment and dosing in all other clinical programs by Advaxis, the manufacturer of AXAL, are unaffected.

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

The NCCN now lists apalutamide as a category 1 recommendation for the treatment of patients with nonmetastatic castration-resistant prostate cancer.

In treatment guidelines issued March 8, 2018, the NCCN included the next-generation androgen receptor inhibitor as a treatment option for patients with M0 disease, especially in those for whom prostate-specific antigen doubling time is less than 10 months.

The FDA approved apalutamide in February 2018 for the treatment of patients with nonmetastatic CRPC. The decision was based on results from the international, placebo-controlled randomized, phase III SPARTAN trial in which apalutamide reduced the risk of metastasis or death by 72% 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.

The median time to metastasis was 40.5 months in the apalutamide arm compared with 16.6 months for placebo and the median progression-free survival was 40.5 months compared with 14.7 months for placebo.

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

This week, we sat down with Dr Andrew Chi, of NYU Langone Health, to discuss the efficacy of checkpoint inhibition in glioblastoma.

That’s all for today.

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