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FDA Approval in CTCL, Breakthrough Therapy Designation in CRC, and More

Gina Columbus
Published: Monday, Aug 13, 2018



Today-

An FDA approval in cutaneous T-cell lymphoma, a breakthrough therapy designation in colorectal cancer, orphan drug status in small cell lung cancer, rolling submission of a new drug application in multiple myeloma, and a European approval in melanoma.

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

The FDA has approved mogamulizumab-kpkc, known by the trade name Poteligeo, for the treatment of patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy.

The decision is specific to patients with mycosis fungoides or Sézary syndrome, which are 2 subtypes of CTCL. The FDA based its decision on findings from the phase III MAVORIC study, which showed that mogamulizumab reduced the risk of progression or death by 47% versus vorinostat in previously treated patients.

Results also showed that the investigator-assessed median PFS was 7.7 months in the mogamulizumab arm versus 3.1 months in the vorinostat arm. By independent review, the median PFS was 6.7 versus 3.8 months, respectively. The PFS benefit with mogamulizumab was observed across patient subgroups.

Moreover, the overall response rate was 28% with mogamulizumab versus 4.8% with vorinostat. Among patients with MF and SS, the ORR was 21.0% vs 7.1% and 37.0% vs 2.3%, respectively. Mogamulizumab also improved ORR in patients with stage III disease at 22.7% versus 0, and stage IV disease at 36.5% versus 3.1%. Among those assigned to vorinostat who crossed over to mogamulizumab, the ORR was 30.1%.

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

In colorectal cancer, the FDA has granted a breakthrough therapy designation to the combination of encorafenib, binimetinib, and cetuximab for the treatment of patients with BRAF V600E–mutant metastatic disease following 1 or 2 prior lines of treatment in the metastatic setting.

The designation is based on data from the safety lead-in phase of the ongoing randomized phase III BEACON CRC trial. Results demonstrated a confirmed overall response rate of 48% and a 1-year overall survival rate of 62% with the regimen.

At 12.6 months’ follow-up, the median OS had not yet been reached. The median progression-free survival was 8 months and was consistent regardless of whether patients had received 1 or 2 prior treatment lines. Among patients who had received only 1 prior line of therapy, the ORR was 62%.

Based on the positive data from the safety lead-in phase, enrollment in the randomized portion of BEACON CRC is ongoing. In this part of the phase III study, patients are randomized to encorafenib/binimetinib plus cetuximab; encorafenib/cetuximab; or investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.

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

The FDA has granted lurbinectedin an orphan drug designation for the treatment of patients with small cell lung cancer.

Data with the marine-derived treatment were presented at the 2018 ASCO Annual meeting for an SCLC cohort from a phase II multicenter basket trial examining lurbinectedin across various solid tumors. The overall response rate was 39.3% in the SCLC cohort.

An additional 7 patients had stable disease for longer than or equal to 4 months for a clinical benefit rate of 50.8%, and another 14 patients had stable disease for less than 4 months, for a disease control rate of 73.8%. The median duration of response was 6.2 months.

The median PFS was 4.1 months. The PFS rate was 51.1% at 4 months and 36.3% at 6 months. The median OS was 11.8 months, and the OS rate was 79.3% at 6 months and 43.1% at 12 months.

The orphan drug program is intended to facilitate the development and review of novel therapies for the treatment of patients with rare diseases or conditions that affect fewer than 200,000 people in the United States.

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

In multiple myeloma, a rolling submission of an FDA new drug application was submitted for selinexor for the treatment of patients with penta-refractory multiple myeloma.

The NDA is based on data from part 2 of the phase IIb STORM trial, in which the XPO1 inhibitor induced an overall response rate of 25.4% in patients with penta-refractory multiple myeloma. There were 2 complete responses and 29 partial responses or very good partial responses, and the median duration of response was 4.4 months. Karyopharm intends to present full data from the phase IIb STORM trial at an upcoming oncology conference.

Previously reported data from part I of the study showed that selinexor achieved an ORR of 20.5% in 78 patients with quad- or penta-refractory myeloma.

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

The European Commission has approved nivolumab as an adjuvant treatment for adult patients with completely resected melanoma with lymph node involvement or metastatic disease, regardless of BRAF mutation status.

The approval was based on results from the randomized phase III CheckMate-238 trial, in which the recurrence-free survival rate at 18 months with nivolumab was 66.4% versus 52.7% for ipilimumab in patients with stage IIIB/C or IV disease. There was a 35% reduction in the risk of recurrence or death with the PD-1 inhibitor versus the CTLA-4 inhibitor.

Moreover, data showed that the median RFS had not yet been reached in either arm of the trial. The 12-month RFS rate with nivolumab was 70.5% versus 60.8% in the ipilimumab group. The median distant metastasis-free survival was not reached in either treatment group, with fewer events noted in the nivolumab arm.

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

This week, we sat down with Dr David Ilson, of Memorial Sloan Kettering Cancer Center, to discuss molecular testing in metastatic gastric and gastroesophageal junction 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 cutaneous T-cell lymphoma, a breakthrough therapy designation in colorectal cancer, orphan drug status in small cell lung cancer, rolling submission of a new drug application in multiple myeloma, and a European approval in melanoma.

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

The FDA has approved mogamulizumab-kpkc, known by the trade name Poteligeo, for the treatment of patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy.

The decision is specific to patients with mycosis fungoides or Sézary syndrome, which are 2 subtypes of CTCL. The FDA based its decision on findings from the phase III MAVORIC study, which showed that mogamulizumab reduced the risk of progression or death by 47% versus vorinostat in previously treated patients.

Results also showed that the investigator-assessed median PFS was 7.7 months in the mogamulizumab arm versus 3.1 months in the vorinostat arm. By independent review, the median PFS was 6.7 versus 3.8 months, respectively. The PFS benefit with mogamulizumab was observed across patient subgroups.

Moreover, the overall response rate was 28% with mogamulizumab versus 4.8% with vorinostat. Among patients with MF and SS, the ORR was 21.0% vs 7.1% and 37.0% vs 2.3%, respectively. Mogamulizumab also improved ORR in patients with stage III disease at 22.7% versus 0, and stage IV disease at 36.5% versus 3.1%. Among those assigned to vorinostat who crossed over to mogamulizumab, the ORR was 30.1%.

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

In colorectal cancer, the FDA has granted a breakthrough therapy designation to the combination of encorafenib, binimetinib, and cetuximab for the treatment of patients with BRAF V600E–mutant metastatic disease following 1 or 2 prior lines of treatment in the metastatic setting.

The designation is based on data from the safety lead-in phase of the ongoing randomized phase III BEACON CRC trial. Results demonstrated a confirmed overall response rate of 48% and a 1-year overall survival rate of 62% with the regimen.

At 12.6 months’ follow-up, the median OS had not yet been reached. The median progression-free survival was 8 months and was consistent regardless of whether patients had received 1 or 2 prior treatment lines. Among patients who had received only 1 prior line of therapy, the ORR was 62%.

Based on the positive data from the safety lead-in phase, enrollment in the randomized portion of BEACON CRC is ongoing. In this part of the phase III study, patients are randomized to encorafenib/binimetinib plus cetuximab; encorafenib/cetuximab; or investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.

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

The FDA has granted lurbinectedin an orphan drug designation for the treatment of patients with small cell lung cancer.

Data with the marine-derived treatment were presented at the 2018 ASCO Annual meeting for an SCLC cohort from a phase II multicenter basket trial examining lurbinectedin across various solid tumors. The overall response rate was 39.3% in the SCLC cohort.

An additional 7 patients had stable disease for longer than or equal to 4 months for a clinical benefit rate of 50.8%, and another 14 patients had stable disease for less than 4 months, for a disease control rate of 73.8%. The median duration of response was 6.2 months.

The median PFS was 4.1 months. The PFS rate was 51.1% at 4 months and 36.3% at 6 months. The median OS was 11.8 months, and the OS rate was 79.3% at 6 months and 43.1% at 12 months.

The orphan drug program is intended to facilitate the development and review of novel therapies for the treatment of patients with rare diseases or conditions that affect fewer than 200,000 people in the United States.

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

In multiple myeloma, a rolling submission of an FDA new drug application was submitted for selinexor for the treatment of patients with penta-refractory multiple myeloma.

The NDA is based on data from part 2 of the phase IIb STORM trial, in which the XPO1 inhibitor induced an overall response rate of 25.4% in patients with penta-refractory multiple myeloma. There were 2 complete responses and 29 partial responses or very good partial responses, and the median duration of response was 4.4 months. Karyopharm intends to present full data from the phase IIb STORM trial at an upcoming oncology conference.

Previously reported data from part I of the study showed that selinexor achieved an ORR of 20.5% in 78 patients with quad- or penta-refractory myeloma.

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

The European Commission has approved nivolumab as an adjuvant treatment for adult patients with completely resected melanoma with lymph node involvement or metastatic disease, regardless of BRAF mutation status.

The approval was based on results from the randomized phase III CheckMate-238 trial, in which the recurrence-free survival rate at 18 months with nivolumab was 66.4% versus 52.7% for ipilimumab in patients with stage IIIB/C or IV disease. There was a 35% reduction in the risk of recurrence or death with the PD-1 inhibitor versus the CTLA-4 inhibitor.

Moreover, data showed that the median RFS had not yet been reached in either arm of the trial. The 12-month RFS rate with nivolumab was 70.5% versus 60.8% in the ipilimumab group. The median distant metastasis-free survival was not reached in either treatment group, with fewer events noted in the nivolumab arm.

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

This week, we sat down with Dr David Ilson, of Memorial Sloan Kettering Cancer Center, to discuss molecular testing in metastatic gastric and gastroesophageal junction cancer.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
 
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Community Practice Connections™: Oncology Best Practice™ Decision Points in Advanced NSCLC: Assessing Treatment Options Beyond Disease ProgressionNov 30, 20181.0
Community Practice Connections™: Precision Medicine for Community Oncologists: Assessing the Role of Tumor-Testing Technologies in Cancer CareNov 30, 20181.0
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