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FDA Approval in Carcinoid Syndrome Diarrhea, Priority Reviews in Bladder Cancer and NSCLC, and More

Gina Columbus
Published: Thursday, Mar 02, 2017



Today, an FDA approval for carcinoid syndrome diarrhea, FDA priority reviews in bladder cancer and lung cancer, a survival benefit in myeloma, and updates from the 2017 ASCO-SITC and BMT Tandem Meetings.

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

The FDA has approved telotristat ethyl for use in combination with somatostatin analog as a treatment for carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors that cannot be adequately controlled by SSA therapy alone.

The safety and efficacy of telotristat ethyl were established in a 12-week, double-blind, placebo-controlled trial in 90 adult participants with well-differentiated metastatic NETs and carcinoid syndrome diarrhea. Despite the use of SSA at a stable dose for at least 3 months, the patients continued to have 4 to 12 daily bowel movements.

Patients continued SSA therapy and were randomized to telotristat ethyl or placebo 3 times daily. In the telotristat ethyl arm, 33% of patients had an average reduction of 2 bowel movements per day compared with 4% of patients on the placebo arm.

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The FDA granted a priority review to a biologics license application for the PD-L1 inhibitor avelumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed after platinum-based therapy.

Under the Prescription Drug User Fee Act, the FDA will make a final approval decision on the application on or before August 27, 2017.

The priority review is based on data from the JAVELIN international development program of avelumab. In the JAVELIN solid tumor phase Ib trial, avelumab had a response rate of 16% in a cohort of patients with metastatic urothelial carcinoma, including 1 complete response and 6 partial responses.

The median duration of treatment was 13 weeks, and the median number of doses administered was 6.5. Median follow-up was 3.5 months. Sixteen patients remained on treatment.

The ongoing phase III JAVELIN Bladder 100 trial is evaluating avelumab in the first-line setting as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma.

The FDA is also currently reviewing an application for avelumab for use as a treatment for patients with metastatic Merkel cell carcinoma.

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The FDA has also granted a priority review to the second-generation ALK inhibitor ceritinib as a first-line treatment for patients with ALK-positive, metastatic non–small cell lung cancer.

The priority review is based on findings from the phase III ASCEND-4 trial, in which ceritinib reduced the risk of disease progression or death by 45% compared with standard chemotherapy. The median progression-free survival benefit favoring ceritinib was 8.5 months.

The FDA also granted frontline ceritinib a breakthrough therapy designation for use in patients with ALK-positive NSCLC and brain metastases. Under the priority review, the application for frontline ceritinib will be reviewed within 6 months of submission, instead of the standard 10-month timeframe.

Ceritinib was previously approved by the FDA in April 2014 for patients with ALK-positive NSCLC following treatment with the ALK inhibitor crizotinib.

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In multiple myeloma, carfilzomib plus dexamethasone improved overall survival by 21% versus dexamethasone plus bortezomib in patients with relapsed or refractory disease, according to findings from the phase III ENDEAVOR trial.

The median OS was 47.6 months in the carfilzomib arm versus 40 months in bortezomib arm. The safety data were consistent with previously reported study outcomes.

The full updated results from the trial will be presented at the 16th International Myeloma Workshop.

Based on the progression-free survival data from the primary analysis, the FDA approved carfilzomib in January 2016 for use in combination with dexamethasone or with lenalidomide plus dexamethasone for patients with relapsed/refractory multiple myeloma following prior treatment with 1 to 3 lines of therapy.


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The 2017 ASCO-SITC Clinical Immuno-Oncology Symposium was recently held in Orlando, Florida. One of the noteworthy abstracts presented showed that treatment with pembrolizumab could elicit long-term survival rates of 21% to 25% for previously-treated patients with PD-L1–positive non–small cell lung cancer compared with 3% to 4% for docetaxel, according to a statistical analysis of findings from the KEYNOTE-010 and -001 trials.

Findings from the analysis shed light on the number of patients with advanced NSCLC expected to benefit for up to 70 months from pembrolizumab. According to survival statistics from the SEER database for 2006 to 2012, the 5-year survival rate was 4.3% for those with lung or bronchus cancer with distant metastases.


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And finally, the 2017 BMT Tandem Meetings took place from February 22 to 26 at the Gaylord Palms Convention Center in Orlando, Florida. In one of the key studies presented at the meeting the anti-CD19 CAR T-cell therapy axicabtagene ciloleucel, or KTE-C19, had an objective response rate of 76% and a complete response rate of 47% in patients with aggressive non-Hodgkin lymphoma followed for at least 1 month, according to a prespecified interim analysis of the phase II portion of the ZUMA-1 trial.

The durable complete response rate at 3 months was 39%, which was 6-fold higher than that in historical controls.

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

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
 
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Today, an FDA approval for carcinoid syndrome diarrhea, FDA priority reviews in bladder cancer and lung cancer, a survival benefit in myeloma, and updates from the 2017 ASCO-SITC and BMT Tandem Meetings.

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

The FDA has approved telotristat ethyl for use in combination with somatostatin analog as a treatment for carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors that cannot be adequately controlled by SSA therapy alone.

The safety and efficacy of telotristat ethyl were established in a 12-week, double-blind, placebo-controlled trial in 90 adult participants with well-differentiated metastatic NETs and carcinoid syndrome diarrhea. Despite the use of SSA at a stable dose for at least 3 months, the patients continued to have 4 to 12 daily bowel movements.

Patients continued SSA therapy and were randomized to telotristat ethyl or placebo 3 times daily. In the telotristat ethyl arm, 33% of patients had an average reduction of 2 bowel movements per day compared with 4% of patients on the placebo arm.

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

The FDA granted a priority review to a biologics license application for the PD-L1 inhibitor avelumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed after platinum-based therapy.

Under the Prescription Drug User Fee Act, the FDA will make a final approval decision on the application on or before August 27, 2017.

The priority review is based on data from the JAVELIN international development program of avelumab. In the JAVELIN solid tumor phase Ib trial, avelumab had a response rate of 16% in a cohort of patients with metastatic urothelial carcinoma, including 1 complete response and 6 partial responses.

The median duration of treatment was 13 weeks, and the median number of doses administered was 6.5. Median follow-up was 3.5 months. Sixteen patients remained on treatment.

The ongoing phase III JAVELIN Bladder 100 trial is evaluating avelumab in the first-line setting as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma.

The FDA is also currently reviewing an application for avelumab for use as a treatment for patients with metastatic Merkel cell carcinoma.

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

The FDA has also granted a priority review to the second-generation ALK inhibitor ceritinib as a first-line treatment for patients with ALK-positive, metastatic non–small cell lung cancer.

The priority review is based on findings from the phase III ASCEND-4 trial, in which ceritinib reduced the risk of disease progression or death by 45% compared with standard chemotherapy. The median progression-free survival benefit favoring ceritinib was 8.5 months.

The FDA also granted frontline ceritinib a breakthrough therapy designation for use in patients with ALK-positive NSCLC and brain metastases. Under the priority review, the application for frontline ceritinib will be reviewed within 6 months of submission, instead of the standard 10-month timeframe.

Ceritinib was previously approved by the FDA in April 2014 for patients with ALK-positive NSCLC following treatment with the ALK inhibitor crizotinib.

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

In multiple myeloma, carfilzomib plus dexamethasone improved overall survival by 21% versus dexamethasone plus bortezomib in patients with relapsed or refractory disease, according to findings from the phase III ENDEAVOR trial.

The median OS was 47.6 months in the carfilzomib arm versus 40 months in bortezomib arm. The safety data were consistent with previously reported study outcomes.

The full updated results from the trial will be presented at the 16th International Myeloma Workshop.

Based on the progression-free survival data from the primary analysis, the FDA approved carfilzomib in January 2016 for use in combination with dexamethasone or with lenalidomide plus dexamethasone for patients with relapsed/refractory multiple myeloma following prior treatment with 1 to 3 lines of therapy.


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

The 2017 ASCO-SITC Clinical Immuno-Oncology Symposium was recently held in Orlando, Florida. One of the noteworthy abstracts presented showed that treatment with pembrolizumab could elicit long-term survival rates of 21% to 25% for previously-treated patients with PD-L1–positive non–small cell lung cancer compared with 3% to 4% for docetaxel, according to a statistical analysis of findings from the KEYNOTE-010 and -001 trials.

Findings from the analysis shed light on the number of patients with advanced NSCLC expected to benefit for up to 70 months from pembrolizumab. According to survival statistics from the SEER database for 2006 to 2012, the 5-year survival rate was 4.3% for those with lung or bronchus cancer with distant metastases.


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

And finally, the 2017 BMT Tandem Meetings took place from February 22 to 26 at the Gaylord Palms Convention Center in Orlando, Florida. In one of the key studies presented at the meeting the anti-CD19 CAR T-cell therapy axicabtagene ciloleucel, or KTE-C19, had an objective response rate of 76% and a complete response rate of 47% in patients with aggressive non-Hodgkin lymphoma followed for at least 1 month, according to a prespecified interim analysis of the phase II portion of the ZUMA-1 trial.

The durable complete response rate at 3 months was 39%, which was 6-fold higher than that in historical controls.

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

That’s all for today.

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