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FDA Approval in Myeloma, Breakthrough Designations in RCC and Aplastic Anemia, and More

Gina Columbus
Published: Wednesday, Jan 17, 2018



The FDA has approved denosumab for the prevention of skeletal-related events in patients with multiple myeloma.

The approval of the RANK ligand inhibitor is based on data from the phase III 482 study, which were presented at the 16th International Myeloma Workshop. In the trial, denosumab demonstrated noninferiority to zoledronic acid at delaying the time to the first SRE in patients with multiple myeloma.

The median time to first on-study SRE was similar between the treatments at 22.83 months with denosumab versus 23.98 months with the bisphosphonate zoledronic acid. The median progression-free survival was 10.7 months higher in the denosumab arm. There was also a nonstatistically significant trend in overall survival favoring denosumab.

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In renal cell carcinoma, the FDA has granted a breakthrough therapy designation to the combination of pembrolizumab and lenvatinib for patients with advanced or metastatic disease.

The designation was based on the results of the RCC cohort in Study 111, which was a multicenter, open-label phase Ib/II clinical trial conducted in the United States and the European Union to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab in subjects with selected solid tumors.

The phase Ib portion was designed to evaluate the maximum-tolerated dose of the regimen. The phase II part was conducted in patients who had select solid tumors with 0 to 2 prior lines of systemic therapy with a recommended dosage of 20 mg of lenvatinib daily and 200 mg of pembrolizumab every 3 weeks as determined based on the results of the phase Ib part.

In pooled results from the trial presented at the 2017 ESMO Congress, patients treated with the combination had an objective response rate of 63.3%, and the median progression-free survival was not yet reached.

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The FDA has granted a breakthrough therapy designation to eltrombopag for use in combination with standard immunosuppressive therapy as a first-line treatment for patients with severe aplastic anemia.

Eltrombopag is already approved in the United States for the treatment of patients with SAA who have had an insufficient response to immunosuppressive therapy.

The designation is based on results from research conducted by the National Heart, Lung and Blood Institute of the National Institutes of Health. Investigators found that eltrombopag, which is a small molecule thrombopoietin receptor agonist, administered concurrently with standard immunosuppressive treatment, was associated with a 52% complete response rate in treatment-naïve patients at 6 months. The overall response rate was 85%.

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In melanoma, results of the phase III KEYNOTE-054 trial found that adjuvant treatment with pembrolizumab reduced the risk of recurrence by 43% in patients with stage III resected high-risk disease.

The hazard ratio for recurrence-free survival was 0.57 for pembrolizumab versus placebo. There were no new safety concerns in the double-blind KEYNOTE-054 trial compared with outcomes reported in previous studies of the PD-1 inhibitor. This study included 1019 patients with resected high-risk melanoma.

The study remains ongoing so that investigators can evaluate additional key endpoints, such as overall survival. Merck, the manufacturer of pembrolizumab, reported in a press release that the full results from the trial will be shared at an upcoming medical meeting and submitted to regulatory authorities.

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The Japanese Ministry of Health, Labor and Welfare has approved the use of pembrolizumab for the treatment of patients with radically unresectable urothelial carcinoma who progressed after chemotherapy.

The approval is based on the phase III KEYNOTE-045 study, in which single-agent pembrolizumab reduced the risk of death by 27% compared with chemotherapy in patients with advanced urothelial carcinoma whose disease progressed after prior treatment.

KEYNOTE-045 was conducted for patients with locally advanced or metastatic, unresectable urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra who had progressed after 1 to 2 lines of platinum-based chemotherapy or who had experienced recurrence after 12 months of chemotherapy.

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This week, we sat down with Dr Alan Venook of the University of California, San Francisco, to discuss upfront therapy approaches in 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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The FDA has approved denosumab for the prevention of skeletal-related events in patients with multiple myeloma.

The approval of the RANK ligand inhibitor is based on data from the phase III 482 study, which were presented at the 16th International Myeloma Workshop. In the trial, denosumab demonstrated noninferiority to zoledronic acid at delaying the time to the first SRE in patients with multiple myeloma.

The median time to first on-study SRE was similar between the treatments at 22.83 months with denosumab versus 23.98 months with the bisphosphonate zoledronic acid. The median progression-free survival was 10.7 months higher in the denosumab arm. There was also a nonstatistically significant trend in overall survival favoring denosumab.

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

In renal cell carcinoma, the FDA has granted a breakthrough therapy designation to the combination of pembrolizumab and lenvatinib for patients with advanced or metastatic disease.

The designation was based on the results of the RCC cohort in Study 111, which was a multicenter, open-label phase Ib/II clinical trial conducted in the United States and the European Union to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab in subjects with selected solid tumors.

The phase Ib portion was designed to evaluate the maximum-tolerated dose of the regimen. The phase II part was conducted in patients who had select solid tumors with 0 to 2 prior lines of systemic therapy with a recommended dosage of 20 mg of lenvatinib daily and 200 mg of pembrolizumab every 3 weeks as determined based on the results of the phase Ib part.

In pooled results from the trial presented at the 2017 ESMO Congress, patients treated with the combination had an objective response rate of 63.3%, and the median progression-free survival was not yet reached.

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

The FDA has granted a breakthrough therapy designation to eltrombopag for use in combination with standard immunosuppressive therapy as a first-line treatment for patients with severe aplastic anemia.

Eltrombopag is already approved in the United States for the treatment of patients with SAA who have had an insufficient response to immunosuppressive therapy.

The designation is based on results from research conducted by the National Heart, Lung and Blood Institute of the National Institutes of Health. Investigators found that eltrombopag, which is a small molecule thrombopoietin receptor agonist, administered concurrently with standard immunosuppressive treatment, was associated with a 52% complete response rate in treatment-naïve patients at 6 months. The overall response rate was 85%.

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

In melanoma, results of the phase III KEYNOTE-054 trial found that adjuvant treatment with pembrolizumab reduced the risk of recurrence by 43% in patients with stage III resected high-risk disease.

The hazard ratio for recurrence-free survival was 0.57 for pembrolizumab versus placebo. There were no new safety concerns in the double-blind KEYNOTE-054 trial compared with outcomes reported in previous studies of the PD-1 inhibitor. This study included 1019 patients with resected high-risk melanoma.

The study remains ongoing so that investigators can evaluate additional key endpoints, such as overall survival. Merck, the manufacturer of pembrolizumab, reported in a press release that the full results from the trial will be shared at an upcoming medical meeting and submitted to regulatory authorities.

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

The Japanese Ministry of Health, Labor and Welfare has approved the use of pembrolizumab for the treatment of patients with radically unresectable urothelial carcinoma who progressed after chemotherapy.

The approval is based on the phase III KEYNOTE-045 study, in which single-agent pembrolizumab reduced the risk of death by 27% compared with chemotherapy in patients with advanced urothelial carcinoma whose disease progressed after prior treatment.

KEYNOTE-045 was conducted for patients with locally advanced or metastatic, unresectable urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra who had progressed after 1 to 2 lines of platinum-based chemotherapy or who had experienced recurrence after 12 months of chemotherapy.

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

This week, we sat down with Dr Alan Venook of the University of California, San Francisco, to discuss upfront therapy approaches in 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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TitleExpiration DateCME Credits
Cancer Summaries and Commentaries™: Update from Chicago: Advances in the Treatment of Breast CancerJul 31, 20181.0
Community Practice Connections™: The Next Generation in Renal Cell Carcinoma Treatment: An Oncology Nursing Essentials WorkshopJul 31, 20181.5
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