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FDA Approvals in HCC, SCLC, and NSCLC, Priority Review in Rare Blood Cancer, and More

Gina Columbus
Published: Monday, Aug 27, 2018



Today-

FDA approvals in hepatocellular carcinoma, small cell lung cancer, and non–small cell lung cancer, a priority review designation in a rare blood cancer, and a Chinese approval in lung cancer.

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

The FDA has approved lenvatinib as a first-line treatment for patients with unresectable hepatocellular carcinoma.

The decision was based on data from the phase III REFLECT trial, which demonstrated that the multikinase inhibitor lenvatinib showed noninferiority to the established first-line standard of care sorafenib. The median overall survival by investigator review with lenvatinib was 13.6 months versus 12.3 months for sorafenib.

Also by investigator review, lenvatinib was superior to sorafenib for progression-free survival and time-to-progression. The median PFS was 7.4 versus 3.7 months for lenvatinib and sorafenib, respectively. Time to progression was 8.9 months for lenvatinib compared with 3.7 months for sorafenib.

Results additionally showed that the objective response rate by investigator review was 24.1% with lenvatinib versus 9.2% with sorafenib. The complete response rate was 1.3% in the lenvatinib group and 0.4% with sorafenib. The median duration of response was 5.7 months with lenvatinib and 3.7 months for sorafenib.

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In small cell lung cancer, the FDA granted an accelerated approval to single-agent nivolumab for the treatment of patients with disease progression following platinum-based chemotherapy and 1 other line of therapy. This marks the first approval for SCLC in nearly 20 years.

The approval is based on the durability of responses in the phase I/II CheckMate-032 trial. The open-label study evaluated nivolumab monotherapy or the combination of nivolumab and ipilimumab in patients with advanced or metastatic solid tumors, including SCLC.

Findings showed that the objective response rate was 12% for nivolumab after platinum-based chemotherapy and 1 other prior line of therapy in 109 patients, according to the new label.

This response rate consisted of partial responses and a complete response. The median duration of response was 17.9 months, with 62% of patients continuing to respond at 12 months and 39% still responding at 18 months.

The approval for nivolumab is contingent on findings from a confirmatory study.

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

In non–small cell lung cancer, the FDA granted a full approval to frontline pembrolizumab for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer.

The decision is based on the phase III KEYNOTE-189 trial, which showed that the addition of pembrolizumab to pemetrexed and either cisplatin or carboplatin in the frontline setting reduced the risk of death by 51% in patients with NSCLC without EGFR or ALK mutations.

The median overall survival was not reached with pembrolizumab cohort versus 11.3 months in the chemotherapy-alone arm. At a median follow-up of 10.5 months, the estimated 12-month OS rate was 69.2% in the pembrolizumab arm compared with 49.4% in the control group.

Additionally, the study met the coprimary endpoint of progression-free survival, with a median PFS of 8.8 months in the pembrolizumab group versus 4.9 months in the control arm.

The prior accelerated approval for pembrolizumab in this setting was based on cohort G in the KEYNOTE-021 trial, in which the 12-month PFS rate was 56% with pembrolizumab combined with pemetrexed and carboplatin versus 34% with chemotherapy alone.

This approval was granted ahead of expectations, under a new FDA approval pathway for supplemental applications. Under the program, called Real-Time Oncology Review, the agency reviews pivotal clinical trial data as soon as it becomes available, prior to the formal submission of an application.

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

The FDA has granted a priority review designation to a biologics license application for SL-401 for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm.

SL-401 is being investigated as a first-line or later treatment in patients with BPDCN in a phase I/II trial, which showed that there is strong activity in this population.

In the trial, which had 3 stages, the overall response rate was 90% in first-line treatment with SL-401, with a complete response. After therapy with SL-401, 45% of patients were bridged to stem cell transplant. In patients with relapsed/refractory BPDCN, the ORR was 69%, with a 38% CR rate, and 1 patient was bridged to SCT.

The median overall survival was not reached in patients who received SL-401 therapy in the first-line setting. In the pivotal stage 3 cohort, the study met its primary endpoint with a 54% CR rate. The ORR was 77% and 46% of patients were bridged to SCT.

Under the Prescription Drug User Fee Act, the FDA is scheduled to decide on the BLA by February 21, 2019.

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

In non–small cell lung cancer, the China National Drug Administration has approved alectinib for the treatment of patients with ALK-positive, advanced disease.

The decision was based on the primary analysis of the phase III ALEX study, in which frontline alectinib reduced the risk of disease progression or death by 53% versus crizotinib in patients with ALK-positive NSCLC. Moreover, the investigator-assessed median progression-free survival had not been reached in the alectinib arm versus 11.1 months in the crizotinib arm. Per independent review, the median PFS was 25.7 months versus 10.4 months, respectively.

There was also an 84% reduction in the risk of progression in the central nervous system with alectinib versus crizotinib.

Updated data presented at the ASCO Annual Meeting showed that the median PFS per investigator assessment was 34.8 months with alectinib versus 10.9 months with crizotinib.

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

This week, we sat down with Dr Sara Hurvitz, of the University of California, Los Angeles, to discuss the role of everolimus in hormone receptor–positive metastatic breast cancer.

That’s all for today.

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

FDA approvals in hepatocellular carcinoma, small cell lung cancer, and non–small cell lung cancer, a priority review designation in a rare blood cancer, and a Chinese approval in lung cancer.

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

The FDA has approved lenvatinib as a first-line treatment for patients with unresectable hepatocellular carcinoma.

The decision was based on data from the phase III REFLECT trial, which demonstrated that the multikinase inhibitor lenvatinib showed noninferiority to the established first-line standard of care sorafenib. The median overall survival by investigator review with lenvatinib was 13.6 months versus 12.3 months for sorafenib.

Also by investigator review, lenvatinib was superior to sorafenib for progression-free survival and time-to-progression. The median PFS was 7.4 versus 3.7 months for lenvatinib and sorafenib, respectively. Time to progression was 8.9 months for lenvatinib compared with 3.7 months for sorafenib.

Results additionally showed that the objective response rate by investigator review was 24.1% with lenvatinib versus 9.2% with sorafenib. The complete response rate was 1.3% in the lenvatinib group and 0.4% with sorafenib. The median duration of response was 5.7 months with lenvatinib and 3.7 months for sorafenib.

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

In small cell lung cancer, the FDA granted an accelerated approval to single-agent nivolumab for the treatment of patients with disease progression following platinum-based chemotherapy and 1 other line of therapy. This marks the first approval for SCLC in nearly 20 years.

The approval is based on the durability of responses in the phase I/II CheckMate-032 trial. The open-label study evaluated nivolumab monotherapy or the combination of nivolumab and ipilimumab in patients with advanced or metastatic solid tumors, including SCLC.

Findings showed that the objective response rate was 12% for nivolumab after platinum-based chemotherapy and 1 other prior line of therapy in 109 patients, according to the new label.

This response rate consisted of partial responses and a complete response. The median duration of response was 17.9 months, with 62% of patients continuing to respond at 12 months and 39% still responding at 18 months.

The approval for nivolumab is contingent on findings from a confirmatory study.

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

In non–small cell lung cancer, the FDA granted a full approval to frontline pembrolizumab for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer.

The decision is based on the phase III KEYNOTE-189 trial, which showed that the addition of pembrolizumab to pemetrexed and either cisplatin or carboplatin in the frontline setting reduced the risk of death by 51% in patients with NSCLC without EGFR or ALK mutations.

The median overall survival was not reached with pembrolizumab cohort versus 11.3 months in the chemotherapy-alone arm. At a median follow-up of 10.5 months, the estimated 12-month OS rate was 69.2% in the pembrolizumab arm compared with 49.4% in the control group.

Additionally, the study met the coprimary endpoint of progression-free survival, with a median PFS of 8.8 months in the pembrolizumab group versus 4.9 months in the control arm.

The prior accelerated approval for pembrolizumab in this setting was based on cohort G in the KEYNOTE-021 trial, in which the 12-month PFS rate was 56% with pembrolizumab combined with pemetrexed and carboplatin versus 34% with chemotherapy alone.

This approval was granted ahead of expectations, under a new FDA approval pathway for supplemental applications. Under the program, called Real-Time Oncology Review, the agency reviews pivotal clinical trial data as soon as it becomes available, prior to the formal submission of an application.

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

The FDA has granted a priority review designation to a biologics license application for SL-401 for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm.

SL-401 is being investigated as a first-line or later treatment in patients with BPDCN in a phase I/II trial, which showed that there is strong activity in this population.

In the trial, which had 3 stages, the overall response rate was 90% in first-line treatment with SL-401, with a complete response. After therapy with SL-401, 45% of patients were bridged to stem cell transplant. In patients with relapsed/refractory BPDCN, the ORR was 69%, with a 38% CR rate, and 1 patient was bridged to SCT.

The median overall survival was not reached in patients who received SL-401 therapy in the first-line setting. In the pivotal stage 3 cohort, the study met its primary endpoint with a 54% CR rate. The ORR was 77% and 46% of patients were bridged to SCT.

Under the Prescription Drug User Fee Act, the FDA is scheduled to decide on the BLA by February 21, 2019.

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

In non–small cell lung cancer, the China National Drug Administration has approved alectinib for the treatment of patients with ALK-positive, advanced disease.

The decision was based on the primary analysis of the phase III ALEX study, in which frontline alectinib reduced the risk of disease progression or death by 53% versus crizotinib in patients with ALK-positive NSCLC. Moreover, the investigator-assessed median progression-free survival had not been reached in the alectinib arm versus 11.1 months in the crizotinib arm. Per independent review, the median PFS was 25.7 months versus 10.4 months, respectively.

There was also an 84% reduction in the risk of progression in the central nervous system with alectinib versus crizotinib.

Updated data presented at the ASCO Annual Meeting showed that the median PFS per investigator assessment was 34.8 months with alectinib versus 10.9 months with crizotinib.

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

This week, we sat down with Dr Sara Hurvitz, of the University of California, Los Angeles, to discuss the role of everolimus in hormone receptor–positive metastatic breast cancer.

That’s all for today.

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