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FDA Approvals in HCC and Gastric Cancer, ODAC Panel Splits on Adjuvant RCC Treatment, and More

Gina Columbus
Published: Friday, Sep 29, 2017



Today-

FDA approvals in liver cancer and gastric cancer, an FDA panel splits on a kidney cancer treatment, and European approvals for lung cancer, bladder cancer, and Merkel cell carcinoma.

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

The FDA has granted an accelerated approval to the PD-1 inhibitor nivolumab for the treatment of patients with hepatocellular carcinoma following prior sorafenib, regardless of PD-L1 status. 

The decision is based on findings from the phase I/II CheckMate-040 trial, in which the overall response rate by blinded independent central review was 18.2% per mRECIST criteria for patients who had previously been treated with sorafenib.

Additionally, 3.2% of patients experienced a complete response. The ORR by RECIST 1.1 was 14.3% with nivolumab and the response duration ranged from 3.2 to more than 38.2 months.

This FDA approval for nivolumab is contingent upon findings from a larger, confirmatory trial. A phase III randomized trial of nivolumab versus sorafenib has been launched in the frontline setting, which has an enrollment goal of 726 patients. The estimated primary completion date is October 2018.

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In gastric cancer or gastroesophageal junction adenocarcinoma, the FDA has approved pembrolizumab for the treatment of patients with PD-L1–positive recurrent or advanced disease who have received 2 or more lines of chemotherapy. This includes fluoropyrimidine- and platinum-containing chemotherapy, and, if appropriate, HER2/neu-targeted therapy.

The approval stems from findings of the phase II KEYNOTE-059 study, in which 143 of 259 patients had PD–L1-positive tumors and microsatellite stable tumor status or undetermined microsatellite instability or mismatch repair status.

Results showed that the overall response rate in these patients was 13.3%, including a complete response rate of 1.4% and a partial response rate of 11.9%.

The duration of response among the 19 responding patients ranged from 2.8 to 19.4 months. Moreover, responses were 6 months or longer in 11 patients and 12 months or longer in 5 patients.

The accelerated approval of pembrolizumab for this indication is contingent on the results of a confirmatory trial.

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The FDA’s Oncologic Drugs Advisory Committee voted 6-6 on the potential approval of sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are at high risk of recurrence.

The panel was voting on the risk-benefit profile of sunitinib in this setting based on findings from the phase III S-TRAC trial. Findings from the study showed that adjuvant sunitinib prolonged disease-free survival by 1.2 years versus placebo following nephrectomy for patients with high-risk clear cell RCC.

After a median follow-up duration of 5.4 years, the median DFS was 6.8 years in the sunitinib arm compared with 5.6 years with placebo. The median DFS was 6.2 versus 4.0 years for sunitinib and placebo, respectively in higher-risk patients. Grade 3/4 adverse events were experienced by 63.4% of patients in the sunitinib group versus 21.7% who received placebo.

The FDA granted a priority review to a supplemental new drug application for sunitinib in this setting in June 2017. The agency will factor the ODAC panel discussion and vote into its final decision, which is scheduled to be made by January 2018.

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The European Commission has granted regulatory approval to atezolizumab monotherapy for the treatment of patients with previously treated locally advanced or metastatic non–small cell lung cancer and previously treated locally advanced or metastatic urothelial carcinoma.

Atezolizumab is indicated following chemotherapy for patients with NSCLC regardless of PD-L1 status. Patients with EGFR-activating mutations or ALK-positive tumor mutations should also undergo targeted therapy prior to starting treatment with atezolizumab.

For patients with mUC, the monoclonal antibody is indicated following platinum-containing chemotherapy or for those who are considered ineligible for cisplatin chemotherapy, regardless of PD-L1 status.

The NSCLC approval is based on results from the phase III OAK study and the phase II POPLAR study, while the mUC indication stems from findings from the IMvigor 211 and cohorts 1 and 2 from the phase II IMvigor 210 trial.

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

In Merkel cell carcinoma, the PD-L1 inhibitor avelumab was granted approval by the European Commission as a treatment for patients with metastatic disease.

The approval, which follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use, is based on promising findings from the phase II JAVELIN Merkel 200 study. 

In Part A of this open-label trial, results showed that the objective response rate with avelumab was 33%, which included an 11.4% complete response rate and a 21.6% partial response rate. The duration of response was at least 6 months in 93% of the responding patients, with 71% having a DOR of 12 months or more. The DOR ranged from 2.8 months to more than 24.9 months.

Avelumab is now approved for this indication in all 28 European Union member states, plus Iceland, Liechtenstein, and Norway. The FDA approved avelumab for Merkel cell carcinoma in March 2017.

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This week, we sat down with Dr Hossein Borghaei of Fox Chase Cancer Center to discuss the exciting data in lung cancer presented at the 2017 ESMO Congress.

That’s all for today.

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

FDA approvals in liver cancer and gastric cancer, an FDA panel splits on a kidney cancer treatment, and European approvals for lung cancer, bladder cancer, and Merkel cell carcinoma.

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

The FDA has granted an accelerated approval to the PD-1 inhibitor nivolumab for the treatment of patients with hepatocellular carcinoma following prior sorafenib, regardless of PD-L1 status. 

The decision is based on findings from the phase I/II CheckMate-040 trial, in which the overall response rate by blinded independent central review was 18.2% per mRECIST criteria for patients who had previously been treated with sorafenib.

Additionally, 3.2% of patients experienced a complete response. The ORR by RECIST 1.1 was 14.3% with nivolumab and the response duration ranged from 3.2 to more than 38.2 months.

This FDA approval for nivolumab is contingent upon findings from a larger, confirmatory trial. A phase III randomized trial of nivolumab versus sorafenib has been launched in the frontline setting, which has an enrollment goal of 726 patients. The estimated primary completion date is October 2018.

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

In gastric cancer or gastroesophageal junction adenocarcinoma, the FDA has approved pembrolizumab for the treatment of patients with PD-L1–positive recurrent or advanced disease who have received 2 or more lines of chemotherapy. This includes fluoropyrimidine- and platinum-containing chemotherapy, and, if appropriate, HER2/neu-targeted therapy.

The approval stems from findings of the phase II KEYNOTE-059 study, in which 143 of 259 patients had PD–L1-positive tumors and microsatellite stable tumor status or undetermined microsatellite instability or mismatch repair status.

Results showed that the overall response rate in these patients was 13.3%, including a complete response rate of 1.4% and a partial response rate of 11.9%.

The duration of response among the 19 responding patients ranged from 2.8 to 19.4 months. Moreover, responses were 6 months or longer in 11 patients and 12 months or longer in 5 patients.

The accelerated approval of pembrolizumab for this indication is contingent on the results of a confirmatory trial.

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

The FDA’s Oncologic Drugs Advisory Committee voted 6-6 on the potential approval of sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are at high risk of recurrence.

The panel was voting on the risk-benefit profile of sunitinib in this setting based on findings from the phase III S-TRAC trial. Findings from the study showed that adjuvant sunitinib prolonged disease-free survival by 1.2 years versus placebo following nephrectomy for patients with high-risk clear cell RCC.

After a median follow-up duration of 5.4 years, the median DFS was 6.8 years in the sunitinib arm compared with 5.6 years with placebo. The median DFS was 6.2 versus 4.0 years for sunitinib and placebo, respectively in higher-risk patients. Grade 3/4 adverse events were experienced by 63.4% of patients in the sunitinib group versus 21.7% who received placebo.

The FDA granted a priority review to a supplemental new drug application for sunitinib in this setting in June 2017. The agency will factor the ODAC panel discussion and vote into its final decision, which is scheduled to be made by January 2018.

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

The European Commission has granted regulatory approval to atezolizumab monotherapy for the treatment of patients with previously treated locally advanced or metastatic non–small cell lung cancer and previously treated locally advanced or metastatic urothelial carcinoma.

Atezolizumab is indicated following chemotherapy for patients with NSCLC regardless of PD-L1 status. Patients with EGFR-activating mutations or ALK-positive tumor mutations should also undergo targeted therapy prior to starting treatment with atezolizumab.

For patients with mUC, the monoclonal antibody is indicated following platinum-containing chemotherapy or for those who are considered ineligible for cisplatin chemotherapy, regardless of PD-L1 status.

The NSCLC approval is based on results from the phase III OAK study and the phase II POPLAR study, while the mUC indication stems from findings from the IMvigor 211 and cohorts 1 and 2 from the phase II IMvigor 210 trial.

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

In Merkel cell carcinoma, the PD-L1 inhibitor avelumab was granted approval by the European Commission as a treatment for patients with metastatic disease.

The approval, which follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use, is based on promising findings from the phase II JAVELIN Merkel 200 study. 

In Part A of this open-label trial, results showed that the objective response rate with avelumab was 33%, which included an 11.4% complete response rate and a 21.6% partial response rate. The duration of response was at least 6 months in 93% of the responding patients, with 71% having a DOR of 12 months or more. The DOR ranged from 2.8 months to more than 24.9 months.

Avelumab is now approved for this indication in all 28 European Union member states, plus Iceland, Liechtenstein, and Norway. The FDA approved avelumab for Merkel cell carcinoma in March 2017.

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

This week, we sat down with Dr Hossein Borghaei of Fox Chase Cancer Center to discuss the exciting data in lung cancer presented at the 2017 ESMO Congress.

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
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