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FDA Approval of a Biosimilar, Priority Review in Epithelioid Sarcoma, and More

Kristi Rosa
Published: Monday, Jul 29, 2019



Today-

An FDA approval of a biosimilar, a priority review designation in epithelioid sarcoma, a breakthrough therapy designation in hepatocellular carcinoma, a label updated in non-small cell lung cancer, and intriguing findings in a lung cancer trial.

Welcome to OncLive News Network! I'm Kristi Rosa.

The FDA has approved the rituximab biosimilar PF-05280586, known by the trade name Ruxience, for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma as a single agent or in combination with chemotherapy, or for patients with CD20-positive chronic lymphocytic leukemia in combination with chemotherapy.

The approval is based on a review of a comprehensive data package, which demonstrated biosimilarity of PF-05280586 to reference rituximab. The package includes findings from the REFLECTIONS B3281006 clinical comparative study, which showed there were no clinically meaningful differences in efficacy or safety versus reference rituximab in patients with CD20-positive, low tumor burden follicular lymphoma.

Results showed that the ORR at week 26 was 75.5% with the biosimilar versus 70.7% for rituximab-EU for a difference of 4.66%. The CR rates were 29.3% versus 30.4% with the biosimilar and rituximab-EU arms, respectively.

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In epithelioid sarcoma, the FDA granted a priority review designation to a new drug application for tazemetostat for the treatment of patients with metastatic or locally advanced disease that is not eligible for curative surgery.

The application is based on findings from the epithelioid sarcoma cohort of a phase II trial that were presented at the 2019 ASCO Annual Meeting. Among 62 patients with epithelioid sarcoma, the overall response rate was 15%, and was comprised of all confirmed partial responses.

At a median follow-up of 59.9 weeks, results showed that the median duration of response with the EZH2 inhibitor was not reached. The median overall survival among all 62 patients was 82.4 weeks, and the median progression-free survival was 23.7 weeks.

The FDA is scheduled to make a decision on the NDA on or before January 23, 2020.

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The FDA has granted a breakthrough therapy designation to the combination of pembrolizumab and lenvatinib for the frontline treatment of patients with advanced unresectable hepatocellular carcinoma that is not amenable to locoregional therapy.

The designation is based on updated interim findings from the phase Ib KEYNOTE-524/Study 116 trial. Earlier interim data, which were presented at the 2019 AACR Annual Meeting, showed that the combination elicited an investigator-assessed overall response rate of 36.7% via modified RECIST criteria in patients with unresectable disease.

In the multicenter, open-label, single-arm, phase Ib KEYNOTE-524/Study 116 trial, no dose-limited toxicities were reported in part 1 of the study, and 24 patients with no prior systemic treatment were enrolled in the expansion phase, known as part 2, of the trial.

At a median follow-up of 9.7 months, the overall response rate was 36.7% by mRECIST per investigator review, 50.0% by mRECIST per independent imaging review, and 36.7% per RECIST 1.1 per independent imaging review.

The FDA previously granted breakthrough therapy designations to this combination in advanced or metastatic renal cell carcinoma in January 2018 and advanced and/or metastatic non-microsatellite instability-high/proficient mismatch repair endometrial carcinoma in July 2018.

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In non-small cell lung cancer, the FDA has updated the label for durvalumab for patients with unresectable, stage III disease that has not progressed following concurrent platinum-based chemoradiation to include overall survival data from the phase III PACIFIC trial.

In results of the primary OS analysis from PACIFIC, the PD-L1 inhibitor demonstrated a 32% reduction in the risk of death compared with placebo, which was a significant and clinically proven survival benefit in this patient population.

Three-year follow-up results of a posthoc OS analysis from PACIFIC were presented at the 2019 ASCO Annual Meeting, and showed that the data were consistent with the initial 2-year findings. Moreover, 57% of patients on durvalumab were alive compared with 44% of those who received placebo at the 3-year mark.

The FDA approved durvalumab in this setting in February 2018 based on the initial PACIFIC data.

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The combination of nivolumab and low-dose ipilimumab was found to be superior in overall survival compared with chemotherapy for the first-line treatment of patients with non-small cell lung cancer whose tumors express PD-L1 of at least 1%, meeting the co-primary endpoint of part 1a of the phase III CheckMate-227 trial.

Moreover, the safety profile of the frontline combination was consistent with prior data of nivolumab at this dosage of the combination in patients with NSCLC.

Results of an exploratory analysis from part 1b of the CheckMate-227 trial showed that the combination also led to a benefit in survival in patients with PD-L1
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Today-

An FDA approval of a biosimilar, a priority review designation in epithelioid sarcoma, a breakthrough therapy designation in hepatocellular carcinoma, a label updated in non-small cell lung cancer, and intriguing findings in a lung cancer trial.

Welcome to OncLive News Network! I'm Kristi Rosa.

The FDA has approved the rituximab biosimilar PF-05280586, known by the trade name Ruxience, for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma as a single agent or in combination with chemotherapy, or for patients with CD20-positive chronic lymphocytic leukemia in combination with chemotherapy.

The approval is based on a review of a comprehensive data package, which demonstrated biosimilarity of PF-05280586 to reference rituximab. The package includes findings from the REFLECTIONS B3281006 clinical comparative study, which showed there were no clinically meaningful differences in efficacy or safety versus reference rituximab in patients with CD20-positive, low tumor burden follicular lymphoma.

Results showed that the ORR at week 26 was 75.5% with the biosimilar versus 70.7% for rituximab-EU for a difference of 4.66%. The CR rates were 29.3% versus 30.4% with the biosimilar and rituximab-EU arms, respectively.

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

In epithelioid sarcoma, the FDA granted a priority review designation to a new drug application for tazemetostat for the treatment of patients with metastatic or locally advanced disease that is not eligible for curative surgery.

The application is based on findings from the epithelioid sarcoma cohort of a phase II trial that were presented at the 2019 ASCO Annual Meeting. Among 62 patients with epithelioid sarcoma, the overall response rate was 15%, and was comprised of all confirmed partial responses.

At a median follow-up of 59.9 weeks, results showed that the median duration of response with the EZH2 inhibitor was not reached. The median overall survival among all 62 patients was 82.4 weeks, and the median progression-free survival was 23.7 weeks.

The FDA is scheduled to make a decision on the NDA on or before January 23, 2020.

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

The FDA has granted a breakthrough therapy designation to the combination of pembrolizumab and lenvatinib for the frontline treatment of patients with advanced unresectable hepatocellular carcinoma that is not amenable to locoregional therapy.

The designation is based on updated interim findings from the phase Ib KEYNOTE-524/Study 116 trial. Earlier interim data, which were presented at the 2019 AACR Annual Meeting, showed that the combination elicited an investigator-assessed overall response rate of 36.7% via modified RECIST criteria in patients with unresectable disease.

In the multicenter, open-label, single-arm, phase Ib KEYNOTE-524/Study 116 trial, no dose-limited toxicities were reported in part 1 of the study, and 24 patients with no prior systemic treatment were enrolled in the expansion phase, known as part 2, of the trial.

At a median follow-up of 9.7 months, the overall response rate was 36.7% by mRECIST per investigator review, 50.0% by mRECIST per independent imaging review, and 36.7% per RECIST 1.1 per independent imaging review.

The FDA previously granted breakthrough therapy designations to this combination in advanced or metastatic renal cell carcinoma in January 2018 and advanced and/or metastatic non-microsatellite instability-high/proficient mismatch repair endometrial carcinoma in July 2018.

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

In non-small cell lung cancer, the FDA has updated the label for durvalumab for patients with unresectable, stage III disease that has not progressed following concurrent platinum-based chemoradiation to include overall survival data from the phase III PACIFIC trial.

In results of the primary OS analysis from PACIFIC, the PD-L1 inhibitor demonstrated a 32% reduction in the risk of death compared with placebo, which was a significant and clinically proven survival benefit in this patient population.

Three-year follow-up results of a posthoc OS analysis from PACIFIC were presented at the 2019 ASCO Annual Meeting, and showed that the data were consistent with the initial 2-year findings. Moreover, 57% of patients on durvalumab were alive compared with 44% of those who received placebo at the 3-year mark.

The FDA approved durvalumab in this setting in February 2018 based on the initial PACIFIC data.

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

The combination of nivolumab and low-dose ipilimumab was found to be superior in overall survival compared with chemotherapy for the first-line treatment of patients with non-small cell lung cancer whose tumors express PD-L1 of at least 1%, meeting the co-primary endpoint of part 1a of the phase III CheckMate-227 trial.

Moreover, the safety profile of the frontline combination was consistent with prior data of nivolumab at this dosage of the combination in patients with NSCLC.

Results of an exploratory analysis from part 1b of the CheckMate-227 trial showed that the combination also led to a benefit in survival in patients with PD-L1
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