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FDA Approval in Sarcoma, Priority Reviews in mCRPC and Myeloma, and More

Gina Columbus
Published: Tuesday, Jan 28, 2020



Today-

An FDA approval in epithelioid sarcoma, priority review designations in prostate cancer and multiple myeloma, and encouraging findings in lung cancer and pancreatic neuroendocrine tumors.

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

The FDA has granted an accelerated approval to tazemetostat, known by the trade name Tazverik, for the treatment of adult and pediatric patients aged 16 years old and older with metastatic or locally advanced epithelioid sarcoma that is not eligible for complete resection.

The approval is primarily based on findings from a cohort of patients with epithelioid sarcoma in the ongoing, single-arm, phase II Study EZH-202 trial, which showed that treatment with tazemetostat elicited an objective response rate of 15%, this included a 1.6% complete response rate and a 13% partial response rate. Among responders in the trial, 67% had a duration of response of at least 6 months.

Epizyme, the developer of the EZH2 inhibitor, stated that it will conduct post-marketing activities, such as clinical pharmacology evaluations, to assess the effect of tazemetostat on liver function as well as the effect of CYP3A inhibitors and inducers on tazemetostat, which will be used to inform aspects of prescribing information.

The company will also expand enrollment of cohort 6 of Study EZH-202 to include at least 60 patients with epithelioid sarcoma. The expansion is planned to provide more patient experience for potential future inclusion in the label.

The accelerated approval of tazemetostat is contingent on the results of a confirmatory trial.

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

In prostate cancer, the FDA has granted a priority review designation to a supplemental new drug application for olaparib for the treatment of patients with metastatic castration-resistant disease who have deleterious or suspected deleterious or somatic homologous recombination repair gene mutations, and who have also progressed on prior therapy with a new hormonal agent.

The designation is based on findings from the phase III PROfound trial, in which olaparib led to a 66% reduction in the risk of disease progression or death compared with either abiraterone acetate or enzalutamide in patients with BRCA1/2- or ATM-mutant mCRPC.

Overall, the trial showed that olaparib demonstrated a 51% reduction in the risk of disease progression or death versus either of the antiandrogen agents in the entire population of patients with HRR-mutant mCRPC who had mutations in genes for BRCA1/2, ATM, CDK12, or 11 other HRR-mutated genes.

The agency is scheduled to decide on the sNDA in the second quarter of 2020.

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

The FDA has granted a priority review designation to a biologics license application for belantamab mafodotin as a treatment for patients with relapsed/refractory multiple myeloma who received prior therapy with an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

The application is based on results from the pivotal DREAMM-2 trial, which showed that belantamab mafodotin elicited an overall response rate of 31% in patients with relapsed/refractory disease who received the treatment at the recommended 2.5 mg/kg dose. This included a very good partial response or better in 18 patients.

In patients who received belantamab mafodotin at 3.4 mg/kg, the ORR was 34%, which included a VGPR or better in 20 patients. There were 3 stringent complete responses or complete responses in each cohort.

Overall, the median duration of response was not reached. At the data cutoff date, 18 patients receiving belantamab mafodotin at 2.5 mg/kg and 25 at the 3.4-mg/kg dose had a DOR of at least 4 months. The median progression-free survival was 2.9 months and 4.9 months in the 2.5-mg/kg and 3.4-mg/kg cohorts, respectively. Overall survival data were immature at the time of the analysis.

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

In pancreatic neuroendocrine tumors, a preplanned interim analysis of the phase III SANET-p trial showed that surufatinib improved progression-free survival compared with placebo in patients with low- or intermediate-grade advanced disease, for whom there is no effective therapy.

The trial was completed by an independent data monitoring committee, which recommended that the study be stopped early, as the predefined primary endpoint of PFS was met. Chi-Med, the developer of surufatinib, stated in a press release that it plans to meet with the China National Medical Products Administration to discuss preparing a new drug application for the agent in this indication. Full findings of the trial will be presented at an upcoming medical meeting.

Previously, a phase Ib/II trial evaluated surufatinib in patients with histologically well-differentiated, low- or intermittent-grade, inoperable or metastatic NETs. Patients were stratified by pancreatic or extrapancreatic subtype.

Results showed that the objective response rates were 19% in the pancreatic NETs cohort and 15% in the extrapancreatic NET cohort. The median PFS was 21.2 months and 13.4 months, respectively.

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

The anti-PD-1 agent tislelizumab in combination with chemotherapy improved progression-free survival compared with chemotherapy alone as a first-line treatment for patients with advanced squamous non-small cell lung cancer, meeting the primary endpoint at a planned interim analysis of the phase III BGB-A317-307 trial.

The analysis, which was conducted by an independent review committee, showed that tislelizumab in combination with either carboplatin/paclitaxel or with carboplatin/nab-paclitaxel crossed the prespecified efficacy boundary versus carboplatin/paclitaxel alone.

Moreover, the safety profile for tislelizumab with either chemotherapy regimen was found to be consistent with the known risks of each study treatment and no new safety signals were identified.

Full findings will be presented at an upcoming medical meeting.

BeiGene, the developer of tislelizumab, stated that it anticipates discussing its plans to file a supplemental new drug application for tislelizumab as a first-line treatment for patients with squamous NSCLC with the Center for Drug Evaluation at the National Medical Products Administration in China.

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

This week, we sat down Dr Vincent T. Ho, of Dana-Farber Cancer Institute, to discuss future directions for the treatment of transplant thrombotic microangiopathy.

That's all for today.

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

An FDA approval in epithelioid sarcoma, priority review designations in prostate cancer and multiple myeloma, and encouraging findings in lung cancer and pancreatic neuroendocrine tumors.

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

The FDA has granted an accelerated approval to tazemetostat, known by the trade name Tazverik, for the treatment of adult and pediatric patients aged 16 years old and older with metastatic or locally advanced epithelioid sarcoma that is not eligible for complete resection.

The approval is primarily based on findings from a cohort of patients with epithelioid sarcoma in the ongoing, single-arm, phase II Study EZH-202 trial, which showed that treatment with tazemetostat elicited an objective response rate of 15%, this included a 1.6% complete response rate and a 13% partial response rate. Among responders in the trial, 67% had a duration of response of at least 6 months.

Epizyme, the developer of the EZH2 inhibitor, stated that it will conduct post-marketing activities, such as clinical pharmacology evaluations, to assess the effect of tazemetostat on liver function as well as the effect of CYP3A inhibitors and inducers on tazemetostat, which will be used to inform aspects of prescribing information.

The company will also expand enrollment of cohort 6 of Study EZH-202 to include at least 60 patients with epithelioid sarcoma. The expansion is planned to provide more patient experience for potential future inclusion in the label.

The accelerated approval of tazemetostat is contingent on the results of a confirmatory trial.

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

In prostate cancer, the FDA has granted a priority review designation to a supplemental new drug application for olaparib for the treatment of patients with metastatic castration-resistant disease who have deleterious or suspected deleterious or somatic homologous recombination repair gene mutations, and who have also progressed on prior therapy with a new hormonal agent.

The designation is based on findings from the phase III PROfound trial, in which olaparib led to a 66% reduction in the risk of disease progression or death compared with either abiraterone acetate or enzalutamide in patients with BRCA1/2- or ATM-mutant mCRPC.

Overall, the trial showed that olaparib demonstrated a 51% reduction in the risk of disease progression or death versus either of the antiandrogen agents in the entire population of patients with HRR-mutant mCRPC who had mutations in genes for BRCA1/2, ATM, CDK12, or 11 other HRR-mutated genes.

The agency is scheduled to decide on the sNDA in the second quarter of 2020.

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

The FDA has granted a priority review designation to a biologics license application for belantamab mafodotin as a treatment for patients with relapsed/refractory multiple myeloma who received prior therapy with an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

The application is based on results from the pivotal DREAMM-2 trial, which showed that belantamab mafodotin elicited an overall response rate of 31% in patients with relapsed/refractory disease who received the treatment at the recommended 2.5 mg/kg dose. This included a very good partial response or better in 18 patients.

In patients who received belantamab mafodotin at 3.4 mg/kg, the ORR was 34%, which included a VGPR or better in 20 patients. There were 3 stringent complete responses or complete responses in each cohort.

Overall, the median duration of response was not reached. At the data cutoff date, 18 patients receiving belantamab mafodotin at 2.5 mg/kg and 25 at the 3.4-mg/kg dose had a DOR of at least 4 months. The median progression-free survival was 2.9 months and 4.9 months in the 2.5-mg/kg and 3.4-mg/kg cohorts, respectively. Overall survival data were immature at the time of the analysis.

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

In pancreatic neuroendocrine tumors, a preplanned interim analysis of the phase III SANET-p trial showed that surufatinib improved progression-free survival compared with placebo in patients with low- or intermediate-grade advanced disease, for whom there is no effective therapy.

The trial was completed by an independent data monitoring committee, which recommended that the study be stopped early, as the predefined primary endpoint of PFS was met. Chi-Med, the developer of surufatinib, stated in a press release that it plans to meet with the China National Medical Products Administration to discuss preparing a new drug application for the agent in this indication. Full findings of the trial will be presented at an upcoming medical meeting.

Previously, a phase Ib/II trial evaluated surufatinib in patients with histologically well-differentiated, low- or intermittent-grade, inoperable or metastatic NETs. Patients were stratified by pancreatic or extrapancreatic subtype.

Results showed that the objective response rates were 19% in the pancreatic NETs cohort and 15% in the extrapancreatic NET cohort. The median PFS was 21.2 months and 13.4 months, respectively.

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

The anti-PD-1 agent tislelizumab in combination with chemotherapy improved progression-free survival compared with chemotherapy alone as a first-line treatment for patients with advanced squamous non-small cell lung cancer, meeting the primary endpoint at a planned interim analysis of the phase III BGB-A317-307 trial.

The analysis, which was conducted by an independent review committee, showed that tislelizumab in combination with either carboplatin/paclitaxel or with carboplatin/nab-paclitaxel crossed the prespecified efficacy boundary versus carboplatin/paclitaxel alone.

Moreover, the safety profile for tislelizumab with either chemotherapy regimen was found to be consistent with the known risks of each study treatment and no new safety signals were identified.

Full findings will be presented at an upcoming medical meeting.

BeiGene, the developer of tislelizumab, stated that it anticipates discussing its plans to file a supplemental new drug application for tislelizumab as a first-line treatment for patients with squamous NSCLC with the Center for Drug Evaluation at the National Medical Products Administration in China.

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

This week, we sat down Dr Vincent T. Ho, of Dana-Farber Cancer Institute, to discuss future directions for the treatment of transplant thrombotic microangiopathy.

That's all for today.

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