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FDA Approvals in Follicular Lymphoma and Prostate Cancer, Biosimilar Is Granted Approval, and More

Gina Columbus
Published: Monday, Sep 25, 2017



Today-

FDA approvals in follicular lymphoma and prostate cancer, a biosimilar approved for several cancers, a new drug application in prostate cancer, results from 2 late-stage prostate cancer trials, and encouraging findings in a chronic lymphocytic leukemia study.

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

The FDA has granted an accelerated approval to copanlisib as a treatment for patients with relapsed follicular lymphoma who have received at least 2 least prior systemic therapies.

The decision is primarily based on findings from the phase II CHRONOS-1 trial, which included patients with follicular lymphoma, marginal zone lymphoma, small lymphocytic lymphoma, and lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia. In the study, 59% of patients achieved objective responses with copanlisib. Additionally, responses were durable, and the median progression-free survival approached 1 year.

The study population had a median PFS of 11.2 months. In the follicular lymphoma subgroup, the median PFS was also 11.2 months.

The accelerated approval of copanlisib is contingent upon the results of a confirmatory trial.

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For the first time, the FDA granted approval to a biosimilar for the treatment of cancer.

The biosimilar for bevacizumab, ABP-215, also know by the trade name Mvasi, is indicated for the treatment of colorectal, lung, brain, kidney, and cervical cancers in adult patients.

A biosimilar is a biological product that is demonstrated to be highly similar to an already-approved biological product, and that has no clinically meaningful differences in terms of safety, purity, and potency from the reference product.

The decision was based on a pair of studies of ABP-215 that demonstrated equivalency to bevacizumab.

As with bevacizumab, ABP-215’s label includes a boxed warning regarding an increased risk of gastrointestinal perforations, surgery and wound healing complications, and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal hemorrhage.

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

In prostate cancer, a supplemental new drug application has been submitted for abiraterone acetate in combination with prednisone and androgen deprivation therapy for high-risk patients with metastatic hormone-naïve disease or newly-diagnosed metastatic hormone-sensitive disease.

The application was based on findings from the phase III LATITUDE trial, which showed superior overall survival with abiraterone acetate, prednisone, and ADT compared with ADT and placebo for patients with high-risk metastatic, castration-sensitive prostate cancer.

Results showed that the addition of abiraterone acetate to ADT reduced the risk of death by 38% versus ADT and placebo. The median OS was not reached with abiraterone acetate versus 34.7 months with placebo.

Moreover, the radiographic progression-free survival with abiraterone acetate was 33.0 months compared with 14.8 months for ADT alone, representing a 53% reduction in the risk of progression or death. The OS rate at 3 years was 66% in the abiraterone acetate group versus 49% with ADT.

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

Also in prostate cancer, the FDA has approved a lower dose of cabazitaxel of 20 mg/m2 every 3 weeks plus prednisone for the treatment of men with metastatic castration-resistant disease who previously received a docetaxel-containing regimen. The agency approved a dose of 25 mg/m2 every 3 weeks in this patient population in 2010.

The approval stems from phase III results from the PROSELICA trial published earlier in 2017, which showed that the lower-dose regimen was noninferior for overall survival and was also associated with a similar safety profile.

The median OS for patients assigned to the 20 mg/m2 dose was 13.4 months compared with 14.5 months for those assigned to the 25 mg/m2 dose.

Additionally, researchers observed no significant difference in the number of patients who experienced a pain response and the rate of pain progression was similar in the 2 groups.

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

The addition of enzalutamide to androgen deprivation therapy was found to significantly improve metastasis-free survival versus ADT alone in patients with nonmetastatic castration-resistant prostate cancer, according to findings from the phase III PROSPER trial.

While no data have been released yet, Pfizer and Astellas, the codevelopers of enzalutamide, are planning to share the results at an upcoming medical meeting.

The multinational, randomized, double-blind, placebo-controlled PROSPER trial is evaluating the efficacy and safety of enzalutamide. Patients in the experimental arm are assigned to 160 mg daily of oral enzalutamide. The primary endpoint is metastasis-free survival, with secondary endpoints being overall survival, time to prostate-specific antigen progression, and time to chemotherapy-free survival.

The companies reported that there have been no new safety signals thus far for enzalutamide in PROSPER.

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

Disappointing interim results of the phase III PROSPECT study showed that the prostate-specific antigen-targeted immunotherapy PROSTVAC was deemed unlikely to demonstrate an improvement in overall survival versus placebo for patients with metastatic castration-resistant prostate cancer.

After the preplanned analysis conducted by an independent Data Monitoring Committee, discontinuation of the PROSPECT trial was recommended. The trial was also designed to detect an 18% reduction in the risk of death with PROSTVAC versus placebo.

Bavarian Nordic, the company developing the immunotherapy with the National Cancer Institute, has not yet released exact numbers from the study.

A phase I/II study is currently exploring PROSTVAC with the PD-1 inhibitor nivolumab and/or the CTLA-4 inhibitor ipilimumab for men with prostate cancer. Additionally, separate phase II studies are examining PROSTVAC with ipilimumab or docetaxel.

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

In chronic lymphocytic leukemia, the combination of venetoclax and rituximab significantly improved progression-free survival versus rituximab plus bendamustine in patients with relapsed or refractory disease, according to findings from the phase III MURANO study.

No data have been released yet, but the developers of venetoclax, Genentech and AbbVie, are planning to announce the results at an upcoming medical meeting.

The FDA previously granted the venetoclax/rituximab combination a breakthrough therapy designation in January 2016, based on data from the phase Ib M13-365 study. In the trial, the combination had an overall response rate of 86%, with deep and durable responses in patients with relapsed/refractory CLL.

Moreover, the MURANO results are intended to support the conversion of the accelerated approval of single-agent venetoclax into a full approval for the treatment of patients with CLL who harbor a 17p deletion and have received at least 1 prior therapy. 

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

This week, we sat down with Dr Guy Young, a pediatric hematologist-oncologist at UCLA Medical Center, to discuss managing thromboembolic events in pediatric patients with 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 follicular lymphoma and prostate cancer, a biosimilar approved for several cancers, a new drug application in prostate cancer, results from 2 late-stage prostate cancer trials, and encouraging findings in a chronic lymphocytic leukemia study.

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

The FDA has granted an accelerated approval to copanlisib as a treatment for patients with relapsed follicular lymphoma who have received at least 2 least prior systemic therapies.

The decision is primarily based on findings from the phase II CHRONOS-1 trial, which included patients with follicular lymphoma, marginal zone lymphoma, small lymphocytic lymphoma, and lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia. In the study, 59% of patients achieved objective responses with copanlisib. Additionally, responses were durable, and the median progression-free survival approached 1 year.

The study population had a median PFS of 11.2 months. In the follicular lymphoma subgroup, the median PFS was also 11.2 months.

The accelerated approval of copanlisib is contingent upon the results of a confirmatory trial.

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

For the first time, the FDA granted approval to a biosimilar for the treatment of cancer.

The biosimilar for bevacizumab, ABP-215, also know by the trade name Mvasi, is indicated for the treatment of colorectal, lung, brain, kidney, and cervical cancers in adult patients.

A biosimilar is a biological product that is demonstrated to be highly similar to an already-approved biological product, and that has no clinically meaningful differences in terms of safety, purity, and potency from the reference product.

The decision was based on a pair of studies of ABP-215 that demonstrated equivalency to bevacizumab.

As with bevacizumab, ABP-215’s label includes a boxed warning regarding an increased risk of gastrointestinal perforations, surgery and wound healing complications, and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal hemorrhage.

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

In prostate cancer, a supplemental new drug application has been submitted for abiraterone acetate in combination with prednisone and androgen deprivation therapy for high-risk patients with metastatic hormone-naïve disease or newly-diagnosed metastatic hormone-sensitive disease.

The application was based on findings from the phase III LATITUDE trial, which showed superior overall survival with abiraterone acetate, prednisone, and ADT compared with ADT and placebo for patients with high-risk metastatic, castration-sensitive prostate cancer.

Results showed that the addition of abiraterone acetate to ADT reduced the risk of death by 38% versus ADT and placebo. The median OS was not reached with abiraterone acetate versus 34.7 months with placebo.

Moreover, the radiographic progression-free survival with abiraterone acetate was 33.0 months compared with 14.8 months for ADT alone, representing a 53% reduction in the risk of progression or death. The OS rate at 3 years was 66% in the abiraterone acetate group versus 49% with ADT.

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

Also in prostate cancer, the FDA has approved a lower dose of cabazitaxel of 20 mg/m2 every 3 weeks plus prednisone for the treatment of men with metastatic castration-resistant disease who previously received a docetaxel-containing regimen. The agency approved a dose of 25 mg/m2 every 3 weeks in this patient population in 2010.

The approval stems from phase III results from the PROSELICA trial published earlier in 2017, which showed that the lower-dose regimen was noninferior for overall survival and was also associated with a similar safety profile.

The median OS for patients assigned to the 20 mg/m2 dose was 13.4 months compared with 14.5 months for those assigned to the 25 mg/m2 dose.

Additionally, researchers observed no significant difference in the number of patients who experienced a pain response and the rate of pain progression was similar in the 2 groups.

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

The addition of enzalutamide to androgen deprivation therapy was found to significantly improve metastasis-free survival versus ADT alone in patients with nonmetastatic castration-resistant prostate cancer, according to findings from the phase III PROSPER trial.

While no data have been released yet, Pfizer and Astellas, the codevelopers of enzalutamide, are planning to share the results at an upcoming medical meeting.

The multinational, randomized, double-blind, placebo-controlled PROSPER trial is evaluating the efficacy and safety of enzalutamide. Patients in the experimental arm are assigned to 160 mg daily of oral enzalutamide. The primary endpoint is metastasis-free survival, with secondary endpoints being overall survival, time to prostate-specific antigen progression, and time to chemotherapy-free survival.

The companies reported that there have been no new safety signals thus far for enzalutamide in PROSPER.

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

Disappointing interim results of the phase III PROSPECT study showed that the prostate-specific antigen-targeted immunotherapy PROSTVAC was deemed unlikely to demonstrate an improvement in overall survival versus placebo for patients with metastatic castration-resistant prostate cancer.

After the preplanned analysis conducted by an independent Data Monitoring Committee, discontinuation of the PROSPECT trial was recommended. The trial was also designed to detect an 18% reduction in the risk of death with PROSTVAC versus placebo.

Bavarian Nordic, the company developing the immunotherapy with the National Cancer Institute, has not yet released exact numbers from the study.

A phase I/II study is currently exploring PROSTVAC with the PD-1 inhibitor nivolumab and/or the CTLA-4 inhibitor ipilimumab for men with prostate cancer. Additionally, separate phase II studies are examining PROSTVAC with ipilimumab or docetaxel.

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

In chronic lymphocytic leukemia, the combination of venetoclax and rituximab significantly improved progression-free survival versus rituximab plus bendamustine in patients with relapsed or refractory disease, according to findings from the phase III MURANO study.

No data have been released yet, but the developers of venetoclax, Genentech and AbbVie, are planning to announce the results at an upcoming medical meeting.

The FDA previously granted the venetoclax/rituximab combination a breakthrough therapy designation in January 2016, based on data from the phase Ib M13-365 study. In the trial, the combination had an overall response rate of 86%, with deep and durable responses in patients with relapsed/refractory CLL.

Moreover, the MURANO results are intended to support the conversion of the accelerated approval of single-agent venetoclax into a full approval for the treatment of patients with CLL who harbor a 17p deletion and have received at least 1 prior therapy. 

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

This week, we sat down with Dr Guy Young, a pediatric hematologist-oncologist at UCLA Medical Center, to discuss managing thromboembolic events in pediatric patients with cancer.

That’s all for today.

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