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FDA Approval of a Biosimilar, Promising Data in Myeloma and GBM, and More

Gina Columbus
Published: Monday, Nov 11, 2019



Today-

An FDA approval of a biosimilar, promising findings in multiple myeloma and glioblastoma multiforme, disappointing results in pancreatic cancer, and a nomination for the next FDA commissioner.

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

The FDA has approved the pegfilgrastim biosimilar LA-EP2006, known by the trade name Ziextenzo, as a treatment to decrease the incidence of infection in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer therapy that is linked with a clinically significant incidence of febrile neutropenia.

The approval is based on analytical, preclinical, and clinical studies, including data from the pivotal three-way pharmacokinetics and pharmacodynamics LA-EP06-104 trial. The study compared the pegfilgrastim biosimilar, which is developed by Sandoz, with US-sourced reference pegfilgrastim; the pegfilgrastim biosimilar with European Union–sourced reference pegfilgrastim; and US- with EU-sourced reference pegfilgrastim.

Results showed that PK and PD similarity were demonstrated in all three comparisons, and there were no clinically meaningful differences observed in safety and immunogenicity among the groups.

In November 2018, the European Commission approved LA-EP2006 as a treatment to reduce the duration of neutropenia and incidence of febrile neutropenia that is associated with anticancer chemotherapy.

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In multiple myeloma, ixazomib as a first-line maintenance therapy significantly improved progression-free survival compared with placebo in adult patients who have not undergone stem cell transplantation, meeting the primary endpoint of the phase III TOURMALINE-MM4 study.

The trial comprised the concept of switch maintenance therapy and enrolled patients who had completed 6 to 12 months of initial therapy and achieved a partial response. The topline findings also showed that ixazomib’s safety profile in this setting was consistent with previously reported data of the proteasome inhibitor, and no new safety signals were reported. Full findings will be submitted for presentation at an upcoming medical meeting.

The FDA initially approved ixazomib in 2015 for use in combination with lenalidomide and dexamethasone as a treatment for patients with multiple myeloma who have received at least 1 prior therapy.

Ixazomib also showed promising activity in the maintenance setting. Results of the phase III TOURMALINE-MM3 trial showed that 2-year maintenance treatment with ixazomib led to a 39% improvement in PFS compared with placebo in patients with newly diagnosed disease who achieved a partial response to induction treatment with a proteasome inhibitor and/or an immunomodulatory agent following autologous stem cell transplant.

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

In interim findings from a phase II trial, the combination of INO-5401 and INO-9012 with cemiplimab plus chemoradiation demonstrated promising 6-month progression-free survival rates in patients with newly diagnosed glioblastoma multiforme that is MGMT methylated or unmethylated.

Results of the 52-patient study showed that 80% of MGMT gene promoter—methylated patients and 75% of MGMT-unmethylated patients were progression-free at 6 months, measured from the time of their first dose. These data are said to exceed historical standard-of-care results, stated Inovio Pharmaceuticals, the developer of INO-5401 and INO-9012.

Detailed results of the study were presented as part of a late-breaking abstract during the 2019 SITC Annual Meeting, which include supportive safety, tolerability, and immunogenicity data. The combination also demonstrated an acceptable safety profile that was consistent with that of cemiplimab as well as INO-5401 and INO-9012.

Final data from the phase II trial are expected in the fourth quarter of 2020.

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

In pancreatic cancer, pegvorhyaluronidase alfa, known as PEGPH20, in combination with gemcitabine and nab-paclitaxel did not show an improvement in overall survival compared with gemcitabine and nab-paclitaxel alone in patients with metastatic disease, missing the primary endpoint of the phase III HALO-109-301 trial.

Results showed that the addition of PEGPH20 led to a median OS of 11.2 months compared with 11.5 months in those who received gemcitabine/nab-paclitaxel alone. There was a higher response rate in the PEGPHO20 arm, but it did not translate into an improvement in progression-free survival, OS, or duration of response.

Due to these findings, Halozyme, the manufacturer of PEGPH20, stated in a press release that it intends to halt development activities for PEGPH20 and will implement an organizational restructuring.

Prior data demonstrated that PEGPH20 showed a benefit in patients with metastatic hyaluran-high pancreatic cancer. In the phase II HALO-109-202 study, the objective response rate in patients with HA-high tumors was 45% with PEGPH20 plus nab-paclitaxel and gemcitabine versus 31% with nab-paclitaxel/gemcitabine alone in patients with untreated, metastatic pancreatic ductal adenocarcinoma.

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

President Donald Trump is nominating Stephen M. Hahn, MD, FASTRO, as the next commissioner of the FDA. Hahn is currently serving as The University of Texas MD Anderson Cancer Center’s chief medical executive and was reportedly the preferred choice of Department of Health and Human Services Secretary Alex Azar.

If the nomination is confirmed by the Senate, the radiation oncologist will serve as the successor to Scott Gottlieb, MD, who resigned from the role in March 2019. This would be Hahn’s first venture into public service in over 2 decades.

Acting Commissioner Ned Sharpless, MD, who was appointed to the position in April 2019, is expected to remain in the position throughout the confirmation hearings. Sharpless is expected to return to his role at the National Cancer Institute if the nomination passes through the Senate.

To meet the terms of the Federal Vacancies Reform Act, the Trump administration has temporarily named the current HHS Assistant Secretary of Health Brett P. Giroir, MD, as the interim FDA chief until Hahn is appointed into his position.

Throughout his career, Hahn has also served as the chief of the NCI’s prostate cancer clinic, the chairman of the Radiation Oncology Department at the University of Pennsylvania Medical School, and is the author of over 200 peer-reviewed journal articles and publications.

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

This week, we sat down with Dr David Hong, of The University of Texas MD Anderson Cancer Center, to discuss future challenges and evolutions with TRK inhibition.

That’s all for today.

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

An FDA approval of a biosimilar, promising findings in multiple myeloma and glioblastoma multiforme, disappointing results in pancreatic cancer, and a nomination for the next FDA commissioner.

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

The FDA has approved the pegfilgrastim biosimilar LA-EP2006, known by the trade name Ziextenzo, as a treatment to decrease the incidence of infection in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer therapy that is linked with a clinically significant incidence of febrile neutropenia.

The approval is based on analytical, preclinical, and clinical studies, including data from the pivotal three-way pharmacokinetics and pharmacodynamics LA-EP06-104 trial. The study compared the pegfilgrastim biosimilar, which is developed by Sandoz, with US-sourced reference pegfilgrastim; the pegfilgrastim biosimilar with European Union–sourced reference pegfilgrastim; and US- with EU-sourced reference pegfilgrastim.

Results showed that PK and PD similarity were demonstrated in all three comparisons, and there were no clinically meaningful differences observed in safety and immunogenicity among the groups.

In November 2018, the European Commission approved LA-EP2006 as a treatment to reduce the duration of neutropenia and incidence of febrile neutropenia that is associated with anticancer chemotherapy.

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

In multiple myeloma, ixazomib as a first-line maintenance therapy significantly improved progression-free survival compared with placebo in adult patients who have not undergone stem cell transplantation, meeting the primary endpoint of the phase III TOURMALINE-MM4 study.

The trial comprised the concept of switch maintenance therapy and enrolled patients who had completed 6 to 12 months of initial therapy and achieved a partial response. The topline findings also showed that ixazomib’s safety profile in this setting was consistent with previously reported data of the proteasome inhibitor, and no new safety signals were reported. Full findings will be submitted for presentation at an upcoming medical meeting.

The FDA initially approved ixazomib in 2015 for use in combination with lenalidomide and dexamethasone as a treatment for patients with multiple myeloma who have received at least 1 prior therapy.

Ixazomib also showed promising activity in the maintenance setting. Results of the phase III TOURMALINE-MM3 trial showed that 2-year maintenance treatment with ixazomib led to a 39% improvement in PFS compared with placebo in patients with newly diagnosed disease who achieved a partial response to induction treatment with a proteasome inhibitor and/or an immunomodulatory agent following autologous stem cell transplant.

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

In interim findings from a phase II trial, the combination of INO-5401 and INO-9012 with cemiplimab plus chemoradiation demonstrated promising 6-month progression-free survival rates in patients with newly diagnosed glioblastoma multiforme that is MGMT methylated or unmethylated.

Results of the 52-patient study showed that 80% of MGMT gene promoter—methylated patients and 75% of MGMT-unmethylated patients were progression-free at 6 months, measured from the time of their first dose. These data are said to exceed historical standard-of-care results, stated Inovio Pharmaceuticals, the developer of INO-5401 and INO-9012.

Detailed results of the study were presented as part of a late-breaking abstract during the 2019 SITC Annual Meeting, which include supportive safety, tolerability, and immunogenicity data. The combination also demonstrated an acceptable safety profile that was consistent with that of cemiplimab as well as INO-5401 and INO-9012.

Final data from the phase II trial are expected in the fourth quarter of 2020.

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

In pancreatic cancer, pegvorhyaluronidase alfa, known as PEGPH20, in combination with gemcitabine and nab-paclitaxel did not show an improvement in overall survival compared with gemcitabine and nab-paclitaxel alone in patients with metastatic disease, missing the primary endpoint of the phase III HALO-109-301 trial.

Results showed that the addition of PEGPH20 led to a median OS of 11.2 months compared with 11.5 months in those who received gemcitabine/nab-paclitaxel alone. There was a higher response rate in the PEGPHO20 arm, but it did not translate into an improvement in progression-free survival, OS, or duration of response.

Due to these findings, Halozyme, the manufacturer of PEGPH20, stated in a press release that it intends to halt development activities for PEGPH20 and will implement an organizational restructuring.

Prior data demonstrated that PEGPH20 showed a benefit in patients with metastatic hyaluran-high pancreatic cancer. In the phase II HALO-109-202 study, the objective response rate in patients with HA-high tumors was 45% with PEGPH20 plus nab-paclitaxel and gemcitabine versus 31% with nab-paclitaxel/gemcitabine alone in patients with untreated, metastatic pancreatic ductal adenocarcinoma.

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

President Donald Trump is nominating Stephen M. Hahn, MD, FASTRO, as the next commissioner of the FDA. Hahn is currently serving as The University of Texas MD Anderson Cancer Center’s chief medical executive and was reportedly the preferred choice of Department of Health and Human Services Secretary Alex Azar.

If the nomination is confirmed by the Senate, the radiation oncologist will serve as the successor to Scott Gottlieb, MD, who resigned from the role in March 2019. This would be Hahn’s first venture into public service in over 2 decades.

Acting Commissioner Ned Sharpless, MD, who was appointed to the position in April 2019, is expected to remain in the position throughout the confirmation hearings. Sharpless is expected to return to his role at the National Cancer Institute if the nomination passes through the Senate.

To meet the terms of the Federal Vacancies Reform Act, the Trump administration has temporarily named the current HHS Assistant Secretary of Health Brett P. Giroir, MD, as the interim FDA chief until Hahn is appointed into his position.

Throughout his career, Hahn has also served as the chief of the NCI’s prostate cancer clinic, the chairman of the Radiation Oncology Department at the University of Pennsylvania Medical School, and is the author of over 200 peer-reviewed journal articles and publications.

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

This week, we sat down with Dr David Hong, of The University of Texas MD Anderson Cancer Center, to discuss future challenges and evolutions with TRK inhibition.

That’s all for today.

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