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The US Food and Drug Administration (FDA) has lifted the partial clinical hold on the investigational new drug (IND) application for pidilizumab (MDV9300) in hematologic malignancies.
This means the phase 2 trial of pidilizumab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), as well as other studies that cross-reference the IND for the drug, may now proceed.
The partial clinical hold on pidilizumab was not related to any safety concerns.
The FDA placed the hold because the company developing pidilizumab, Medivation Inc., determined that the drug is not an inhibitor of PD-1, as researchers previously thought.
The phase 2 trial of pidilizumab in DLBCL was launched in late 2015 but had not enrolled any patients before the FDA placed the partial clinical hold.
Patients who were receiving pidilizumab through investigator-sponsored trials have continued to receive treatment despite the hold, and those investigators have been told to update their protocols and informed consent documents to reflect that pidilizumab is not an anti-PD-1 antibody.
Medivation has likewise revised the investigator brochure, protocols, and informed consent documents related to the phase 2 trial of DLBCL patients.
The company said it is still trying to determine pidilizumab’s mechanism of action.
“We are delighted that the FDA has lifted the partial clinical hold and that we may proceed with our potentially pivotal trial in this area of high unmet medical need,” said David Hung, MD, founder, president, and chief executive officer of Medivation.
“As we move forward, we also are working to determine the compound’s exact binding mechanism which, we believe, modulates the body’s innate immune response and differentiates it from the heavily crowded immuno-oncology space that targets the adaptive side of immunity.”
Medivation said it intends to submit an amendment to the Chemistry, Manufacturing, and Controls section of the IND for pidilizumab to provide for larger manufacturing lot sizes to better support the current and planned clinical activities for the drug.
The company also said it plans to resume the phase 2 trial of pidilizumab in DLBLCL in the second half of this year.
The trial is expected to enroll approximately 180 patients who had an incomplete response to salvage therapy or autologous stem cell transplant for relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma, or primary mediastinal B-cell lymphoma.
The patients will be assessed in 2 parallel cohorts of approximately 90 patients each. One cohort will enroll patients who have received an autologous stem cell transplant, and the other will enroll patients who have received salvage chemotherapy but are ineligible for transplant.
Pidilizumab will be given at a dose of 200 mg by intravenous infusion. The primary endpoint of the trial is best overall response rate. 
The US Food and Drug Administration (FDA) has lifted the partial clinical hold on the investigational new drug (IND) application for pidilizumab (MDV9300) in hematologic malignancies.
This means the phase 2 trial of pidilizumab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), as well as other studies that cross-reference the IND for the drug, may now proceed.
The partial clinical hold on pidilizumab was not related to any safety concerns.
The FDA placed the hold because the company developing pidilizumab, Medivation Inc., determined that the drug is not an inhibitor of PD-1, as researchers previously thought.
The phase 2 trial of pidilizumab in DLBCL was launched in late 2015 but had not enrolled any patients before the FDA placed the partial clinical hold.
Patients who were receiving pidilizumab through investigator-sponsored trials have continued to receive treatment despite the hold, and those investigators have been told to update their protocols and informed consent documents to reflect that pidilizumab is not an anti-PD-1 antibody.
Medivation has likewise revised the investigator brochure, protocols, and informed consent documents related to the phase 2 trial of DLBCL patients.
The company said it is still trying to determine pidilizumab’s mechanism of action.
“We are delighted that the FDA has lifted the partial clinical hold and that we may proceed with our potentially pivotal trial in this area of high unmet medical need,” said David Hung, MD, founder, president, and chief executive officer of Medivation.
“As we move forward, we also are working to determine the compound’s exact binding mechanism which, we believe, modulates the body’s innate immune response and differentiates it from the heavily crowded immuno-oncology space that targets the adaptive side of immunity.”
Medivation said it intends to submit an amendment to the Chemistry, Manufacturing, and Controls section of the IND for pidilizumab to provide for larger manufacturing lot sizes to better support the current and planned clinical activities for the drug.
The company also said it plans to resume the phase 2 trial of pidilizumab in DLBLCL in the second half of this year.
The trial is expected to enroll approximately 180 patients who had an incomplete response to salvage therapy or autologous stem cell transplant for relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma, or primary mediastinal B-cell lymphoma.
The patients will be assessed in 2 parallel cohorts of approximately 90 patients each. One cohort will enroll patients who have received an autologous stem cell transplant, and the other will enroll patients who have received salvage chemotherapy but are ineligible for transplant.
Pidilizumab will be given at a dose of 200 mg by intravenous infusion. The primary endpoint of the trial is best overall response rate.
The US Food and Drug Administration (FDA) has lifted the partial clinical hold on the investigational new drug (IND) application for pidilizumab (MDV9300) in hematologic malignancies.
This means the phase 2 trial of pidilizumab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), as well as other studies that cross-reference the IND for the drug, may now proceed.
The partial clinical hold on pidilizumab was not related to any safety concerns.
The FDA placed the hold because the company developing pidilizumab, Medivation Inc., determined that the drug is not an inhibitor of PD-1, as researchers previously thought.
The phase 2 trial of pidilizumab in DLBCL was launched in late 2015 but had not enrolled any patients before the FDA placed the partial clinical hold.
Patients who were receiving pidilizumab through investigator-sponsored trials have continued to receive treatment despite the hold, and those investigators have been told to update their protocols and informed consent documents to reflect that pidilizumab is not an anti-PD-1 antibody.
Medivation has likewise revised the investigator brochure, protocols, and informed consent documents related to the phase 2 trial of DLBCL patients.
The company said it is still trying to determine pidilizumab’s mechanism of action.
“We are delighted that the FDA has lifted the partial clinical hold and that we may proceed with our potentially pivotal trial in this area of high unmet medical need,” said David Hung, MD, founder, president, and chief executive officer of Medivation.
“As we move forward, we also are working to determine the compound’s exact binding mechanism which, we believe, modulates the body’s innate immune response and differentiates it from the heavily crowded immuno-oncology space that targets the adaptive side of immunity.”
Medivation said it intends to submit an amendment to the Chemistry, Manufacturing, and Controls section of the IND for pidilizumab to provide for larger manufacturing lot sizes to better support the current and planned clinical activities for the drug.
The company also said it plans to resume the phase 2 trial of pidilizumab in DLBLCL in the second half of this year.
The trial is expected to enroll approximately 180 patients who had an incomplete response to salvage therapy or autologous stem cell transplant for relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma, or primary mediastinal B-cell lymphoma.
The patients will be assessed in 2 parallel cohorts of approximately 90 patients each. One cohort will enroll patients who have received an autologous stem cell transplant, and the other will enroll patients who have received salvage chemotherapy but are ineligible for transplant.
Pidilizumab will be given at a dose of 200 mg by intravenous infusion. The primary endpoint of the trial is best overall response rate.