— Enrolled Patients in These Studies May Continue Receiving Study Medicine —
— Studies Outside of Combination with Azacitidine Unaffected —
FOSTER CITY, CA, USA I January 25, 2022 I Gilead Sciences Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms. While no clear trend in the adverse reactions or new safety signal has been identified by Gilead at this time, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA.
During the partial clinical hold, screening and enrollment of new study participants will be paused in any study investigating the combination of magrolimab with azacitidine. Patients already enrolled in these clinical studies may continue to receive magrolimab and azacitidine, or placebo, and continue to be closely monitored according to the current study protocol. Gilead is currently notifying clinical investigators and global regulatory authorities about the partial clinical hold. Other magrolimab studies, or cohorts, that are not studying the combination of magrolimab plus azacitidine, will continue without any impact by the partial clinical hold.
“The safety and well-being of people enrolled in our studies is our top priority. We will share more information with the medical and patient community as soon as we can,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Considering the high unmet need for new medicines in myelodysplastic syndrome and acute myeloid leukemia, we will work closely with regulatory authorities worldwide to continue the magrolimab development program appropriately. We remain confident in the potential of magrolimab across a broad range of tumors, including the other, ongoing magrolimab studies. We are grateful to those participating in our studies, their families, and the investigators for their continued contributions to the clinical program for magrolimab.”
Gilead is working with regulatory authorities to determine next steps to release the partial clinical hold for new patient enrollment for the affected studies.
The studies impacted by this partial clinical hold include:
- Phase 3 ENHANCE study in myelodysplastic syndrome (MDS; NCT04313881)
- Phase 3 ENHANCE-2 study in acute myeloid leukemia (AML; TP53 mutated patients; NCT04778397)
- Phase 3 ENHANCE-3 study in unfit AML (NCT05079230)
- Phase 1b study in MDS (NCT03248479)
- Phase 2 study in myeloid malignancies (NCT04778410) *only the azacitidine combination cohorts
The studies not impacted include:
- Phase 2 study in diffuse large B-cell lymphoma (NCT02953509)
- Phase 2 study in multiple myeloma (NCT04892446)
- Phase 2 study in head and neck squamous cell carcinoma (NCT04854499)
- Phase 2 study in solid tumors (NCT04827576)
- Phase 2 study in triple-negative breast cancer (NCT04958785)
- Phase 2 study in colorectal cancer, planned and not currently recruiting
About Magrolimab
Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the “don’t eat me” signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic cancers, including myelodysplastic syndrome (MDS), as well as solid tumor malignancies.
More information about clinical trials with magrolimab is available at www.clinicaltrials.gov.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
SOURCE: Gilead Sciences
Post Views: 556
— Enrolled Patients in These Studies May Continue Receiving Study Medicine —
— Studies Outside of Combination with Azacitidine Unaffected —
FOSTER CITY, CA, USA I January 25, 2022 I Gilead Sciences Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms. While no clear trend in the adverse reactions or new safety signal has been identified by Gilead at this time, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA.
During the partial clinical hold, screening and enrollment of new study participants will be paused in any study investigating the combination of magrolimab with azacitidine. Patients already enrolled in these clinical studies may continue to receive magrolimab and azacitidine, or placebo, and continue to be closely monitored according to the current study protocol. Gilead is currently notifying clinical investigators and global regulatory authorities about the partial clinical hold. Other magrolimab studies, or cohorts, that are not studying the combination of magrolimab plus azacitidine, will continue without any impact by the partial clinical hold.
“The safety and well-being of people enrolled in our studies is our top priority. We will share more information with the medical and patient community as soon as we can,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Considering the high unmet need for new medicines in myelodysplastic syndrome and acute myeloid leukemia, we will work closely with regulatory authorities worldwide to continue the magrolimab development program appropriately. We remain confident in the potential of magrolimab across a broad range of tumors, including the other, ongoing magrolimab studies. We are grateful to those participating in our studies, their families, and the investigators for their continued contributions to the clinical program for magrolimab.”
Gilead is working with regulatory authorities to determine next steps to release the partial clinical hold for new patient enrollment for the affected studies.
The studies impacted by this partial clinical hold include:
- Phase 3 ENHANCE study in myelodysplastic syndrome (MDS; NCT04313881)
- Phase 3 ENHANCE-2 study in acute myeloid leukemia (AML; TP53 mutated patients; NCT04778397)
- Phase 3 ENHANCE-3 study in unfit AML (NCT05079230)
- Phase 1b study in MDS (NCT03248479)
- Phase 2 study in myeloid malignancies (NCT04778410) *only the azacitidine combination cohorts
The studies not impacted include:
- Phase 2 study in diffuse large B-cell lymphoma (NCT02953509)
- Phase 2 study in multiple myeloma (NCT04892446)
- Phase 2 study in head and neck squamous cell carcinoma (NCT04854499)
- Phase 2 study in solid tumors (NCT04827576)
- Phase 2 study in triple-negative breast cancer (NCT04958785)
- Phase 2 study in colorectal cancer, planned and not currently recruiting
About Magrolimab
Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the “don’t eat me” signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic cancers, including myelodysplastic syndrome (MDS), as well as solid tumor malignancies.
More information about clinical trials with magrolimab is available at www.clinicaltrials.gov.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
SOURCE: Gilead Sciences
Post Views: 556
