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Time for Gilead to cut magrolimab loose
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Another week, another magrolimab setback. The four remaining solid tumour trials of the Gilead anti-CD47 MAb that were formally still ongoing have now been placed on clinical hold by the FDA, according to a statement Gilead quietly slipped out last night. Last week the project’s key phase 3 AML trial Enhance-3 was discontinued, along with all work in haematology, after an increased risk of death was seen in magrolimab-treated patients, and at the time Gilead said the solid tumour studies were ongoing, pending further review. Those remaining trials, involving triple-negative breast, head and neck, colorectal, lung and bladder cancers, are now suspended, a hold Gilead said also applied to solid tumour trials sponsored by academic centres, of which OncologyPipeline identifies at least five. Given the drip-drip of bad news that each magrolimab setback brings, it’s high time for Gilead to discontinue the project formally and accept that the $4.9bn acquisition of its maker, Forty Seven, was one of the worst business development decisions of recent years.
Last solid tumour trials standing, until yesterday
Study | Setting | Design |
---|---|---|
Elevate TNBC | Triple-negative breast cancer | +chemo/Trodelvy |
Elevate HNSCC | Head & neck squamous cell carcinoma | +chemo +/-Keytruda/zimberelimab |
Elevate CRC | Colorectal cancer | +chemo +Avastin |
Elevate Lung & Urothelial Carcinoma | Solid tumours | +chemo |
NCT06046482* | Head & neck squamous cell carcinoma | +Erbitux +Keytruda/chemo |
Macocuc-01* | Urothelial carcinoma | +chemo |
PNOC025* | Brain tumours | Monotherapy |
NCT05807126** | Breast & prostate cancers | +Lynparza |
NCT04751383** | Neuroblastoma & osteosarcoma | +Unituxin |
Note: *academic sponsored; **NCI sponsored. Source: OncologyPipeline.
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