Gilead’s magrolimab shows promising responses in untreated myelodysplastic syndrome and acute myeloid leukaemia at ASCO 2020

pharmafile | June 1, 2020 | News story | Research and Development, Sales and Marketing ASCO 2020, Cancer, Gilead, leukaemia, magrolimab 

Gilead took the opportunity at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting to unveil new Phase 1b data on the combination of its investigational anti-CD47 monoclonal antibody magrolimab with azacitidine, showing positive responses in treatment-naïve myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) patients.

Sixty-eight trial participants had received the drug combo by the time of data cut-off; 39 had higher-risk MDS, while 29 were AML patients who were not eligible for intensive chemotherapy. Both groups were previously untreated.

The researchers found 33 of the MDS patients to be evaluable, and 30, or 91%, of this number achieved an objective response rate; 41% scored a complete response, and this grew to 56% after six months.  

Twenty five AML patients in the trial were deemed evaluable, with 16, or 64%, achieving an objective response, with 56% achieving complete response with or without incomplete blood count recovery. In the 12 patients whose disease was TP53-mutated, 75% achieved this same benchmark.

Data on median duration of response or overall survival had not yet matured by the time of analysis.

“We continue to be encouraged by the response rates observed with magrolimab and azacitidine in first-line, high-risk MDS and AML,” remarked Dr David Sallman of the H Lee Moffitt Cancer Center and Research Institute, who served as an investigator for the trial. “Particularly impressive are the responses in some of the most difficult-to-treat patients, including AML patients with a TP53 mutation. This patient group suffers from a lack of effective treatment options. These results support further study in these patients and provide hope for a potentially meaningful clinical advance.”

Gilead plans to continue enrolment for the ongoing trial, with the ambition of including a total of 257 participants, while also bringing in additional studies in MDS and TP53-mutant AML.

Matt Fellows

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