BerGenBio posts updated data on trial of elderly AML patients

Shares in BerGenBio are down more than 30% so far in June. (BerGenBio)

BerGenBio has posted updated data from its phase 2 trial of bemcentinib in acute myeloid leukaemia (AML). The study is assessing the effect of the oral AXL inhibitor when given to elderly AML patients in combination with low-intensity chemotherapy.

The presence of a population of elderly AML patients who are unfit for intensive chemotherapy has been a draw for European biotechs. Erytech tried to develop its encapsulated form of L-asparaginase, eryaspase, in the indication, only to come unstuck when adding the drug to low-dose cytarabine failed to improve overall survival in a phase 2b.  

Norway’s BerGenBio is coming at the problem from a different angle. Bemcentinib, formerly known as BGB324, targets AXL kinase, a cell membrane receptor that suppresses immune attacks on tumors. Overexpression of AXL is associated with negative outcomes in AML.

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BerGenBio presented data from the phase 2 trial at the American Society of Clinical Oncology (ASCO) annual meeting earlier this month and arrived at the 2019 congress of the European Hematology Association (EHA) this week with a slightly updated data set.

The biotech now has response data on another patient, a nonresponder. That additional subject caused the objective response rate to slip a few percentage points to 43%. As at ASCO, the EHA data feature two patients who had partial responses and four who experienced complete remission, in some cases with incomplete hematologic recovery.

The biggest change is in the median relapse-free survival of the four patients in complete remission. In the older data, the figure stood at 6.2 months. Now, it is up to 7.9 months. The survival data are yet to mature.

Shares in BerGenBio are down more than 30% so far in June, a month that began with the release of data at ASCO. The stock gained around 6% following the release of the EHA data, dragging it out of the low it hit yesterday—when at one point it was down 42% over the start of June—but still leaving it well short of the pre-ASCO level.  

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