Hutchmed enrols last patient in lymphoma treatment trial
Hutchmed China announced the completion of patient enrollment in a phase two registration trial of ‘amdizalisib’ on Monday, for the treatment of relapsed or refractory follicular lymphoma (FL), which is a subtype of non-Hodgkin's lymphoma.
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The AIM-traded firm said the last patient was enrolled on 24 February.
It said the clinical trial is a multi-centre, single-arm, open-label study to evaluate the safety and efficacy of amdizalisib once-a-day oral monotherapy in patients with relapsed or refractory FL or marginal zone lymphoma (MZL).
The trial was being conducted in more than 35 sites in China, with 108 relapsed or refractory FL patients enrolled.
Hutchmed said the primary endpoint was the objective response rate, while the secondary endpoints included complete response rate, progression-free survival, time-to-response, and duration of response.
“Topline results on the patients in this trial are expected to be reported in the second half of 2023, followed by submission of results for presentation at an appropriate medical conference,” the Hutchmed board said in its statement.
“If positive, Hutchmed would initiate plans to apply for marketing authorization of amdizalisib for relapsed or refractory FL from the China National Medical Products Administration.”
At 1341 GMT, shares in Hutchmed China were up 1.24% at 269.29p.
Reporting by Josh White for Sharecast.com.