Genmab announces positive interim results in phase I/II HuMax(R)-CD20 CLL study
Genmab A/S announced that treatment with HuMax-CD20 significantly reduced leukemia cells in patients with relapsed chronic lymphocytic leukemia (CLL) in a Phase I/II study. In a preliminary analysis at week 11, a response rate of 52% (12 of 23 evaluable patients) was observed in patients treated at the highest dose level (2000 mg). This includes a complete response rate of 22% (5 patients, bone marrow and CT pending) and a partial response rate of 30% (7 patients).
After the fourth and final treatment, all patients treated at the highest dose level (2000 mg) experienced pronounced leukemia cell depletion. Markedly reduced leukemia cell counts were observed in 3 of 6 patients treated at the 500 and 1000 mg dose levels and the depletion was sustained in one of these patients. In addition, at week 11, 15 patients experienced a more than 50% reduction in the size of enlarged lymph nodes.
HuMax-CD20 was well tolerated by CLL patients in the study and the maximum tolerated dose was not reached. Investigators reported 5 serious adverse events assessed as potentially related to HuMax-CD20: hepatic cytolysis, herpes zoster, neutropenia (2 patients) and one death from pneumonia. The pneumonia event was reported 4 weeks after the last treatment. The patient suffered from CLL for 10 years and had a history of 3 episodes of interstitial pneumonia in the years up to enrolment in the trial.
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