15 October 2000, ESMO, Germany - Clinical data reveal that Mylotarg® (gemtuzumab ozogamicin) shows promising treatment potential for patients over 60 with first relapse acute myeloid leukaemia (AML)1 and may also be effective in enabling AML patients to receive additional post-remission therapy.
This is according to data presented today at 25 European Society for Medical Oncology2 (ESMO) by Dr Dimitris Voliotis, University Hospital Cologne, Germany, from an international team examining pooled data from three phase II clinical trials.
In the clinical trials, patients in first relapse AML were treated with Mylotarg at 9mg/m2 IV administered two weeks apart. Of the 142 patients receiving Mylotarg monotherapy, disease remission was observed in 34 per cent of patients less than 60 of years age and 26 per cent of patients aged 60 and over. Median overall survival for all patients was 5.9 months.
No clinically significant differences in adverse events were revealed in patients younger or older than 60 years of age.
‘Open label phase II trials of Mylotarg have shown a comparable remission rate and a favourable side effect profile for both patient groups, compared to historic control measures used in other chemotherapy trials’, says Dr Voliotis, University Hospital, Cologne, Germany.
‘Forty-two of the 142 patients achieved remission and 19 patients went on to receive post-remission therapy3. This suggests that Mylotarg may be effective in enabling patients to receive additional treatments offering the best hope for cure’, continues Dr Voliotis.
A majority of myeloid leukaemia cells as well as normal committed myeloid precursor cells in the bone marrow express CD33. This specificity means that myeloid leukaemic cells, but not pluripotent stem cells, are the therapeutic focus for this potent chemotherapy. For patients, this means that while Mylotarg causes bone marrow suppression, normal bone marrow function will return after treatment since the pluripotent stem cells are not effected.
Mylotarg is the first ever antibody-targeted chemotherapy using monoclonal antibody technology for AML. It is FDA approved4 to treat AML in first relapse in patients over sixty years of age who are not candidates for cytotoxic chemotherapy. As a novel anticancer therapy it is the first approved in its class of antibody-targeted chemotherapy.
Mylotarg was co-developed by Wyeth-Ayerst Pharmaceuticals and Celltech Group. Under the terms of the collaborative agreement, Mylotarg is marketed by Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products.
Universität zu Köln Klinik I für Innere Medizin
Director: Professor Dr. Volker Deihl
For further information, please contact:
On-site at ESMO, 12-13 October:
Stephen Morgan, Ketchum, mobile + 44 7771 788067
Email: stephen.morgan@ketchumcomms.co.uk
Off-site, Europe:
Rebecca Hunt, Ketchum, tel: + 44 20 7465 7698
Email: rebecca.hunt@ketchumcomms.co.uk
Off-site, US:
Tami Holden, Ketchum, tel: + 1 202 835 9465
Email: tami.holden@ketchum.com
Notes for editors
1. AML is the most common form of acute leukaemia in adults. It is characterised by a rapid accumulation of abnormal white blood cells in the blood and bone marrow, resulting in severe anaemia and susceptibility to infection and haemorrhage during the course of the disease. If untreated, AML is a rapidly fatal disease.
2. Voliotis et al, The efficacy and safety of gemtuzumab ozogamicin (CMA-676) in patients with acute myeloid leukemia in first relapse, to be presented as an oral presentation at ESMO – 15 October, Hall 8, Congress Centrum Hamburg, 09.20am CET.
3. Post remission therapy: haematopoietic stem cell translation [HSCT], or combination therapy for patients
4. Mylotarg’s FDA-approved indication is for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy