Patients Respond Well To First Study To Test Higher Doses Of an Anti-Cancer Drug
Clinical trial reveals limited side effects and evidence of clinical activity
Researchers in the UK and the United States have found that a drug composed of an antibody carrying a highly toxic anti-cancer agent is well tolerated by patients at much higher doses than have been used before.
The drug, BB-10901 (huN901-DM1), is being tested in a phase I clinical trial in patients who have relapsed or failed to respond to previous treatment for a range of cancers, such as small cell lung cancer (SCLC), other tumours in the lungs of neuroendocrine origin and non-pulmonary small cell carcinomas. Although the trial is not designed to test the efficacy of the drug, researchers report promising clinical responses in patients, including one patient who has remained in remission for more than a year.
Dr Paul Lorigan reported to the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Prague today (Friday): "The results are important in that, in contrast to a prior regimen investigated in a phase I trial in the United States, significantly higher dose intensity is achieved with the current schedule. This has implications for the design of future trials with this agent, especially as the amount of the drug given is likely to be important in determining clinical response and outcome. In addition, the presence of a durable, complete response as well as other hints of clinical activity are very encouraging.
"The tolerability of this agent compares very favourably with that of standard chemotherapy. The lack of clinically significant bone marrow toxicity by BB-10901 raises the possibility that such an agent could be used either alone or in combination with standard chemotherapy in future clinical trials."
Dr Lorigan, a senior lecturer in medical oncology at the Christie Hospital, Manchester, UK, worked with colleagues in the UK and USA to investigate different dose levels, any adverse effects and how the drug was cleared from the body (pharmacokinetics). The drug, also known as huN901-DM1, is an immunoconjugate