on the eve of World CML Day, Novartis has achieved the latest milestone in its unique clinical trial programme evaluating the potential for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) to maintain undetectable levels of disease after stopping drug therapy, a concept called treatment-free remission. More than 100 study sites are now enrolling patients to the trial programme.
Since 2008, organisations around the world have recognised World CML Day[1]. The date, September 22 or 9/22, was symbolically chosen to represent the genetic material that is associated with CML, the missing section from chromosome 22 shifts to chromosome 9 and vice versa, in a phenomenon called ‘translocation[2].” Known as the Philadelphia chromosome, this genetic mutation is present in about 95 per cent of CML patients[3].
“As a leader in CML, Novartis is proud to support World CML Day through our continued dedication to ongoing research in this disease,” said Hervé Hoppenot, President, Novartis Oncology. “Given that nilotinib has been shown in large clinical trials to drive deeper levels of responses in more than twice as many patients as imatinib, we are now looking to the next phase and exploring if nilotinib can treat the disease to a point where drug therapy is no longer needed, representing the next step in what may be possible for patients living with Ph+ CML.”
Over the past decades, Novartis research in Ph+ CML has helped transform the disease from a fatal diagnosis to a chronic condition for many patients. Today, the company continues its long-standing commitment to the global CML community. The Novartis treatment-free remission clinical trial programme* includes eight studies that are now underway and actively enrolling Ph+ CML patients in more than 100 global sites across 40 countries[4]. In total, it is planned that more than 2,500 patients will be enrolled in these studies and an estimated nearly 1,000 patients will aim to stop treatment as part of these studies[4].
References:
* In the Novartis treatment-free remission clinical trial program, molecular response (reduction of BCR-ABL transcripts in the blood of patients) is measured at four levels, based on an international standard:
MMR (<= 0.1% BCR-ABL)
MR4 (<= 0.01% BCR-ABL)
MR4.5 (<= 0.0032% BCR-ABL)
Undetectable BCR-ABL (no detectable BCR-ABL transcript level with sample sensitivity of at least 4.5 log)
1. What is World CML Day? CML Advocates Network. http://www.cmladvocates.net/worldcmlday/what-is-world-cml-day
2. National Comprehensive Cancer Network (NCCN): Clinical Practice Guidelines in Oncology: Chronic Myelogenous Leukemia, V.4.2013. Available at: http://www.nccn.org/professionals/physician_gls/pdf/cml.pdf
3. Faderl, Stefan, et al. “The biology of chronic myeloid leukemia.” New England Journal of Medicine.1999; 341.3: 164-172.
4. Novartis data on file.
EP News Bureau – Mumbai