Six-year results from the randomized Phase 3 ENESTnd study continue to demonstrate the superiority of Tasigna (nilotinib) compared to Glivec (imatinib) at achieving higher rates of early, deep and sustained molecular responses in newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) patients. The six-year update from the ENESTnd trial was presented at the 56th annual meeting of the American Society of Hematology (ASH) in San Francisco.
"At the ENESTnd six-year follow up, we still see consistent evidence of deeper molecular response and fewer progressions to advanced disease in patients taking Tasigna compared to those on Glivec," said Giuseppe Saglio, MD, ENEST studies investigator, professor of Internal Medicine and Haematology and director of the Department of Molecular Medicine and Targeted Therapy, San Luigi University Hospital at the University of Turin, Orbassano, Italy. "These data provide further evidence of the consistent clinical profile of Tasigna as a leading treatment in newly-diagnosed patients."
The six-year data demonstrated higher rates of early and deeper sustained molecular response with Tasigna, including MR4.5, and a reduced risk of progression compared to Glivec. The difference in the rates of MR4.5 showed continued improvement for both Tasigna 300 mg and 400 mg twice-daily arms compared to Glivec. MR4.5 represents an extremely low level of detectable BCR-ABL protein, the cause of Ph+ CML. A higher proportion of patients in the Tasigna arms versus the Glivec arm achieved BCR-ABLIS <= 10% at 3 months.
Further, there were fewer progressions to accelerated phase/blast crisis (AP/BC) with Tasigna versus Glivec. Sixteen patients treated with Glivec had CML-related deaths, compared to 6 and 4 patients on the Tasigna 300 mg and 400 mg twice-daily arms, respectively. The safety profile of Tasigna remained consistent with previous reports. The most common adverse events were rash, headache, ALT increase and nausea, and the cardiovascular events rates were higher in the Tasigna arms compared to Glivec.
"Fifteen years ago at ASH, our first pivotal CML data were presented, representing the start of a revolutionary shift in the treatment of patients with this disease. Through our ongoing research, we better understand today the role that early, deep and sustained molecular responses have on the outcomes of patients with CML," said Bruno Strigini, President, Novartis Oncology. "We are now taking this knowledge a step further by exploring deeper molecular response like MR4.5 and the impact it may have on how we treat CML in the future."