Novartis has reported findings from three large, randomized phase III studies demonstrate the superiority of Tasigna (nilotinib) compared to Glivec (imatinib) at achieving deeper molecular responses across various Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) patient populations, including newly diagnosed patients, patients with residual disease who switched to Tasigna after long-term treatment with Glivec, and patients who failed to respond to frontline Glivec (as defined by 2013 European LeukaemiaNet [ELN] guidelines).

These results were presented in oral sessions at the 55th annual meeting of the American Society of Hematology (ASH) in New Orleans, add to the growing body of evidence confirming the superiority of Tasigna to Glivec at achieving molecular response in Ph+ CML patients.

"These new and updated data reaffirm the superiority of Tasigna over Glivec at achieving deeper molecular responses and provide even more evidence supporting Tasigna as an appropriate treatment of choice in newly diagnosed patients and in those who switch to Tasigna after long-term treatment with 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 at San Luigi Hospital, University of Turin, Italy. "Now we are looking at how deeper molecular responses may help guide our approach towards how we treat CML in the future."

Presented at ASH were the five-year ENESTnd data, which continued to support the use of Tasigna in newly diagnosed Ph+ CML patients and demonstrated higher rates of early and deeper sustained molecular response, including MR4.5, and a reduced risk of progression compared to Glivec. The difference in the rates of both MR4 and MR4.5 continued to be higher for both Tasigna 300 mg and 400 mg twice daily arms compared to Glivec (MR4: 9-14 per cent difference by one year, 21-24 per cent difference by five years; MR4.5: 6-10 per cent difference by one year, 21-23 per cent difference by five years). Data indicated a trend for higher overall survival (OS) and event-free survival (EFS) rates in patients treated with Tasigna compared to patients treated with Glivec. Fifteen patients treated with Glivec had CML-related deaths, compared to six and four patients on the Tasigna 300 mg and 400 mg twice daily arms, respectively. Few new adverse events (AEs) and laboratory abnormalities were observed between four and five years. Rates of patients with AEs leading to discontinuation were 11.1 per cent, 17.7 per cent and 13.2 per cent in the Tasigna 300 mg twice daily, Tasigna 400 mg twice daily and Glivec arms, respectively.

In a separate follow-up analysis, results from the 36-month ENESTcmr data continued to show that Ph+ CML patients with residual disease following long-term treatment with Glivec achieved deeper molecular responses after switching to Tasigna. Among patients without documented MR4.5 at baseline, cumulative incidence of MR4.5 was higher in patients randomized to Tasigna versus Glivec (46.9% vs. 33.3%; nominal p=0.0453). MR4.5 was achieved faster with median time to response of 24.0 months in the Tasigna arm and was not reached in the Glivec arm (nominal p=0.0011). The safety profiles for Tasigna and Glivec were consistent with prior studies. By 36 months, no patients in either arm progressed to accelerated phase/blast crisis (AP/BC).

Also presented were results from the LASOR study, which demonstrated higher rates of molecular response in patients who failed to achieve a cytogenetic response (CCyR) with frontline Glivec (patients who do not achieve CCyR by six months, have loss of response at any time or have intolerance) who switched to Tasigna, versus those who dose escalated on Glivec (600 mg daily). While the primary endpoint of CCyR at six months after randomization, which was confounded by high rates of crossover to Tasigna from the Glivec arm, did not achieve statistical significance (p=0.3844), the clinical benefit of Tasigna was best evaluated when considering cross-over patients as non-responders. A sensitivity analysis conducted supported the efficacy of Tasigna over Glivec. The safety profile for both drugs was consistent with prior reports of patients who switched therapy after inadequate responses to Glivec.

"Today, we know from clinical studies that patients who achieve and maintain deep levels of response, known as MR4.5, do not progress to the advanced stages of CML," said Hervé Hoppenot, president, Novartis Oncology. "These large studies continue to establish the benefits of Tasigna at achieving deeper molecular responses and we are committed to exploring the impact this may have on how we treat CML in the future."

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies and also offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products.