Swiss drugmaker Novartis AG (NVS) said findings from three large, randomized Phase III studies demonstrate the superiority of Tasigna or nilotinib compared to Glivec or imatinib at achieving deeper molecular responses across various Philadelphia chromosome-positive chronic myeloid leukemia or Ph+ CML patient populations.
These populations include 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.
Tasigna is approved in over 110 countries for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to at least one prior therapy, including Glivec.
These results were presented in oral sessions at the 55th annual meeting of the American Society of Hematology or ASH in New Orleans. They add to the growing body of evidence confirming the superiority of Tasigna to Glivec at achieving molecular response in Ph+ CML patients, Novartis noted.
The five-year ENESTnd data presented 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.
ENESTnd data indicate trend for longer overall survival and event-free survival in newly diagnosed Ph+ CML patients on Tasigna compared to Glivec.
A separate study, ENESTcmr, confirmed that treatment with Tasigna led to deeper molecular response in patients who switch after long-term treatment with Glivec.
New data showed that patients who failed to respond to frontline Glivec achieved higher rates of molecular response with switch to Tasigna in comparison with Glivec dose escalation.
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