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news.Drug demonstrates greater efficacy over Glivec in patients with early-stage chronic myeloid leukemia
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Novartis has reported result of Tasigna Phase III clinical trial. In the study, Tasigna (nilotinib) demonstrated greater efficacy over Glivec (imatinib) in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
In the first head-to-head comparison of these two oral therapies as initial treatment for blood cancer, Tasigna results showed positive improvement over Glivec in every measure of efficacy, including major molecular response (MMR), complete cytogenetic response (CCyR) and prevention of progression to accelerated or blastic phase.
Repotedly, at 12 months, fewer patients progressed to accelerated or blastic phase on Tasigna 300mg twice daily than on Glivec 400mg once daily, demonstrating a positive improvement in disease control. In the study, Tasigna was well tolerated.
The company said that with Tasigna 300mg twice daily, the rate of MMR at 12 months was twice that of patients receiving Glivec 400mg once daily. In addition, 80% of patients achieved CCyR with Tasigna versus 65% with Glivec 400mg once daily. Responses were achieved faster in the Tasigna group than in the Glivec group.
Giuseppe Saglio, a member of the study management committee, said: “The positive rates of response observed with Tasigna, combined with the very low rate of disease progression, strongly indicate that patients who begin their treatment with Tasigna may have long-term improvement of progression-free survival. The efficacy results and tolerability of Tasigna should support its use in newly diagnosed Ph+ CML patients.”
David Epstein, president and CEO of oncology and molecular diagnostics, Novartis, said: “Considering the already low rates of progression to advanced disease and the excellent long-term survival of patients on Glivec, the efficacy and safety profile of Tasigna at 12 months is fantastic news and brings promise for further improving the outcomes of patients with Ph+ CML.”