Novartis NVS announced new long-term follow-up data from the ongoing, pivotal open-label ENESTfreedom and ENESTop trials.
The data from the trials showed sustained treatment-free remission (TFR) after stopping frontline and second-line Tasigna (nilotinib) therapy in eligible adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase (CP).
Results from the ENESTfreedom study showed that about 44% of patients remained in treatment-free remission (84/190) for 192 weeks, after stopping frontline Tasigna treatment. The treatment-free survival rate at 192 weeks was nearly 49%.
The ENESTop trial also showed consistent results. About 46% of patients remained in TFR (58/126) for 192 weeks after stopping second-line Tasigna treatment.
The results support and extend previous findings of long-term durability of molecular response after stopping Tasigna, reducing time on drug for many CML patients.
Tasigna is already approved for the treatment of adult patients with newly diagnosed Ph+ CML in CP, and those with chronic and accelerated phase Ph+ CML resistant or intolerant to at least one prior therapy, including Glivec. The drug is also approved for the treatment of pediatric patients with newly diagnosed Ph+ CML in CP and those with resistance or intolerance to prior TKI therapy.
Novartis also announced promising results from a phase I study on asciminib (ABL001), an investigational allosteric BCR-ABL inhibitor, in combination with three different tyrosine kinase inhibitors (TKIs) in heavily pre-treated Ph+ CML-CP patients. The company is developing asciminib both as a potential monotherapy in a broad program, phase III ASCEMBL third-line CML study, and in combination with other therapies, and the phase II ASC4MORE study investigating asciminib plus imatinib for patients with CML-CP without deep molecular response.
Novartis is striving hard to strengthen its oncology portfolio with drugs like Afinitor, Exjade, Jakavi, Zykadia, Tasigna, Luthathera, Promacta and Jadenu.
Share price of the company has increased 4.4% in a year compared with the industry's 2.2% growth.
Novartis’ generic arm, Sandoz, announced data from the phase III ADMYRA trial. The study showed that the efficacy and safety of biosimilar Hyrimoz match that of AbbVie’s ABBV Humira, with no clinically meaningful differences in patients with moderate-to-severe rheumatoid arthritis (RA) with inadequate response to disease modifying antirheumatic drugs (DMARDs), including methotrexate (MTX).
The 48-week study successfully met its primary and secondary endpoints, showing sustained efficacy benefits in patients switched from Humira to Hyrimoz at week 24. Hyrimoz was approved in the EU and the United States in 2018.
Sandoz currently has eight marketed biosimilars in its portfolio and more than 10 in development stage.
However, it continues to face pricing pressure in the United States.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Celgene Corp. CELG and Merck and Co., Inc. MRK. Both the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Merck’s earnings per share estimates have moved up from $4.65 to $4.73 for 2019 and from $5.18 to $5.21 for 2020 in the past 60 days.
Celgene’s earnings estimates have moved up by a cent to $10.72 over the past 60 days.
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