Novartis (NVS) recently presented data from a large late-stage trial (n=400) which demonstrated that its cancer drug Glivec led to significant improvement in both recurrence-free survival and overall survival after three years of adjuvant treatment.
The treatment was for patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) versus the standard one-year treatment currently approved. The data were presented at the American Society of Clinical Oncology (ASCO).
Data from the study revealed that after five years, 66% of the patients who had taken Glivec for 3 years after surgery to remove KIT+GIST were free from cancer recurrence (primary endpoint) versus 48% of those who had taken the drug for one year.
Moreover, 92% of patients who had taken Glivec for 3 years showed overall survival (secondary endpoint) versus those who had taken the medicine for a year. This is the first ever study demonstrating the survival benefits of longer treatment with Glivec.
Gastrointestinal stromal tumors are a rare, life-threatening cancer of the gastrointestinal tract. These patients run the risk of recurrence even after successful and complete surgical removal of the tumor. Glivec thus provides a treatment option for such patients by improving recurrence free survival when the post-surgical duration of Glivec treatment is extended.
Glivec is currently approved for the treatment of all forms of Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). It is also approved for the treatment of KIT+GIST which cannot be surgically removed and/or have already spread to other parts of the body (metastasized).
Our Recommendation
Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #3 Rank (“Hold” rating) in the short run. Though pleased with Novartis’ wide range of products and its efforts to diversify further, as is evident by the acquisition of eye-care company Alcon, we prefer to remain on the sidelines due to the imminent patent cliff faced by the company.
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