Novartis NVS announced positive results from a phase III study, RATIFY, on leukemia candidate, PKC412 (midostaurin). Results showed that patients under 60 years of age with newly-diagnosed FLT3-mutated acute myeloid leukemia experienced a 23% improvement in overall survival when treated with PKC412 plus standard induction and consolidation chemotherapy, as compared to those treated with standard induction and consolidation chemotherapy alone.
RATIFY is being conducted to evaluate the addition of either PKC412 or placebo to Cerubidine /Depocyt in the induction phase. This phase was followed by high-dose Depocyt in the consolidation phase. Thereafter, patients, who achieved complete remission after consolidation chemotherapy, continued treatment with PKC412 or placebo as a single agent for up to one year.
Novartis expects to file for an approval of PKC412 in 2016. We note that Novartis has collaborated with privately held biotechnology company, Invivoscribe Technologies, for the diagnosis of patients who may have a FLT3 mutation and potentially benefit from treatment with PKC412. Invivoscribe will lead regulatory submissions for a companion diagnostic.
Simultaneously, Novartis announced results from an ongoing phase IIa study on CTL019.
The company is evaluating CTL019, an experimental chimeric antigen receptor (CAR) therapy, for the treatment of pediatric and adult patients suffering from relapsed/refractory (r/r) acute lymphoblastic leukemia.
It is conducting the study to evaluate the safety and efficacy of CTL019 in certain types of r/r non-Hodgkin lymphoma.
CTL019 uses CAR technology to reprogram a patient's own T cells to look for cancer cells that express specific proteins called CD19. Once reprogrammed, the T cells (called CTL019 after reprogramming) are released into the patient's blood so as to proliferate and bind to the targeted CD19+ cancer cells and destroy them.
We note that the University of Penn has an exclusive global agreement with Novartis to research, develop and commercialize personalized CAR T cell therapies for the treatment of cancers.
The study showed an overall response rate (ORR) of 47% in adult patients suffering from r/r diffuse large B-cell lymphoma and an ORR of 73% in adult patients with follicular lymphoma.
Earlier, Novartis had announced positive results from a phase III study, COMFORT-II, on myelofibrosis drug (MF), Jakavi. Results showed an overall survival advantage for patients with MF, following crossover to Jakavi from the best available therapy arm after the primary analysis at 48 weeks. Half of the patients with MF demonstrated significant reductions in spleen size with Jakavi therapy and sustained this benefit over a prolonged period of time.
Approval of new drugs and label expansion of existing ones should bode well for Novartis as it has been facing stiff generic competition for some of its key drugs like Diovan. Additionally, its oncology drugs are facing competition in the form of new immuno-oncology therapies.
Moreover, its Alcon segment is facing a decline in surgical equipment sales in the U.S. and emerging markets, while Ophthalmic Pharmaceuticals is facing the threat of increased generic competition in the U.S.
Novartis currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the healthcare sector include AstraZeneca PLC AZN, Eli Lilly and Company LLY and Biodel Inc. BIOD. AstraZeneca sports a Zacks Rank #1 (Strong Buy), while Eli Lilly and Biodel carry a Zacks Rank #2 (Buy).
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