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Novartis Presents Positive Data on CAR-T Cell Therapy Drug
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Novartis AG (NVS - Free Report) announced data from an interim analysis from its multi-center global phase II study, JULTIET (NCT02445248). The study examined pipeline candidate CTL019 among adult patients suffering from relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
The study showed a three-month overall response rate (ORR) of 45% (23 of the 51 patients evaluated), with 37% achieving a complete response (CR) and 8% achieving a partial response (PR), respectively. The study met its primary objective at interim analysis.
Complete results are expected to be available later in 2017 and will be used for regulatory submissions in both the U.S. and EU.
We remind investors that JULIET is the first multi-center global registration study for CTL019 in adult patients with r/r DLBCL and the second global CAR-T cell therapy trial, following the ELIANA study (NCT02435849) in pediatric and young adult patients with r/r B-cell acute lymphoblastic leukemia (ALL).
The FDA granted Breakthrough Therapy designation to CTL019 based on data from the JULIET study in Apr 2017.
Novartis and Penn entered into a global collaboration in 2012 to further research, develop and then commercialize CAR-T cell therapies, including CTL019 for the treatment of cancers.
The FDA accepted the company's Biologics License Application filing and granted priority review for CTL019 in the treatment of r/r pediatric and young adult patients with B-cell ALL in Mar 2017.
Novartis broadened its oncology portfolio by acquiring GlaxoSmithKline plc’s (GSK - Free Report) certain oncology products and pipeline compounds in Mar 2015 after having divested its Animal Health Division to Eli Lilly and Co. (LLY - Free Report) .
Novartis’ has outperformed the Zacks classified industry year to date. The stock has rallied 4.9% compared with the Large Cap Pharmaceuticals industry’s gain of 4.5%.
Going forward, we expect that the approval of new drugs and label expansion of existing ones will bode well for Novartis. The recent FDA approval of Kisqali, for use in combination with an aromatase inhibitor for the first-line treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer will further boost the oncology portfolio.
Meanwhile, the FDA approved a label expansion of Zykadia to include the first-line treatment of patients with metastatic non-small cell lung cancer. Also, strong performance of growth products should be able to offset the impact of generic competition for Gleevec.
Zacks Rank & Key Pick
Novartis currently carries a Zacks Rank #3 (Hold).
VIVUS’s loss per share estimates lessened from 50 cents to 39 cents for 2017 in the last 30 days. The company posted positive earnings surprises in all four trailing quarters with average beat of 233.69%.
More Stock News: This Is Bigger than the iPhone!
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Novartis Presents Positive Data on CAR-T Cell Therapy Drug
Novartis AG (NVS - Free Report) announced data from an interim analysis from its multi-center global phase II study, JULTIET (NCT02445248). The study examined pipeline candidate CTL019 among adult patients suffering from relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
The study showed a three-month overall response rate (ORR) of 45% (23 of the 51 patients evaluated), with 37% achieving a complete response (CR) and 8% achieving a partial response (PR), respectively. The study met its primary objective at interim analysis.
Complete results are expected to be available later in 2017 and will be used for regulatory submissions in both the U.S. and EU.
We remind investors that JULIET is the first multi-center global registration study for CTL019 in adult patients with r/r DLBCL and the second global CAR-T cell therapy trial, following the ELIANA study (NCT02435849) in pediatric and young adult patients with r/r B-cell acute lymphoblastic leukemia (ALL).
The FDA granted Breakthrough Therapy designation to CTL019 based on data from the JULIET study in Apr 2017.
Novartis and Penn entered into a global collaboration in 2012 to further research, develop and then commercialize CAR-T cell therapies, including CTL019 for the treatment of cancers.
The FDA accepted the company's Biologics License Application filing and granted priority review for CTL019 in the treatment of r/r pediatric and young adult patients with B-cell ALL in Mar 2017.
Novartis broadened its oncology portfolio by acquiring GlaxoSmithKline plc’s (GSK - Free Report) certain oncology products and pipeline compounds in Mar 2015 after having divested its Animal Health Division to Eli Lilly and Co. (LLY - Free Report) .
Novartis’ has outperformed the Zacks classified industry year to date. The stock has rallied 4.9% compared with the Large Cap Pharmaceuticals industry’s gain of 4.5%.
Going forward, we expect that the approval of new drugs and label expansion of existing ones will bode well for Novartis. The recent FDA approval of Kisqali, for use in combination with an aromatase inhibitor for the first-line treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer will further boost the oncology portfolio.
Meanwhile, the FDA approved a label expansion of Zykadia to include the first-line treatment of patients with metastatic non-small cell lung cancer. Also, strong performance of growth products should be able to offset the impact of generic competition for Gleevec.
Zacks Rank & Key Pick
Novartis currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in healthcare sector include VIVUS, Inc. which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’s loss per share estimates lessened from 50 cents to 39 cents for 2017 in the last 30 days. The company posted positive earnings surprises in all four trailing quarters with average beat of 233.69%.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020. Click here for the 6 trades >>