Novartis NVS presented positive results from the third phase III trial on breast cancer drug Kisqali (ribociclib) in advanced or metastatic breast cancer at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
The phase III trial, MONALEESA-3, showed Kisqali plus Faslodex significantly prolonged progression-free survival (PFS) compared to Faslodex alone in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.
The median PFS was not reached in the subgroup of patients taking Kisqali plus fulvestrant in the first-line setting. However, 70% were estimated to remain progression-free at median follow-up of 16.5 months.
Moreover, results from MONALEESA-7 showed consistent treatment benefit among premenopausal women with HR+/HER2- advanced breast cancer, regardless of prior chemotherapy treatment in the advanced setting.
We remind investors that Kisqali was approved by the FDA in Mar 2017 and by the European Commission in August 2017, as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor.
Novartis is currently in discussions with the FDA to submit a supplemental New Drug Application (sNDA), seeking approval of Kisqali plus Faslodex for the treatment of postmenopausal women with HR+/HER2- advanced breast cancer.
The company also presented data from two long-term Treatment-free Remission (TFR) studies, ENESTop and ENESTfreedom in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase (CP). The results from the open-label phase II trials, ENESTop and ENESTfreedom, show sustained TFR in patients treated with both front-line and second-line Tasigna (nilotinib) therapy.
The 144-week trials evaluate the potential to maintain molecular response (MR) after stopping therapy in eligible adult patients with Ph+ CML-CP. Data showed durability and safety of TFR with Tasigna. Nearly all patients who lost TFR regained major molecular response after restarting therapy.
Novartis has a strong oncology portfolio of drugs like Afinitor, Exjade, Jakavi, Zykadia, Tasigna, Jadenu and Kisqali, which continue to boost sales. The approval of Kymriah for acute lymphoblastic leukemia is a major boost, given the potential in the CAR-T therapy space. The FDA recently expanded Kymriah's label which should boost sales.
Last week, Novartis completed the divestiture of its 36.5% stake in a consumer healthcare joint venture with GlaxoSmithKline PLC GSK for $13 billion.
The company also announced that its generic arm, Sandoz, obtained a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for marketing authorization of a proposed biosimilar of AbbVie’s ABBV blockbuster drug Humira. The generic division is seeking approval of the proposed biosimilar for use in all indications of the branded drug including those in rheumatology, gastroenterology and dermatology.
A tentative approval will further boost the generic division, which has been struggling with competitive pricing. Last month, Sandoz obtained approval for Zessly, a biosimilar version of Remicade, in Europe. With Zessly’s approval, Sandoz now has six approved biosimilars in its portfolio. Zessly is the third biosimilar that has been approved by the EC in the last 12 months for Sandoz.
The CHMP has also recommended approval for Aimovig (erenumab) for the prevention of migraine in adults who have at least four migraine days per month. The drug was recently approved by the FDA. Novartis and Amgen AMGN are co-commercializing the drug in the United States. While Amgen has exclusive commercialization rights to the drug in Japan, Novartis has exclusive rights to commercialize in the rest of the world.
Novartis’ shares have declined 7.4% in the last six months compared with the industry’s decline of 1.9%.
The approval of new drugs bode well for Novartis as the company is facing the loss of patent protection for some of the key drugs.
Zacks Rank
Novartis carries a Zacks Rank #3 (Hold). You can see see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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