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Novartis (NVS) NSCLC Study Fails to Meet Primary Endpoint

·3 min read

Novartis NVS recently announced the late-stage CANOPY-A study evaluating adjuvant treatment with canakinumab (ACZ885) in patients with non-small cell lung cancer (NSCLC) failed.

CANOPY-A is a phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of canakinumab as adjuvant treatment in patients with NSCLC stages II-IIIA and IIIB. Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to human IL-1β and inhibits IL-1β activity by blocking its interaction with its receptors.

The study did not meet its primary endpoint of disease-free survival (DFS) versus placebo.

Novartis launched the CANOPY study program after observing significantly lower-than-expected rates of lung cancer mortality among patients in phase III cardiovascular CANTOS trial. The CANTOS trial evaluated canakinumab as a secondary prevention measure for cardiovascular events in patients following a heart attack.

Earlier, the phase III CANOPY-2 study evaluating canakinumab in combination with docetaxel, did not meet its primary endpoint of overall survival (OS).  The phase III CANOPY-1 study also did not meet its primary endpoints of OS and progression-free survival (PFS) in patients with previously untreated locally advanced or metastatic NSCLC.

The failure is a setback for Novartis as the successful development of the candidate would have boosted its strong oncology portfolio, which comprises Tafinlar + Mekinist for NSCLC.

Canakinumab is already approved under the brand name Ilaris for arthritis, among others.

Shares of Novartis have lost 2.4% so far this year against the industry’s growth of 0.4%.


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Another drug in NVS’ portfolio that is also approved for NSCLC is Tabrecta.  The drug is approved in several countries, including the United States and EU.  Tabrecta is a kinase inhibitor that targets MET. The drug was developed by Incyte INCY and licensed to Novartis in 2009.

Under the agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain backup compounds in all indications.

Novartis’ performance in the second quarter was good on improvement in the lagging Sandoz business and cardiovascular drug Entresto’s momentum.  Drugs like Cosentyx, Entresto, Kesimpta, Zolgensma, Kisqali and Leqvio should continue to fuel growth and offset the impact of generic competition.

The strategic review of Sandoz is on track, and the company expects to provide an update by the end of 2022.

Novartis carries a Zacks Rank #3 (Hold).  A couple of better-ranked stocks in the sector are Alkermes ALKS and Dynavax DVAX. Both carry a Zacks Rank #2 (Buy).  You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

ALKS’ earnings estimates for 2022 reversed from a loss of 17 cents to earnings of 20 cents in the past 60 days. Alkermes surpassed earnings in all the trailing four quarters, the average being 325.48%.

Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax have surpassed estimates in two of the trailing four quarters.

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