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Novartis (NVS) Lutathera Meets Primary Goal in Phase III Study
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Novartis (NVS - Free Report) announced that the late-stage NETTER-2 study on Lutathera achieved its primary endpoint in first line advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The phase III NETTER-2 is an open-label, multi-center, randomized, comparator-controlled study evaluating if Lutathera plus long-acting octreotide, when taken as a first line treatment, can prolong progression-free survival (PFS) in patients with high-proliferation rate tumors as compared with treatment with high-dose (60 mg) long-acting octreotide.
Data from the study showed that first line treatment with Lutathera, in combination with long-acting octreotide, demonstrated a significant improvement in PFS in patients with newly diagnosed somatostatin receptor (SSTR-positive), Grade 2 and 3 and advanced GEP-NETs as compared with only high-dose long-acting octreotide.
Please note that Lutathera is a radioligand therapy (RLT) that was approved in the United States in 2018 for the treatment of SSTR-positive GEP-NETs, including foregut, midgut and hindgut neuroendocrine tumors in adults.
The approval was based on the results of the NETTER-1 study, which demonstrated highly significant and clinically meaningful PFS prolongation for patients treated with Lutathera in combination with long-acting octreotide as compared with high-dose long-acting octreotide for SSTR-positive, inoperable midgut NETs who were progressing despite standard treatment.
The RLT was added to the portfolio with the acquisition of Advanced Accelerator Applications.
It is also approved in Europe for unresectable or metastatic, progressive, well-differentiated SSTR-positive GEP-NETs in adults.
Sales from Lutathera came in at $299 million in the first half of 2023, driven by increased demand in the United States and Japan. Growth in the United States was also fueled by strong field execution. In Japan, growth was driven by increased demand following the transfer of the marketing authorization back to Novartis from Fujifilm Toyama Chemical.
Results of NETTER-2 show the potential for radioligand therapy to make a meaningful impact on newly diagnosed patients living with advanced GEP-NETs.
Novartis plans to discuss the results with regulatory authorities and regulatory submissions are expected to follow soon.
The company is also evaluating a broad portfolio of RLTs, exploring their treatment potential in a range of advanced cancers beyond prostate and GEP-NET, including lung, breast, pancreatic and colon cancer.
Concurrently, Novartis confirmed plans for the 100% spin-off of its generic arm, Sandoz, with trading of new Sandoz Group AG shares and American Depositary Receipts (ADRs) to commence on Oct 4, 2023.
The spin-off will be completed via the distribution of a dividend-in-kind by Novartis. Each Novartis shareholder will receive one Sandoz share for every five Novartis shares and each Novartis ADR holder will receive one Sandoz ADR for every five Novartis ADRs.
Novartis shareholders and ADR holders will receive a cash amount for any fractional interest. The spin-off is expected to be tax-neutral for Swiss tax and US federal income tax purposes.
Shares of Novartis have risen 11.5% year-to-date compared with the industry’s 5.7% growth.
Image Source: Zacks Investment Research
With the planned spin-off of Sandoz, Novartis is looking to become a pure-play pharmaceutical company.
While the older drugs face generic competition, the continued strong performance of Entresto, Pluvicto, Kesimpta and Kisqali fueled growth and should maintain momentum.
The strong performance of key drugs, strategic acquisitions and a streamlined focus should pave the way for solid growth for NVS in the quarters ahead.
Zacks Rank and Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
Some well-placed stocks in the industry are Eton Pharmaceuticals (ETON - Free Report) and Dynavax Technologies (DVAX - Free Report) . Eton currently sports a Zacks Rank #1 (Strong Buy) and Dynavax carries a Rank #2 (Buy).
Loss estimates for Eton for 2023 have narrowed to 10 cents from 31 cents in the past 60 days, while earnings estimates for 2024 are pegged at 26 cents per share.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share.
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Novartis (NVS) Lutathera Meets Primary Goal in Phase III Study
Novartis (NVS - Free Report) announced that the late-stage NETTER-2 study on Lutathera achieved its primary endpoint in first line advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The phase III NETTER-2 is an open-label, multi-center, randomized, comparator-controlled study evaluating if Lutathera plus long-acting octreotide, when taken as a first line treatment, can prolong progression-free survival (PFS) in patients with high-proliferation rate tumors as compared with treatment with high-dose (60 mg) long-acting octreotide.
Data from the study showed that first line treatment with Lutathera, in combination with long-acting octreotide, demonstrated a significant improvement in PFS in patients with newly diagnosed somatostatin receptor (SSTR-positive), Grade 2 and 3 and advanced GEP-NETs as compared with only high-dose long-acting octreotide.
Please note that Lutathera is a radioligand therapy (RLT) that was approved in the United States in 2018 for the treatment of SSTR-positive GEP-NETs, including foregut, midgut and hindgut neuroendocrine tumors in adults.
The approval was based on the results of the NETTER-1 study, which demonstrated highly significant and clinically meaningful PFS prolongation for patients treated with Lutathera in combination with long-acting octreotide as compared with high-dose long-acting octreotide for SSTR-positive, inoperable midgut NETs who were progressing despite standard treatment.
Novartis AG Price and Consensus
Novartis AG price-consensus-chart | Novartis AG Quote
The RLT was added to the portfolio with the acquisition of Advanced Accelerator Applications.
It is also approved in Europe for unresectable or metastatic, progressive, well-differentiated SSTR-positive GEP-NETs in adults.
Sales from Lutathera came in at $299 million in the first half of 2023, driven by increased demand in the United States and Japan. Growth in the United States was also fueled by strong field execution. In Japan, growth was driven by increased demand following the transfer of the marketing authorization back to Novartis from Fujifilm Toyama Chemical.
Results of NETTER-2 show the potential for radioligand therapy to make a meaningful impact on newly diagnosed patients living with advanced GEP-NETs.
Novartis plans to discuss the results with regulatory authorities and regulatory submissions are expected to follow soon.
The company is also evaluating a broad portfolio of RLTs, exploring their treatment potential in a range of advanced cancers beyond prostate and GEP-NET, including lung, breast, pancreatic and colon cancer.
Concurrently, Novartis confirmed plans for the 100% spin-off of its generic arm, Sandoz, with trading of new Sandoz Group AG shares and American Depositary Receipts (ADRs) to commence on Oct 4, 2023.
The spin-off will be completed via the distribution of a dividend-in-kind by Novartis. Each Novartis shareholder will receive one Sandoz share for every five Novartis shares and each Novartis ADR holder will receive one Sandoz ADR for every five Novartis ADRs.
Novartis shareholders and ADR holders will receive a cash amount for any fractional interest. The spin-off is expected to be tax-neutral for Swiss tax and US federal income tax purposes.
Shares of Novartis have risen 11.5% year-to-date compared with the industry’s 5.7% growth.
Image Source: Zacks Investment Research
With the planned spin-off of Sandoz, Novartis is looking to become a pure-play pharmaceutical company.
While the older drugs face generic competition, the continued strong performance of Entresto, Pluvicto, Kesimpta and Kisqali fueled growth and should maintain momentum.
The strong performance of key drugs, strategic acquisitions and a streamlined focus should pave the way for solid growth for NVS in the quarters ahead.
Zacks Rank and Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
Some well-placed stocks in the industry are Eton Pharmaceuticals (ETON - Free Report) and Dynavax Technologies (DVAX - Free Report) . Eton currently sports a Zacks Rank #1 (Strong Buy) and Dynavax carries a Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for Eton for 2023 have narrowed to 10 cents from 31 cents in the past 60 days, while earnings estimates for 2024 are pegged at 26 cents per share.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share.