Novartis Reports Positive Phase III Results for Lutathera in GEP-NETs

Novartis Stock

Novartis (NYSE:NVS) has announced encouraging results from the late-stage NETTER-2 study, which evaluated Lutathera as a first-line treatment for advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This open-label, randomized study assessed whether Lutathera in combination with long-acting octreotide could prolong progression-free survival (PFS) compared to high-dose long-acting octreotide alone in patients with high-proliferation rare tumors.

Key findings from the study include

  1. Significant PFS Improvement: The data demonstrated a significant improvement in PFS in patients with newly diagnosed, somatostatin receptor (SSTR-positive), Grade 2 and 3 advanced GEP-NETs when treated with Lutathera in combination with long-acting octreotide compared to those receiving only high-dose long-acting octreotide.
  2. Previously Approved for GEP-NETs: Lutathera, a radioligand therapy (RLT), was previously approved in the United States in 2018 for the treatment of SSTR-positive GEP-NETs, including foregut, midgut, and hindgut neuroendocrine tumors in adults. This approval was based on the results of the NETTER-1 study, which demonstrated significant PFS prolongation in patients treated with Lutathera in combination with long-acting octreotide compared to high-dose long-acting octreotide alone for inoperable midgut NETs.
  3. Positive Sales Performance: Sales of Lutathera reached $299 million in the first half of 2023, driven by increased demand in the United States and Japan. The growth in the United States was attributed to strong field execution, while in Japan, it was driven by increased demand following the transfer of marketing authorization back to Novartis from Fujifilm Toyama Chemical.

Novartis plans to discuss the positive results with regulatory authorities, and regulatory submissions are expected in the near future. The company is also exploring the potential of radioligand therapy in various advanced cancers beyond prostate and GEP-NETs, including lung, breast, pancreatic, and colon cancer.

Additionally, Novartis has confirmed its plans for a 100% spin-off of its generic arm, Sandoz, with trading of new Sandoz Group AG shares and American Depositary Receipts (ADRs) set to commence on October 4, 2023. This spin-off aims to position Novartis as a pure-play pharmaceutical company.

Novartis has seen its shares rise by 11.5% year-to-date, outperforming the industry’s growth of 5.7%. The strong performance of key drugs, strategic acquisitions, and a streamlined focus on pharmaceuticals are expected to contribute to the company’s growth in the coming quarters.

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