- Novartis’ radiopharmaceutical drug Lutathera met its goal in a Phase 3 trial as a first-line treatment for a type of gastrointestinal cancer, the company said Monday. A combination of Lutathera with the hormone treatment octreotide kept newly diagnosed patients alive and without disease progression for significantly longer than those receiving octreotide alone.
- The data could help Novartis expand use of the drug, which won Food and Drug Administration approval in 2018 after succeeding in a study of patients whose disease had progressed on standard treatment.
- Novartis has invested heavily in targeted radiotherapies like Lutathera and its prostate cancer drug Pluvicto, sparking investment from rivals as well as in new biotechs developing similar treatments. The Swiss drugmaker has struggled to meet demand, however, as quality concerns caused production at some plants to be halted last year.
Lutathera combines a drug component that binds to cancer cells with a radioactive substance, allowing precise delivery of a tumor-killing dose with fewer side effects than systemic radiotherapy. Novartis has bet big on this approach, buying Lutathera’s developer for nearly $4 billion and Pluvicto’s for more than $2 billion.
The Phase 3 NETTER-2 study is in a rare type of cancer Lutathera is already approved in, gastroenteropancreatic neuroendocrine tumors that are sensitive to treatment with octreotide. This type of cancer has a variety of treatments, including Sutent and Afinitor, although treatment can vary based on the origin of the tumor.
In NETTER-1, the study that earned Lutathera its initial FDA approval, the drug plus octreotide reduced the risk of progression or death by 79% compared with octreotide alone. The combination reduced or eliminated tumors in 13% of the trial participants who received it.
Novartis didn’t release detailed data from NETTER-2, and will disclose them at an upcoming medical conference. In a statement, Jeff Legos, Novartis’ global head of oncology development, described the data as “quite remarkable,” adding that they “represent the potential for radioligand therapy to make a meaningful impact for newly diagnosed patients.”
The drugmaker’s targeted radiotherapy franchise is one of its faster growing businesses. In the first half of 2023, Lutathera had sales of $291 million, an increase of 57% over 2022. Pluvicto had sales of $451 million in the first half of 2023, which is its first full year on the market.
When reporting the company’s second quarter earnings, CEO Vas Narasimhan said Novartis expects Pluvicto sales to exceed $1 billion in 2023.