Novartis targets first-line use for radiotherapy Lutathera after trial win in neuroendocrine tumors

More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-founder Steve Jobs.

The cancer is called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In the study, combining Lutathera with Novartis’ long-acting Sandostatin significantly extended the time before disease progression or death compared with high-dose Sandostatin alone in newly diagnosed patients with somatostatin receptor-positive stage 2 and 3 GEP-NETs, the company said Monday.

Lutathera has been approved in the U.S. for somatostatin receptor-positive GEP-NETs since 2018. The positive phase 3 NETTER-2 trial readout now makes Lutathera the first radioligand therapy to show a clinically meaningful progression-free survival benefit in any first-line cancer setting, Novartis pointed out.

Novartis will discuss the results with regulatory authorities and share them at an upcoming medical meeting.

NETs are rare and can be found in the neuroendocrine system across the digestive tract, the lungs and pancreas. While grade 1 tumors grow slowly, higher grade NETs are more aggressive.  

Treatment options are few. Besides Lutathera and Sandostatin, Novartis’ Afinitor and Pfizer’s Sutent are also used to treat NETs. In China, Hutchmed in 2020 introduced surufatinib, marketed as Sulanda, initially to treat non-pancreatic NETs. But the drug suffered an FDA rejection last year, and Hutchmed has also withdrawn its application with the European Medicines Agency.

Lutathera was the first product from Novartis’ radiotherapy portfolio to reach the market. The drug generated $299 million in the first half of the year, representing 42% growth over the same period last year.

Lutathera has recently been upstaged by Novartis’ second radiopharmaceutical treatment, the prostate cancer therapy Pluvicto. Approved by the FDA last March for previously treated PSMA-positive metastatic castration-resistant prostate cancer, Pluvicto pulled in $451 million in sales in the first six months of 2023.

Trying to also move Pluvicto into earlier lines of treatment, Novartis recently touted the phase 3 PSMAfore win. The positive readout could enable the use of the drug before patients get taxane-based chemotherapy and triple or quadruple its addressable patient base.

The clinical success of Pluvicto stress-tested Novartis’ radiotherapy production capacity, leading to a few months of supply shortfalls earlier this year. Novartis also temporarily stopped producing Pluvicto and Lutathera last May at two facilities in Italy and New Jersey after spotting some potential manufacturing issues.

Novartis has expanded its existing radioligand therapy manufacturing sites and is awaiting FDA clearance for a new facility in Indianapolis, which is expected to be operational this year.

Besides NETs, Novartis is also in phase 2 tests of Lutathera against brain cancer and small cell lung cancer.