Clinical Trials Arena

Novartis discontinues blood cancer candidate after Phase III flunk

The sabatolimab trial failed to meet its primary endpoint with Novartis saying the termination allows prioritisation of key programmes.

Novartis has pulled the plug on its blood cancer candidate sabatolimab after a pivotal trial of the candidate failed to meet its primary endpoint.

The company announced in a Q4 statement on 31 January that it is discontinuing the sabatolimab (MBG453) programme after the failure to prioritise other key programmes in its portfolio. Novartis’ stocks took a hit following the announcement, dropping by 2.7%.

Novartis did not respond to the Clinical Trials Arena's request for further comment on the termination.

The Phase III Stimulus trial (NCT04266301) was investigating the candidate in combination with the chemotherapy drug azacitidine in patients with high or very high-risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukaemia-2 (CMML-2) with an indication for treatment with azacitidine in first-line setting and are not eligible for intensive chemotherapy or haematopoietic stem cell transplantation (HSCT).

Stimulus was a global, randomised, two-arm parallel-group, double-blind, placebo-controlled trial which enrolled 530 patients.

Full data is yet to be released but the trial failed to meet its primary endpoint of overall survival (OS).

Novartis is also terminating ongoing earlier phase trials of the candidate in acute myelocytic leukaemia (AML) and low-risk MDS.

The discontinuation of sabatolimab makes GSK’s cobolimab, which focuses on solid tumours, the most advanced TIM-3 candidate in trials.

Sabatolimab is a monoclonal antibody that acts by targeting T cell immunoglobulin mucin-3 (TIM-3). The candidate binds to and blocks TIM-3 to increase Type 1 T helper (Th1) cells. This induces the production of interferon-gamma (IFN-gamma) and interferes with all the immune-suppressive functions of TIM-3.

The candidate received fast-track designation from the US Food and Drug Administration in May 2021, with the European Commission (EC) granting with candidate orphan drug designation the month before.

Sabatolimab is not the only pipeline candidate to get the axe, with Novartis confirming it is also terminating the development of its BTK inhibitor remibrutinib in Sjögren’s syndrome, saying this is due to the company wanting to prioritise other key programmes in its portfolio.

GlobalData had a global predicted sales forecast of $166m for sabatolimab in 2029.

GlobalData is the parent company of the Clinical Trials Arena.