Novartis highlights potential of its radioligand therapy in prostate cancer at ASCO

Novartis has revealed new data from a phase 3 trial evaluating its targeted radioligand therapy (RLT) in late stage advanced prostate cancer at the 2021 American Society of Clinical Oncology (ASCO) annual meeting.

The phase 3 VISION study, which is evaluating the efficacy and safety of the targeted RLT Lu-PSMA-617 plus best standard of care in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), met both primary endpoints, Novartis announced at ASCO.

The data showed that men who were treated with Lu-PSMA-617 plus best standard of care achieved a 38% reduction in the risk of death and a 60% reduction in the risk of radiographic disease progression or death compared to best standard of care alone.

The results show promise for the RLT therapy as a potential new treatment option for advanced mCRPC patients, particularly considering participants in the VISION study had already been treated with taxane and androgen pathway inhibitors.

Novartis said that it would include the results from the VISION study in an upcoming EU regulatory submission, although it did not specify the exact timeline.

“Men with metastatic prostate cancer have about a three in ten chance of surviving five years and need new treatment options. [This] data from the first phase 3 study of a radioligand therapy in this advanced prostate cancer setting confirm[s] the potential of 177Lu-PSMA-617 targeted therapy to improve clinical outcomes,” said Alessandra Dorigo, general manager UK, Ireland, Baltics and Nordics in Novartis Advanced Accelerator Applications (AAA).

“With more than 15 dedicated early to late development and research programmes underway, our comprehensive development programme will continue to explore targeted radioligand therapy, in prostate and across a number of tumour types,” she added.

Novartis also presented data from the phase 3 MONALEESA-3 trial analysing the efficacy and safety of Kisqali (ribociclib) in combination with fulvestrant in postmenopausal women with HR-positive/HER2-negative advanced breast cancer.

As previously reported, the Kisqali plus fulvestrant treatment arm demonstrated statistically significant longer median overall survival compared to placebo – the longest OS benefit seen in a CDK4/6 inhibitor plus fulvestrant in this population, according to Novartis.

The updated analysis found that the need for chemotherapy was delayed by four years (48.1 months) in patients taking the Kisqali combination and 28.8 months for fulvestrant alone.