On 23 March 2021 Novartis announced positive results of the phase III trial with radioligand therapy ¹⁷⁷Lu-PSMA-617 in patients with castrate-resistant metastatic prostate cancer (mCRPC) after taxane chemotherapy and several androgen deprivation therapies (ADT).

Over a median follow-up of 20.9 month, the therapy demonstrated an increased overall survival rate by a median of 4.0 months as well as a delay in cancer progression by a median of 5.3 months amongst patients who underwent a combination of 1¹⁷⁷Lu-PSMA-617 treatment and standard care compared to the control group under standard care alone. 

Further subgroup analyses showed consistency in the benefits of the ¹⁷⁷Lu-PSMA-617 therapy regardless of standard care used, demographic and disease characteristics. 50% to 80% decline in PSA (PSA increase is usually associated with tumor growth) was also significantly more common amongst the ¹⁷⁷Lu-PSMA-617 group.

These encouraging results led Novartis to set up new phase III trials in patients who have not undergone chemotherapy and at an even earlier stage -  combining ¹⁷⁷Lu-PSMA-617 with antihormonal therapy vs. antihormonal therapy alone.