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.