Benzinga | Jun 3, 2021 03:21PM EDT

Novartis' Prostate Cancer Radioligand Therapy Extended Overall Survival by Four Months

* Novartis AG (NYSE:NVS) has announced results from Phase 3 VISION study evaluating 177Lu-PSMA-617, a targeted radioligand therapy, plus best standard of care (SOC) in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

* Novartis said it would file for approval for the drug, known as Lu-PSMA-617, in the US and Europe in the second half of 2021 while pushing forward with pivotal studies on earlier-stage patients.

* The company first announced the trial hit every endpoint in the Phase 3 trial in March but released no data at the time.

* The new study showed that in patients with metastatic castration-resistant prostate cancer who exhausted three lines of therapy, the drug improved median overall survival from 11.3 months to 15.3 months and progression-free survival from 3.4 months to 8.7 months.

* It also lengthened the time patients went before suffering a skeletal event -- a common symptom of metastatic prostate cancer -- from 6.8 months to 11.5 months.

* Severe/life-threatening drug-related treatment-emergent adverse events occurred in 28.4% of the 177Lu-PSMA-617 arm compared to 3.9% in the best standard of care only arm, including some degree of bone compression.

* Price Action: NVS shares are up 0.29% at $89.15 during the market session on the last check Thursday.