Novartis announces positive result of phase III study with radioligand therapy 177Lu-PSMA-617 in patients with advanced prostate cancer

• Phase III VISION study with ¹⁷⁷Lu-PSMA-617 met both primary endpoints, significantly improving overall survival (OS) and radiographic progression-free survival (rPFS) in patients with PSMA-positive metastatic castration-resistant prostate cancer¹

• VISION trial findings to be presented at upcoming medical meeting, with regulatory submissions in the US and EU anticipated in 2021

• Novartis is committed to reimagining prostate cancer through targeted radioligand therapy with ¹⁷⁷Lu-PSMA-617

• More than 15 dedicated early to late development and research programs underway to identify the next wave of radioligand therapies for cancer

Basel, March, 23, 2021 — Novartis today reported the first interpretable results of the Phase III VISION study evaluating the efficacy and safety of ¹⁷⁷Lu-PSMA-617, a targeted radioligand therapy in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) compared to best standard of care alone. The trial met both primary endpoints of overall survival and radiographic progression-free survival¹, helping to move closer the ambition of becoming the targeted treatment for >80% of patients with advanced prostate cancer. The safety profile was consistent with data reported in previous clinical studies¹. Results from the VISION trial will be presented at an upcoming medical meeting and included in US and EU regulatory submissions.

“Patients with metastatic castration-resistant prostate cancer have a less than 1 in 6 chance of surviving 5 years² and need new treatment options. These groundbreaking data confirm our belief in the potential of ¹⁷⁷Lu-PSMA-617 to reimagine outcomes for these patients through phenotypic precision medicine. We intend to submit these data to regulatory authorities as soon as possible,” said John Tsai, Head of Global Drug Development and Chief Medical Officer for Novartis. “We would like to thank the patients who volunteered to participate in this study as well as the clinical teams at each of the trial sites. We would not be able to realize our commitment to reimagining medicine without the partnership of patients and their families.”