Researchers found an overall response rate of 29.8% in patients treated with 177Lu-PSMA-617, compared to a 1.7% partial response in the standard of care only arm.
Newly published survival data suggests that the investigational radioligand therapy 177Lu-PSMA-617 plus standard of care significantly improved overall survival and radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer (mCRPC).
177Lu-PSMA-617 is an investigational PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer and is a type of precision treatment that combines a ligand with a therapeutic radioisotope. After administration, it binds to prostate cancer cells that express PSMA, at which point emissions from the radioisotope damage tumor cells.
According to study results published in The New England Journal of Medicine, the VISION trial results found that the median time to the first symptomatic skeletal event or death was 11.5 months in patients receiving 177Lu-PSMA-617 plus standard of care therapy, compared to 6.8 months in the standard of care only arm.
The overall response rate in patients with measurable or non-measurable disease at baseline was 29.8% partial or complete response in the 177Lu-PSMA-617 plus standard of care arm, compared to 1.7% partial response in the standard of care only arm.
The incidence of grade 3 or higher treatment-emergent adverse effects (TEAEs) was 52.7% in the 177Lu-PSMA-617 arm, compared to 38% in the standard of care only arm. Similarly, serious drug-related TEAEs were seen in 9.3% of patients in the 177Lu-PSMA-617 arm, compared to 2.4% in the standard of care arm.
“We are proud of these data showing that 177Lu-PSMA-617 can significantly shrink tumors and extend life for patients with prostate cancer, who have been heavily pre-treated and currently have limited treatment options,” said Jeff Legos, MD, global head of oncology development at Novartis, in the press release. “We believe that radioligand therapy with 177Lu-PSMA-617 has great potential to improve outcomes in advanced prostate cancer and have already started two new phase III studies in earlier lines of treatment.”
Two additional studies of 177Lu-PSMA-617 are ongoing in earlier lines of treatment for metastatic prostate cancer. Researchers are investigating potential clinical uses in the mCRPC pre-taxane setting and in the metastatic hormone-sensitive setting.
Positive survival data for Novartis investigational radioligand therapy 177Lu-PSMA-617 published in The New England Journal of Medicine. News release. Novartis. June 23, 2021. Accessed June 29, 2021. https://www.novartis.com/news/media-releases/positive-survival-data-novartis-investigational-radioligand-therapy-177lu-psma-617-published-new-england-journal-medicine