by John R. Fischer
, Senior Reporter | March 25, 2021
Novartis’ Phase III VISION study showed positive findings in overall survival and radiographic progression-free survival for patients who received 177Lu-PSMA-617, a targeted radioligand therapy for progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
The results are the first interpretable ones comparing the therapy to the best standard of care alone and are seen by Novartis as a sign of potential for the therapy to become the targeted treatment for more than 80% of patients with advanced prostate cancer. They will be presented at an upcoming medical meeting and included in U.S. and EU regulatory submissions.
“Patients with metastatic castration-resistant prostate cancer have a less than one in six chance of surviving five years 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,” said John Tsai, head of global drug development and chief medical officer for Novartis, in a statement.
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Radioligand therapy combines a targeting compound that binds to markers expressed by tumors and a radioactive isotope. The two together damage DNA to inhibit tumor growth and replication. This allows for targeted delivery of radiation to the tumor and limits damage to the surrounding normal tissue.
The safety profile of the Phase III trial correlates with data reported in previous clinical studies conducted by Novartis, as well as those by other organizations. For example, a 2019 phase I/II trial of 16 men with progressing mCRPC
paired the treatment with the tumor-specific radiation sensitizer idronoxil (NOX66) to assess responses. Nearly 70% saw a more than 50% drop in PSA levels after the combination treatment. In addition, adverse side effects, such as fatigue and pneumonitis, were reported in 31% of all patients.
“The initial results of this phase I dose escalation study show that the combination targeted treatments were well tolerated together, with no increase in toxicity from 177Lu-PSMA-617, and an apparent high efficacy in men who have already had extensive treatments,” said Dr. Louise Emmett, associate professor at the University of New South Wales in Sydney, at the time.
The first U.S. multi-center clinical trial for 177Lu-PSMA-617 was approved in 2017 for targeted Radioligand Therapy (RLT) in patients with castration-resistant prostate cancer.
More than 15 dedicated early to late development and research programs are underway
to identify the next wave of radioligand therapies for cancer, according to Novartis. The company is increasing capacity for delivery of radioligand therapies like 177Lu-PSMA-617 to patients in need.