Novartis NVS announced results of the phase III VISION study on 177Lu-PSMA-617, a targeted radioligand therapy during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting plenary session.
This late-stage study is an international, randomized, open-label, multicenter, phase III program to assess the efficacy and safety of 177Lu-PSMA-617 (7.4 GBq administered by intravenous infusion every 6 weeks for a maximum of 6 cycles) plus the investigator-chosen best standard of care (SOC) in the investigational arm versus the best standard of care in the control arm.
The study demonstrated that 177Lu-PSMA-617 improves disease progression and prolongs survival of the metastatic castration-resistant prostate cancer (mCRPC) population.
It showed a significant improvement in overall survival (OS) from the rate achieved by SOC alone in patients with progressive PSMA-positive mCRPC.
The difference in OS between the study arms was statistically significant with an estimated 38% reduction in risk of death demonstrated in the 177Lu-PSMA-617 arm (n=551) compared to the best standard of care only arm.
Patients receiving 177Lu-PSMA-617 also demonstrated a statistically significant 60% risk reduction for radiographic progression-free survival or death (rPFS) compared to the best standard of care only arm.
However, there was a higher rate of drug-related treatment-emergent adverse events reported in the 177Lu-PSMA-617 treatment arm compared to the standard of care alone.
Meanwhile, Novartis plans to start two additional studies with 177Lu-PSMA-617 radioligand therapy in the earlier lines of treatment for metastatic prostate cancer in the first half of 2021.
Radioligand therapy combines a targeting compound, which binds to markers expressed by tumors and a radioactive isotope, causing DNA damage that inhibits tumor growth and replication.
Novartis also posted the final analysis of the pivotal NETTER-1 study with targeted radioligand therapy Lutathera, comparing Lutathera (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) plus 30 mg octreotide LAR to 60 mg of octreotide LAR in patients with midgut neuroendocrine tumors.
The previously-reported primary analysis demonstrated a statistically significant improvement in progression free survival. In the final analysis of overall survival that constitutes the secondary objective of the trial, treatment with Lutathera resulted in a clinically relevant prolongation of the median overall survival of 11.7 months compared to the control arm. However, this analysis did not reach any statistical significance
Novartis is currently pursuing four different cancer treatment platforms, which are radioligand therapy, cell and gene therapy, targeted therapy and immunotherapy.
Shares of Novartis have lost 4.7% so far this year against the industry’s growth of 5%.
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Novartis has a strong oncology portfolio but faces stiff competition in the space from the likes of Roche RHHBY (OTC:RHHBY), Bristol-Myers BMY and AstraZeneca (NASDAQ:AZN) AZN among others.
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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