Novartis (NVS) Announces Radioligand Therapy Data at ASCO



Novartis NVS announced the results of the phase III VISION study of 177Lu-PSMA-617, a targeted radioligand at the plenary session of the 2021 annual meeting of the American Society of Clinical Oncology (ASCO).

This advanced-stage study is an international, randomized, open-label, multicenter, phase III program to evaluate the efficacy and safety of 177Lu-PSMA-617 (7.4 GBq administered by intravenous infusion every 6 weeks for a period of maximum of 6 cycles) plus the best standard of care (SOC) chosen by the investigator in the experimental arm compared to the best standard of care in the control arm.

The study demonstrated that 177Lu-PSMA-617 improves disease progression and prolongs survival in the metastatic castration-resistant prostate cancer (mCRPC) population.

It showed a significant improvement in overall survival (OS) compared to the rate achieved by SOC alone in patients with progressive mCRPC positive for PSMA.

The difference in OS between 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% reduction in the risk of progression-free survival or radiographic death (rPFS) compared to the best standard of care arm alone.

However, there was a higher rate of treatment-related adverse events reported in the 177Lu-PSMA-617 treatment arm compared to standard treatment alone.

Meanwhile, Novartis plans to start two additional studies with 177Lu-PSMA-617 radioligand therapy in the first 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 published the final analysis of the pivotal NETTER-1 study with targeted radioligand therapy Lutathera, comparing Lutathera (INN: lutetium (177Lu) oxodoteotide / USAN: lutetium Lu 177 dotatate) plus 30 mg octreotide LAR to 60 mg of octreotide LAR in patients with neuroendocrine tumors of the midgut.

The previously reported primary analysis demonstrated a statistically significant improvement in progression-free survival. In the final analysis of overall survival, which is the secondary objective of the trial, treatment with Lutathera resulted in a clinically relevant prolongation of median overall survival of 11.7 months compared to the control arm. However, this analysis did not reach statistical significance.

Novartis is currently pursuing four different cancer treatment platforms, namely radioligand therapy, cell and gene therapy, targeted therapy and immunotherapy.

Shares of Novartis have lost 4.7% so far this year against industry growth of 5%.

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Novartis has a strong oncology portfolio, but faces stiff competition in the space from companies like rock RHHBY, Bristol Myers BMY and AstraZeneca AZN among others.

Novartis currently holds a Zacks Rank # 3 (Hold). You can see The full list of today’s Zacks # 1 Rank (Fort Buy) stocks here.

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