Novartis’ Acquired Asset from Endocyte Shines in Phase 3 Prostate Cancer Trial

Novartis’ targeted radioligand therapy, 177Lu-PSMA-617 showed remarkably improved overall survival (OS) and radiographic progression-free survival (rPFS) in patients with PSMA-positive metastatic castration-resistant prostate cancer. The results were based on the hyped Phase 3 VISION trial.

Prostate cancer is the second most common cancer in men with the five-year survival rate being approximately 15% for patients with metastatic castration-resistant prostate cancer, showing the unmet needs for this disease.

The radioligand treatment approach by Novartis to combat this type of cancer comprises a targeting compound, capable of binding to markers expressed by tumors along with a radioactive isotope. This tactic causes DNA damage, blocks tumor growth and further duplication.

Since the therapy focuses on targeted delivery, it refrains from damaging surrounding healthy cells, a major advantage in the area.

“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.

Novartis has a lot riding on its radioligand after it acquired it from Endocyte for a staggering $2.1 billion. Previously Endocyte had taken 177Lu-PSMA-617 into Phase 3 trials with patients who were formerly treated with drugs such as Pfizer’s Xtandi and Johnson & Johnson’s Zytiga. After which they decided to accept Novartis’s generous deal.

Hence, it is crucial for Novartis to start generating revenue from their radioligand which would provide a strong boost to their broader radiopharmaceutical strategies.

VISION Trial

VISION is a Phase 3, multi-center, randomized, open-label study which examined the efficacy and safety of their radioligand, 177Lu-PSMA-617. The study enrolled 831 patients with PSMA-positive metastatic castration-resistant prostate cancer to receive either investigator-chosen best standard of care or that regimen with up to six infusions of 177Lu-PSMA-617.

Results show that the radioligand achieved both endpoints OS and rPFS with drug safety similar to previously reported data. Novartis has not yet released the full results as it plans to present it at medical conferences scheduled later this year but is gearing up to seek approvals in the EU and USA.

Dr. Tsai further added, “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.”

Novartis’ Radiopharmaceutical Advances

The company is building up its radiopharmaceutical unit with acquisitions and additional infrastructures. Novartis acquired Lutathera for $3.9 billion by buying out Advanced Accelerator Applications and then took over Endocyte. Lutathera raked $441 million in 2019 alone.

These takeovers have made Novartis’s radiopharmaceutical platform much stronger and have added to their already established expertise in gene therapy, targeted therapy, and immunotherapy.

They have continued their streak of acquisition by investing in many biopharmaceuticals including Aktis Oncology. Additionally, Novartis has been looking to add multiple manufacturing facilities for expanding their radioligand platform including a 50,000 sq ft facility at Indianapolis scheduled to open in 2023.

Market analysts estimate that if 177Lu-PSMA-617 is approved, Novartis could be looking at peak sales of approximately $600 million and could be higher if they plan to target other treatment areas. This could be the start Novartis would need to navigate the market and bring hope to the patients suffering from PSMA-positive metastatic castration-resistant prostate cancer.

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Author

Tulip Chakraborty