Dec 13, 2022
  • EC approval based on results from pivotal Phase III VISION trial, in which Pluvicto® plus best standard of care (BSoC) significantly improved overall survival and radiographic progression-free survival in patients with pre-treated PSMA–positive mCRPC1
  • Pluvicto® becomes the first targeted radioligand therapy commercially available for people with advanced prostate cancer, addressing a significant unmet need for new treatment option to improve therapeutic outcomes2
  • Additional Phase III trials underway to evaluate Pluvicto® for treatment in earlier stages of metastatic prostate cancer
  • Novartis is advancing a broad portfolio of radioligand therapies to treat cancer and is investing in manufacturing capacity to meet the growing global demand for treatment

Basel, December 13, 2022 — Novartis today announced the European Commission (EC) approved Pluvicto® (INN: lutetium (177Lu) vipivotide tetraxetan), a targeted radioligand therapy. Pluvicto® is approved in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition, for the treatment of adult patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC)3. These patients have been treated with AR pathway inhibition and taxane-based chemotherapy3.

The approval follows a positive opinion issued in October by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union member states plus Iceland, Norway, Northern Ireland and Liechtenstein.

The EC approval was granted based on results from the pivotal Phase III VISION trial, where participants, previously treated with AR pathway inhibition and taxane based chemotherapy, receiving Pluvicto® plus best standard of care (BSoC) had a 38% reduction in the risk of death and a statistically significant reduction (60%) in the risk of radiographic disease progression or death (rPFS) compared to BSoC alone1. About a third (30%) of patients with evaluable disease at baseline demonstrated an objective response (per RECIST 1.1) with Pluvicto® plus BSoC, compared to the 2% in the BSoC-alone arm1.

“Today’s approval of Pluvicto® by the European Commission marks a major milestone for patients with advanced prostate cancer who have few alternative treatments at this stage of their disease,” said Haseeb Ahmad, President Europe, Novartis. “We are excited by the potential of Pluvicto® to bring groundbreaking clinical benefits to these patients, transforming cancer care for the third-most diagnosed cancer globally4.”

Approximately 473,300 prostate cancer cases and 108,000 prostate cancer-related deaths occurred across Europe in 20205. Patients with metastatic prostate cancer have an approximate 3 in 10 chances of surviving 5 years6, indicating a high unmet need for new targeted treatment options for these patients2. Novartis is committed to addressing this need by reimagining cancer care with radioligand therapy and precision medicine, with a goal to reduce the global disease burden, extend the lives of patients with prostate cancer and elevate current standards of care.

About Pluvicto® (lutetium (177Lu) vipivotide tetraxetan)
Pluvicto® is an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177)1. After administration into the bloodstream, Pluvicto® binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein1. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells disrupting their ability to replicate and/or triggering cell death3.

Pluvicto® is approved in the US and other countries including Great Britain and Canada to treat adults with a type of advanced cancer called prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA–positive mCRPC) and who have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy)3,7,8.

Novartis is also evaluating opportunities to investigate Pluvicto® radioligand therapy in earlier stages of prostate cancer9,10.

About VISION
VISION is an international, prospective, randomized, open-label, multicenter, phase III study that assessed the efficacy and safety of Pluvicto® (lutetium (177Lu) vipivotide tetraxetan) (7.4 GBq administered by IV infusion every 6 weeks for a maximum of 6 cycles) plus investigator-chosen standard of care (BSoC) in the investigational arm, versus BSoC in the control arm1. Patients with PSMA PET-scan positive mCRPC who have received androgen receptor (AR) pathway inhibition and taxane-based chemotherapy, were randomized in a 2:1 ratio in favor of the investigational arm1. The alternate primary endpoints were rPFS and OS1. The study enrolled 831 patients1.

Novartis and Prostate Cancer
With more 1.4 million new cases and 375,000 deaths in 2020 alone, prostate cancer is the most frequently diagnosed cancer in men in 112 countries—more than half the world5.

At Novartis, we are harnessing the innovation of our world-class scientists, strategic partnerships, and one of the industry’s most competitive pipelines to explore the potential of new, targeted therapies and precision medicine platforms to address the greatest unmet needs in prostate cancer.

Through the bold science of targeted therapies, our goal is to reduce the global disease burden, extend the lives of patients with prostate cancer, and elevate current standards of care.

Novartis and Radioligand Therapy (RLT)
Novartis is reimagining cancer care with radioligand therapy for patients with advanced cancers. By harnessing the power of radioactive atoms and applying it to advanced cancers, RLT is theoretically able to deliver radiation to target cells anywhere in the body11,12. Novartis has established global expertise, specialized supply chain and manufacturing capabilities across its network of radioligand therapy production sites. In order to support growing demand for our RLT platform, we are investing in the expansion of our RLT production capabilities in Millburn, New Jersey (US), Zaragosa (Spain) and Ivrea (Italy), as well as building a new radioligand manufacturing facility in Indianapolis, Indiana (US), that is planned to be operational in 2023. We are continually evaluating additional opportunities to expand capacity.

About Phenotypic Precision Medicine in advanced prostate cancer
Despite advances in prostate cancer care, there is a high unmet need for new targeted treatment options to improve outcomes for patients with mCRPC. More than 80% of patients with prostate cancer highly express a phenotypic biomarker13 called prostate-specific membrane antigen (PSMA)13-17, making it a promising diagnostic (through positron emission tomography (PET) scan imaging) and therapeutic target for radioligand therapy18. This differs from ‘genotypic’ precision medicine which targets specific genetic alterations in cancer cells19.

Disclaimer
This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. We deliver high-value medicines that alleviate society’s greatest disease burdens through technology leadership in R&D and novel access approaches. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. About 108,000 people of more than 140 nationalities work together to bring Novartis products to nearly 800 million people around the world. Find out more at https://www.novartis.com

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References

  1. Sartor O, J. de Bono KN, Chi K, et al. Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. NEJM 2021; doi: 10.1056/NEJMoa2107322.
  2. Nuhn P, De Bono JS, Fizazi K et al. Update on systemic prostate cancer therapies: management of metastatic castration-resistant prostate cancer in the era of precision oncology. Eur Urol. 2019;75(1):88–99.
  3. Pluvicto Summary of Product Characteristics, 2022.
  4. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-249. Doi:10.3322/caac.21660.
  5. World Health Organization (WHO). (2022) Cancer population fact sheet: Europe. Available online: https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf
  6. SEER. Cancer stat facts: prostate cancer April 2021. Available online: https://seer.cancer.gov/statfacts/html/prost.html
  7. Pluvicto [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; 2022.
  8. Advanced Accelerator Applications USA, Inc. PLUVICTO™ Canadian Product Monograph. August 25, 2022.
  9. Novartis Pharmaceuticals. 177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (PSMAfore). U.S. National Library of Medicine: Clinical Trials. 2020; NCT04689828.
  10. Novartis Pharmaceuticals. An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Soc, Versus SoC Alone, in Adult Male Patients With Mhspc (PSMAddition). U.S. National Library of Medicine: Clinical Trials. 2021; NCT04720157.
  11. Jadvar H. Targeted radionuclide therapy: an evolution toward precision cancer treatment. AJR Am J Roentagenol. 2017;209(2);277-288.
  12. Jurcic JG, Wong JYC, Knoc SJ, et al. Targeted radionuclide therapy. In: Tepper JE, Foote RE, Michalski JM, eds. Gunderson & Tepper’s Clinical Radiation Oncology. 5th ed. Elsevier, Inc. 2021;71(3):209-249
  13. Hope TA, Aggarwal R, Chee B, et al. Impact of 68Ga-PSMA-11 PET on management in patients with biochemically recurrent prostate cancer. J Nucl Med 2017;58(12):1956–61.
  14. Hupe MC, Philippi C, Roth D, et al. Expression of prostate-specific membrane antigen (PSMA) on biopsies is an independent risk stratifier of prostate cancer patients at time of initial diagnosis. Front Oncol 2018;8:623.
  15. Bostwick DG, Pacelli A, Blute M, et al. Prostate specific membrane antigen expression in prostatic intraepithelial neoplasia and adenocarcinoma: a study of 184 cases. Cancer 1998;82(11):2256–61.
  16. Pomykala KL, Czernin J, Grogan TR, et al. Total-body 68Ga-PSMA-11 PET/CT for bone metastasis detection in prostate cancer patients: potential impact on bone scan guidelines. J Nucl Med 2020;61(3):405–11.
  17. Minner S, Wittmer C, Graefen M, et al. High level PSMA expression is associated with early PSA recurrence in surgically treated prostate cancer. Prostate 2011;71(3):281–8
  18. Hofman MS, Violet J, Hicks RJ et al. [177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2.
  19. Sant GR, Knopf KB, Albala DM. Live-single-cell phenotypic cancer biomarkers-future role in precision oncology? NPJ Precision Oncology 2017;1(1):21.

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