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NUBEQA® (darolutamide) Impact on Local Symptoms Evaluated in Men with Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)  

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WHIPPANY, N.J.–()–A post-hoc evaluation of the Section III ARAMIS trial introduced on the 2021 AUA Annual Meeting assessing NUBEQA® (darolutamide) in males with non-metastatic castration-resistant prostate most cancers (nmCRPC) reinforces the established medical profile.1,2 NUBEQA is indicated in the U.S. for the remedy of males with nmCRPC.

Analysis introduced on the assembly discovered that NUBEQA plus androgen deprivation remedy (ADT) extended time to first prostate cancer-related invasive procedures, an exploratory endpoint (HR=0.416; 95% CI, 0.279-0.620), and was related with a discount in domestically invasive procedures versus ADT alone (4.7% versus 9.6%). In a post-hoc evaluation, NUBEQA plus ADT additionally delayed the time to deterioration in high quality of life (QoL) in two of the six subscales of the European Group for Analysis and Remedy of Cancer High quality of Life Questionnaire (EORTC-QLQ-PR25): urinary signs (25.8 versus 14.8 months; HR=0.64; 95% CI, 0.54-0.76) and bowel signs (18.4 versus 11.5 months; HR=0.78; 95% CI, 0.66-0.92) versus ADT alone.1

Within the Section III ARAMIS trial main evaluation, severe hostile reactions in ≥ 1% of sufferers who obtained NUBEQA included urinary retention, pneumonia, and hematuria.

Local signs from the prostate and surrounding tissues will be very detrimental to sufferers’ QoL. The incidence of native signs and invasive procedures is essential in preliminary nmCRPC remedy discussions between sufferers and physicians,” mentioned Neal Shore, MD, FACS, Medical Director, CPI, Carolina Urologic Analysis Heart. “The outcomes on QoL and invasive procedures reinforce NUBEQA’s worth in nmCRPC.”

Knowledge from the Section III ARAMIS Trial

Beforehand revealed outcomes in 1,509 sufferers from the Section III ARAMIS trial demonstrated a extremely vital enchancment in the first efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months (n=955) with NUBEQA plus ADT, in comparison with 18.4 months (n=554) for placebo plus ADT (p<0.001). MFS is outlined because the time from randomization to the time of first proof of blinded impartial central evaluation (BICR)-confirmed distant metastasis or demise from any trigger inside 33 weeks after the final evaluable scan, whichever occurred first.2

The six subscales of the EORTC-QLQ-PR25 are: urinary signs, bowel signs, hormone treatment-related signs, incontinence support use, sexual exercise and sexual functioning.

The confirmed tolerability of NUBEQA was supported by the three hostile reactions occurring extra ceaselessly in the NUBEQA arm (≥2% over placebo): fatigue (16% versus 11%), ache in extremity (6% versus 3%) and rash (3% versus 1%). NUBEQA was not studied in ladies and there’s a warning and precaution for embryo-fetal toxicity.2

About NUBEQA® (darolutamide)2

NUBEQA is an androgen receptor inhibitor (ARi) with a definite chemical construction that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.2 A Section III examine in metastatic hormone-sensitive prostate most cancers (ARASENS) is ongoing. Details about this trial will be discovered at www.clinicaltrials.gov.

INDICATION FOR NUBEQA® (darolutamide)

NUBEQA® (darolutamide) is an androgen receptor inhibitor indicated for the remedy of sufferers with non-metastatic castration-resistant prostate most cancers.

IMPORTANT SAFETY INFORMATION FOR NUBEQA® (darolutamide)

Embryo-Fetal Toxicity: Security and efficacy of NUBEQA haven’t been established in females. NUBEQA could cause fetal hurt and lack of being pregnant. Advise males with feminine companions of reproductive potential to make use of efficient contraception throughout remedy with NUBEQA and for 1 week after the final dose.

Opposed Reactions

Severe hostile reactions occurred in 25% of sufferers receiving NUBEQA and in 20% of sufferers receiving placebo. Severe hostile reactions in ≥1 % of sufferers who obtained NUBEQA have been urinary retention, pneumonia, and hematuria. General, 3.9% of sufferers receiving NUBEQA and three.2% of sufferers receiving placebo died from hostile reactions, which included demise (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), basic bodily well being deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Opposed reactions occurring extra ceaselessly in the NUBEQA arm (≥2% over placebo) have been fatigue (16% vs 11%), ache in extremity (6% vs 3%) and rash (3% vs 1%).

Clinically vital hostile reactions occurring in ≥2% of sufferers handled with NUBEQA included ischemic coronary heart illness (4.0% vs 3.4% on placebo) and coronary heart failure (2.1% vs 0.9% on placebo).

Drug Interactions

Impact of Different Medication on NUBEQA Mixed P-gp and robust or reasonable CYP3A4 inducers lower NUBEQA publicity, which can lower NUBEQA exercise. Keep away from concomitant use.

Mixed P-gp and robust CYP3A4 inhibitors improve NUBEQA publicity, which can improve the chance of NUBEQA hostile reactions. Monitor extra ceaselessly and modify NUBEQA dose as wanted.

Results of NUBEQA on Different MedicationNUBEQA inhibits breast most cancers resistance protein (BCRP) transporter. Concomitant use will increase publicity (AUC) and maximal focus of BCRP substrates, which can improve the chance of BCRP substrate-related toxicities. Keep away from concomitant use the place doable. If used collectively, monitor extra ceaselessly for hostile reactions, and think about dose discount of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use could improve plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor extra ceaselessly for hostile reactions and think about dose discount of those substrates.

Overview the prescribing info of medicine which can be BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For essential threat and use details about NUBEQA, please see the accompanying full Prescribing Information.

About Prostate Cancer

Prostate most cancers is the second mostly identified malignancy in males worldwide.3 In 2020, about 192,000 males in the U.S. have been identified with prostate most cancers and an estimated 33,000 have died from the illness.4 Prostate most cancers is the fifth main reason for demise from most cancers in males.3 Prostate most cancers outcomes from the irregular proliferation of cells inside the prostate gland, which is a part of a person’s reproductive system.5 It primarily impacts males over the age of fifty, and the chance will increase with age.6

Remedy choices vary from surgical procedure to radiation remedy to remedy utilizing hormone-receptor antagonists, i.e., substances that cease the formation of testosterone or stop its impact on the goal location.7 Nonetheless, in practically all instances, the most cancers ultimately turns into resistant to standard hormone remedy.8

Castration-resistant prostate most cancers (CRPC) is a sophisticated type of the illness the place the most cancers retains progressing even when the quantity of testosterone is decreased to very low ranges in the physique. The sphere of remedy choices for castration-resistant sufferers is evolving quickly for CRPC sufferers who’ve prostate most cancers that has not unfold to different elements of the physique with rising prostate-specific antigen (PSA) ranges regardless of a castrate testosterone stage, which known as non-metastatic castration-resistant prostate most cancers, or nmCRPC.9,10 About one-third of males with nmCRPC go on to develop metastases inside two years.11 In males with progressive nmCRPC, a brief PSA doubling time is correlated with shortened time to first metastasis and demise.10

About Oncology at Bayer

Bayer is dedicated to delivering science for a greater life by advancing a portfolio of revolutionary remedies. The oncology franchise at Bayer contains six marketed merchandise and a number of other different property in varied phases of medical improvement. Collectively, these merchandise mirror the corporate’s strategy to analysis, which prioritizes targets and pathways with the potential to impression the best way that most cancers is handled.

About Bayer

Bayer is a world enterprise with core competencies in the life science fields of well being care and diet. Its services are designed to assist individuals and planet thrive by supporting efforts to grasp the foremost challenges introduced by a rising and getting old international inhabitants. Bayer is dedicated to drive sustainable improvement and generate a optimistic impression with its companies. On the identical time, the Group goals to extend its incomes energy and create worth by way of innovation and development. The Bayer model stands for belief, reliability and high quality all through the world. In fiscal 2020, the Group employed round 100,000 individuals and had gross sales of 41.4 billion euros. R&D bills earlier than particular objects amounted to 4.9 billion euros. For extra info, go to www.bayer.com.

© 2021 Bayer

BAYER, the Bayer Cross and NUBEQA are registered emblems of Bayer.

Ahead-Wanting Statements

This launch could include forward-looking statements based mostly on present assumptions and forecasts made by Bayer administration. Numerous identified and unknown dangers, uncertainties and different components may result in materials variations between the precise future outcomes, monetary state of affairs, improvement or efficiency of the corporate and the estimates given right here. These components embody these mentioned in Bayer’s public reviews which can be found on the Bayer web site at www.bayer.com. The corporate assumes no legal responsibility in anyway to replace these forward-looking statements or to adapt them to future occasions or developments.

References

  1. Shore N. et al. Impact of darolutamide on native signs in sufferers with nonmetastatic castration-resistant prostate most cancers [abstract]. AUA 2021. Presentation PD34-10.
  2. NUBEQA® (darolutamide) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Prescription drugs, January 2021.
  3. GLOBAL CANCER OBSERVATORY: Prostate Cancer. Cancer At the moment. http://gco.iarc.fr/today/data/pdf/fact-sheets/cancers/cancer-fact-sheets-19.pdf. Revealed 2018. Final Accessed August 2021.
  4. American Cancer Society. Cancer Details & Figures 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. Accessed August 2021.
  5. American Cancer Society. What’s Prostate Cancer? https://www.cancer.org/content/dam/CRC/PDF/Public/8793.00.pdf. Accessed August 2021.
  6. American Cancer Society. Prostate Cancer Threat Components. https://www.cancer.org/content/dam/CRC/PDF/Public/8794.00.pdf. Accessed August 2021.
  7. Nationwide Cancer Institute. Hormone Remedy for Prostate Cancer. https://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet. Accessed August 2021.
  8. Nakazawa, Mary; Paller, Channing; Kyprianou, Natasha. Mechanisms of Therapeutic Resistance in Prostate Cancer. Curr Oncol Rep (2017) 19:13.
  9. Mayo Clinic. Prostate most cancers screening: Must you get a PSA take a look at?. https://www.mayoclinic.org/tests-procedures/psa-test/in-depth/prostate-cancer/art-20048087. Accessed August 2021.
  10. Howard, Lauren; Moreira, Daniel M; DeHoedt, Amanda; Aronson, William J., et al. Thresholds for PSA doubling time in males with non-metastatic castration-resistant prostate most cancers. BJU Int 2017;120: E80-E86.
  11. Kirby, Mike, Hirst, Ceri, Crawford. E. David. Characterising the castration-resistant prostate most cancers inhabitants: a scientific evaluation. Int J Clin Pract. 2011;65(11):1180-1192. doi:10.1111/j.1742-1241.2011.02799.

PP-NUB-US-1297-2 9/21

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