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Pipeline Plus

Exciting Therapies Ahead in Prostate Cancer

Kunj Gohil PharmD, RPh

Prostate cancer has become the second most common type of cancer affecting men (skin cancer is number one), with approximately 240,000 patients diagnosed each year.1 Their prognosis depends on various factors, such as the stage of the cancer and other patient characteristics, including age, race, and overall health. If prostate cancer is diagnosed early, localized therapies such as prostatectomy and radiotherapy can be used, resulting in a virtual 100% five-year survival rate.2 Unfortunately, the risk of metastases increases as the disease progresses; the most common areas of metastases are the adrenal gland, bone, liver, and lung.3 A poorer prognosis results as the cancer advances, with a five-year survival rate of 37%.2

Traditionally, chemotherapy was the mainstay of treatment for metastatic prostate cancer. Docetaxel was the primary agent because it improved overall survival (OS), but its unfavorable toxicity profile has since relegated it to later-line therapy. Since 2010, multiple hormone therapies have been approved and have become favored options for the treatment of metastatic prostate cancer. They fall into different drug categories and have contributed to overall U.S. market sales estimated at $1.6 billion in 2013.3,4

The pipeline is filled with exciting therapies designed with various mechanisms of action. As physicians continue to gain experience with newer therapies, the reception for future drugs should be positive. With the robust pipeline and efficacious current agents, overall market sales are expected to grow to $3.7 billion in the U.S. by 2023.4

Future Therapies

Drug
Manufacturer
Status Regimen Information Pivotal Studies Expected Approval Anticipated Peak Year Sales/Pricing
Yervoy (ipilimumab)
Bristol-Myers Squibb
Phase 3 10 mg/kg IV every three weeks for four times, then once every 12 weeks NCT01057810 2016 Anticipated pricing similar to current Yervoy melanoma pricing, despite increased dose; U.S. sales expected to reach $210 million by 2023
Custirsen sodium
OncoGenex
Phase 3 1,920-mg IV loading dose followed by 640 mg IV weekly AFFINITY 2016 Anticipated pricing competitive with Zytiga; U.S. sales expected to reach $182 million by 2023
ProstVac (vaccinia-PSA-TRICOM/fowlpox-PSA-TRICOM)
Bavarian Nordic
Phase 3 SC injection of ProstVac-V-TRICOM at week 1; six injections of ProstVac-F-TRICOM at weeks 3, 5, 9, 13, 17, 21 PROSPECT 2017 Anticipated pricing at a 30% discount to Provenge; U.S. sales expected to reach $140 million by 2023
Tasquinimod
Active BioTech/Ipsen
Phase 3 0.25 mg, 0.5 mg, or 1.0 mg orally once daily NCT01234311 2017 Anticipated pricing competitive with Xtandi; U.S. sales expected to reach $101 million by 2023
ARN-509
Johnson & Johnson
Phase 3 240 mg orally once daily SPARTAN 2017 Anticipated pricing competitive with Xtandi; U.S. sales expected to reach $152 million by 2023
ProstAtak
Advantagene
Phase 3 1st dose 15 days before radiotherapy; 2nd dose 0–3 days before radiotherapy; 3rd dose 15–22 days after 2nd dose NCT01436968 2018 Anticipated pricing at a 30% discount to Provenge; U.S. sales expected to reach $503 million by 2023
ODM-201
Bayer
Phase 3 300 mg orally twice daily NCT02200614 2019 Anticipated pricing competitive with Xtandi; U.S. sales expected to reach $35 million by 2023
DCVAC/PCa
Sotio
Phase 3 10 doses of dendritic cells (1 × 107 cells) injected SC every six weeks NCT02111577 2019 Anticipated pricing competitive with Provenge; U.S. sales of $42 million in 2023

IV = intravenous; SC = subcutaneous

Sources: FDA; GlobalData; company websites; ClinicalTrials.gov

Current Therapiesa

Drug
Manufacturer
Approval Date Indicationb Regimen Informationc Cost of Course of Therapy per Monthd
Targeted Therapies
Xofigo (radium 223 dichloride)
Bayer
May 15, 2013 Metastatic castration-resistant prostate cancer 1.35 microcuries per kilogram of body weight injected every four weeks for six injections $14,391e,f
Xtandi (enzalutamid)
Astellas
August 31, 2012 Metastatic castration-resistant prostate cancer 160 mg (four 40-mg capsules) orally once daily $10,618
Zytiga (abiraterone acetate)
Johnson & Johnson
April 28, 2011 Metastatic castration-resistant prostate cancer 1,000 mg (four 250-mg tablets) orally once daily $9,595
Chemotherapies
Jevtana (cabazitaxel)
Sanofi
June 17, 2010 Hormone-refractory metastatic prostate cancer 25 mg/m2 one-hour IV infusion every three weeks $5,813g
Therapeutic Vaccines
Provenge (sipuleucel-T)
Dendreon
April 29, 2010 Metastatic castration-resistant prostate cancer Three doses at two-week intervals $91,769f
Hormone Therapies
Firmagon (degarelix)
Ferring
December 29, 2008 Advanced prostate cancer 240-mg SC starting dose, then 80 mg every 28 days Starting dose, $1,659; maintenance, $553
Eligard (leuprolide acetate)
Sanofi/Astellas
December 16, 2004 Palliative treatment of advanced prostate cancer 7.5 mg SC every month $493
Trelstar (triptorelin acetate)
Actavis
June 15, 2000 Palliative treatment of advanced prostate cancer 3.75 mg IM every four weeks $976f
Zoladex (goserelin acetate)
AstraZeneca
July 28, 1998 Stage B2-C prostatic carcinoma, prostatic carcinoma 3.6 mg SC every 28 days $601f
Casodex (bicalutamide)
AstraZeneca
October 4, 1995 D2 metastatic carcinoma of the prostate 50 mg orally once daily $630
Lupron Depot (leuprolide acetate)
AbbVie
January 26, 1989 Palliative treatment of advanced prostatic cancer 7.5 mg IM every four weeks $1,401f

aThis list is not all-inclusive; additional therapies may be available for this disease state.

bAbbreviated indication provided; for full indication, please refer to prescribing information.

cRegimens based on the recommended dosage and maintenance phases from prescribing information; typical doses and titration schedules may vary based on patient-specific requirements.

dCosts calculated using average wholesale price and regimen provided for 30 days (unless otherwise noted), rounded to the nearest dollar.

e80.7 kg used as average U.S. male’s weight.

fPrice was calculated for a four-week dose.

gPrice was calculated for a three-week dose, using 1.9 m2 as the average U.S. male’s body surface area.

IM = intramuscular; IV = intravenous; SC = subcutaneous

Sources: Red Book; Drugs@FDA; and prescribing information for all medications

Author bio: 
Dr. Gohil is Central Services Manager with Medical Services at MediMedia Managed Markets in Yardley, Pennsylvania.

References

  1. CancerCare. Treatment update: metastatic prostate cancer. Available at: https://www.cancercare.org/publications/180-treatment_update_metastatic_prostate_cancer. Accessed July 10, 2015.
  2. GlobalData. Prostate Cancer—Global Drug Forecast and Market Analysis to 2023 April 2015;
  3. National Cancer Institute. Metastatic cancer. March 2013;Available at: https://www.cancer.gov/about-cancer/what-is-cancer/metastatic-fact-sheet. Accessed July 10, 2015.
  4. Decision Resources. Driven by the launches of promising emerging therapies, the prostate cancer drug market will experience robust growth over the next decade, increasing from $3.6 billion in 2010 to $10.1 billion in 2020. November 2011. Available at: https://decisionresourcesgroup.com/newsroom/. Accessed July 10, 2015.