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DUBLIN, July 16, 2021 / PRNewswire / – “Disease Analysis: Prostate Cancer” report has been added to ResearchAndMarkets.com offer.
The publisher estimates that in 2018 there were 1.3 million incident cases of prostate cancer worldwide in men aged 40 and over, and predicts that number will rise to 1.5 million. cases by 2027.
In the United States, prostate cancer is the most commonly diagnosed malignant noncutaneous tumor in men and the second leading cause of cancer death in men behind lung cancer.
The overall probability of approval of a phase I active in prostate cancer is 4.7%, and the average probability that a drug will progress from phase III is 51.5%. Prostate cancer drugs take an average of 9.0 years from phase I to approval, compared to 9.6 years across the cancer space.
Pfizer’s Next Generation Androgen Receptor (AR) Inhibitor, Xtandi, Is The Prostate Cancer Market Leader Due To Its Established Effectiveness In All Prostate Cancer Segments And Lack Of Generic Competition short term. With recent and planned expansions in other prostate cancer segments, Xtandi will continue to be the primary option in this indication. Opportunities for future expansion include potential use in combination with the PARP inhibitors Talzenna or Rubraca in patients with metastatic castration-resistant prostate cancer (mCRPC).
The late phase PARP inhibitors Zejula and Talzenna are also being developed in combination with next generation treatments and will join an overcrowded PARP treatment space. Zejula is being tested in combination with abiraterone against abiraterone alone as a first-line treatment for patients with mCRPC. Likewise, Talzenna is being studied in combination with Xtandi or enzalutamide at the physician’s choice in patients with mCRPC, also as a first-line option.
The potential synergy of PARP inhibitors with AR modulators is promising, but an important advantage should be seen to justify the first-line use of mCRPC. If approved, it is likely that these treatment regimens will be limited to HRD or even BRCA populations, where they will have high utility but somewhat limited commercial impact due to the relatively low prevalence of these biomarkers.
Next-generation RA inhibitors Nubeqa and Erleada have shifted the treatment paradigm to include these therapies in earlier segments of the disease, such as non-metastatic castration-resistant prostate cancer (nmCRPC) and cancer of hormone-sensitive metastatic prostate (mHSPC). Expansion into previous segments and lines of therapy is underway. Bayer is seeking to expand the Nubeqa label to include use in very high-risk localized patients and hormone-sensitive metastatic patients.
Johnson & Johnson will continue to try to differentiate Erleada with an aggressive development plan that includes potential extensions in mCRPC chemotherapy-naïve patients as part of a combination with abiraterone, as well as in the localized setting for treated patients. by prostatectomy or radiotherapy.
Akt inhibitors, ipatasertib and capivasertib, are a potential new mechanistic addition to the prostate cancer space, but the efficacy / tolerability profile of these PI3K / Akt / mTOR pathway inhibitors may prevent approval and potential use. Ipatasertib is a pan-Akt inhibitor from Roche currently in development for asymptomatic or mildly symptomatic mCRPC patients with loss of PTEN in combination with abiraterone.
Loss of PTEN is not a standard target in this indication, but represents a significant market opportunity as it is estimated to occur in approximately 20% of primary prostate cancers and up to 50% of castration resistant tumors. However, ipatasertib is beset by known class toxicities of PI3K / Akt / mTOR pathway inhibitors such as diarrhea, rash, and elevations of ALT / ASAT which could impair its chances of regulation. AstraZeneca’s Akt inhibitor capivasertib has also shown mixed results in prostate cancer.
In the phase I / II ProCAID trial, capivasertib in combination with docetaxel failed to meet the primary endpoint of improvement in progression-free survival in patients with mCRPC. However, the combination improved overall survival in these patients regardless of PI3K / Akt / mTOR pathway mutations. This led to the launch of the phase III trial CAPItello-281 testing capivasertib in combination with abiraterone in de novo mHSPC with loss of PTEN.
Main topics covered:
PREVIEW
BACKGROUND OF THE ILLNESS
- Definition
- Risk factors
- Symptoms
- Diagnostic
- Prognosis
- Patient segmentation
- Clinical states
TREATMENT
- Sponsorship models
- Localized prostate cancer
- Locally advanced prostate cancer
- Recurrent / progressive prostate cancer
- Metastatic hormone-sensitive prostate cancer
- Non-metastatic castration-resistant prostate cancer
- Castration-resistant metastatic prostate cancer
EPIDEMIOLOGY
MARKETED MEDICINES
MEDICINES BY PIPELINE
KEY REGULATORY EVENTS
- Oral Orgovyx May Reduce Patient’s Risk of COVID-19 Exposure
- Telix takes the radiopharmaceutical route to the prostate cancer market
- AstraZeneca / Merck’s Lynparza obtains second-line indication for prostate cancer
- Rubraca de Clovis is the first PARP for prostate cancer, but Lynparza d’AZ is coming soon
- Myovant submits first NDA for Relugolix and plans another in May
- Testing issues complicate Tookad’s journey to approval
- Steba’s Tookad: US FDA Panel to Weigh New Parameters, Missing Data and Toxicities
LIKELIHOOD OF SUCCESS
GRANT OF LICENSES AND ACQUISITION OF ASSETS
- Pfizer obtains new commercial drug Orgovyx in agreement with Myovant
- Janssen and Xencor team up against prostate cancer
- Diaprost obtains PSA antibody PI from Memorial Sloan kettering
LANDSCAPE OF CLINICAL TRIALS
- Sponsors by status
- Sponsors by phase
- Recent events
DRUG EVALUATION MODEL
MARKET DYNAMICS
FUTURE TRENDS
- Xtandi will remain top-selling therapy for the next decade
- Generics of abiraterone have largely supplanted the prescription of Zytiga
- Johnson & Johnson to rely on Erleada to make up for lost Zytiga revenue
- Prescribing Next Generation Hormone Therapies in Prior Treatment Settings Will Drive Market Growth
- Drugs in the pipeline targeting mCRPC patients will generate only moderate absorption
CONSENSUS FORECASTS
RECENT EVENTS AND ANALYST ADVICE
- Orgovyx for prostate cancer (September 29, 2020)
- AMG 160 for prostate cancer (September 21, 2020)
- Ipatasertib for prostate cancer (September 20, 2020)
- Ipatasertib for prostate cancer (June 18, 2020)
- Capivasertib for prostate cancer (May 30, 2020)
- HPN424 for prostate cancer (May 29, 2020)
- Orgovyx for prostate cancer (May 29, 2020)
- Lutetium 177Lu-PSMA-617 for prostate cancer (May 13, 2020)
- Tookad for prostate cancer (February 26, 2020)
- Tookad for prostate cancer (February 24, 2020)
- Multiple drugs for prostate cancer (February 13, 2020)
- Cabometyx / Cometriq for prostate cancer (February 10, 2020)
KEY UPCOMING EVENTS
KEY OPINION LEADERS OVERVIEW
BIBLIOGRAPHY
APPENDIX
For more information on this report, visit https://www.researchandmarkets.com/r/ubdzkp
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