Combo Tx No Help After PSA Progression in mCRPC

Excerpt:

“Adding abiraterone acetate (Zytiga) to enzalutamide (Xtandi) did not improve progression-free survival (PFS) after prostate-specific antigen (PSA) progression in men on enzalutamide monotherapy for chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC), researchers found.

“In the randomized, double-blind PLATO trial, the median PFS in patients treated with enzalutamide plus abiraterone and prednisone was 5.7 months. By comparison, the PFS was 5.6 months in the control group treated with abiraterone and prednisone plus placebo (hazard ratio [HR] 0.83; P=0.22).”

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AR-V7+ CTCs Predicted Worse PFS, OS in mCRPC

Excerpt:

“Detection of circulating tumor cells (CTCs) positive for the nuclear-specific AR-V7 protein was an independent predictor of shortened progression-free survival (PFS) and overall survival (OS) when treating metastatic castration-resistant prostate cancer (mCRPC) with abiraterone or enzalutamide, according to results of the PROPHECY study (abstract 5004). The findings were presented at the 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO), held June 1–5 in Chicago.

“’Men with AR-V7–positive CTCs have a very low probability of benefit from abiraterone or enzalutamide, ranging from 0% to 11%,’ said Andrew J. Armstrong, MD, of Duke Cancer Institute. ‘However, a lack of AR-V7 detection does not guarantee response or benefit’ where these therapies are concerned, he added.”

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Abiraterone May Be More Effective in Black Men With Prostate Cancer

Excerpt:

“Black men with metastatic castration-resistant prostate cancer (CRPC) who received hormonal therapy with the adrenal inhibitor abiraterone had greater and longer-lasting responses compared with white men, according to the results of a late-breaking study (abstract LBA5009) presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago June 1–5.

“The prospective study found that black men were more likely to have a decline in prostate-specific antigen (PSA) and had a longer median time to PSA worsening than white men. The findings were presented by Daniel George, MD, professor of medicine and surgery at Duke University.”

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Novel Radionuclide Treatment Demonstrates Promising Results in mCRPC

Excerpt:

“Updated results from the phase II LuPSMA study published in The Lancet Oncology showed radionuclide treatment with Lutetium-177 [177Lu]-PSMA-617 nearly doubled median PSA progression-free survival (PFS) in men with progressive metastatic castrate-resistant prostate cancer (mCRPC) compared with previous results with another radiopharmaceutical, radium-223 (Ra-223; Xofigo).

“In LuPSMA, the median PSA PFS was 7.6 months (95% CI, 6.3-9.0) and 27 (90%) of 30 men experienced PSA progression. The median overall survival (OS) was 13.5 months (95% CI, 10.4-22.7) and 22 (73%) men had died by the November 2017 data cutoff.”

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Xtandi Granted Priority Review for Prostate Cancer Treatment

Excerpt:

“The Food and Drug Administration granted Xtandi (enzalutamide) a priority review to a supplemental new drug application for the treatment of patients with nonmetastatic castration-resistant prostate cancer, according to the companies developing the drug, Pfizer and Astellas.

“The sNDA is based on data from the phase 3 PROSPER trial in which the combination of Xtandi and androgen deprivation therapy (ADT) reduced the risk of metastases or death by 71 percent compared with ADT alone for patients with nonmetastatic CRPC. In the double-blind study, the median metastasis-free survival (MFS) was 36.6 months with Xtandi plus ADT versus 14.7 months with ADT alone.”

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Apalutamide, Enzalutamide Improve Metastasis-Free Survival in Nonmetastatic Castrate-Resistant Prostate Cancer

Excerpt:

In two separate trials presented at the 2018 Genitourinary Cancers Symposium, apalutamide and enzalutamide (Xtandi), respectively, reduced the risk of metastasis and prolonged metastasis-free survival in men with high-risk nonmetastatic castrate-resistant prostate cancer. In the SPARTAN trial, apalutamide reduced the risk of developing metastasis and death by 72% compared with placebo, and in the PROSPER trial, enzalutamide reduced the risk of metastasis or death by 71% compared with placebo. In both studies, men were treated with ongoing androgen-deprivation therapy.”

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FDA Approves New Treatment for a Certain Type of Prostate Cancer Using Novel Clinical Trial Endpoint

Excerpt:

“The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.”

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Apalutamide Granted FDA’s Priority Review for Nonmetastatic CRPC

Excerpt:

“Based on data from the phase III SPARTAN trial (ARN-509-003), apalutamide (ARN-509) has been granted a priority review by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.

“The trial evaluated the safety and efficacy of apalutamide versus placebo in patients with a rapidly rising prostate specific antigen (PSA) level despite receiving continuous androgen deprivation therapy (ADT). The primary endpoint of the study is metastasis-free survival.”

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Bipolar Androgen Therapy Induces PSA Reductions in Metastatic CRPC

Excerpt:

“The use of bipolar androgen therapy (BAT), involving rapid cycling between high and low serum concentrations, was safe and resulted in responses and resensitization to enzalutamide in men with metastatic castration-resistant prostate cancer (CRPC) who progressed after initial enzalutamide therapy, according to a new study.

“ ‘Clinically, metastatic CRPC that has progressed after enzalutamide treatment is minimally responsive to further therapy that inhibits androgen receptor signaling,’ wrote study authors led by Benjamin A. Teply, MD, of Johns Hopkins School of Medicine in Baltimore. ‘Theoretically, rapidly varying the androgen concentrations between the extremes of supraphysiological and near-castrate, a strategy termed BAT, provides insufficient time for CRPC cells to adaptively regulate androgen receptor concentrations,’ and thus may promote cancer cell death and prevent resistance.”

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