Apalutamide Submitted for FDA Approval in Prostate Cancer

Excerpt:

“Janssen Biotech has submitted a new drug application to the FDA for apalutamide (ARN-509) for the treatment of non-metastatic castration-resistant prostate cancer (CRPC), the manufacturer of the next-generation oral androgen receptor inhibitor announced today.

“Apalutamide inhibits the action of testosterone in prostate cancer cells and prevents androgen from binding to the androgen receptor. Currently, there are no FDA-approved treatments for patients with nonmetastatic CRPC, Janssen noted in a press release.”

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Pivotal Role Remains With Bone-Targeting Agents in mCRPC

Excerpt:

“Prostate cancer researchers are continuing to explore strategies to optimally integrate bone-targeted agents into patient care.

“For example, an ongoing trial is assessing the combination of a radiopharmaceutical, radium-223 dichloride (Xofigo), with an androgen receptor-directed therapy, either abiraterone acetate (Zytiga) or enzalutamide (Xtandi). The open-label, phase IIa study is accruing patients with metastatic castration-resistant prostate cancer (mCRPC). The primary endpoint of the trial, which hopes to enroll 68 patients, is patient bone scan response rate (NCT02034552).”

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Novel Blood Test May Identify New Biomarker in Prostate Cancer

Excerpt:

“By assessing plasma androgen receptor (AR) gene status assessment with multiplex droplet digital PCR (ddPCR), European researchers could predict which patients with castration-resistant prostate cancer (CRPC) were most likely to have poorer outcomes while undergoing targeted therapy, according to results from the PREMIER trial published in the Annals of Oncology.

“Researchers said there was a ‘significant association’ for AR gain and poorer overall survival (OS) for both chemotherapy-naïve patients (HR, 3.98; 95% CI, 1.75-9.10; P <.001) and patients previously treated with docetaxel (HR, 3.81; 95% CI, 2.28-6.37; P <.001). AR gain was also associated with poorer OS for chemotherapy-naïve patients treated with enzalutamide (Xtandi) or abiraterone acetate (Zytiga; HR, 2.18; 95% CI, 1.08-4.39; P = .03) and for patients previously treated with docetaxel (HR, 1.95; 95% CI, 1.23-3.11; P = .01).”

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New Therapeutic Agent Proves More Effective Treatment for Advanced Prostate Cancer

Excerpt:

“A German multicenter study, initiated by the German Society of Nuclear Medicine, demonstrates that lutetium-177 (Lu-177)-labeled PSMA-617 is a promising new therapeutic agent for radioligand therapy (RLT) of patients with metastatic castration-resistant prostate cancer (mCRPC). The study is published in the January 2017 issue of the Journal of Nuclear Medicine and is the featured article.

“Prostate-specific membrane antigen (PSMA) is overexpressed in and even more so with castration-resistant disease. This makes development of new tracers for PSMA-targeted radionuclide therapies a promising treatment approach. Prostate cancer deaths are usually the result of mCRPC, and the median survival for men with mCRPC has been less than two years.”

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Safety, Survival Advantages of Radium-223 Continue to Offer Benefit in mCRPC

Excerpt:

“The manageable safety profile of radium-223 dichloride (Xofigo) compared with other radiopharmaceuticals is appealing to oncologists treating castration-resistant prostate cancer (CRPC) that is metastatic to the bone, says Richard G. Stock, MD.

“ ‘With previous radiopharmaceuticals, there has been a limitation with bone marrow toxicity,’ said Stock, senior faculty, Radiation Oncology, Mount Sinai Hospital. ‘Radium-223 really spares the bone marrow to a much greater degree than prior treatments, and that is why it has been embraced and much more widely utilized than any of the other radiopharmaceuticals.’ ”

“The FDA approved radium-223 in May 2013 based on findings from the phase III ALSYMPCA trial. In the study, radium-223 demonstrated a median overall survival of 14.9 months compared with 11.3 months with placebo for patients with bone-metastatic CRPC (HR, 0.70; P <.001).”

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Expert Says Xofigo Is "Game Changer" for Bone Metastatic CRPC

Excerpt:

“Radium-223 dichloride (Xofigo) opened an entirely new chapter in the treatment landscape of castration-resistant prostate cancer with bone metastases (mCRPC), says E. David Crawford, MD, professor of Radiation Oncology, Department of Surgery, at the University of Colorado Denver.

“ ‘Radium-223 is sort of a surprise drug, at least to me,’ says Crawford. “We have had radioisotopes around for a long period of time, including phosphorus-32, samarium-153 (Quadramet), strontium-89 (Metastron), and others. But, they all had a lot of baggage with them, in terms of side effects.

” ‘Now, we have a new one—radium-223—which is not associated with the side effects that we were seeing with the other ones, but it is associated with an improvement in survival rate. It’s a game changer.’ ”

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Radium-223 Improves QoL Over Placebo in CRPC

“Analyses from the phase III ALSYMPCA trial showed that treatment with the alpha-emitting radiopharmaceutical radium-223 resulted in quality-of-life (QoL) improvements over placebo in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases.

“ ‘Patients with CRPC and bone metastases often present with symptoms such as pain fatigue, anorexia, and, rarely, spinal cord compression, contributing to rapid and significant deterioration in health-related QoL and mortality,’ wrote study authors led by Sten Nilsson, MD, PhD, of Karolinska University Hospital in Stockholm.

“The ALSYMPCA trial found that radium-223 prolonged overall survival (OS) as well as time to first symptomatic skeletal event by significant periods. The trial included prospective QoL measurements using the EuroQoL EQ-5D and the Functional Assessment of Cancer Therapy–Prostate (FACT-P). The results from these tests were published online ahead of print in Annals of Oncology.”


Precision Medicine on the Horizon for Prostate Cancer

“While still in its early stages, integrative genomic testing could be the future for personalizing therapy for patients with castration-resistant prostate cancer (CRPC), according to Tomasz M. Beer, MD, FACP.

“In an interview with Targeted Oncology, Beer, deputy director, Knight Cancer Institute, Oregon Health and Science University, explained that understanding the genetic makeup of CRPC could lead to new treatments, both single-agents and combinations. One of the most recent examples was the discovery of BRCA genetic mutations within CRPC, he said. While BRCA mutations are mostly associated with breast and ovarian cancers, this discovery could provide a new avenue for treating men with CRPC.

“In the interview, Beer discussed the current state of genetic testing for prostate cancer and changes on the horizon that are currently being explored in clinical trials.”


Enzalutamide Superior to Bicalutamide for Castration-Resistant Prostate Cancer

“The oral androgen receptor inhibitor enzalutamide significantly reduced the risk for prostate cancer progression or death compared with bicalutamide in patients with castration-resistant prostate cancer, according to findings from the STRIVE trial.

“Enzalutamide (Xtandi, Astellas) has been found to improve survival in men with castration-resistant prostate cancer prior to and following chemotherapy. It binds the androgen receptor in the same way as bicalutamide does, but with greater affinity, according to researchers.

“Since bicalutamide is the standard treatment for this population of patients, researchers conducted this phase 2 trial to compare the two treatments.”