Retreatment With Radium-223 Found Safe in mCRPC

Excerpt:

“To determine if a higher dose of radium-223 would be safe, an international, multicenter, prospective study examined 44 patients with mCRPC with bone metastases. Radium-223 was found to be well tolerated in this study, with incidence of adverse advents in retreated patients comparable or lower than those seen in the ALSYMPCA trial. No new safety concerns were observed with the higher dose.

“In an interview with OncLive, Nordquist, an investigator on the trial, provides more insight on the study and the ongoing potential of radium-223 in mCRPC.”

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Steroid Use With Abiraterone Offers Multidimensional Benefits to Patients With mCRPC

Excerpt:

“For decades, the standard of care for men with advanced prostate cancer has been the depletion or inhibition of androgens. While androgen-deprivation therapy (ADT) often results in temporary tumor regression or symptom relief in some patients, disease progression ultimately occurs over time. For patients with metastatic disease, the median overall survival (OS), until very recently, had been less than 2 years after chemotherapy.

“While tumor progression with ADT was previously believed to be hormone-refractory or androgen-independent, a large body of evidence supports that metastatic castration-resistant prostate cancer (mCRPC) is commonly driven by elevated steroid synthesis, increased expression or splice variants of the androgen receptor (AR), or AR ligand promiscuity, indicating the ongoing need for targeted androgen therapies.”

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Advaxis Combination Trial with Merck Completes First Two Dose-Escalation Cohorts

Excerpt:

Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and Merck & Co., Inc. (MRK), today announced that they have completed the first two dose-escalation cohorts and launched the third dose-escalation cohort in their KEYNOTE-046 clinical trial. The Phase 1/2 study is evaluating the combination of ADXS-PSA (ADXS31-142) and KEYTRUDA® (pembrolizumab), the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC).

“The KEYNOTE-046 trial is the first-in-human study of Advaxis’ Lm immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer.”

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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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Janssen's Zytiga Boosts Survival in Early-Stage Prostate Cancer

“Janssen has announced data from a post-hoc analysis of a Phase III trial showing that Zytiga plus prednisone boosted overall survival (OS) by 11.8 months compared with placebo plus prednisone, in men with early and less aggressive metastatic castration-resistant prostate cancer (mCRPC) who had not received chemotherapy.

“Data presented today at the European Association of Urology (EAU) 2016 Congress in Munich, Germany, demonstrated that in the COU-AA-302 trial, Zytiga (abiraterone acetate) increased OS to 53.6 months versus the 41.8 months achieved by patients treated with prednisone alone. This benefit was shown to be 4.4 greater than that previously reported for the combo in the final analysis of the COU-AA-302 trial in 2014.

“The post-hoc analysis divided patients into two groups to identify which group experienced a greater treatment benefit. The patients in group 1 were in an earlier, less advanced and less symptomatic stage of the disease, while those in group 2 were in a later, more advanced and more symptomatic stage of the disease.”


Abituzumab Improves Bone Lesion Progression, not PFS in CRPC

“Abituzumab did not extend progression-free survival (PFS) compared with placebo in a phase II study of patients with metastatic castration-resistant prostate cancer. The agent did, however, offer a lower incidence of bone lesion progression, and researchers say it still warrants further investigation.

“Previous research has suggested that integrins play a role in the progression of metastatic prostate cancer and associated bone lesions, wrote researchers led by Maha Hussain, MB, ChB, of the University of Michigan in Ann Arbor. Abituzumab is a pan-αv integrin inhibitor; a phase I trial previously showed that the agent has activity in patients with castration-resistant prostate cancer and bone metastases.

“The new phase II trial randomized 180 patients between three arms: a 750-mg abituzumab group, a 1,500-mg abituzumab group, or placebo. All groups also received standard of care. The results were published in Clinical Cancer Research.”


FDA Grants Olaparib Breakthrough Designation in mCRPC

“Olaparib (Lynparza) has received an FDA breakthrough therapy designation as a treatment for patients with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer (mCRPC) in those who have received a prior taxane-based chemotherapy and at least either hormonal agent enzalutamide (Xtandi) or abiraterone acetate (Zytiga).

“The designation, which will accelerate the development and review of the first-in-class oral PARP inhibitor, is based on data from the phase II TOPARP-A trial that demonstrated that olaparib monotherapy had an overall response rate (ORR) of nearly 90% in a biomarker-defined subgroup of patients who had DNA-repair defects.


Radium-223 Benefits Survival, Not Just for Palliative Care

“Despite what many believe, not all radiopharmaceuticals are just for pain palliation, says Phillip J. Koo, MD, a radiologist of Memorial Hospital and University of Colorado Hospital.

“The ALSYMPCA trial, which was the basis for the 2013 FDA approval of radium-223 dichloride (Xofigo) showed a median overall survival (OS) of 14 months with radium-223 versus 11.2 months with placebo (HR, 0.70; P = .00185) in patients with metastatic castration-resistant prostate cancer (mCRPC).

“Despite the fact that it has been 3 years since the pivotal ALSYMPCA trial and the coinciding FDA approval, many oncologists still need to be educated regarding radium-223’s benefits, says Koo.”


Multiple Trials Explore Radium-223 Combinations for mCRPC

“Clinical trials are now assessing how to best use radium-223 (Xofigo) in combination with androgen inhibitors, following the rapid approval of several agents for men with castration-resistant prostate cancer (CRPC).

“In the first of these studies, a phase III being conducted by the European Organisation for Research and Treatment of Cancer (EORTC), single-agent enzalutamide (Xtandi) is being compared with radium-223 plus enzalutamide for men with asymptomatic or mildly symptomatic bone metastatic CRPC (NCT02194842). Additionally, this same approach is being examined in a phase II study conducted by the All Ireland Cooperative Oncology Research Group (NCT02225704).”