Clovis Oncology and Strata Oncology Announce Collaboration to Accelerate Enrollment in Rucaparib Prostate Cancer Development Program

Excerpt:

“Clovis Oncology, Inc. (NASDAQ: CLVS) and Strata Oncology, Inc. today announced an agreement to accelerate patient identification and enrollment for Clovis’ ongoing TRITON (Trial of Rucaparib in Prostate Indications) clinical trial program, which includes Phase 2 and Phase 3 clinical trials of rucaparib in metastatic castration-resistant prostate cancer, both of which are open for enrollment.

“Rucaparib is an oral inhibitor of poly ADP-ribose polymerase (PARP), approved in the U.S. in 2016 as Rubraca™ (rucaparib) as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy by an FDA-approved companion diagnostic. Emerging data suggest PARP inhibition may also provide activity in the treatment of metastatic prostate cancers harboring deleterious mutations in BRCA1/2 and ATM or other human genes associated with DNA damage repair. These mutations may be germline (inherited) or somatic (acquired).”

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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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Cabazitaxel/Abiraterone Combination Promising in mCRPC

Excerpt:

“The combination of cabazitaxel and abiraterone was well tolerated and showed antitumor activity in previously treated patients with metastatic castration-resistant prostate cancer (mCRPC), according to a new phase I/II study.

” ‘Therapeutic options for men with mCRPC have evolved considerably with the approval of five therapies associated with improved overall survival,’ wrote study authors led by Christophe Massard, MD, PhD, of Gustave Roussy Cancer Campus in Villejuif, France. Still, ‘there is a need to provide robust evidence on how these agents should be used, in sequence or in combination, to achieve optimal medical management.’ ”

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Adding Bone Drugs to Radium-223 May Enhance Benefit in mCRPC

Excerpt:

“Men with bone-metastatic castration-resistant prostate cancer (mCRPC) appeared to derive additional benefits from treatment with radium-223 with concomitant bone-targeted therapies, according to data from an extended-access program.

“After a median follow-up of 7.5 months from initial injection of radium-223, patients on concomitant denosumab had yet to reach a median overall survival (OS), whereas patients treated with radium-223 alone had a median survival of 13.4 months.”

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Enzalutamide Shows Efficacy in Prostate Cancer With Visceral Mets

Excerpt:

“Patients with metastatic castration-resistant prostate cancer (mCRPC) and visceral metastases (liver and lung) fare better with the androgen receptor inhibitor enzalutamide than placebo, according to a new analysis from the phase III AFFIRM trial. There were differences in response based on which of those two sites had metastases, suggesting they should be considered differently for treatment.

” ‘Visceral metastases are identified in approximately 22% to 30% of patients with mCRPC and are associated with unfavorable outcomes,’ wrote study authors led by Yohann Loriot, MD, PhD, of Université Paris-Saclay in Villejuif, France.”

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Video: An Overview of the ALSYMPCA Study in Metastatic Prostate Cancer

Excerpt:

“Luke Nordquist, MD, FACP, a urologic medical oncologist and CEO of the Urology Cancer Center and GU Research Network, gives an overview of the Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) study, and he discusses ongoing trials examining the use of radium-223 dichloride (Xofigo) in metastatic castration-resistant prostate cancer (mCRPC).”

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Custirsen Combo Falls Short in Phase III mCRPC Trial

Excerpt:

“Adding custirsen to cabazitaxel (Jevtana) and prednisone in the second-line setting failed to improve overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC) in the phase III AFFINITY trial, according to OncoGenex, the company developing the drug.

“The open-label AFFINITY trial included 634 men with mCRPC who progressed on docetaxel. Patients were randomized to cabazitaxel plus prednisone with or without weekly custirsen. Treatment was administered until progression, unacceptable toxicity, or the completion of 10 cycles. The study was conducted at 95 locations in North America, Europe, Russia, and Australia.”

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Pivotal ARMOR 3-SV Prostate Cancer Trial Discontinued After PFS Rates Miss the Mark

Excerpt:

“The pivotal phase III prostate cancer trial ARMOR 3-SV will be discontinued based on recommendations made by the trial’s independent data monitoring committee (DMC), according to the manufacturer Tokai Pharmaceuticals. The DMC concluded that ARMOR 3-SV would unlikely meet its primary endpoint of demonstrating improved radiographic progression-free survival (PFS) based on its review of all safety and efficacy data. Top-line data from the trial is not expected until next year.

“It’s a big setback for the company, which was seeking the right niche for the agent in a crowded prostate cancer treatment market. ARMOR 3-SV compared galeterone with enzalutamide (Xtandi) in patients with treatment-naïve metastatic castration-resistant prostate cancer (mCRPC), particularly in patients whose prostate tumors expressed AR-V7. These truncated ARs are missing the C-terminal end of the AR that contains the ligand-binding domain, which is known as C-terminal loss. AR-V7 is the most common form of C-terminal loss of androgen receptors (ARs), a key target in resistance. This form of AR-V7 is also thought to make patients unlikely to respond to either enzalutamide or abiraterone acetate (Zytiga).”

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Shore Shares Insight on Challenges of Bone Metastases in mCRPC

Excerpt:

“Bone metastases in castration-resistant prostate cancer (mCRPC) create a significant problem, Neal Shore, MD, medical director of the Carolina Urologic Research Institute, said in a recent presentation at the 2016 American Urological Association Annual Meeting.

” ‘A bone-metastatic event is really a seminal event,’ said Shore, who discussed the prevalence of bone metastases and possible preventative solutions. ‘It is quite an outstanding biologic and prognostic factor in mortality and, often times, in morbidity.’ ”

“Prostate cancer represents 21% of all new cancer cases in men and is the second most common cause of cancer death among American men after lung cancer, reported Shore.”

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