Prostate Cancer

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

As the new coronavirus disease 2019 creates problems internationally, health-wise and economically, it is also becoming a cause for concern throughout the oncology community.

The addition of apalutamide to androgen deprivation treatment improved time to pain progression and other quality-of-life out­come measures in patients with metastatic castration-sensitive prostate cancer in the phase III TITAN trial.

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

According to findings from a retrospective analysis published in JAMA Oncology, the testosterone-related genetic variant HSD3B1 (1245C) is associated with more aggressive disease in patients with metastatic prostate cancer. This is the first clinical trial to validate the relationship between the variant and clinical outcomes, and the results may help physicians determine which patients are more likely to benefit from more aggressive therapy.

Stephen J. Freedland, MD, discussed an analysis real-world patients with metastatic castration-resistant prostate cancer, which he presented at the 2020 Genitourinary Cancers Symposium.

To help clinicians cope with an increasing number of geriatric patients with cancer, the Association of Community Cancer Centers is addressing this problem with a 2-pronged approach that focuses on the delivery of care and diagnostic assessment.

In an interview with Targeted Oncology, Martin T. King, MD, PhD,discusses INTREPId following his poster presentation of the trial design at the 2020 Genitourinary Cancer Symposium. He also discusses other another promising studies being presented at the conference.

William K. Oh, MD, discusses phase III studies in the prostate cancer setting which led to the use of these new treatments, such as androgen receptor targeted therapies with chemotherapy in earlier disease settings.

Combining cabozantinib plus androgen-deprivation therapy as first-line therapy in patients with hormone-naïve metastatic prostate cancer yields promising clinical activity, according to the new single-arm phase II study, which was published in Clinical Cancer Research.

Apalutamide plus androgen deprivation therapy reduced the risk of second progression or death regardless of hormonal or taxane therapy as the first subsequent life-prolonging therapy in patients with metastatic castration-sensitive prostate cancer.

Men with metastatic castration-resistant prostate cancer had inferior immune responses with the combination of sipuleucel-T and radium-223 but improved clinical outcomes as compared with sipuleucel-T alone, a small randomized trial showed.

Combining cabozantinib and atezolizumab induced durable responses in men with metastatic castration-resistant prostate cancer who had soft tissue progression after prior hormonal therapy.<br /> &nbsp;

The combination of cabozantinib in combination with atezolizumab demonstrated encouraging efficacy and tolerability in patients with metastatic castration-resistant prostate cancer, according to the updated results of the phase Ib COSMIC-021 trial. The trial &nbsp;is evaluating the combination in locally advanced or metastatic solid tumors, Elexis, Inc, announced in a press release.

In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.

A. Oliver Sartor, MD, discusses the current treatment options for patients with nonmetastatic castration-resistant prostate cancer (CRPC) and what physicians should consider when selecting treatment for their patients.

Darolutamide and androgen deprivation therapy improved overall survival compared with placebo in patients with nonmetastatic castration-resistant prostate cancer, meeting one of the end points of the phase III ARAMIS study, Bayer announced in a press release.

The FDA has granted a Priority Review to the New Drug Application for olaparib as treatment for patients with metastatic castration-resistant prostate cancer and deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations, who have progressed following prior treatment with a new hormonal agent, AstraZeneca reported in a press release.

Integrating a geriatric assessment into the care of older adults who are receiving cancer treatment in communi&shy;ty oncology practices improves patient and caregiver satisfaction and encourages commu&shy;nication about aging-related concerns, accord&shy;ing to results of a clinical trial that enrolled 541 patients with advanced cancer.

The FDA has granted priority review status on a supplemental New Drug Application for rucaparib in advanced prostate cancer, according to a release issued by Clovis Oncology.1 The sNDA seeks approval for rucaparib as monotherapy treatment in patients with a BRCA1/2 mutation resulting in recurrent metastatic castrate-resistant prostate cancer. The agency has assigned a Prescription Drug User Fee Act date of May 15, 2020.

The present and future benefits of telehealth in oncology can be observed through Tahoe For&shy;est Cancer Center and its affiliation with the UC Davis Cancer Center, use of other remote clinics, and participation in virtual tumor boards. Even though there are roadblocks to telehealth reaching more locations and more patients, the potential benefit warrants the time needed to get over those hurdles.

Neeraj Agarwal, MD, discusses the results from the randomized phase III TITAN trial, which enrolled over 1,000 patients with newly diagnosed metastatic castration-sensitive prostate cancer and randomized them to either androgen deprivation therapy plus the novel androgen receptor inhibitor apalutamide or ADT alone.

In December 2019, the FDA approved a number of new treatments in lung cancer, pancreatic cancer, urothelial carcinoma, breast cancer, and prostate cancer. A&nbsp;tissue complete assay was also approved by the FDA for use in a clinical trial evaluating pembrolizumab.

The Cchek Prostate Cancer Confirmation test&mdash;which utilizes artificial intelligence, flow cytometry, and liquid-biopsy technology to detect prostate cancer&mdash;has been commercially launched, according to Anixa Biosciences, Inc., developer of the test. Once it becomes available, this test will reduce the need for expensive and invasive biopsy procedures to diagnose patients with prostate cancer in certain patients.<br /> &nbsp;

A new study has found that enzalutamide given with androgen deprivation therapy significantly reduced the risk of metastatic progression or death in men with metastatic hormone-sensitive prostate cancer versus placebo plus ADT, including patients with low-volume disease and/or prior docetaxel therapy.<br /> &nbsp;

Heather H. Cheng, MD, PhD, discusses the role of genetic testing in prostate cancer as it continues to evolve in this space. This year, the&nbsp;2019 NCCN guidelines&nbsp;focused more on genetic testing in select patients with prostate cancer.

Enzalutamide is now approved by the FDA for the treatment of metastatic castration-sensitive prostate cancer, making it the first oral agent to be approved for three different types of advanced prostate cancer, according to a press release from Pfizer.<br /> &nbsp;

A significant proportion of patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations responded well to treatment with olaparib in a phase II TOPARP-B trial, making olaparib the first targeted therapy to show benefit in this patient population, the Institute of Cancer Research reported in a press release.

In patients whose solid<strong> </strong>tumors harbor a mutation in <em>KRAS </em>G12C, therapy with MRTX849 has produced promising responses and acceptable toxicity across 3 tumors types, according to data presented at the 2019 American Association for Cancer Research&ndash;National Cancer Institute&ndash;European Organization for Research and Treatment of Cancer International Conference on Molecular Targets and Cancer Therapeutics.

The combination of onvansertib with abiraterone acetate decreased the prostate-specific antigen levels in most of the evaluable patients treated in a phase II study, which used the combination in adult patients with metastatic castration-resistance prostate cancer, according to a press release from onvansertib developer, Trovagene, Inc.