Tony Berberabe, MPH

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 standard of care for some patients with intermediate-stage hepa­tocellular carcinoma may include lenvatinib if investigators further explore results from a proof-of-concept obser­vational study. The recommended treatment for intermediate-stage hepatocellular carcinoma, transarterial chemo­embolization, is unsuitable in patients with high-tumor-burden hepatocellular carcinoma, leaving a signif­icant unmet need in clinical practice for this patient subgroup.

A new drug application has been filed for accelerated approval with the FDA for lurbinectedin in patients with small cell lung cancer who have progressed after prior platinum-containing therapy, according to the manufacturer, PharmaMar.1 The filing was based on results from a phase II basket trial, presented at the 2019 ASCO Annual Meeting.

New clinical practice guidelines for HCT have been published by the National Comprehensive Cancer Network. The guidelines provide step-by-step information on best practices in evaluating patients for HCT and managing complications.

Selumetinib, an oral MEK inhibitor, demonstrated clinical benefit without significant toxicity in adult patients affected by symptomatic neurofibromatosis type 1 (NF1) with associated plexiform neurofibromas (PN), according to Geraldine O’Sullivan Coyne, MD, PhD, in a preconference briefing of the 2019 American Association for Cancer Research–National Cancer Institute–European Organisation for Research and Treatment of Cancer International Conference on Molecular Targets and Cancer Therapeutics, held October 26 to 30, 2019, in Boston, Massachusetts.

A large proportion of children diagnosed with neurofibromatosis type 1-related plexiform neurofibromas have no appropriate treatment available to them and represent a significant unmet medical need. To determine demographics, clinical characteristics, and treatments, a cross-sectional analysis of existing data from the Children’s Tumor Foundation registry was undertaken by Jinghua He, PhD, MPH, and colleagues.

Patients with both high-grade and low-grade glioma harboring the <em>BRAF</em> V600E mutation demonstrated positive benefit in response, duration of response, and progression-free survival when given the combination of dabrafenib and trametinib in a phase IIa study.

Adding the PARP inhibitor veliparib to standard therapy for newly diagnosed patients with unmethylated MGMT glioblastoma multiforme was well-tolerated in a phase II trial, according to findings presented at the 24th Annual Meeting and Education Day of the Society of NeuroOncology.

A drug with a greater than 30-year history that was originally investigated as a treatment for trypanosomiasis has garnered interest from investigators seeking a treatment for the rare brain cancer anaplastic astrocytoma.<br /> &nbsp;

This year&rsquo;s Hot Topic Symposium during Society for Immunotherapy of Cancer&rsquo;s 34th Annual Meeting, co-chaired by Jennifer A. Ligibel, MD, and Jennifer Mcquade, MD, MS, MA, focused on modifiable factors that can affect tumor response to treatment.

The advent of immunotherapy has delivered unprecedented and durable anti-tumor responses as well as long-lasting survival benefits in some patients. Yet many clinicians may not be familiar with managing the unique toxicities that accompany these emerging cancer treatments.

Although the use of PD-1 and CTLA-4 pathway blockade in non&ndash;small cell lung cancer has had mixed results in the past, the combination of nivolumab and ipilimumab has demonstrated positive benefit in overall survival and adverse event profile compared with chemotherapy. Research suggests that anti&ndash;CTLA-4 helps induce T-cell responses and anti&ndash;PD-1 aids to restore anti-tumor T cell function.

The anti&ndash;CD27 agonist, MK-5890, demonstrated acceptable safety findings when administered as monotherapy and in combination with pembrolizumab in numerous solid tumors, according to findings of an open-label phase I trial presented by Ronnie Shapira-Frommer, MD, head of the Onco-Gynecological Cancer Unit at The Ella Lemelbaum Institute for Immuno-Oncology, Ramat Gan, Israel, during the Society for Immunotherapy of Cancer&rsquo;s 34^th Annual Meeting.

Although a vaccine for the human papillomavirus (HPV) is widely available, an average of 34,800 HPV-associated cancers attributable to the virus, including cervical, vaginal, vulva, penile, anal, and oropharynx were reported in the United States from 2012 through 2016, according to data published in Morbidity and Mortality Weekly Report.

During a <em>Targeted Oncology </em>live case-based peer perspectives discussion, Ruben A. Mesa, MD, discussed risk assessment and treatment options available based on these assessments for patients with primary myelofibrosis with a group of physicians. Mesa, director of the UT Health San Antonio Cancer Center, explained these treatment options based on a case scenario of a patient with PMF.

The addition of direct oral oral anticoagulants for the management of venous thromboembolism in patients with cancer is the latest change to previous guidelines issued by the American Society of Clinical Oncology.

The discussion about the pros and cons of a 4-drug regimen for patients with multiple myeloma was highlighted during the 2019 Debates and Didactics in Hematology and Oncology conference.

Michael R. Migden, MD, spoke with a group of physicians during a <em>Targeted Oncology </em>live case-based peer perspectives discussion about responses in patients with cutaneous squamous cell carcinoma to immunotherapy treatment.

Thomas J. Herzog, MD, provided an overview of clinical research in cervical, endometrial, and ovarian cancer settings that covered cancer vaccines, adoptive T-cell transfer therapy, and immune checkpoint inhibitors during the 14th Annual New Orleans Summer Cancer Meeting.

In an interview with&nbsp;<em>Targeted Oncology</em>&nbsp;during the 17th IMW Scientific Program, Simon J. Harrison, MBBS, PhD, discussed the subgroup findings from the ICARIA-MM study in relapsed/refractory multiple myeloma.

Daratumumab in combination with&nbsp;bortezomib, thalidomide, and dexamethasone demonstrated benefit compared with VTd alone in subgroup analyses of patients with high-risk multiple myeloma from the&nbsp;phase III CASSIOPEIA trial.

Twenty to 30 years ago, delivering a diagnosis of lung cancer to a patient was a difficult conversation to have for many oncologists. But that has given way to greater optimism today, according to Mark A. Socinski, MD.

Management of neuroendocrine liver metastases relies on many treatment modalities, ranging from surgery to ablation. Clinicians have in their armamentarium interventional radiology techniques that use regional and systemic treatments spanning a diverse group of biologic, cytotoxic, and targeted agents.

The American Society of Clinical Oncology and Friends of Cancer Research have issued a joint research statement that broadens eligibility criteria affecting 2 patient subgroups: patients with treated/stable brain metastases and those with new, active, or progressive brain metastases.<br /> &nbsp;

Findings from a phase I study investigating the use of nonengineered T-cell therapy suggest that the therapy is safe and feasible in pancreatic cancer and may offer benefit to patients. The novel therapy targets the tumor-associated antigens PRAME, SSX2, MAGEA4, NY-ESO-1, and Survivin.

Anna C. Pavlick, DO, MS, MBA, spoke with a group of physicians about the systemic therapy options, including immunotherapeutics, for treating patients with cutaneous carcinomas in a recent&nbsp;<em>Targeted Oncology&nbsp;</em>live case-based peer perspectives discussion. Pavlick explained treatment options based on 2 case scenarios of patients with cutaneous malignancies.

In a data set of 292&nbsp;oncologists who responded to questions about current awareness and incorporation of molecular testing in the treatment of cancer, almost 69% incorrectly matched the molecular alteration with the appropriate targeted therapy.

Jane Lowe Meisel, MD, reviewed systemic therapy options for treating patients with breast cancer with a group of physicians during a&nbsp;<em>Targeted Oncology&nbsp;</em>live case-based peer perspectives discussion. Meisel explained the treatment considerations she makes for treating patients with breast cancer during the dinner event in terms of 2 case studies.

The SOLAR-1 findings were presented during a satellite symposium at the 2019 European Society for Medical Oncology Breast Cancer Annual Congress in Berlin, Germany.&nbsp;The trial demonstrated the role of&nbsp;<em>PIK3CA&nbsp;</em>as a predictive marker for alpelisib&rsquo;s clinical efficacy, said Peter A. Fasching, MD, associate professor of gynecology and obstetrics at Friedrich-Alexander University of Erlangen-Nuremberg in Germany, during the symposium.

Biomarker expansion has enjoyed a boom since 2006, with patient incidence of positive biomarkers reaching up to 50% in non&ndash;small cell lung cancer and melanoma and 25% in acute myeloid leukemia and myelodysplastic syndromes, according&nbsp; to the <em>Global Oncology Trends 2018</em> report.