News

The detection of circulating tumor DNA in human papillomavirus with an experimental blood test has been associated with high positive predictive value and negative predictive value for identifying disease recurrence in HPV-positive oropharyngeal cancer, according to a press release from the University of North Carolina Lineberger Comprehensive Cancer Center.

The FDA has extended the Prescription Drug User Fee Act date by 3 months for the new drug application of avapritinib from February 14, 2020, to May 14, 2020, the manufacturer, Blueprint Medicines Corporation, announced in a news release. The NDA was seeking accelerated approval for the kinase inhibitor for the treatment of adults with fourth-line gastrointestinal stromal tumors.

Tremelimumab monotherapy showed clinical activity with durable responses in patients with metastatic urothelial carcinoma and documented transitional cell carcinoma of the urothelium who failed first-line platinum-based chemotherapy, according to results from a phase II study, which is evaluating the drug in solid tumors.

The majority of patients with relapsed or refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia who were participants in a phase I/IIa trial had clinical responses to treatment with TAK-007, a cord blood–derived chimeric antigen receptor natural killer–cell therapy that targets CD19, with no major toxicities experienced by patients, according to a press release from the University of Texas MD Anderson Cancer Center.

Performing a liquid biopsy of circulating tumor cells may help identify patients who are at risk for node-positive melanoma relapse and identify patients who wish to avoid the toxicities associated with systemic adjuvant therapy, according to the results of a prospective study from The University of Texas MD Anderson Cancer Center, which was recently published in Clinical Cancer Research.

The incidence of colorectal cancer is rising among people who are below 50 years of age, the colonoscopy screening age as recommended by the United States Preventive Service Task Force of the National Cancer Institute. To date, there is no research that can explain the rise which has led physicians to deliberation on whether the recommended screening age for colonoscopies should be lowered or left as is. During a debate at the 2020 Gastrointestinal Cancers Symposium, Uri Ladabaum, MD, and David S. Weinberg, MD, MSc, presented their stances on the topic.

The combination of talimogene laherparepvec plus pembrolizumab led to a promising objective response rate in patients with advanced sarcoma who typically have limited treatment options, according to a phase II clinical trial&nbsp;&nbsp;published in&nbsp;<em>JAMA Oncology</em>.

Continuous dosing of the MEK inhibitor binimetinib plus buparlisib, a PI3K inhibitor, demonstrated promising activity as treatment of patients with ovarian cancer harboring either a&nbsp;RAS&nbsp;or&nbsp;BRAF&nbsp;mutation, according to results from a phase Ib clinical trial.

In an interview with&nbsp;Targeted Oncology, Daniel H.&nbsp;Ahn, DO, discussed the phase Ib/II study of onvansertib plus FOLFIRI and bevacizumab for the treatment of patients with metastatic colorectal cancer &nbsp;with a&nbsp;KRAS mutation.

Afatinib demonstrated clinical activity against uncommon and compound <em>EGFR</em> mutations in patients with EGFR tyrosine kinase inhibitor-naive non&ndash;small cell lung cancer, a patient population for which limited data exist on the efficacy of treatment with EGFR- tyrosine kinase inhibitors, according to Yang et al.

The addition of the dinutuximab injection to irinotecan did not improve overall survival in patients with relapsed/refractory small cell lung cancer, failing to meet the primary end point of the phase III DISTINCT trial, according to top-line results announced in a press release from United Therapeutics, developer of dinutuximab.

In an interview with&nbsp;Targeted Oncology, Noa Biran, MD, discussed the findings from 2 clinical trials evaluating consolidation therapy post-transplant in patients with high-risk multiple myeloma.

A new phase II study of trastuzumab and pertuzumab added to neoadjuvant chemoradiotherapy followed by surgery in patients with esophageal adenocarcinoma has found the combined regimen to be feasible and worthy of further study.

In an interview with&nbsp;Targeted Oncology, Shoba A. Navai, MD,&nbsp;discussed the evolving role of CAR T-cell therapy in solid tumors, including sarcomas and how the efficacy and safety compare with CAR T cells in this space compared with hematologic malignancies.

Patients with aggressive meningiomas presented with clinical and radiological activity when receiving a combination of everolimus&nbsp; and octreotide in the single-arm phase II CEVOREM trial.<br /> &nbsp;

In an interview with&nbsp;Targeted Oncology, Arati Desai, MD, co-director of the University of Pennsylvania Brain Tumor Cancer Program Center, assistant professor of clinical medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, discussed the implications of the STELLAR trial, the role of eflornithine, and how&nbsp;IDH1/2&nbsp;mutational status affects outcomes in patients with anaplastic astrocytomas.

The tyrosine kinase inhibitor lenvatinib demonstrated promising activity and safety in patients with advanced hepatocellular carcinoma in a retrospective multicenter observational analysis in Korea, according to a poster presentation at the 2020&nbsp;Gastrointestinal Cancers Symposium.

The combination of APR-246 and azacytidine was granted Breakthrough Therapy Designation by the FDA for the treatment of myelodysplastic syndromes with susceptible TP53 mutations, Aprea Therapeutics, Inc, developer of APR-246, announced in a press release.

The Investigational New Drug application for small molecule dual antagonist TPST-1495 was cleared by the FDA to begin a clinical investigation into the treatment of prostaglandin-driven tumors, according to a press release from Tempest Therapeutics.

Following the FDA approval of gemtuzumab ozogamicin with induction and consolidation therapy in newly diagnosed CD33-positive acute myeloid leukemia, investigators led by Richard F. Schlenk, MD, hypothesized that patients with NPM1-mutated acute myeloid leukemia,&nbsp;which occurs in 20% to 30% of the patient population,&nbsp;could also derive benefit from gemtuzumab.

In an interview with&nbsp;Targeted Oncology,&nbsp;Paul M. Barr, MD, discussed the rationale and preliminary findings for the phase I/II study evaluating umbralisib and ublituximab plus venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia. He also explained how the role of combination therapy continues to evolve in this space.

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.

In a phase II trial, the combination of lenvantinib and pembrolizumab demonstrated a manageable safety profile and encouraging antitumor activity in patients with selected advanced solid tumors.&nbsp;The decision to combine the agents was based on preclinical data, which suggested that VEGF and FGF signaling may enhance the therapeutic efficacy of lenvatinib.

The New Drug Application for selpercatinib was granted FDA Priority Review for the treatment of patients with advanced&nbsp;RET&nbsp;fusion&ndash;positive non&ndash;small cell lung cancer,&nbsp;RET-mutant medullary thyroid cancer, and&nbsp;RET&nbsp;fusion&ndash;positive thyroid cancer, based on data from the phase I/II LIBRETTO-001 trial, Eli Lilly and Company announced in a press release.

The HER2-targeted antibody-drug conjugate trastuzumab deruxtecan demonstrated promising activity and manageable safety profile in patients with HER2-positive gastric or gastroesophageal junction cancer, meeting the primary end point of the study, according to a press release.

Research has shown that patients with para-aortic lymph node metastasis, human&nbsp;papillomavirus-18, and those with certain histocompatibility genes in their cervical tumors also have a poor prognosis. Preclinical research suggests, however, that immune checkpoint blockade with radiation can enhance immune-mediated activity in patients who have up to stage IV disease.

The CDK4/6 inhibitor ribociclib plus endocrine therapy with letrozole may induce molecular downstaging of disease in certain patients with high-risk, early-stage, hormone receptor&ndash;positive, HER2-negative breast cancer compared with multiagent chemotherapy, according to results from the randomized phase II CORALLEEN trial.

Maintenance of quality of life on patient-reported assessments was prolonged with encorafenib plus cetuximab with or without binimetinib, out-performing the standard of care in patients with <em>BRAF</em>&nbsp;V600E-mutant metastatic colorectal cancer.

In an interview with&nbsp;Targeted Oncology, Elizabeth Mittendorf, MD, PhD, discussed the highlights from the 2019 San Antonio Breast Cancer Symposium for the treatment of patients with triple-negative breast cancer, as well as those with&nbsp;HER2-positive breast cancer. She also shared her thoughts on the key takeaways from the 2019 meeting.

A new retrospective exploratory analysis has found no association between treatment with sorafenib and the development of sarcopenia among patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.&nbsp;However, this analysis, which was published recently in Thyroid, did find that sorafenib had a significant effect on muscle mass.