News

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 Targeted Oncology, Shoba A. Navai, MD, 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.

A supplemental Biologics License Application has been submitted to the FDA for the combination of atezolizumab and bevacizumab or the treatment of patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy, according to a press release from Roche.

Cetuximab plus mFOLFOX6 with the addition of avelumab resulted in an overall response rate of 81% in patients with RAS/BRAF-wildtype metastatic colorectal cancer, according to results of the phase II AVETUX study that were presented during the 2020 Gastrointestinal Cancers Symposium. But despite promising tumor responses, the trial missed its primary progression-free survival end point.

Atezolizumab failed to meet the primary end point, disease-free survival, as adjuvant monotherapy in patients with muscle-invasive urothelial cancer compared with observation in the phase III IMvigor010 clinical trial, according to a press release from Roche, developer of the drug.

Accelerated approval has been granted by the FDA to the methyltransferase inhibitor tazemetostat for the treatment of metastatic or locally advanced epithelioid sarcoma in adult and adolescent patients who are not eligible for complete resection.<br /> &nbsp;

A phase Ib/II clinical trial of the experimental anti-mitochondrial drug devimistat in combination with cisplatin and gemcitabine has been initiated in patients with biliary tract cancer, according to a press release from Rafael Pharmaceuticals, Inc. The company will collaborate with Michigan Medicine to proceed with the randomized multicenter clinical trial.

Myriad Genetics, Inc, has submitted a supplementary premarket approval application to the FDA for the myChoice CDx test for use in predicting outcomes for women with frontline platinum-responsive advanced ovarian cancer who are treated with niraparib, a PARP inhibitor, according to a press release from Myriad Genetics, Inc., the manufacturer of the test.

Neoadjuvant systemic therapy may enable patients with triple-negative breast cancer who are ineligible for breast conservation therapy to become eligible, according to a prespecified secondary analysis of the results from the phase III BrighTNess trial.

Entrectinib led to clinically meaningful responses in patients with NTRK-fusion-positive solid tumors, according to results from a pooled analysis of the phase I ALKA-372-001, the phase I STARTRK-1, and the phase II STARTRK-2 studies.

In an interview with&nbsp;Targeted Oncology, Benjamin Besse, MD, PhD,&nbsp;<a>discussed&nbsp;</a>the research around the Tedopi vaccine and how it addresses an unmet medical need for the treatment of patients with non-small cell lung cancer who have failed immune checkpoint inhibitors. He also explained the use of genomic testing to aid the treatment of non-small cell lung cancer.

In an interview with&nbsp;Targeted Oncology, Jennifer Woyach, MD, discussed the rationale for evaluating a response-dependent treatment discontinuation strategy for older patients with previously untreated chronic lymphocytic leukemia. She highlighted the importance of determining an optimal discontinuation strategy in this patient population.

Dasatinib, a second-generation Abl-tyrosine kinase inhibitor, used concurrently with an intensive chemotherapy regimen yields superior outcomes compared with imatinib plus chemotherapy in pediatric patients with Philadelphia chromosome-positive acute lymphoblastic leukemia, according to the results from the first randomized phase III clinical trial comparing the 2 drugs in this patients&nbsp;<a>population</a>.

In an interview with&nbsp;Targeted Oncology, Richard Kim, MD, discussed the research from several trials that support the use of doublet and triplet regimens as treatment of patients with metastatic colorectal cancer harboring a&nbsp;BRAF&nbsp;mutation.