News

Everolimus proved to be effective tool for overcoming endocrine resistance in postmenopausal women with ER-positive, HER2-negative metastatic breast cancer that have become resistant to aromatase inhibitor therapy.

According to results from the MABLE trial, the combination of rituximab plus bendamustine demonstrated significant value as a frontline treatment option for fludarabine-ineligible patients with chronic lymphocytic leukemia.

Based on findings from the phase III IMpower150 trial, a supplemental biologics license application for atezolizumab has been granted a priority review by the FDA for use in combination with bevacizumab, carboplatin, and paclitaxel for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer.

Arlene O. Siefer-Radtke, MD, recently spoke on the treatment considerations and decisions she makes when treating patients with urothelial carcinoma.

Results of an interim analysis from a small phase I trial presented at the 2018 American Society of Pediatric Hematology/Oncology Conference showed that CAR T-cell therapy can induce next generation sequencing negativity in patients with relapsed/refractory acute lymphoblastic leukemia, suggesting a “synergistic” relationship with hematopoietic cell transplant that could enhance patient outcomes.

The combination of&nbsp;dabrafenib (Tafinlar) and&nbsp;trametinib (Mekinist) has been approved by the FDA&nbsp;for the treatment of patients with unresectable or metastatic<em> BRAF</em> V600E&ndash;positive anaplastic thyroid cancer.&nbsp;

Results from a recent study conducted at the University of Pennsylvania may demonstrate why some patients with chronic&nbsp;lymphocytic leukemia are resistant to tisagenlecleucel, while potentially providing a pathway to enhance patient response.

The Hassenfeld Children&rsquo;s Hospital at NYU Langone and Perlmutter Cancer Center recently welcomed 2 new leaders in pediatric oncology, Elizabeth A. Raetz, MD, and Theodore P. Nicolaides, MD.

The FDA has received a supplemental biologics license application seeking approval for pembrolizumab in combination with standard chemotherapy as a treatment for patients with metastatic squamous non&ndash;small cell lung cancer.

CB-839 has been granted Fast Track designation by the FDA in combination with cabozantinib for the treatment of patients with metastatic renal cell carcinoma who have received 1 or 2 prior lines of therapy, according to Calithera Biosciences, the manufacturer of the first-in-class glutaminase inhibitor.

Antibiotics administered within 30 days of initiating treatment with PD-1 and PD&shy;-L1 inhibitors were associated with poorer survival and increased risk for disease progression in patients with renal cell carcinoma or non-small cell lung cancer.

The combination of bendamustine and rituximab induced a 12-month progression-free survival of 78.6% for patients with chronic lymphocytic leukemia, suggesting that the combination is an effective first salvage regimen.

In top-line results from part 2 of the phase IIb STORM trial, selinexor induced an overall response rate of 25.4% in patients with penta-refractory multiple myeloma, according to&nbsp;Karyopharm Therapeutics,&nbsp;the manufacturer of the oral SINE compound.

Based on data from the phase II JULIET study, tisagenlecleucel has received FDA approval for the treatment of&nbsp;adult patients with relapsed/refractory large B-cell lymphoma&mdash;including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma&mdash;after 2 or more lines of systemic therapy.

The FDA approved several indications throughout the month of April 2018.&nbsp;A number of drugs were granted priority review and Fast Track designation. The FDA also halted all clinical trials using&nbsp;tazemetostat as treatment, and new initiatives were introduced&nbsp;to help ease the development of genetic and genomic-based tests.&nbsp;Check out our list of all FDA happenings from April 2018.

A new set of National Comprehensive Cancer Network guidelines have been created for the diagnosis and management of uveal melanoma. During the 2018 NCCN Annual Conference, a member of the NCCN Melanoma Subcommittee, Christopher A. Barker, MD, presented the inaugural guidelines as &ldquo;the first pathway-based guidelines&rdquo; to be developed for the disease.

A priority review has been granted by the FDA to a biologics license application (BLA) for the PD-1 inhibitor cemiplimab as a treatment for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or those with locally advanced CSCC not eligible for surgery.

Based on data from the phase III COMBI-AD study, the combination of&nbsp;dabrafenib and trametinib has been granted FDA approval for&nbsp;the adjuvant treatment of patients with BRAF V600E&ndash; or V600K&ndash;positive stage III melanoma following complete resection.

A 4-week dosing schedule for&nbsp;nivolumab has been approved by the European&nbsp;Commission&nbsp;for the treatment of patients with advanced melanoma and previously treated renal cell carcinoma, Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor, has announced.

Based on data from the phase III KEYNOTE-189 trial, frontline pembrolizumab has been granted a priority review by the FDA&nbsp;for use in combination with standard chemotherapy for patients with metastatic nonsquamous non&ndash;small cell lung cancer, according to Merck, the manufacturer of the PD-1 inhibitor.&nbsp;

A recommendation&nbsp;has been made by the&nbsp;European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use to add&nbsp;final overall survival data&nbsp;from the open-label phase III ASPIRE trial to the label for&nbsp;carfilzomib for the treatment of patients with relapsed/refractory multiple myeloma.

Experts are now questioning the previously established methods and strategies for the treatment of patients with multiple myeloma while new agents and treatment techniques continue to emerge in the field.

Zhijian &ldquo;James&rdquo; Chen, PhD, has proudly been recognized by the Foundation for the National Institutes of Health for his breakthrough discovery of the enzyme cyclic GMP-AMP synthase and its corresponding pathway. He will receive the 2018 Lurie Prize in Biomedical Sciences during the FNIH Award Ceremony to be held on May 16 in Washington, DC.

In a recent phase Ib study, the combination of carboxyamidotriazole orotate (CTO) and&nbsp;temozolomide (Temodar)&nbsp;produced positive safety and efficacy results in patients with glioblastoma (GBM) or anaplastic gliomas, with or without treatment with radiotherapy.

The National Cancer Institute-designated UC Davis Comprehensive Cancer Center has chosen Primo Nery Lara, Jr., MD, to serve as director. His position will include leading a team of over 300 scientists in their annual research, with an estimated annual research funding of $90 million. The clinical enterprise also serves over 10,000 regional patients annually.

The use of personalized neoantigen vaccines demonstrated promising results in a recent phase I/Ib trial of patients with glioblastoma.

Based on data from the ongoing phase III ADMIRAL study, Astellas Pharma, the manufacturer of&nbsp;gilteritinib, has announced the submission of a new drug application to the FDA seeking approval for the FLT3 inhibitor as a treatment for adult patients with <em>FLT3</em> mutation&ndash;positive relapsed or refractory acute myeloid leukemia.

The immunotherapy agent balixafortide (POL6326) has been granted Fast Track designation by the FDA in combination with eribulin (Halaven) for the treatment of patients with HER2-negative metastatic breast cancer who have previously received at least 2 chemotherapeutic regimens in the metastatic setting, according to Polyphor, the manufacturer of the potent and highly selective CXCR4 antagonist.

While relapsed/refractory mantle cell lymphoma (MCL) is considered an aggressive disease, new findings show patients may benefit from adding chimeric antigen receptor T-cell therapy to their treatment regimen. ZUMA-2, a currently ongoing trial, aims to understand the potential benefits with axicabtagene ciloleucel, an&nbsp;anti-CD19 CAR T-cell product, for&nbsp;patients with relapsed/refractory MCL.

Voxtalisib (XL765) monotherapy induced objective responses in 41.3% of patients with follicular lymphoma, but displayed minimal efficacy in patients with other lymphomas, according to results from a phase II trial of patients with relapsed or refractory lymphoma or chronic lymphocytic leukemia that were recently published in the Lancet Haematology.