News

The anti–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’s 34^th Annual Meeting.

The FDA has approved luspatercept-aamt for the treatment of anemia in adult patients with beta thalassemia who need regular red blood cell transfusions.

TT-00420, an investigational spectrum-selective multiple kinase inhibitor received an orphan drug designation from the FDA for the treatment of cholangiocarcinoma, TransThera Biosciences Co. Ltd announced in a press release.

In an interview with&nbsp;<em>Targeted Oncology</em>, Benjamin Weinberg, MD, discussed the treatment options available for the various subpopulations in mCRC.<br /> &nbsp;

The American Cancer Society has estimated that in 2019 in the United States, approximately 13,240 new patients will receive a diagnosis of cervical cancer and 4170 individuals will die from the disease. However, because of effective screening programs using cytology and/or high-risk human papillomavirus DNA testing in industrialized nations, incidence and mortality rates have declined.

In an interview with&nbsp;Targeted Oncology, Winston Tan, MD, discussed advances in thyroid cancer that may be competitors to the current standard of care. He also shared ongoing challenges that he has experienced in treating patients with thyroid cancer.

There are many greatdebates in the field of multiple myeloma, and one that is becoming increasingly relevant in the era of modern therapies is whether or not to treat patients with asymptomatic disease. While the etiology of MM remains unknown, a major advancement in understanding myeloma pathogenesis has been the observation that all patientsprogress, albeit at differing rates, through an asymptomatic phase of either monoclonal gammopathy of undetermined significance or smoldering MM.

In an interview with&nbsp;Targeted Oncology, Alan Bryce, MD, discussed the significance of the data from PROfound for men with mCRPC. He also highlighted findings from the CARD trial and where the field is headed in terms of targeted therapies versus chemotherapies.

Pegfilgrastim-bmez, a biosimilar of pegfilgrastim, is now FDA approved to decrease the incidence of infection caused by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive therapy, according to a press release from Sandoz Inc., a division of Novartis. LA-EP2006 is already being sold in Europe and the developer now plans to bring the drug to the United States this year.^&nbsp;<br /> &nbsp;

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.

Following a meeting with the FDA, AVEO Oncology has decided to push back the planned New Drug Application submission for tivozanib to the first quarter of 2020 and to narrow for the proposed indication for tivozanib to the treatment of relapsed or refractory renal cell carcinoma, according to a press release from the company.

Detailed results of the phase III ADMIRAL trial, which evaluated the use of gilteritinib in adult patients with FLT3 mutation&ndash;positive relapsed or refractory acute myeloid leukemia, have been published in the New England Journal of Medicine and reaffirm the improved overall survival rate seen with gilteritinib compared with chemotherapy in these patients, according to a press release from Astellas Pharma Inc.

The combination of pegylated human hyaluronidase with gemcitabine and nab-paclitaxel failed to improve the median overall survival in patients with metastatic pancreatic cancer, missing the primary endpoint of the phase III HALO-301 trial, Halozyme Therapeutics, Inc. reported in a press release.

Yuma Regional Medical Center Cancer Center has implemented a genetic cancer screening and testing for their patients through collaboration with Myriad Genetics, a molecular diagnostic testing company, according to a presentation by Erica Martinez, RN, OCN, at the Association of Community Cancer Centers&rsquo; 2019 National Oncology Conference. After partnering with Myriad Genetics, the cancer center saw a 4-fold increase in genetic testing of patients with cancer in the first 4 months, which led to a change in clinical management in 20% of those cases.

In an interview with&nbsp;<em>Targeted Oncology</em>, Arlene Siefker-Radtke, MD,&nbsp;examined the treatment landscape for bladder cancer and how factors like BCG shortages and prognoses in the elderly population are causing a shift toward novel immunotherapy agents.

In October 2019, the FDA approved a new treatment option for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer, as well as a new dosing regimen for patients receiving moderately emetogenic chemotherapy. Additionally, the FDA granted breakthrough therapy designations to 2 therapies, as well as an orphan drug designation, a priority review, and 2 fast track designations.

In solid tumors, targeted therapies are scarce for patients with mutations like KRAS or fusions like NRG1. Two clinical trials are investigating novel agents targeting these alterations to improve outcomes in patients with these particular genetic drivers of disease. The research was recently presented at the 2019 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.

The phase III VOYAGER study may soon introduce a new treatment option for patients with locally advanced metastatic or unresectable gastrointestinal stromal tumors, a patient population with an unmet need for novel agents that are durable and can target specific drivers. The trial is looking at the efficacy of novel drug avapritinib versus standard-of-care regorafenib.<br /> &nbsp;

During a recent&nbsp;Targeted Oncology&nbsp;live case-based peer perspectives event, Olga Frankfurt, MD, discussed the complications that could development during the treatment of patients with graft-vs-host disease. Frankfurt explained these complications in the context of a patient who develops acute GVHD after undergoing hematopoietic cell transplant.&nbsp;

Umbralisib monotherapy demonstrated positive responses in patients with previously treated follicular lymphoma, meeting the primary end point for the follicular lymphoma cohort of the phase IIb UNITY-NHL trial, TG Therapeutics announced in a press release.

Topline results from Re-MIND, an observational retrospective study, demonstrated that the combination of tafasitamab with lenalidomide had a statistically significant and superior objective response rate compared with lenalidomide monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma who were not eligible for high-dose chemotherapy and stem cell transplant, announced MorphoSys AG, the manufacturer of tafasitamab, in a press release.

In an interview with&nbsp;<em>Targeted Oncology</em>, Catherine Sinclair, MD, discussed the importance of early detection in patients with thyroid cancer. She also highlighted surgical decisions for these patients and how she makes these choices for each patient.

In an interview with&nbsp;Targeted Oncology, Jia Ruan, MD, PhD, examined the evolving treatment landscape for mantle cell lymphoma. She also discussed modern strategies like precision medicine and ctDNA liquid biopsy that are aiding the evolution.

A new exploratory study has found that increased levels of&nbsp;plasma VEGF-A and serum thyroglobulin adversely affected clinical outcomes in patients with radioactive iodine-refractory differentiated thyroid cancer, although no biomarker successfully predicted sorafenib response. This study, which was published recently in&nbsp;Clinical Cancer Research, was a retrospective analysis conducted using samples from the earlier phase III DECISION trial.

Durvalumab in combination with tremelimumab and chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in previously untreated patients with stage IV non&ndash;small cell lung cancer, according to findings from the final PFS analysis of the phase III POSEIDON trial.

The FDA plans to split up the submitted New Drug Application for avapritinib into 2 separate NDAs in the treatment of 2 different populations of patients with gastrointestinal stromal tumors, according to a press release from Blueprint Medicines.

In an interview with&nbsp;Targeted Oncology, Hannah Linden, MD, discussed the current treatment landscape during Breast Cancer Awareness Month. She also highlighted the value of liquid biopsy, tissue biopsy, and imaging techniques in this space for identifying patients with targetable mutations and how these assays and techniques can further impact treatment and outcomes of these patients.

In an interview with&nbsp;Targeted Oncology, Raoul S. Concepcion, MD, discussed the existing challenges with implementing genetic testing and genetic counseling in community practices and how they can potentially be addressed.

According to a statement from the FDA, the agency has issued a draft guidance proposing labeling recommendations for breast implant&nbsp;manufacturers that would help patients understand the benefits and risks of implants. The labeling recommendations would include the addition of a boxed warning.

Atezolizumab as monotherapy or in combination with platinum-based chemotherapy may improve progression-free survival in patients with locally advanced or metastatic urothelial carcinoma, based on the <a href="https://www.targetedonc.com/conference/esmo-2019/firstline-atezolizumabchemotherapy-improves-outcomes-in-metastatic-urothelial-cancer">results from the phase III IMvigor130 trial</a>.