A phase II study of experimental anti-mitochondrial drug devimstat in patients with relapsed/refractory Burkitt’s lymphoma/leukemia has been expanded to include patients at Massachusetts General Hospital in Boston, Massachusetts, according to a press release from Rafael Pharmaceuticals, Inc.
The FDA has granted priority review to a new supplemental Biologics License Application for pembrolizumab, for which Merck is seeking approval for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma-in-situ with or without papillary tumors who are either ineligible for cystectomy or have chosen not to undergo the procedure, according to a press release from Merck.
A supplemental Biologics License Application for durvalumab has been accepted by the FDA, and the drug has been granted priority review for the treatment of previously untreated extensive-stage small cell lung cancer, according to a press release from AstraZeneca.
GDC-0084, an investigational PI3K inhibitor, may delay the progression of disease in patients with newly diagnosed glioblastoma and unmethylated MGMT promotor status, based on results of a phase IIa study, Kazia Therapeutics reported in a press release.
Surufatinib has been granted FDA Orphan Drug Designation for the treatment of pancreatic neuroendocrine tumors, according to a press release from Hutchison China MediTech Limited.
In an interview with Targeted Oncology, at the 2019 Chemotherapy Foundation Symposium, Marcia Brose, MD, PhD, discussed the cases of thyroid cancer in which molecular testing can be initiated upfront to aid in the treatment decisions of oncologists. She also advised physicians on how to decide when to test patients with the disease.
Dacomitinib monotherapy significantly prolonged progression-free survival in Asian patients with locally advanced or metastatic non–small cell lung cancer with epidermal growth factor receptor-activating mutations, according to results of a subgroup analysis from the phase III ARCHER 1050 study, Pfizer reported in a press release.
The frontline combination of atezolizumab and bevacizumab statistically and clinically improved progression-free survival and overall survival compared with sorafenib in patients with hepatocellular carcinoma in the phase III IMbrave150 study, according to a press release from Roche.
The combination of nivolumab with ipilimumab showed no statistically significant benefit in patients with stage IIIB/C/D or stage IV melanoma compared with nivolumab alone in the phase III CheckMate 915 study, missing the co-primary endpoint of recurrence-free survival in patients with <1% PD-L1 expression in their tumor cells, according to a press release from Bristol-Myers Squibb.
In an interview with Targeted Oncology at the 2019 Chemotherapy Foundation Symposium, Richard R. Furman, MD, reviewed his presentation on prognostic markers and their importance in the treatment of patients with chronic lymphocytic leukemia.
The phase III B-MIND study of the investigational humanized Fc-engineered monoclonal antibody, tafasitamab plus bendamustine versus rituximab plus bendamustine for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, has passed the pre-planned, event-driven interim analysis for futility, resulting in a recommendation to increase the number of study participants from 330 to 450, according to a press release from MorphoSys.
Male patients with advanced prostate cancer had a 97% response rate to relugolix, a gonadotropin-releasing hormone receptor antagonist, in the phase III HERO study, meeting the primary end point of the study. The trial also met all 6 of its key secondary end points, according to a press release from Myovant Sciences.
In an interview with Targeted Oncology at the IKCS meeting, Gennady Bratslavsky, MD, provided his expert opinion on the optimal first-line therapy for non–clear cell renal cell carcinoma, a topic he debated on with peers at the 2019 International Kidney Cancer Symposium.
In an interview with Targeted Oncology during the 2019 International Kidney Cancer Symposium, Yinghong Wang, MD, PhD, MS, discussed the management of gi-related toxicity in patients with kidney cancer from the perspective of a gastrointestinal specialist. She also explained the multidisciplinary collaboration between oncology and gastrointestinal departments to enhance care.
Patients with untreated advanced EGFR-mutant non–small cell lung cancer showed an improvement in progression-free survival with the combination of gefitinib, a TKI that targets EGFR, with carboplatin plus pemetrexed compared with gefitinib alone, according to the results of the NEJ009 study.
In an interview with Targeted Oncology, Jeffrey S.Weber, MD, PhD, discussed the 3-year efficacy and biomarker results from the phase III CheckMate 238 trial, which he presented at the 2019 European Society of Medical Oncology Congress.
A supplemental New Drug Application for the combination of ibrutinib and rituximab has been submitted to the FDA for the first-line treatment of patients aged 70 years or younger with chronic lymphocytic leukemia or small lymphocytic lymphoma, according to a press release from ibrutinib developer, AbbVie.
In an interview with Targeted Oncology during the 2019 Prostate Cancer Consensus Conference, James L. Mohler, MD, explained the reasons for changes to the NCCN guidelines on genetic testing and counseling in prostate cancer. He also discussed what needs to be addressed in the future to further increase knowledge of genetic testing and improve its use.
A supplemental Biologics License Application for the combination of nivolumab and ipilimumab for the treatment of patients with advanced hepatocellular carcinoma previously treated with sorafenib has been accepted by the FDA and given Priority Review status. The supplemental Biologics License Applicationwas given a Prescription Drug User Fee Act goal date of March 10, 2020, according to a press release from Bristol-Myers Squibb.<br />
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 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.
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.<sup> </sup><br />
Detailed results of the phase III ADMIRAL trial, which evaluated the use of gilteritinib in adult patients with FLT3 mutation–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.
In an interview with <em>Targeted Oncology</em>, Arlene Siefker-Radtke, MD, 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 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 />
In an interview with 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.
In an interview with 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.
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>.