In an interview with Targeted Oncology, James A. Reeves, MD, discussed how targeted therapies are being used presently in lung cancer and the potential of these agents in the future.
Indigenous American ancestry has been linked to an increased incidence of HER2-positive breast cancer, according to the Peruvian Genetics and Genomics of Breast Cancer Study study published in Cancer Research.
The FDA has granted Fast Track designation to balstilimab, an investigational anti-PD-1 agent for the treatment of patients with cervical cancer, based on comprehensive data that suggest balstilimab can fill an unmet medical need in the space, Agenus, Inc announced in a press release. In light of the new designation, the company now plans to submit 2 Biologic License Applications in 2020, for this indication and the other for the combination of balstilimab and zalifrelimab in metastatic cervical cancer.
Sacituzumab govitecan was granted Fast Track designation by the FDA for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 or programmed death-ligand 1 inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, including patients who are platinum ineligible.
Treatment with sacituzumab govitecan resulted in “compelling evidence of efficacy” in patients with metastatic triple-negative breast cancer, leading to an early halt of the phase III ASCENT study, announced Immunomedics in a press release.
Durable remissions were elicited with KTE-X19 in a majority of patients with relapsed or refractory mantle cell lymphoma, according to the updated results from the ZUMA-2 trial published in the New England Journal of Medicine. The treatment did, however, cause serious adverse events that were consistent with known toxicities of chimeric antigen receptor T-cell therapy.
The FDA has provided clearance for the initiation of, and immediate enrollment for, a new phase II trial to explore the use of the investigational oncologic agent leronlimab in treating patients with coronavirus disease 2019 who experience mild to moderate respiratory complications.<br />
The immunotherapeutic vaccine OSE-2101 demonstrated a favorable 12-month survival rate as second- or third-line treatment of patients with HLA-A2-positive advanced non–small cell lung cancer, meeting the primary end point of overall survival in the phase III Atalante 1 study, according to a press release from the drug developer, OSE Immunotherapeutics, Inc.
The FDA has granted Fast Track Therapy designation to ME-401, an investigational selective oral inhibitor of phosphatidylinositol 3-kinase inhibitor as treatment of patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.
In the neoadjuvant setting, physicians treating resectable pancreatic cancer have more treatment options than ever before. Recently, however, the routine use of radiotherapy has been called into question, leading to a debate at the 5th Annual School of Gastrointestinal Oncology, hosted by Physicians’ Education Resource, LLC.
In an interview with <em>Targeted Oncology</em> at the 5th Annual School of Gastrointestinal Oncology, Jonathan Strosberg, MD explained the importance of having multidisciplinary teams when treating patients with neuroendocrine tumors.
A Biologics License Application has been submitted to the FDA for the investigational B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy idecabtagene vicleucel as treatment of patients with multiple myeloma who have received at least 3 prior therapies.
Chemotherapy demonstrated superior progression-free survival to multiple EGFR tyrosine kinase inhibitors as first- or second-line treatment of patients with EGFR-mutant exon 20 non–small cell lung cancer. This finding is based on results from the largest real-world study of patients with EGFR exon 20 mutations conducted in China.
Subcutaneous daratumumab, a monoclonal antibody was determined to be non-inferior to FDA approved intravenous daratumumab in terms of efficacy and pharmacokinetics as treatment of patients with relapsed or refractory multiple myeloma, according to results from the phase III COLUMBA trial. The study also showed an improved safety profile with SC versus IV daratumumab.
Melphalan flufenamide in combination with dexamethasone achieved an overall response rate of 26% in patients with relapsed/refractory multiple myeloma, according to results from the pivotal phase II HORIZON study. The achievement serves as basis for the submission of a New Drug Application to the FDA.
Treatment with an investigational targeted anti-cancer gene-therapy agent, VB-111, in addition to paclitaxel met the pre-specified efficacy criterion of an absolute percentage advantage of 10% or higher CA-125 response rate in patients with platinum-resistant ovarian cancer, according to results from the planned interim analysis of the phase III OVAL trial.<br />
The spread of COVID-19 has slowed down processes in many areas of health care, and there is widespread curiosity on how the pandemic will impact regulatory action in the United States. In the oncology community, providers and their patients await vital drugs that have been shown to approve upon survival and in some case are considered curative for different cancers.
The addition of cetuximab to irinotecan, fluorouracil, and folinic acid leucovorin demonstrated superior overall survival compared with the addition of bevacizumab in patients with metastatic colorectal cancer who developed skin toxicity from cetuximab exposure, according to results from the phase II FIRE-3 trial, published in the Annals of Oncology.
The mortality rate for cutaneous melanoma was significantly reduced between 2013 to 2016 as a result of new targeted therapies for metastatic disease, according to a recent report in the American Journal of Public Health. It is the largest death decline ever recorded for skin cancer.
In an interview with Targeted Oncology, Kashyap Patel, MD, discussed the COVID-19 pandemic and the implementation of new precautions in his practice as the number of COVID-19 infected persons rises in the state.<br />
Oncologists have unanswered questions about how to deal with resistance mechanisms for multikinase inhibitors and selective RET inhibitors, and how efficacy is impacted when they combine 2 or more such drugs into a treatment regimen for RET-positive lung cancer. In a paper, researchers led by Vivek Subbiah, et al review the existing data.
Venetoclax in combination with azacytidine demonstrated a statistically significant improvement in overall survival and achieved a satisfactory composite complete remission rate in previously untreated patients with acute myeloid leukemia, meeting the co-primary end points of the phase III VIALE-A study. Genentech, the developer of venetoclax, announced the positive news in a press release, also noting that safety profiles of both drugs were consistent with prior reports.
Treatment with pembrolizumab demonstrated antitumor activity along with tolerable toxicity in patients with 4 different rare and hard-to-treat malignancies, according to results from a phase II study led by The University of Texas MD Anderson Cancer Center researchers and published in the Journal for ImmunoTherapy of Cancer.
GEN-1 immunotherapy demonstrated dose-dependent efficacy results in newly diagnosed patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer when treated in combination with the standard of care, according to results from the OVATION 2 study. Based on positive data in the phase I portion, the study is moving on to phase II with enrollment expected to begin in the second half of the year.
Nelipepimut-S in combination with granulocyte-macrophage colony-stimulating factor demonstrated doubling of the difference in the increase in antigen-specific CD8 cytotoxic T-lymphocytes in patients with ductal carcinoma in situ of the breast who were HLA-A2-positive or A3-positive, express HER2 at immunohistochemistry1+, 2+, or 3+ levels, and are pre- or post-menopausal, according to preliminary results from the phase II VADIS study.
Bendamustine debulking followed by ofatumumab and ibrutinib demonstrated an overall response rate of 92% in patients with chronic lymphocytic leukemia, meeting the primary end point of the phase II CLL2-BIO trial, and was well-tolerated with no new safety signals. Results from the study were published in Haematologica.
Ruxolitinib was found to be safe and effective for long-term treatment of patients with polycythemia vera who are resistant to or intolerant of hydroxyurea, according to the 5-year follow-up data from the phase III RESPONSE trial, recently published in The Lancet Haematology.
The addition of tremelimumab to frontline durvalumab and the standard of care, platinum-based chemotherapy, did not demonstrate a statistically significant improvement in overall survival in patients with extensive-stage small cell lung cancer, missing the co-primary end point of the phase III CASPIAN trial, according to high-level results from the final analysis of the trial.
Vemurafenib monotherapy is an effective treatment for patients with BRAF V600-mutated non–small cell lung cancer, according to results from the phase II AcSe vemurafenib trial II study published in the Annals of Oncology.
Researchers have developed a baseline score to determine the risk for heart failure in patients with acute leukemias, to address the scarcity in knowledge around the increasing incidence and risk factors of symptomatic heart failure in this patient population. The findings were published in JACC: CardioOncology.