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, which occurs in 20% to 30% of the patient population, could also derive benefit from gemtuzumab.
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. 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 RET fusion–positive non–small cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion–positive thyroid cancer, based on data from the phase I/II LIBRETTO-001 trial, Eli Lilly and Company announced in a press release.
Research has shown that patients with para-aortic lymph node metastasis, human 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.
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.
In an interview with Targeted Oncology, Benjamin Besse, MD, PhD, <a>discussed </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.
The FDA granted Priority Review to the Biologics License Application for belantamab mafodotin, an anti–B cell maturation antigen monoclonal antibody for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapies included an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, GlaxoSmithKline plc announced in a press release.<br />
Durvalumab and tremelimumab have been granted Orphan Drug Designation for the treatment of hepatocellular carcinoma, according to a press release from AstraZeneca.
The Investigational New Drug Application for the novel EGFR tyrosine kinase inhibitor BBT-176 was cleared by the FDA for treatment of EGFR C797S–mutant non–small cell lung cancer, according to a press release from Bridge Biotherapeutics, Inc, developer of BBT-176.
Lenvatinib demonstrated a longer median overall survival compared with palliative therapy in patients with stage IVC anaplastic thyroid cancer, a rare disease for which the survival rate has not improved in roughly 20 years. The introduction of targeted therapy to the treatment landscape for anaplastic thyroid cancer has been challenging in the past because some patients do not have time to undergo therapy on a clinical trial because the process is time-consuming, and the procedure for study enrollment may exceed time to progression.
Ruxolitinib plus low-dose pegylated interferon-a2 improved peripheral blood cell counts, bone marrow cellularity and fibrosis, and symptom burden with acceptable toxicity in patients with polycythemia vera or proliferative myelofibrosis, according to the 2-year, end-of-study results of the phase II COMBI study, which were recently published in Haematologica.
A rolling submission of a New Drug Application for umbralisib has been initiated by drug developer, TG Therapeutics, Inc, which is requesting accelerated approval of the agent from the FDA for the treatment of patients with previously treated marginal zone lymphoma and follicular lymphoma. The company reported in a press release that one application was considered to be acceptable for both drugs and the NDA will be completed in the first half of 2020.<br />
The FDA has granted priority review to the Biologics License Application for nivolumab in combination with ipilimumab for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations, according to a press release from the Bristol-Myers Squibb Company.<br />
Salvage therapy with high‐dose cyclophosphamide showed meaningful clinical activity in a cohort of 6 patients with mantle cell lymphoma who were previously treated with ≥2 prior lines of therapy and had no other available options. These patients made up 14% of the 42 participants in a phase II study showing similar efficacy in adult patients with other relapsed or refractory B‐cell non‐Hodgkin lymphomas.
The supplemental New Drug Application for olaparib, a PARP inhibitor, in combination with bevacizumab has been granted Priority Review by the FDA as maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy, based on the results from the phase III PAOLA-1 trial, according to a press release from AstraZeneca and Merck & Co, Inc.1<br />
The real-world efficacy and safety demonstrated with tisagenlecleucel, a chimeric antigen receptor T-cell therapy for the treatment of patients with diffuse large B-cell lymphoma, was similar to results from the pivotal JULIET trial, according to Samantha Jaglowski, MD professor at the Ohio State University Comprehensive Cancer Center patients.
Pralsetinib a highly-selected RET inhibitor, achieved a favorable overall response rate with prolonged durability in patients with RET fusion–positive non–small cell lung cancer who were previously treated with platinum-based chemotherapy, according to top-line results from the phase I/II ARROW trial, announced the Blueprint Medicines Corporation in a press release.
The FDA has approved avapritinib for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor who harbor platelet-derived growth factor receptor alpha exon 18 mutation, including PDGFRA D842V mutations. This approval makes avapritinib the first precision medicine therapy for a genomically defined population of patients with GIST, according to a press release from the Blueprint Medicines Corporation.
An update to the phase II study of loncastuximab tesirine in patients with relapsed or refractory diffuse large B-cell lymphoma showed promising overall response rate, according to a press release from ADC Therapeutics SA.
The phase II TELLOMAK trial, which is evaluating the safety and efficacy of lacutamab in patients with advanced T-cell lymphomas, has been placed on a partial clinical hold by the FDA. The decision was made following discussions regarding Good Manufacturing Practice deficiencies at a subcontractor site that manufacturers the agent in December of 2019, according to a press release from Innate Pharma SA.
The combination of pembrolizumab and chemotherapy improved progression-free survival in patients with small cell lung cancer compared with chemotherapy alone, meeting 1 of the primary end points of the phase III KEYNOTE-604 study, according to a press release from pembrolizumab developer, Merck. Compared with a chemotherapy regimen of either etoposide plus cisplatin or cisplatin alone, the progression-free survival mprovement with pembrolizumab was significant.
In an interview with <em>Targeted Oncology</em>, Constantine S. Tam, MD, discussed the findings of the phase III CAPTIVATE study.
In an interview with Targeted Oncology at the 2019 San Antonio Breast Cancer Conference, Antionette Tan, MD, shared the results of the FeDEriCa study and explained how the results can impact the treatment of patients with HER2-positive breast cancer in the clinical setting.
Overall survival was significantly improved in patients with locally advanced or metastatic urothelial cancer who received first-line maintenance treatment with avelumab versus standard of care, meeting the primary end point of the phase III JAVELIN Bladder 100 study, Pfizer announced in a press release.
Infigratinib has been granted Fast Track Designation by the FDA for the treatment of cholangiocarcinoma in adult patients with first-line advanced or metastatic disease, according to a press release from QED Therapeutics, a subsidiary of BridgeBio Pharma, Inc, and developer of infigratinib.
In an interview with Targeted Oncology at the 2019 Ruesch Symposium, Fearon, professor, Weil Cornell Medicine, discussed his presentation on the CXCL-12 pathway, which can exclude T cells from pancreatic ductal adenocarcinoma. He also shared his opinion on how to advance the treatment landscape in the future.
CLR 131, a small-molecule, targeted Phospholipid Drug Conjugate, has been granted Orphan Drug Designation by the FDA for the treatment of patients with lymphoplasmacytic lymphoma, according to a press release from Cellectar BioSciences, Inc, developer of the drug.<br />