BRAIN CANCER

Final overall survival and long-term safety results of the phase 3 NETTER-1 trial were presented during the World Congress on Gastrointestinal Cancer 2021.

The FDA has accepted the filing of a new drug application for surufatinib to be indicated as treatment of patients with advanced neuroendocrine tumors. The FDA set a Prescription Drug User Fee Act target action date of April 30, 2022.

The first patient has been dosed in a study designed to evaluate the safety and feasibility of IL13Rα2 chimeric antigen receptor T cell therapy for the treatment of leptomeningeal brain tumors, such as glioblastoma, ependymoma, and medulloblastoma.

A rolling submission of a new drug application to the FDA has been initiated for surufatinib as a potential treatment option for patients with pancreatic and extra-pancreatic neuroendocrine tumors.

The FDA has granted a rare pediatric disease designation to the novel p-STAT3 inhibitor WP1066 for the treatment of patients with the rare brain and spinal cord malignancy, ependymoma.

The FDA has granted orphan drug designation to CYNK-001, a non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer cell therapy, for the treatment of patients with malignant gliomas.

The FDA has issued a letter to the developer of the immunotherapy vaccine, ERC1671, recommending that the phase 2 clinical trial of ERC1671 in combination with granulocyte-macrophage colony-stimulating factor, and cyclophosphamide for the treatment of glioblastoma be terminated.

The FDA has granted CYNK-001, a natural killer cell therapy, with a fast track designation for the treatment of adult patients with recurrent glioblastoma multiforme, according to a press release from developer Celularity.

The FDA granted orphan drug designation to the CDK2/4/6 inhibitor, NUV-422, for the treatment of patients with malignant gliomas.

Treatment with lanreotide autogel in patients with pancreatic neuroendocrine tumors, and midgut neuroendocrine tumors did not cause deterioration in quality-of-life, according to new data from the Phase II CLARINET FORTE study.

The investigational, potent, oral CDK9 inhibitor, zotiraciclib in combination with temozolomide, demonstrated early improvement in progression-free survival as treatment of patients with recurrent high-grade gliomas, meeting the primary end point of the phase 1B 17-C-0009 trial clinical trial.

The first patient with newly diagnosed glioblastoma multiforme has been dosed with the first-in-class small molecule enzastaurin in combination with temozolomide and radiotherapy in the phase 3 ENGAGE clinical trial with an aim of determining the overall survival outcome of the drug in this patient population.

The FDA has granted approval to the naxitamab as treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease on prior treatment.

The investigational drug Rhenium NanoLiposome demonstrated efficacy in an interim analysis presented at the 2020 Society for Neuro-Oncology Annual Meeting for patients with recurrent glioblastoma.

Patients with newly-diagnosed, recurrent, and first-line MGMT-unmethylated glioblastoma multiforme exhibited a promising median progression-free survival and median overall survival in two phase 2 trials of VAL-083 compared with historical data.

Positive preliminary data from the phase 1 DUET-1 study examining XmAb18087 in patients with neuroendocrine tumors demonstrated promising safety and efficacy findings.

Results of the CLARINET FORTE study indicate that a dosing strategy of lanreotide given every 14 days may be a viable and safe option when the standard administration of every 28 days is not acceptable.

The FDA has accepted an investigational New Drug application for the investigational CDK2/4/6 inhibitor NUV-422 for the treatment of patients with high-grade gliomas.

In an interview with Targeted Oncology, David Roberge, MD, discussed the role of radiation treatment in patients with brain metastases and the clinical trial evaluating treatment approaches for patients with more than 5 brain metastases.

Results from the DUNE trial of durvalumab added to tremelimumab in patients with advanced neuroendocrine tumors of gastroenteropancreatic and lung origins showed limited activity, according to a presentation held during the 2020 European Society of Medical Oncology Virtual Congress.

Enzastaurin is on track to serve an unmet medical need in the treatment landscape of glioblastoma. Neuro-oncologists are waiting on the launch of an important clinical trial to further demonstrate the efficacy of the drug.

The FDA has granted an Orphan Drug designation to rhenium nanoLiposomes for the treatment of patients with recurrent glioblastoma.

The FDA announced draft guidance, which provides recommendations for the design of clinical trials and biological products for product labeling for those with brain metastases regulated by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.

The FDA granted a Fast Track designation to paxalisib for the treatment of patients with newly diagnosed glioblastoma with unmethylated MGMT promotor status who have completed initial radiation and temozolomi

In an interview with Targeted Oncology, Stephanie Weiss, MD, reviewed the treatment landscape for HER2-positive metastatic breast cancer and gave her predictions on how the paradigm will evolve for patients with brain metastases now that tucatinib has demonstrated efficacy.

In the first pooled prospective study to show the long-term outcomes of cranial radiation in patients with limited brain metastases, it was observed that whole-brain radiotherapy was associated with worse cognitive outcomes and mixed quality of life compared with stereotactic radiosurgery for these patients over time, according to a presentation from Joshua Palmer, MD, at the 2020 Virtual Conference on Brain Metastases.

Multiple positive responses were observed in an exploratory efficacy analysis evaluating tucatinib in combination with trastuzumab and capecitabine in patients with previously treated HER2-positive metastatic breast cancer with brain metastases in the previously reported HER2CLIMB trial.

A completed Biologics License Application was submitted to the FDA for omburtamab, an investigation monoclonal antibody, which is intended for the treatment of pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma.

In an interview with Targeted Oncology, David Reardon, MD, discussed the background and findings for the phase 1/2 clinical trial of INO-5401 and INO-9012 plus cemiplimab in patients with newly diagnosed glioblastoma.

Enzastaurin, a first-in-class small molecule, has been granted a Fast Track designation by the FDA for the potential treatment of patients with newly diagnosed glioblastoma.