Articles

dding trastuzumab to standard cisplatinum/fluoropyrimidine chemotherapy for patients with HER2-positive advanced gastric cancer results in a median survival of 13.8 months, compared with 11.1 months with chemotherapy alone, according to a new study (Lancet. 2010;376 [9742]:687-97. Epub 2010 Aug 19).

Chicago, IL—Taking part in clinical research poses administrative, logistic, and financial challenges to community oncology practices, but also presents these organizations with opportunities for a more active role in shaping patient care.

Silver Spring, MD—Risk Evaluation and Mitigation Strategies (REMS) are required from some drug manufacturers as part of a new US Food and Drug Administration (FDA) regulation designed to draw the attention of sponsors, providers, and patients to the likelihood of severe adverse events accompanying certain drugs and biologic agents.

On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with bortezomib, thalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem-cell transplant (ASCT). The FDA granted this application priority review.

On June 27, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with lenalidomide (Revlimid; Celgene) and dexamethasone for the first-line treatment of patients with multiple myeloma who are ineligible for autologous stem-cell transplantation (ASCT). This approval was granted a priority review and used the Oncology Center of Excellence Real-Time Oncology Review program. This is the sixth indication for daratumumab in multiple myeloma and the second indication for newly diagnosed patients.

On July 3, 2019, the FDA granted accelerated approval to selinexor (Xpovio; Karyopharm Therapeutics), a nuclear export inhibitor, in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received ≥4 previous therapies and did not respond to other forms of treatment, including ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-­CD38 monoclonal antibody. The FDA reviewed selinexor using its fast track program, and granted it an orphan drug designation.

Chicago, IL—Patients with metastatic urothelial cancer receive first-line treatment with platinum-based chemotherapy and second-line treatment with a checkpoint inhibitor. There is currently no approved third-line therapy for this malignancy. The investigational antibody-drug conjugate enfortumab vedotin may be a good choice for third-line therapy, based on the results of a phase 2 clinical trial presented at ASCO 2019.

Chicago, IL—ONC201, a small-molecule DRD2 antagonist, results in durable tumor regression in adults with recurrent high-grade H3-K27M gliomas, reported lead investigator Isabel Arrillaga-Romany, MD, PhD, Associate Clinical Director, Neuro-Oncology, Massachusetts General Hospital Cancer Center, Boston, at ASCO 2019.

Chicago, IL—A mesothelin-targeted chimeric antigen receptor (CAR) T-cell immunotherapy demonstrated encouraging antitumor activity in combination with pembrolizumab in patients with mesothelin-associated malignant pleural solid tumors, primarily mesothelioma, who had disease progression after platinum-containing chemotherapy, according to results presented at ASCO 2019.

Chicago, IL—Gilteritinib (Xospata), a recently approved FLT3 inhibitor, prolonged survival in patients with relapsed or refractory acute myeloid leukemia (AML) and an FLT3 mutation in the phase 3 ADMIRAL clinical trial. A new analysis presented at ASCO 2019 was focused on the impact of baseline co-mutations and FLT3-ITD allelic burden on overall response and on overall survival (OS) in patients with relapsed or refractory AML who received treatment with gilteritinib.