August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO

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.

Chicago, IL—In the phase 3 CLL14 trial, fixed-duration therapy with the combination of venetoclax (Venclexta) plus obinutuzumab (Gazyva) was superior to the combination of chemotherapy with chlorambucil plus obinutuzu­mab as front-line therapy in older patients with chronic lymphocytic leukemia (CLL) and comorbidities. Kirsten Fischer, MD, Center for Integrated Oncology Cologne-Bonn, University Hospital, Germany, presented the study results at ASCO 2019 and were published simultaneously (Fischer K, et al. N Engl J Med. 2019;380:2225-2236).

Chicago, IL—The addition of the cyclin-dependent kinase (CDK)4/CDK6 inhibitor ribociclib (Kisqali) to standard endocrine therapy significantly extended overall survival (OS) compared with endocrine therapy alone in premenopausal women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer, according to results of the phase 3 MONALEESA-7 clinical trial presented at ASCO 2019.

Chicago, IL—Maintenance therapy with the targeted drug olaparib (Lynparza) after first-line platinum-based chemotherapy prolonged progression-­free survival (PFS) in patients with metastatic pancreatic cancer and a germ­line BRCA mutation, according to results of the phase 3 POLO clinical trial presented at the plenary session at ASCO 2019. Lead investigator Hedy L. Kindler, MD, FASCO, Medical Director, Gastrointestinal Oncology, University of Chicago Medicine, IL, presented the results.

Chicago, IL—Approximately 25% of children, adolescents, and young adults with advanced cancer were eligible for a targeted therapy after genotyping of their tumors in the Pediatric Molecular Analysis for Therapy Choice (MATCH) clinical trial. That rate is more than double the 10% that researchers had projected.