February 2020, Vol 11, No 1 | Payers’ Perspectives In Oncology | Including ASH 2019 Highlights

On January 9, 2020, the FDA accelerated the approval of avapritinib (Ayvakit; Blueprint Medicines Corporation), a kinase inhibitor, for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes GIST that harbors a PDGFRA D842V mutation, which is the most common exon 18 mutation. The FDA granted breakthrough therapy and orphan drug designations to avapritinib.

On January 23, 2020, the FDA accelerated the approval of tazemetostat (Tazverik; Epizyme Inc), an EZH2 methyltransferase blocker, for the treatment of patients aged ≥16 years with metastatic or locally advanced epithelioid sarcoma (a subtype of soft-tissue sarcoma) that is not eligible for complete resection. Tazemetostat received an orphan drug designation for this indication.

Orlando, FL—The impact of poverty and low socioeconomic status on health and survival among children may be even more debilitating than suspected, according to new data presented at ASH 2019. Even in clinical trials, which are designed to provide consistent treatment across groups, socio­economic status was associated with “substantial” differences in survival, researchers were surprised to find out.

Orlando, FL—Mosunetuzumab is an investigational bi-specific T-cell engager (BiTE) agent dually targeting 2 proteins on the surface of lymphoma cells—CD3 (on the surface of T-cells) and CD20 (on the surface of B-cells).

On December 18, 2019, the FDA accelerated the approval of enfortumab vedotin-ejfv (Padcev; Astellas Pharma), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for the treatment of adults with locally advanced or metastatic urothelial cancer after immunotherapy with a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy. These are the current standard treatments for patients with bladder cancer, the sixth most common cancer in the United States. Urothelial cancer accounts for >90% of bladder cancers.

Orlando, FL—Tazemetostat (Tazverik), a first-in-class, oral, selective EZH2 inhibitor, has demonstrated single-agent antitumor activity in patients with relapsed or refractory follicular lymphoma, according to results of a phase 2 clinical trial presented at ASH 2019.

Orlando, FL—Nivolumab (Opdivo) monotherapy can be used as an effective bridge therapy to autologous stem-cell transplant (ASCT) in many patients with relapsed or refractory Hodgkin lymphoma, reported Matthew Mei, MD, Assistant Clinical Professor, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA, at ASH 2019.

Orlando, FL—The combination of the BCL2 inhibitor venetoclax (Venclexta) and intensive chemotherapy has demonstrated notable results in fit patients with newly diagnosed or relapsed or refractory acute myeloid leukemia (AML), according to results from a phase 1b/2 single-center clinical trial presented at ASH 2019.

Orlando, FL—The combination of du­velisib (Copiktra) plus venetoclax (Venclexta) is a promising all-oral regimen for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).