ASCO 2015 Highlights

In 2017, the US Food and Drug Administration (FDA) approved 46 new drugs, a 21-year high. In addition to these impressive approvals, the first-ever 3 gene therapies were also approved. FDA Commissioner Scott Gottlieb, MD, noted that these approvals represent “a whole new scientific paradigm for the treatment of serious diseases.”

The Lynx Group is pleased to bring you the Third Annual Oncology Guide to New FDA Approvals. The goal of this Guide is to offer oncologists, pharmacists, oncology nurses, and other healthcare stakeholders a comprehensive overview of new hematology oncology drugs approved by the US Food and Drug Administration (FDA) in 2017. This practical tool offers a quick, yet detailed, evidence-based resource for oncology providers to guide their management of patients with cancer.

Enasidenib and ivosidenib monotherapy have demonstrated induction of clinical responses in patients with mutant IDH (mIDH) relapsed/refractory acute myeloid leukemia (AML), whereas azacitidine (AZA) monotherapy prolongs survival in older patients with the newly diagnosed (ND) AML. Based on these results and coupled with preclinical evidence of synergy with combination of mIDH inhibitors plus AZA, an ongoing phase 1b/2 study evaluated the efficacy and safety of this combination in ND AML; results of the phase 1b portion were reported at ASH 2017.

Midostaurin, a multikinase inhibitor targeting FLT3 and KIT, is indicated for the treatment of patients with newly diagnosed, FLT3 mutation–positive acute myeloid leukemia (AML) in combination with standard induction and consolidation chemotherapy, based on demonstrations of superior survival outcomes versus placebo in the randomized, double-blind, phase 3 RATIFY trial. The Radius-X open-label expanded treatment protocol (ETP) was designed to provide access to midostaurin and obtain additional insights into the safety and tolerability profile of midostaurin in adult patients with newly diagnosed, FLT3 mutation–positive AML.

Enasidenib (AG-221) is a novel, small-molecule oral inhibitor of mutated IDH2 (mIDH2) proteins that is currently indicated for the treatment of adult patients with mIDH-positive relapsed or refractory (R/R) acute myeloid leukemia (AML). The phase 1 AG221-C-001 study demonstrated the clinical efficacy of enasidenib in patients with mIDH2 R/R AML. Given the limited treatment options for older patients with untreated AML, the current analysis sought to evaluate the clinical outcomes for older patients with previously untreated mIDH2 AML who received enasidenib monotherapy in the AG221-C-001 study.

Available preclinical and clinical evidence suggests that inhibition of PD-1/PD-L1 pathways increases antileukemic responses in acute myeloid leukemia (AML). Moreover, azacitidine treatment results in upregulation of PD-1 signaling, which is associated with azacitidine resistance. Based on this rationale, the current study evaluated the safety and efficacy of combination nivolumab plus azacitidine treatment in 2 patient cohorts: those with relapsed or refractory (R/R) AML with poor-risk features, and in elderly patients with untreated AML.

Atlanta, GA—A positron emission tomography (PET)-directed approach after standard chemotherapy can guide the need for consolidation radiation therapy in patients with diffuse large B-cell lymphoma (DLBCL). This approach can spare patients from further treatments, such as salvage chemotherapy and stem-cell transplant, as well as unnecessary radiation therapy, according to a study presented at ASH 2017.

Atlanta, GA—Interim results from a phase 1/2 study of the combination of brentuximab vedotin (Adcetris) and nivolumab (Opdivo) have demonstrated a high overall response rate (ORR) in patients with relapsed or refractory Hodgkin lymphoma. According to data presented at ASH 2017, 83% of patients responded to the combination, which included a 62% rate among efficacy-evaluable patients.

Atlanta, GA—Among patients with untreated follicular lymphoma, 75% achieved complete responses with the 3-drug combination of atezolizumab (Tecentriq), obinutuzumab (Gazyva), and bendamustine (Treanda), results of a small, preliminary clinical trial reported at ASH 2017 showed.

Atlanta, GA—Adding brentuximab vedotin (Adcetris) to doxorubicin, vinblastine, and dacarbazine (A+AVD) instead of the standard regimen with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) as frontline treatment for advanced Hodgkin lymphoma reduced the risk for disease progression, death, or the need for additional therapy by 23%, according to new data presented at ASH 2017.