Emerging Therapies

Oral and poster presentations of several promising agents in early- and late-phase clinical trials dotted the program at ASCO 2016. The presentations included studies with positive findings associated with many investigational therapies, including first-in-class therapies such as chimeric antigen receptor (CAR) T-cells for the treatment of patients with B-cell malignancies or acute myeloid leukemia (AML); a vaccine (galinpepimut-S) for the treatment of patients with AML; and a chimeric monoclonal antibody against claudin 18.2 for the treatment of patients with advanced gastric cancers.

The addition of venetoclax, an oral selective small-molecule BCL-2 inhibitor, to bortezomib and dexamethasone resulted in impressive response rates in a phase 1b trial of patients with heavily pretreated relapsed or refractory multiple myeloma, said Cyrille Touzeau, MD, of Centre Hospitalier Universitaire de Nantes, France, who presented the trial’s results at ASCO 2016.

When added to standard chemotherapy, IMAB362, a chimeric monoclonal antibody against the claudin 18.2 protein, reduced the risks for disease progression and death by 50% compared with standard chemotherapy alone as first-line treatment for patients with advanced or recurrent gastric cancer and gastroesophageal junction carcinomas, according to data presented at ASCO 2016.

Short-course (hypofractionated) radiotherapy plus concomitant and adjuvant temozolomide therapy significantly prolonged survival versus short-course radiotherapy alone in elderly patients with newly diagnosed glioblastoma. These results of a global cooperative group phase 3 clinical trial were 1 of 4 presentations selected for the plenary session at ASCO 2016.

Serial vaccination with galinpepimut-S induces immunologic responses in patients with acute myeloid leukemia (AML) who are in remission. Disease-free survival (DFS) and overall survival (OS) improved in patients with AML who had an immune response to galinpepimut-S, according to data from a phase 2 trial of galinpepimut-S that were presented at ASCO 2016.

A new biosimilar to trastuzumab (Herceptin) antibody, MYL-14010, showed efficacy and safety comparable to the reference drug (trastuzumab) as first-line treatment for patients with HER2-positive advanced breast cancer, according to results from the 24-week, randomized phase 3 HERITAGE study presented at ASCO 2016.

The first-in-class antibody-drug conjugate rovalpituzumab tesirine (Rova-T) may be a new treatment option for patients with small-cell lung cancer (SCLC), which has a very poor prognosis and few treatment options.
Many presentations at ASH 2015 focused on novel therapies currently in development for the treatment of patients with hematologic malignancies.
The multikinase inhibitor midos­taurin is the first targeted therapy to improve overall survival (OS) in patients with acute myeloid leukemia (AML) and the FLT3 mutation.
The oral, investigational, small-­molecule BCL-2 inhibitor venetoclax has shown excellent and durable responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). All patients in the trial harbored the 17p deletion (del 17p), which signals poor prognosis.
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