FDA Pipeline: Breakthrough Therapy for Melanoma, Investigational New Drug for Advanced Solid Tumors
This week, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to bempegaldesleukin in combination with nivolumab for advanced melanoma and cleared an investigational new drug application for a phase I trial of SB 11285 in advanced solid tumors.
Breakthrough Therapy Designation for Bempegaldesleukin in Combination With Nivolumab for Melanoma
The FDA granted Breakthrough Therapy designation for the investigational agent bempegaldesleukin (NKTR-214) in combination with nivolumab for the treatment of patients with previously untreated unresectable or metastatic melanoma. The designation is based on data that were recently reported at the 2019 ASCO Annual Meeting from a cohort of patients with metastatic melanoma who were treated with the doublet therapy in the ongoing PIVOT-02 phase I/II clinical study.
Bempegaldesleukin is an investigational CD122-preferential IL-2 pathway agonist designed to provide activation and proliferation of cancer-killing immune cells, known as CD8-positive effector T cells and natural killer cells.
A phase III clinical trial evaluating first-line bempegaldesleukin in combination with nivolumab vs nivolumab alone in advanced melanoma is currently recruiting patients.
IND Application Cleared for SB 11285 for Advanced Solid Tumors
An investigational new drug application for a phase I trial of SB 11285, an intravenously (IV)-administered STING (stimulator of interferon gene) agonist development candidate, has been approved by the FDA. The phase I trial aims to evaluate the safety, tolerability, and initial antitumor activity of IV SB 11285 in patients with advanced solid tumors.
SB 11285 is a second-generation STING agonist immunotherapeutic agent being investigated for the treatment of selected cancers, including some breast and lung cancers, colorectal cancer, and melanoma. In vitro and in vivo preclinical findings indicate that SB 11285, if approved, may be used to target a variety of tumors at various anatomic sites and has the potential to enhance the activity of other therapeutic modalities, such as immune checkpoint inhibitors. Preclinical studies have also indicated that SB 11285 could be administered clinically either intratumorally or intravenously.
Part 1 of the IV SB 11285 phase I trial is a dose-escalation study with monotherapy followed by combination with a checkpoint inhibitor. It is designed to determine a recommended phase II dose. Part 2 of the trial will explore IV SB 11285 antitumor activity in combination with a checkpoint inhibitor in selected tumor types. The trial will be conducted at multiple sites in the United States, and early results may be reported in mid-2020.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
