Nektar Therapeutics Initiates PROPEL Clinical Study to Evaluate Combination of NKTR-214, a CD122-Biased Agonist, with TECENTRIQ® (atezolizumab) or KEYTRUDA® (pembrolizumab)

On September 12, 2017 Nektar Therapeutics (Nasdaq: NKTR) reported that it has begun dosing in the PROPEL clinical study which will evaluate the efficacy and safety of NKTR-214, the company’s lead immuno-oncology candidate in combination with approved checkpoint inhibitors, TECENTRIQ (atezolizumab) and KEYTRUDA (pembrolizumab) (Press release, Nektar Therapeutics, SEP 12, 2017, View Source [SID1234520483]). NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting T cells and natural killer (NK) cells directly in the tumor microenvironment and increase expression of PD-1 on these immune cells.

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Atezolizumab is a monoclonal antibody designed to bind with programmed death-ligand 1 (PD-L1). Pembrolizumab is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

"NKTR-214 directly increases the numbers of tumor infiltrating lymphocytes (TILs) in vivo and its unique mechanism is designed to have synergy with all mechanisms of checkpoint inhibition, including the PD-1/PD-L1 pathway," said Mary Tagliaferri, M.D., Senior Vice President of Clinical Development at Nektar Therapeutics. "The PROPEL study is intended to show the synergies of NKTR-214 when combined with either atezolizumab or pembrolizumab and it complements our ongoing PIVOT clinical program which combines NKTR-214 with nivolumab in eight different cancer indications. Many patients fighting cancer lack sufficient TIL populations to benefit from approved checkpoint inhibitor therapies and we believe the combination of NKTR-214 with these agents could expand treatment options for patients in multiple tumor settings."

NKTR-214 targets CD122 specific receptors found on the surface of cancer-fighting immune cells in order to stimulate their proliferation and activation. In clinical and preclinical studies, treatment with NKTR-214 resulted in expansion of these cells and mobilization into the tumor micro-environment.1,2 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.

The Phase 1/2 PROPEL study is a Nektar-sponsored trial that will enroll patients into two separate arms concurrently. The first arm will evaluate an every three-week dose regimen of NKTR-214 in combination with atezolizumab in up to 30 patients in approved treatment settings of atezolizumab, including patients with non-small cell lung cancer or bladder cancer. The second arm will evaluate an every three-week dose regimen of NKTR-214 in combination with pembrolizumab in up to 30 patients in approved treatment settings of pembrolizumab, including patients with melanoma, non-small cell lung cancer or bladder cancer.