NKTR-262 in combination with bempegaldesleukin

INDICATION: Locally Advanced or Metastatic Solid Tumor Malignancies

Discovered and wholly owned by Nektar


Phase 1/2

About NKTR-262

Cancer treatments that couple pharmacological activation of tumor antigen presentation with activation and expansion of CD8+ T and natural killer (NK) cells in the tumor environment have the potential to induce an effective anti-tumor immune response in patients.  NKTR-262 is a novel small molecule agonist designed to activate toll-like receptors (TLRs).  Intratumoral delivery of NKTR-262 promotes TLR activation to induce the development of antigen-specific immunity by initiating the process by which the immune system generates antigen-specific cytotoxic T cells to the patient’s specific tumor.1 Bempegaldesleukin targets CD122 specific receptors found on the surface of these cancer-killing immune cells, known as CD8+ effector T cells. By first generating antigen-specific cytotoxic T cells with NKTR-262 and then growing these CD8+ effector T cells with bempegaldesleukin, the patient’s entire immunity cycle can potentially be engaged to fight cancer.  

In preclinical studies, a single intra-tumoral dose of NKTR-262, administered in combination with bempegaldesleukin, resulted in complete abscopal tumor regressions in multiple mouse syngeneic tumor models.2


About the REVEAL Phase 1/2 Program: NKTR-262 in combination with bempegaldesleukin

REVEAL is a Nektar-sponsored, open-label, multicenter, dose escalation and dose expansion study of NKTR-262 administered as intra-tumoral injections in combination with bempegaldesleukin administered as an IV infusion systemically (doublet). The study also may evaluate the doublet combination with nivolumab (triplet). During the dose escalation phases, recommended Phase 2 dose (RP2D) regimens of the doublet and/or triplet combinations will be established.  Following dose escalation, the dose expansion phase will evaluate the doublet and/or triplet combinations in up to 350 patients who have been diagnosed with a range of locally advanced or metastatic cancers including: melanoma, Merkel cell carcinoma, triple-negative breast cancer, renal cell carcinoma, colorectal cancer, squamous cell carcinoma of the head and neck, or sarcoma. For more information, please visit clinicaltrials.gov and search NCT03435640.


1.    Adams S. Toll-like receptor agonists in cancer therapy. Immunotherapy. 2009;1(6):949-964. doi:10.2217/imt.09.70.

2.    Kivimae, S., et al., Journal for ImmunoTherapy of Cancer 2017, 5(Suppl 2):P275

2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting

2019 ASCO-SITC Clinical Immuno-Oncology Symposium

SITC 2018

2018 ESMO Congress

2018 American Association for Cancer Research (AACR) Annual Meeting

Society for Immunotherapy in Cancer (SITC) 32nd Annual Meeting, National Harbor, MD

World Preclinical Congress 2017