Bempegaldesleukin Precision Cancer Medicine for Melanoma
by Dr. C.H. Weaver M.D. 8/2019
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational agent bempegaldesleukin (NKTR-214) in combination with Opdivo® (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma.
The Breakthrough Therapy Designation is based on updated clinical data demonstrating that 53% of previously untreated advanced melanoma patients responded to treatment with the combination and 24% had a complete disappearance of their cancer.
The study results were reported at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting from patients with metastatic melanoma that were treated in the ongoing PIVOT-02 Phase 1/2 clinical study. (1)
About Bempegaldesleukin (NKTR-214)
Bempegaldesleukin is a novel precision cancer medicine designed to stimulate cancer-killing immune cells in the body by targeting CD122 receptors found on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these effector T cells. (2) In clinical and preclinical studies, treatment with bempegaldesleukin resulted in expansion of these cells and mobilization into the tumor micro-environment. (3,4)
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to harness the body’s own immune system to help restore anti-tumor immune response.
FDA Breakthrough Therapy Designation is intended to expedite the development and review of medicines aimed at treating a serious or life-threatening disease where there is preliminary clinical evidence that the investigational therapy may offer substantial improvement over existing therapies on at least one clinically significant endpoint.
Boyman, J., et al., Nature Reviews Immunology, 2012, 12, 180-190.
Charych, D., et al., Clin Can Res; 22(3) February 1, 2016
Diab, A., et al., Journal for ImmunoTherapy of Cancer 2016, 4(Suppl 1): P369
CA045-001: A phase III, randomized, open label study of bempegaldesleukin (NKTR-214) plus nivolumab (NIVO) versus NIVO monotherapy in patients (pts) with…
TPS9601 CA045-001: A phase III, randomized, open label study of bempegaldesleukin (NKTR-214) plus nivolumab (NIVO) versus NIVO monotherapy in patients (pts) with previously untreated, unresectable or metastatic melanoma (MEL). Nikhil I. Khushalani, Adi Diab, Paolo Antonio Ascierto, James M.G. Larkin, Shahneen Kaur Sandhu, Mario Sznol, Henry B. Koon, Anthony Jarkowski, Ming Zhou, Rui Wang, Gaurav Bajaj, Georgina V. Long; Moffitt Cancer Center, Tampa, FL; Department of Medical Oncology, MD Anderson Cancer Center, Houston, TX; Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale IRCCS, Napoli, Italy; Royal Marsden NHS Foundation Trust, London, United Kingdom; Peter MacCallum Cancer Centre, The University of Melbourne, Melbourne, Australia; Yale Cancer Center, Yale–New Haven Hospital, New Haven, CT; Bristol-Myers Squibb, Princeton, NJ; Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Misericordiae Hospital, Wollstonecraft, NSW, Australia