GU Cancers 2019 | NKTR-214 + nivolumab in first-line advanced/mUC: updated results from PIVOT-02

Arlene Siefker-Radtke

Arlene Siefker-Radtke, MD of the University of Texas MD Anderson Cancer Center, Houston, TX, speaks at the 2019 Genitourinary Cancers Symposium, held in San Francisco, CA. She describes the rationale, design and updated results for the PIVOT-2 trial of NKTR-214 + nivolumab in first-line advanced/metastatic urothelial carcinoma.

Transcript (edited for clarity):

Earlier today at the poster session we saw some early results of a clinical trial combining bempegaldesleukin with nivolumab. Bempegaldesleukin is a modified IL-2 targeting agent where essentially they’ve agent six polyethylene glycols to IL-2, which results in sustained presence of this therapy in the circulation, much more sustained than you would achieve with IL-2 alone. It also selectively targets the receptors associated with proliferating T lymphocytes associated with the tumor response.

So, in essence, I consider it a mini CAR T-cell strategy every time you give a dose of treatment. They’ve combined it with an immune checkpoint inhibitor, nivolumab, and what happens is you give a dose, you proliferate lymphocytes that are presumably attracted or developing expression against novel antigens against the tumor, and then the nivolumab helps the lymphocytes target the tumor more directly.

What we saw at this earlier poster session is there is evidence of clinical activity with response rates in nearly 50% of patients receiving therapy, and not only are there partial responses, complete responses have been observed in 19% of patients, which is a level that we haven’t seen with single-agent immune checkpoint inhibition.

One more thing to point out. This therapy appears to work in PD-L1-low tumors, and PD-L1-low tumors have historically had response rates less than 5 to 10% with a single checkpoint immune inhibitor. So the combination does appear very promising, and while the data are small, I look forward to seeing this treatment applied to a larger population of patients because it certainly appears to have potential in the therapy for urothelial cancer.

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