WASHINGTON, DC — One of Nektar Therapeutics’ top cancer drugs gained the spotlight at the Society for Immunotherapy of Cancer meeting over the weekend with the first cut of some promising response rates in a range of tumor types. And the public biotech $NKTR believes the results point them to a short path at the FDA that could lead to the drug’s first, fast approval.
The drug is NKTR-214, an IL-2 immuno-oncology therapy — built from the ground up by the biotech — which is designed to bind to the CD122 receptor on the surface of CD-8 and CD-4 positive immune cells to whip up an attack on various cancers. Nektar struck a 50/50 deal with Bristol-Myers Squibb $BMY to use their drug in combination with Opdivo (nivolumab), matching a therapy aimed at driving an immune response with a popular checkpoint blockbuster that helps take the brakes off the assault.
At SITC, the company produced a medley of data points, including:
- In treatment-naïve first-line patients with stage IV melanoma, researchers tracked responses in 7 of 11 patients (63%), with 2 complete responses — no visible signs of the disease — and 5 partial responses. Not all of these numbers are precise. It’s important to note though that one of the CRs and one of the PRs were unconfirmed — emphasizing just how early these results are.
- Among 13 kidney cancer patients with one or more baseline scans, responses were observed in 6 (46%), with 1 complete response and 5 partials.
- For a small group of 4 patients with advanced PD-L1/negative non-small cell lung cancer, the investigators tracked a response in 3 (75%), with 1 complete and 2 partials.
“Single-agent nivolumab is known for all these indications, with a 34% response for melanoma,” Mary Tagliaferri, senior vice president, clinical at Nektar, tells me. “We have a 64% reduction.”
That’s what investors liked to hear. Nektar’s stock quickly jumped 23% in pre-market trading on Monday.
“Our response rate is just over 50% even in PD-L1 negative patients,” says Jonathan Zalevsky, Nektar’s senior vice president of biology and preclinical development. “And what we like about those metrics, it gives us a nice confirmation of the increase we’re seeing in our combination.”
This is an early snapshot of this drug, to be sure, but Nektar’s team believes that the safety and efficacy profiles they’re seeing in the first snapshot of data underscores the biotech’s chances of going after an accelerated approval for certain patient groups that face particularly poor prospects.
“There is an opportunity for Nektar to pursue an accelerated pathway in those patient populations where the response rate is very, very low,” says Tagliaferri.
They wouldn’t be the first to succeed at that, either. The FDA has proven eager to get new therapies to patients with poor prospects, and Nektar has filed for “breakthrough” status to help enlist regulators’ support for their plans.
The Phase II has now been expanded from 250 to 330 patients with 13 cohorts.
So what’s an approval worth here?
Cowen analyst Chris Shibutani is one of the most optimistic analysts covering the drug, estimating its 2023 revenue at $950 million — but everything has to go right for it to get close to the blockbuster mark.
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