CHICAGO — Bristol-Myers Squibb $BMY has gone all in on Nektar’s $NKTR approach to amping up their checkpoint strategy, partnering on NKTR-214. But instead of taking a bow at #ASCO18 on positive data, researchers spent the weekend explaining why their latest data readout from a small study shouldn’t be cause for panic.
It’s not what they were looking for, to put it mildly.
Unlike most of the more closely-watched programs here at ASCO, the researchers involved never offered a preview of the data that came out Saturday evening. And that was a serious misstep, particularly as the reporters covering this session struggled to figure out what was being reported — and what it meant.
As it happens, investigators executed a two-stage trial process, signing up a small group of patients to test the drug in different cancer types, then moving on to the next stage with a new group of recruits. Doing that, says Mary Tagliaferri, the chief medical officer at Nektar, meshed well with their strategy for jumping into late-stage studies as they communicated with regulators.
“The goal,” she tells me, “was always to assess moving very quickly into Phase III.”
Investors, though, weren’t happy with the way this all came down, and they bolted when the market opened, with Nektar’s stock plunging a stinging 32% — exactly the kind of rout that Bristol-Myers (down 1.6%) doesn’t need right now as it tries to restore confidence in its pipeline. And it kept getting worse later in the day, with shares down 42%.
Here’s what Nektar has found so far.
In their melanoma project, researchers saw that 11 of 13 patients treated with a combination of Opdivo and NKTR-214 responded in round 1 — which is outstanding. But, when they added 15 more patients, they only boosted their response rate by 3 patients. And 3 out of 15 is not outstanding.
In kidney cancer, the step one response rate of 64% was followed up with an overall step 2 rate of 46%.
Investors hate to see a falling response rate, for any reason, as it indicates a problem that can seriously affect a cancer drug’s longterm financial success.
Twitter’s day-trading crew picked it up from there, with all sorts of #ASCO18 chatter about a trial disaster in the making. And as often happens, Twitter is not a great source of real-time information, particularly when the companies failed to explain what the numbers meant with analysts.
In the followup discussion, though, Tagliaferri offered the rationale that it’s early days for the second batches of patients and they expect to see more responses with time. And they have reason to believe that, after tracking a 46% ORR in RCC at SITC that has now grown to 71% at ASCO.
“You’ll see the ORR going up,” says Tagliaferri, as they have a chance to collect multiple scans on the second-stage patients. “It s a little frustrating that people aren’t understanding that.”
Also important, they say, is clear evidence that the combination of NKTR-214 is doing what they really wanted: Sparking responses in PD-L1 negative tumors where Opdivo is not successful. If that all plays out in the ambitious pivotal program now underway, it will easily justify Bristol-Myers’ record $3.6 billion wager.
In melanoma, researchers saw 5 out of 11 PD-L1 negative patients respond; in kidney cancer it was 9 out of 17, or 53%. Those numbers are fine.
Right now, though, they’ve created an atmosphere of doubt that will make every turn of data a catalyst for the gamblers now lining up their bets for and against the combination. That will either help or hurt these companies, which are now betting heavily that step 2 will ultimately play out in their favor.
We’ll find out more at the next SITC conference in November, Tagliaferri adds, with abstracts due in August.
My take on the Nektar data is that it just became the biggest battleground in biotech. Either you believe 1) the new patients from the phase two expansions will turn into responses with time or 2) phase one was a low n mirage. We’ll only know with time.
— Brad Loncar (@bradloncar) June 3, 2018
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