Juliet, where art thou?
I'm referring to the Novartis (NVS - Get Report) clinical trial known as JULIET, investigating the use of the company's genetically altered cell therapy CTL019 in patients with diffuse large B-cell lymphoma (DLBCL) whose disease has returned or is unresponsive to prior treatments.
The data to emerge from Novartis' JULIET study is of keen interest to investors because it will be compared against Kite Pharma's (KITE) competing "CAR-T" KTE-C19 in the same DLBCL patients.
Both Novartis and Kite have already submitted their respective CAR-T therapies to the FDA but the initial approval requests are for different types of blood cancer patients. Novartis' marketing package for CTL019 covers children with acute lymphoblastic leukemia (ALL.) Kite is going for approval of KTE-C19, also known as axi-cel, in DLBCL.
But Novartis is trying to move fast to expand use of CTL019 into DLBCL, setting up a more direct competitive battle against Kite. And that's why the JULIET study results are so important.
So, where are those JULIET data?
"We are on track with our regulatory filings and we will present the data from JULIET at an upcoming medical meeting," said Novartis spokesman Eric Althoff, in an email response to my question.
Novartis provided investors with this timeline of the JULIET study at an R&D meeting in January.
If Novartis keeps to this timelines, interim results from JULIET in the first 50 DLBCL patients are known to the company already. But what about investors and everyone else? When do we see the data?
"At this time, we can't predict how and when we will announce the data," Althoff tells me, reiterating Novartis' pledge to present the data at a medical meeting.
Novartis is a big pharmaceutical company, so data from a single clinical trial are not necessarily material. That gives Novartis a lot of leeway in how it chooses to disclose the JULIET study results -- to the frustration of everyone else who really wants to know how CTL019 matches up against Kite's axi-cel in DLBCL.
You could argue that Novartis' JULIET data are more material to Kite. The JULIET results, positive or negative, could have a big impact on Kite's stock price.
Kite shares dropped $1.33 Wednesday to $74.57. Novartis shares dropped a buck to $73.77
With Novartis playing coy on the visibility of the CTL019 data in DLBCL, one can only speculate:
Novartis reiterated the fourth-quarter regulatory submission guidance, so does that mean interim results from the first 50 DLBCL patients were strong enough to file?
That's good but it doesn't tell us anything about how CTL019 compares to Kite's axi-cel, so...
Is Novartis keeping the interim look at JULIET under wraps because the results aren't as good as what Kite has already shown from its DLBCL study, Zuma-1? Or...
Is Novartis keeping the interim look at JULIET under wraps because the results are superior to Kite's ZUMA-1 study but Novartis doesn't want Kite to know quite yet for competitive reasons?