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The First Look At Incyte's ASCO '14 Study Results

NEW YORK (TheStreet) -- Incyte (INCY - Get Report) was the focus of much buzz heading into tonight's American Society of Clinical Oncology (ASCO) 2014 research abstract reveal. Investors are particularly interested in two clinical studies presenting at this year's meeting: A melanoma study of Incyte's immuno-oncology candidate INCB024360 ('360) combined with Bristol-Myers Squibb's (BMY - Get Report) Yervoy; and a mid-stage study of Jakafi in advanced pancreatic cancer.

Here's a recap of both studies, based on the preliminary data contained in the abstracts released by ASCO.

Abstract No. 3010: Preliminary results from a phase 1/2 study of INCB024360 combined with ipilimumab (ipi) in patients (pts) with melanoma.

Eight melanoma patients were treated with a 25 mg, twice-daily dose of '360 plus Yervoy. Three patients (38%) had a confirmed partial response with duration lasting 179, 148 and greater than 127 days (ongoing.) Another three patients had stable disease for an overall disease control rate of 75%. No progression-free survival or overall survival data are reported in the abstract.

Must Read: 2014 FDA Drug Approval Calendar

The abstract describes (and Incyte previously disclosed) a second cohort of melanoma patients treated with 300 mg of '360, which was stopped because of significant increases in liver enzymes.

At the 25 mg dose of '360, one patient reported significantly elevated ALT levels, but this patient also had extensive liver metastases. One patient each discontinued from the study due to colitis and salivary amylase elevation.

Additional patients were enrolled into the study and treated with a 50 mg dose of '360. Those data will be presented at the ASCO meeting and we were not disclosed in the abstract.

This is a small and early study but important because of the excitement centered on drugs which manipulate the immune system to identify and kill cancer cells. Bristol's Yervoy was one of the first immuno-oncology drugs approved. Scientists hope for even better results from combinations of immune system-stimulating cancer drugs. AstraZeneca (AZN - Get Report) and Incyte announced a collaboration earlier today to combine the former's PD-1 checkpoint inhibitor with '360 in a study of multiple tumor types.

On its own, Yervoy typically shrinks tumors in 11-15% of patients. Investors were expecting a '360-Yervoy response rate of 20-25%, according to Oppenheimer analyst Boris Peaker, in a recent research note. Ahead of tonight's data release, J.P. Morgan analyst Cory Kasimov called a 38% response rate from the 25 mg '360 dose "enough to maintain interest."

There are considerable leaps of faith required when comparing results from a much larger Yervoy monotherapy study with a tiny, eight-patient study of '360+Yervoy.

The 38% melanoma response rate to the Jafaki-Yervoy combination is still inferior to what's been observed in larger studies of the PD-1 checkpoint inhibitors under development by Bristol-Myers Squibb and Merck (MRK). Investors will have to wait for two weeks to see what the 50 mg dose of '360 an deliver, and even longer for data from the AstraZeneca-Incyte combination study collaboration.

Incyte's '360 works by blocking an enzyme IDO-1, which cancer cells use to hide from a patient's immune system.

Abstract No. 4000: A randomized double blind phase 2 study of ruxolitinib (RUX) or placebo (PBO) with capecitabine (CAPE) as second line therapy in patients (pts) with metastatic pancreatic cancer (mPC).

Jakafi is Incyte's approved drug for myelofibrosis. The company is trying to expand Jakafi's use into solid cancers.

In this study, 127 patients with pancreatic cancer no longer responding to gemcitabine were randomized to receive either Roche's RHHBY Xeloda plus Jakafi or a placebo.

The results: Treatment with Jakafi reduced the risk of death (overall survival) and tumor re-growth (progression-free survival) by 21% and 25% compared to placebo, respectively, but neither result was statistically significant.

Just under 8% of Jakafi-treated patients reported tumor shrinkage compared to zero patients in the placebo arm.

In a pre-specified subset of 60 patients with inflammation (defined as c-reactive proteins levels greater than 13 mg/dl), Jakafi lowered the risk of death by 53% compared to placebo with statistical significance. In the same subgroup of patients, Jakafi reduced the risk of tumor re-growth by 38%, which was not statistically different from placebo.

Heading into tonight's ASCO abstract release, investors were expecting Incyte to identify a biomarker that might be used to select pancreatic cancer patients more likely to benefit from Jakafi therapy. However, CRP-defined inflammation was cited specifically by Morgan Stanley analyst David Friedman in a recent research report as an example of a biomarker thought to be weak and unreliable. "We believe a more drug/tumor specific [biomarker] is better," Friedman wrote.

Incyte's Jakafi abstract contains no data on a drug or tumor-specific biomarker correlating positively with overall survival or a better tumor response.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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