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Winners And Losers in CLL at ASCO '13

NEW YORK ( TheStreet) -- New products in development for chronic lymphocytic leukemia (CLL), an incurable B-cell cancer, will transform the treatment of this disease over the next few years.

CLL offers a big market opportunity as more than 150,000 people in the U.S. and Europe have the disease, and about a third of these require first or second-line therapy.

After PD-1/PD-L1 immunotherapy, CLL was one of the hottest topics at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago last weekend.

Some of the companies with interesting new CLL data at the meeting included Gilead Sciences (GILD - Get Report), Roche (RHHBY), Infinity Pharmaceuticals (INFI - Get Report) and AbbVie (ABBV - Get Report).

A key drug in development for CLL, albeit one with little new data at ASCO, was the Bruton kinase inhibitor ibrutinib from Pharmacyclics (PCYC) and Johnson & Johnson (JNJ). Ibrutinib data had already been presented at prior conferences. Approval for ibrutinib in mantle cell lymphoma (MCL) is highly likely by the end of the year -- a point made by TheStreet contributor David Sobek in a recent column.

Celgene's (CELG) development activities in CLL was also missing from ASCO this year. There was no mention of the phase III trial for Revlimid in CLL or any data on AV-292, a potential competitor to ibrutinib that Celgene obtained with the purchase of Avila Therapeutics last year.

Here are my winners and losers in CLL from this year's ASCO meeting:

Winner: Gilead's Idelalisib

Gilead had some of the most impressive CLL data at ASCO. Of particular note were the results from the phase II clinical trial of idelalisib, a targeted, highly selective, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta, in combination with rituximab in frontline CLL. The data are particularly meaningful because patients enrolled in this trial were not cherry-picked to be those who were the fittest and most likely to respond. Patients were elderly (median age 71) with existing medical conditions, more typical of the majority of CLL patients seen in community practice.

Dr. Susan O'Brien from the University of Texas M.D. Anderson Cancer Center in Houston presented data that showed significant efficacy -- highlighted by a rapid reduction in size of lymph nodes. Nineteen percent of the 74 patients in the trial achieved a complete response and 78 percent a partial response.

At 24 months, 93 percent of patients had not seen their disease progress. The addition of rituximab to idelalisib also removed the raised lymphocyte count (lymphocytosis) seen with idelalisib when used on its own, suggesting a combination strategy offers significant clinical benefit.

These data were a big win for Gilead at ASCO.

Winner: Roche's Obinutuzumab (GA101)

Roche is developing a novel, next-generation anti-CD20 monoclonal antibody -- obinutuzumab (GA101) -- with potentially greater efficacy than its predecessor Rituxan.

In the preliminary results of a phase III trial, Roche showed adding obinutuzumab to the chemotherapy chlorambucil offered significant benefit. This trial was also undertaken in an elderly patient population with co-morbidities who would not be eligible to receive standard chemoimmunotherapy with fludarabine and cyclophosphamide (FC) with or without Rituxan.
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PCYC $0.00 0.00%
RHHBY $31.57 0.00%
ABBV $61.00 0.00%
GILD $88.21 0.00%
INFI $5.80 0.00%


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