ASH roundup: AbbVie, Gilead join Novartis in the center ring

Carl June and the Novartis/Penn team weren't the only players to grab the spotlight at the global gathering of hematology experts at the big American Society of Hematology meeting in New Orleans. Several companies touted new data for their therapies over the weekend, and FierceBiotech focused on a roundup of the news related to some top contenders in the field.

AbbVie's CLL drug posts 'unprecedented' Phase I results

AbbVie's ($ABBV) chronic lymphocytic leukemia drug ABT-199 wowed researchers in a Phase I study, Reuters reports, as 84% of patients experienced at least a 50% reduction in signs of the disease. The BCL-2 blocker led to complete remission for 23 of the 67 CLL patients, and investigator John Seymour told the news service ABT-199 could have future applications in breast, prostate and lung cancers.

"To achieve that magnitude of complete remission is extraordinarily promising and unprecedented in this particular type of leukemia, among patients with otherwise resistant disease," Seymour said, adding that the drug was well-tolerated in the early study.

AbbVie is developing ABT-199 through a partnership with Roche ($RHHBY).

- read the story

Gilead's lymphoma treatment trots toward early approval with strong Phase II data

Gilead ($GILD) looks like it will follow up its big win in hepatitis C with an advance in oncology. Its PI3K delta inhibitor idelalisib posted positive data in a Phase II study of indolent non-Hodgkin's lymphoma that proved resistant to Rituxan. Seventy-one of the 125 patients in the study responded to the therapy, with 7 of the responder group seeing a complete remission, 63 a partial response and one a minor response.

"It has been more than 10 years since a treatment with a novel mechanism of action has been approved for indolent NHL, underscoring the medical need for new treatments for patients who are no longer responsive to currently available therapies," said Ajay Gopal, an associate professor of the University of Washington School of Medicine. "The overall response rate and durability of response observed in this study suggest that idelalisib may become a valuable new therapy for iNHL patients who have very limited treatment options."

Gilead plans to use the data to back up its application for an early approval of idelalisib for iNHL.

- here's the release

Celgene's bone marrow therapy impresses in high-risk patients

Celgene ($CELG) is touting promising early results for CC-486, an oral treatment for myelodysplastic syndromes that leave patients with abnormally low levels of marrow-grown blood cells. In an ad hoc analysis of 23 higher-risk patients from ongoing Phase I and II studies, the drug posted an overall response rate of 48%, sending 17% of patients into complete remission and charting a 30% rate of hematologic improvement. Four patients dropped out of the study due to adverse events.

CC-486 is an oral formulation of azacitidine, an injectable treatment Celgene has marketed as Vidaza for myelodysplastic syndrome since 2004.

- read the release

ALSO: Infinity Pharmaceuticals ($INFI) turned up in New Orleans to update its Phase I data on IPI-145, its oral PI3K-delta/gamma inhibitor which has had a topsy turvy relationship with investors. This morning Infinity ($INFI) shares spiked 16% on the biotech's assertion that IPI-145 "was highly active in patients with relapsed/refractory CLL… with a nodal response rate of 89% and an overall response rate of 48%, including one complete response and 12 partial responses among patients receiving IPI-145." Release

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