publication date: Mar. 31, 2015
20150331 - Mar. 31, 2015
March 2015PDF

 Leukemia

Phase III Trial of Imbruvica Unblinded Following Significant Increase in PFS

An independent data monitoring committee recommended unblinding the phase III HELIOS trial, which is evaluating Imbruvica in combination with bendamustine and rituximab in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, following clinically meaningful and statistically significant treatment benefit.

The study has met its primary endpoint in extending progression-free survival. The safety profile of Imbruvica combination was consistent with prior clinical experience. Imbruvica is jointly developed and commercialized by Pharmacyclics and Janssen Biotech Inc.

HELIOS, an international, placebo-controlled trial enrolled 578 CLL or SLL patients who had received at least one line of prior systemic therapy. Patients were randomized to receive either Imbruvica orally once daily in combination with six cycles of BR; or placebo orally once daily with six cycles of BR, with treatment continuing until disease progression or unacceptable toxicity.

 Prostate Cancer

Provenge Immune Response Continued For Two Years in Phase II Study in BRPC

Preliminary results from the phase II STAND trial showed a robust immune response with Provenge (sipuleucel-T) that continued two years after completing treatment in men with biochemically-recurrent prostate cancer. 

The STAND study is a randomized trial consisting of two patient study groups. One group completed Provenge two weeks before initiation of androgen deprivation therapy and the second received Provenge three months after the start of ADT.

Preliminary results from STAND indicate that immune responses were observed in both study arms and suggest there may be a greater cellular immune response in patients who received Provenge prior to ADT compared with those who received Provenge following three months of ADT. Humoral immune responses were observed and similar between both treatment arms.

 Drugs and Targets

FDA Grants Accelerated Approval to Farydak for Patients with Multiple Myeloma

FDA granted accelerated approval to Farydak (panobinostat) for the treatment of patients with multiple myeloma.

An improvement in survival or disease-related symptoms has not yet been established for Farydak. The drug’s sponsor, Novartis Pharmaceuticals, is required to conduct confirmatory trials to verify and describe the clinical benefit of Farydak. FDA had previously granted Farydak priority review and orphan product designation.

Farydak inhibits histone deacetylases, which may slow the over-development of plasma cells in multiple myeloma patients or cause these cells to die. Farydak is the first HDAC inhibitor approved to treat multiple myeloma. 

Also: FDA approves Unituxin, the EU approves Jakavi, and more

 Soft Tissue Sarcoma
Phase III Halaven Trial Shows Extended OS over Dacarbazine
 Brain Cancer
Study Shows 73% Survival at Three Years by Combining Radiation Therapy and Chemotherapy
 Myelofibrosis
Pacritinib Phase II Study Shows Reduction in Spleen Volume
 NCI CTEP-Approved Trials for the Month of March

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