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Old 07-30-2013, 02:37 PM
gdpawel gdpawel is offline
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Default Positive Results for Adding Obinutuzumab to Chlorambucil in CLL

Genentech/Roche announced positive results from Stage 1 of CLL11, a Phase 3 randomized study to investigate the efficacy and safety profile of the investigational medication obinutuzumab (GA101) plus chlorambucil chemotherapy compared to chlorambucil alone in previously untreated Chronic Lymphocytic Leukemia (CLL). GA101 is the first glycoengineered, type 2 anti-CD20 monoclonal antibody in development for B-cell malignancies. It targets CD20 proteins found on B-cells and is designed to result in cell death.

CLL11 is a multicenter, open-label, randomized, three-arm study investigating the safety and efficacy profile of GA101 plus chlorambucil compared to Rituxan plus chlorambucil or chlorambucil alone in about 800 previously untreated people with CLL and coexisting medical conditions. The primary endpoint of CLL11 is progression-free survival (PFS). An improvement in PFS was achieved as GA101 plus chlorambucil significantly reduced the risk of disease worsening or death compared to chlorambucil alone.

Genentech/Roche's experimental leukemia drug known as GA101 delayed disease progression in people with one of the most common forms of blood cancer longer than its top-seller Rituxan, the Swiss drugmaker said.

A late stage study showed GA101, or obinutuzumab, used in combination with chemotherapy, helped people with a particular form of leukemia live longer without their disease worsening when compared with Rituxan which is also known as MabThera.

The drugs were given in conjunction with the commonly used chemotherapy chlorambucil to previously untreated patients with chronic lymphocytic leukemia (CLL) who also had other health problems, such as heart disease.

Genentech/Roche said specific sugar molecules in GA101 were modified to change its interaction with the body's immune cells, creating a unique antibody designed to engage the patient's own immune system to help attack the cancerous cells.

Roche said final data from the study would be submitted to the American Society of Hematology's annual meeting in December.
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Old 07-30-2013, 02:41 PM
gdpawel gdpawel is offline
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Default Obinutuzumab Delays Disease Progression in CLL

Genentech announced that its Phase 3 CLL11 study met its primary endpoint demonstrating that obinutuzumab (GA101) plus chlorambucil helped patients with previously untreated chronic lymphocytic leukema live significantly longer without their disease worsening (progression-free survival; PFS) compared to Rituxan (rituximab) plus chlorambucil.

Obinutuzumab (GA101) is the first type II anti-CD20 medicine that is glycoengineered, which creates a unique antibody designed to act as an immunotherapy, engaging the patient's own immune system to help attack the cancerous cells. In addition, GA101 binds to CD20 with the aim of inducing direct cell death.

CLL11 is a Phase 3, multicenter, open-label, randomized three-arm study investigating the efficacy and safety profile of either obinutuzumab plus chlorambucil or Rituxan plus chlorambucil compared to chlorambucil alone in 781 previously untreated people with CLL and co-existing medical conditions who are in need of therapy. The study included two stages of analysis.

Stage 1 included 589 patients and compared obinutuzumab plus chlorambucil to chlorambucil alone and Rituxan plus chlorambucil to chlorambucil alone. Stage 1 results showed that obinutuzumab plus chlorambucil doubled the time people lived without their disease worsening compared to chlorambucil alone (23 months compared to 10.9 months, HR=0.14, 95% CI 0.09-0.21, P<.0001).

Stage 2 enrolled an additional 192 patients to enable the final direct comparison of obinutuzumab vs. Rituxan, both in combination with chlorambucil.

Due to the significance of the positive trial results and the serious and life threatening nature of CLL, the FDA granted the GA101 application both Breakthrough Therapy Designation and Priority Review.

This article originally appeared on MPR. [url]http://www.empr.com/
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Old 09-16-2013, 11:05 AM
gdpawel gdpawel is offline
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Default Breakthrough status for Arzerra (ofatumumab)

The US Food and Drug Administration has granted breakthrough therapy designation to GlaxoSmithKline and Genmabís already-marketed leukaemia drug Arzerra as a potential first-line treatment.

The agency has concluded that Arzerra (ofatumumab) qualifies as breakthrough in combination with chlorambucil in patients with chronic lymphocytic leukaemia who have not received prior treatment and are inappropriate for fludarabine-based therapy. The designation is based on the results from a Phase III trial in more than 400 patients with previously untreated CLL.

Breakthrough therapy designation is distinct from the FDA's other fast-track programmes, such as accelerated approval and priority review, as it involves more intensive guidance from the agency on putting together an efficient drug development programme.

CLL, the most common form of leukaemia in adults, is estimated to cause more than 4,580 deaths in the USA alone in 2013. At present, no curative chemotherapy is available, GSK and Genmab note.

This is the second drug developed by Genmab to receive breakthrough therapy designation, the other being daratumumab (partnered with Johnson & Johnson) for multiple myeloma. The FDA approved Arzerra for CLL in October 2009 for patients who have not responded to Sanofi unit Genzymeís Campath (alemtuzumab) or fludarabine.

Source: PharmaTimes
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Old 11-04-2013, 11:16 AM
gdpawel gdpawel is offline
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Default FDA approves leukemia drug Gazyva (obinutuzumab)

Genentech won FDA approval for its Gazyva (obinutuzumab) drug for patients with leukemia, the first medicine approved by the Food and Drug Administration under its new breakthrough therapy designation. Genentech is a subsidiary of Roche Holding, based in Switzerland.

Gazyva is a drug for patients with leukemia who haven't been treated before. The medicine - also known as obinutuzumab - is cleared to treat chronic lymphocytic leukemia and is the first breakthrough therapy to receive approval. The FDA granted Gazyva the designation after preliminary evidence indicated it might offer substantial improvement over current treatment.

Chronic lymphocytic leukemia is a blood and bone marrow disease that typically worsens slowly. About 15,680 Americans will be diagnosed with the disease and 4,580 will die from it this year.

Approval was based on data that showed Gazyva plus chemotherapy had an 84 percent reduction in the risk of the disease worsening or death compared with chemotherapy alone. People who received Gazyva and chemotherapy lived 23 months without their disease worsening compared with 11 months with chemotherapy alone.

Congress gave the FDA the authority to designate breakthrough therapies last year, allowing the agency to work more closely with drugmakers whose medicines are particularly promising to usher the products to market.

The drug will carry a boxed warning regarding hepatitis B reactivation and a rare nerve disorder in the brain, the FDA said.

Source: Bloomberg News

Note: According to investigator Dr. Brad S. Kahl, clinicians must be aware of the potential for increased toxicity with obinutuzumab, particularly manageable infusion reactions mainly with the first treatment, but he believes the benefit of obinutuzumab make it difficult to use rituximab in patients receiving chlorambucil. And of course, an important related question is how this agent fits in with other chemotherapeutic regimens.

[url]http://www.researchtopractice.com/sites/default/files/5mjc/5MJCASH2014/4/1/pdf/5MJCASH2014_4-Goede.pdf

[url]http://www.researchtopractice.com/sites/default/files/5mjc/5MJCASH2014/4/2/pdf/5MJCASH2014_4-Brown523.pdf
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Last edited by gdpawel : 03-06-2014 at 12:29 PM. Reason: additional info
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