Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘obinutuzumab CLL’

The Food and Drug Administration (FDA) today approved Roche/Genentech’s obinutuzumab (Gazyva), also known as GA101, for untreated Chronic Lymphocytic Leukemia (CLL) in combination with the chemotherapy chlorambucil. Updated CLL11 trial data will be presented at the 2013 annual meeting of the American Society of Hematology (twitter #ASH13) in New Orleans from December 7-10. Gazyva is the first drug with a Breakthrough Therapy Designation to be approved by the FDA.

“Gazyva is an important new medicine for people with newly diagnosed chronic lymphocytic leukemia as it more than doubled the time a person lived without their disease worsening compared to chlorambucil alone,” said Hal Barron, M.D., chief medical officer and head of Global Product Development in a press release this morning.

Blog readers who attended the Roche analyst event in Chicago during the ASCO annual meeting in June will have noted that Roche’s long-term corporate strategy is focused on combining cancer drugs to improve treatment outcomes; a theme echoed by Charles Sawyers, President of the American Association for Cancer Research (AACR) during his ASCO Science of Oncology award lecture on “Overcoming Resistance to Cancer Drug Therapy“.

One of the combinations that Roche COO Daniel O’Day highlighted in the analyst event at ASCO was obinutuzumab/GA101 (Gazyva) with GDC-0199 (ABT-199) for the treatment of B-cell hematological malignancies such as CLL & non Hodgkin’s lymphoma (NHL). Obinutuzumab is a glyco-engineered CD20 antibody, while GDC-0199 is a Bcl-2 inhibitor. Both cause apoptosis (cell death) through complementary mechanisms of action.

An abstract on the preclinical data for this combination will be presented at the ASH annual meeting in New Orleans. A phase 1 clinical trial in CLL with this combination is currently underway and recruiting patients (NCT01685892).

I had the great pleasure at the recent AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics meeting in Boston to talk with Deepak Sampath, PhD the leader of Genentech’s Bcl-2 preclinical research about the rational for the obinutuzumab plus GDC-0199 combination.

In this SoundCloud, Dr Sampath introduces himself and what his lab does at Genentech:

What he said during the interview makes for interesting reading, and suggests this combo could have blockbuster potential!

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Earlier this month, Janssen/Pharmacyclics announced they had submitted a New Drug Application (NDA) for Food & Drug Administration (FDA) approval of ibrutinib, an oral Bruton’s tyrosine kinase inhibitor (BTK) in chronic lymphocytic leukemia (CLL) for the treatment of patients with a deletion of the short arm of chromosome 17 (del17p). Here’s a link to July 10 press release.

The company have requested Priority review; approval later this year or in early 2014 is highly likely given that the agent has also been designated a Breakthrough Therapy by the FDA.

This is great news for CLL patients!

CLL is an incurable disease. It is the most common leukemia in the United States with 15,500 new diagnoses a year.

Chromosomal abnormalities are fairly common in CLL and predict both time to first treatment and overall survival i.e. how long someone will live. Sadly, those with a 17p deletion have the worst outcome and a poor prognosis.

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It’s exciting times in Chronic Lymphocytic Leukemia (CLL) with a lot of new data in expected at the forthcoming 2013 annual meeting of the American Society of Hematology (#ASH13) in New Orleans.  Several products have received Breakthrough Therapy status from the FDA.

At ASCO 2013, Sally Church (@MaverickNY) interviewed Dr Susan O’Brien who is the Ashbel Smith Professor in the Department of Leukemia at the University of Texas MD Anderson Cancer Center and someone who is making a difference to the lives of CLL patients.

This video was originally published on Pharma Strategy Blog. It’s long (17minutes – and took a whole weekend to edit in FCP X!) but Dr O’Brien covers a lot of points e.g. IPI-145, what effect does the gamma isoform have in CLL? On ABT-199 she discusses the Tumor Lysis Syndrome seen. Other products discussed include ibrutinib, idelalisib, AV-292 and obinutuzumab.

It’s well worth watching again in the run up to ASH 2013. Subscribers to Premium Content can login in below to view it.

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THE data of the 2013 annual meeting of the American Society of Clinical Oncology (ASCO) that starts later this week in Chicago is expected to be the early clinical trial results for new breakthrough immunotherapies that target PD-1/PD-L1.

However, I’m also excited about the data being presented for the treatment of Chronic Lymphocytic Leukemia (CLL), a disease that kills 75,000 people a year around the world. ASCO typically does not have a strong focus on hematology and blood cancers, so it’s a reflection of the clinical significance of the data that it’s a hot topic at the meeting.

Several companies are in the race to bring promising new CLL drugs to market, and have presentations in Chicago.

Earlier this year, the FDA gave it’s new Breakthrough Designation to two CLL new products: ibrutinib, a bruton’s tyrosine kinase inhibitor from Pharmacyclics and obinutuzumab, an anti-CD20 monoclonal antibody from Roche Glycart. The breakthrough therapy designation recognizes the potential of these drugs to change the standard of care in CLL and meet unmet medical needs.

In many ways the changing CLL landscape reminds me of where prostate cancer was a few years ago just before new treatments such as enzalutamide and abiraterone came to market.

If you haven’t already done so I encourage you to watch the ASCO 2013 preview video from Sally Church (@MaverickNY) in which she highlights several of the key CLL oral presentations and posters. Update Sept 18: this video is now available on the Premium Content Video page.

A few of the CLL new products I’ll be looking out for at ASCO 2013 include:

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