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Promising clinical results for new drug combination for CLL (GA101 plus Chlorambucil)

Some information from Cardiff to add to the recent GA101 posts

Professor Chris Fegan and patient discuss the promising results of the clinical trial of obinutuzumab (GA101) in combination with Chlorambucil cardiffandvaleuhb.wales.nhs... Cardiff CLL Research Group cardiffcll.wordpress.com

May 2013

"Leukaemia specialists at Cardiff and Vale University Health Board have led a successful trial of a first-of-its kind cancer treatment, offering new hope for elderly patients with leukaemia.

The data from the trial run by Roche will be presented at the world’s biggest cancer conference, the American Society of Clinical Oncology, in Chicago at the start of June.

The data is on GA101, a targeted cancer antibody which reduced the risk of cancer worsening or death during the study, when used with a conventional form of chemotherapy, known as chlorambucil.

Professor Chris Fegan, a haematologist who led the United Kingdom part of this international study at the Clinical Research Facility at the University Hospital of Wales, said:

“This data marks an exciting step forward in the treatment of chronic lymphatic leukaemia, the most common type of adult leukaemia in the western world.

“One of the key challenges we face in treating chronic lymphatic leukaemia is that the majority of patients are over 60 and have pre-existing medical conditions which make them unfit to receive the most aggressive treatments.

“This data shows that adding GA101 to chlorambucil chemotherapy can improve response and remission time for these patients.

“As the leading haematology centre in Wales we are always looking to get involved in cutting-edge studies in the hope that they can benefit our patients.

“The CLL research group base at the University Hospital of Wales site works on all aspects of drug development from the lab to the patients; it is always rewarding to see new treatments develop from our work”.

John White from Barry has CLL and took part in the study. His treatment under the programme resulted in a complete response which should keep his disease at bay for a long time. Professor Fegan hopes that this will enable John to have a normal life expectancy.

John said: “It was the most professional treatment, Professor Fegan and the whole staff are so dedicated, I can’t praise them enough. There was no pain with the treatment, it was absolutely wonderful. The results are marvellous, I’m still alive and kicking and have no pain"

Cardiff & Vale University Health Board


In a 14 second ITV news video sample Professor Fegan describes the drug as a "game changer"

THU 16 MAY 2013 itv.com/news/wales/topic/ca...

The express: on the topic express.co.uk/news/uk/40000...


"Study author Professor Chris Fegan, from Cardiff and Vale University Health Board, said: "These significant data mark an exciting step forward in the treatment of this disease. One of the key challenges we face in treating CLL is that many patients are over the age of 60 and suffer from co-existing medical conditions such as diabetes and heart disease, which make them unfit to receive the most aggressive treatments.

"These data show that adding GA101 to chlorambucil chemotherapy offers a tolerable combination that can substantially improve response and remission time for patients in urgent need of new treatment options."

Professor Chris Bunce, research director at Leukaemia and Lymphoma Research, added: "The blood cancer chronic lymphocytic leukaemia (CLL) is the most common type of adult leukaemia but it is currently incurable, so new treatments are desperately needed. These results give hope to those patients who previously had few options left for effective treatment.

"In recent years the introduction of treatments known as monoclonal antibodies, which harness the body's own immune system to target cancer cells, has successfully prolonged survival times for CLL patients when combined with traditional chemotherapy. However, not all patients respond to treatment.

"Obinutuzumab is the first 'second generation' monoclonal antibody and it appears to be significantly more effective than earlier versions. Monoclonal antibody treatments are used in the treatment of many types of lymphoma as well as CLL, so the development of a more effective version could be a very exciting prospect. In the immediate term, these results give hope of effective, life-prolonging treatment to those CLL patients who previously had few options left.""

Roche Media release ahead of Asco roche.com/media/media_relea... :

Can anyone provide further information folowing the ASCO presentation ?

6 Replies

Oooops I just found your thread; Obinutuzumab Active in Elderly Chronic Lymphocytic Leukemia cllsupport.healthunlocked.c... and the Medscape article following ASCO: medscape.com/viewarticle/80...

Thanks for this



These articles make good and positive reading.Thank you HAIRBEAR. Being an elderly (70 does not feel old to me, tiredness notwithstanding) Cardiff patient I'm doing my best to stay fit and these articles and blogs make me feel positive about the future.


We are fortunate to be so close to UHW

Yes It is good to read about effective new developments and reassuring to know our physicians are at the cutting edge and we are in good hands.


Yes the author should know better. As the average age of CLLdiagnosis is 72 you are a young CLL patient :-)

It is fitness that matters the ability to tolerate a treatment not age. There are many older patients able to tolerate what the younger with comorbidities cannot.

Staying as fit as you can is a good strategy to help you across any bumps that may lay ahead in the road.




And here's an article on this research from the BBC dated 9th December 2013:


"GA101 is is not currently licensed in the UK and is only available through clinical trials.

But Prof Fegan said he expected it would be licensed both in the US and Europe in the next few months."


Gazyva (obinutuzimab, GA101) was FDA approved for use with chlorambucil in the U.S., Nov 1st, 2013. Other approvals will follow. More here: gazyva.com/hcp


After European license then NiCE appraisal in UK to look forward to..

From the post and discussion two weeks ago: healthunlocked.com/cllsuppo... further threads discussing progress this year. One was Chris's post announcing the FDA approval.

A month ago - FDA APPROVED...Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated CLL.https://healthunlocked.com/cllsupport/posts/130266395/fda-approved-gazyva-obinutuzumab-for-use-in-combination-with-chlorambucil-to-treat-patients-with-previously-untreated-cll

5 Months ago - Chris Fegan Cardiff - Promising clinical results for new drug combination for CLL (GA101 plus Chlorambucil) healthunlocked.com/cllsuppo...

5 months ago - Obinutuzumab (GA101) delayed disease progression longer than MabThera/Rituxan - Roche press release on CLL11 study healthunlocked.com/cllsuppo...

7 months ago - Genentech has announced an Expanded Access Program (EAP) for Obinutuzumab (GA101) healthunlocked.com/cllsuppo...

7 months ago - GA101, new drugs, chemo, asco 2013 healthunlocked.com/cllsuppo...

10 months ago - Roche’s GA101 Met Goals in Stage One of Trial to Replace Rituxan healthunlocked.com/cllsuppo...


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