The ACE-LY-004 study of acalabrutinib monotherapy for mantle cell lymphoma

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Published: 11 Dec 2017
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Dr Michael Wang - MD Anderson Cancer Center, Houston, USA

Dr Wang speaks with ecancer at the 2017 ASH annual meeting about the phase 2 ACE-LY-004 study, looking at efficacy and safety of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma. 

He describes the changing landscape of B Cell lymphoma management, with research initiatives conducted through the Cancer Moonshot program working towards doubling disease survival, and the impact of successive generations of TKIs.

Click here to read about the FDA approval of acalabrutinib for mantle cell lymphoma.

ecancer's filming has been kindly supported by Amgen through the ECMS Foundation. ecancer is editorially independent and there is no influence over content.

The moonshot project is a very ambitious project with many cancers that originated from MD Anderson. I’m the overall co-leader of the B-cell lymphoma moonshot. As you know, lymphoma is quite a common cancer in the USA. In the USA about 0.7 million people live with this disease. The majority of the lymphomas are B-cell lymphoma and the moonshot is the B-cell lymphoma moonshot. In this B-cell moonshot, moonshot means that we are going to land a person on the moon as ambitious, so similar with that ambition we would like to double the cure rate from 30% to 60% for B-cell lymphoma within a short period of time, from 5-10 years and we are already three years into it. So B-cell lymphomas have many subtypes, for example large cell lymphoma, follicular lymphoma, marginal zones, small lymphocytic and mantle cell lymphoma.

It is impossible for me to tell you about everything in this interview but let me point you to mantle cell lymphoma. It’s a rare disease, however at this ASH a second generation Bruton’s tyrosine kinase inhibitor, acalabrutinib, has been presented and this is an international clinical trial I have the honour to lead, it’s conducted internationally in 40 hospitals across ten countries in three continents. So, based on this very clinical trial, the FDA approved acalabrutinib for relapsed and refractory mantle cell lymphoma through the breakthrough mechanism six weeks ago, on October 31st 2017. So it is really exciting for the patients and families after bortezomib, lenalidomide, ibrutinib and now the fourth drug approved that’s chemo-free. Chemo-free therapy is replacing chemotherapy. Think about it – in the past when we wanted to achieve chemotherapy efficacy we gave the patients 4-5 drugs that get rid of their hair, nausea, vomiting, low blood counts, bleeding, infections, hospitals, suffering. But nowadays with the pill that’s taken outside of the hospital without any catheter, orally, and with that pill you don’t have to lose any hair, suffer nausea, vomiting and all that and this pill can cause even better efficacy. The side effects are not very impressive at all, it’s tolerated very well. So we are in the chemo-free therapy era and the chemo-free therapy does not mean only less side effects, it means more survival, more efficacy. So we are very, very excited. Acalabrutinib approval is another major step in our journey to cure mantle cell lymphoma and my lifetime mission is not only to lead the B-cell lymphoma moonshot programme but my deep mission, my American dream, is to contribute to the cure of B-cell lymphoma and also, especially, mantle cell lymphoma.

If I might press you on the moonshot programme, there are some who say that whilst the ambition is absolutely to be admired there are some concerns over the affordability of drugs generated and the sequencing. Your thoughts on this?

You touched on a very sensitive spot about the cost and all that. Let me tell you, the B-cell lymphoma project is mainly a scientific project and we basically work outside the cost. We just focus on the science. Our ambition to double the cure is not based just on ambition but based on data. We have had data at MD Anderson for seventy years, each ten years tremendous progress has been made, we have much more technologies and science than any other generation in history. Therefore we have the responsibility to make things happen faster. I really want to leave the drug cost to the politicians, to our government, to our overall public leaders to antagonise that America is a great country and I’m sure eventually we’re going to work out the healthcare problems.