Can Global Biopharmaceutical Alliances Bring the World Closer Together?

While covering the American Society of Hematology (ASH) conference this past week, I was moved by the international flavor of the event. For a few days, the world seemed refreshingly small. And united. Science can do that. Sometimes. It’s not like the 30,000-some cancer researchers joined hands and sang a verse of “Kumbaya.” But it was darn close.

ASH is the largest blood cancer and blood disease conference in the world. I cover it each year. And it never fails to educate me and frankly light my fire. ASH reminds me just how much groundbreaking research is going on out there. Here's what matters: much of what you see at ASH will eventually make its way to your local cancer clinic and prolong, improve and save lives.

I always learn from this event, but there was something about this year’s ASH that stopped me in my tracks. I guess I never fully considered just how global and significant this thing really is, and what it can mean not only for cancer research but for the planet. ASH’s international impact was on glorious display as companies and scientists from 25 countries announced their latest data. And most of these scientists don’t just take their research home to their respective countries. They share their research, and clinical trials, with clinicians, and patients, around the world.

Drug companies now are literally global. Many of them anyway. And many of these companies from Europe, Asia and other corners of the globe now have a presence in North America, and vice versa, and are actually partnering with American pharma and American cancer hospitals.

Can pharmaceutical companies bring this world a little closer together via science? Well, one might argue that they’re already doing just that. Pharma has gotten some bad press in recent years. But let us please remember that drug companies are seeking and finding new treatments and cures every day.

And they are working together in a way they have never done before. Providing combination treatments and joint clinical trials in multiple countries is an undeniably good thing for patients and for the future of this wobbly blue sphere. It's harder for countries to fight when they are working together every day to find cures for cancer.

Here are some examples:

Daiichi Sankyo

Daiichj Sankyo, the pharmaceutical concern based in Tokyo, has an increasing presence in the US, and globally. Daiichi provides innovative products in oncology and much more to 20 countries around the world.

Daiichi is studying a new treatment for adult T-cell lymphoma (ATL), one of the most aggressive forms of non-Hodgkin’s lymphoma.

At ASH, Daiichi announced encouraging early results for valemetostat, the company’s oral, potential first-in-class EZH1/2 dual inhibitor, in patients with relapsed/refractory ATL. Although rare, ATL occurs with greater frequency in certain regions including Japan. An often fast-growing form of T-cell lymphoma, ATL is associated with human T-cell lymphotropic virus type 1 (HTLV-1).

Treatments for ATL, which is a complex and heterogeneous disease, have to date been largely limited to systemic chemotherapy combinations, and patients who relapse often face a difficult prognosis.

Arnaud Lesegretain, vice president, oncology R&D at Daiichi Sankyo, explained to me during the ASH conference that research has shown that EZH1 and EZH2 are highly expressed or mutated in many blood cancers and are involved in suppression of genes that control tumor cell growth and proliferation.

Valemetostat has displayed preliminary activity in various blood cancers in preclinical models. Early clinical data is very encouraging, said Lesegretain, who noted that the response rate among ATL patients is 55 percent in 9 patients. “We have four patients that have remained on the treatment for more than 300 days,” he said. “But it is early.”

As Lesegretain explained, this is the only dual inhibitor in development, and it is an oral treatment. “This is not chemotherapy. Patients benefit and can stay on it. The safety profile appears to be manageable and acceptable,” he said.

In addition to the pivotal phase 2 trial in relapsed/refractory ATL, valemetostat is in phase 1 clinical development for several types of non-Hodgkin’s lymphomas, including ATL, peripheral T-cell lymphoma (PTCL) and B-cell lymphomas.

 

Trials are now enrolling patients in the U.S. and Japan. A phase 1 study is also underway with valemetostat in other blood cancers including acute myeloid leukemia (AML) and acute lymphocytic leukemia.

“Valemetostat is a novel targeted therapy that has demonstrated preliminary potential in several types of NHL including ATL, which represents one of the greatest areas of need among lymphoma patients, particularly in Japan,” Kaszushi Araki, DVM, PhD, valemetostat global team leader, Oncology Clinical Development Department, Oncology Function, Daiichi Sankyo, said last week at ASH.

Added Lesegretain, “We want to fulfill our commitment to science and technology and deliver first in-class treatments that can change the standard of care. It is early, there is still lot of work to be able to fulfill our vision, but we are on a very interesting journey to defeat cancer.” 

BeiGene

I have been writing about China for more than a decade. I have many friends and colleagues in China, I covered the Beijing Olympics for Newsweek, and I have covered China’s booming biopharmaceutical industry for the last several years.

I'm currently directing a technology and friendship initiative, The China Lymphoma Project, which will provide support and information to my friends in China who have been diagnosed with lymphoma and their families.

Among the most significant pharmaceutical companies in the lymphoma space in China is BeiGene, a company that began with a handful of scientists in Beijing and is now a global entity with a large presence in the United States. 

BeiGene’s slogan? We have no borders.

BeiGene just announced last month that the American Food and Drug Administration (FDA) has granted accelerated approval to BeiGene’s lead cancer drug, Brukinsa (zanabrutinib), for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

BeiGene also showed its presence at ASH with new data on its successful drug Brukinsa for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.

In two oral presentations, the treatment demonstrated consistent safety and a high overall response rate. Brukinsa combined with BeiGene’s investigational anti-PD-1 antibody tislelizumab in patients with previously treated B-cell malignancies showed preliminary efficacy and was generally well tolerated.

Jane Huang, M.D., chief medical officer, hematology at BeiGene, said the trial results demonstrated “robust clinical activity and a safety profile consistent with what we’ve observed to date in our clinical trials, including safety data that supported the recent U.S. FDA accelerated approval in patients with previously treated mantle cell lymphoma.”

That's the world. Coming together.