Biotech Strategy Blog

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

Posts tagged ‘Acalabrutinib’

For years we’ve followed the trials and tribulations of targeted therapies seeing many approved and quite a few disappear forlornly (and officially) off to dog drug heaven. Many more sit in no-man’s land as companies eagerly wait in a holding pattern for other trial readouts in different tumour types. Sadly, sometimes these studies don’t generate enough compelling data either. With so much competition about, there are no shortcuts or low-hanging fruit in biotech or cancer drug development any more.

ASCO16 Chicago 1

En route to Chicago and ASCO!

Then along came antibody drug conjugates (ADCs), with some encouraging results in a range of cancers in both solid tumours and hematologic malignancies that lead to the approval of several new therapies.

After that, the next big advance was immunotherapies, specifically checkpoint blockade, with encouraging single agent activity in melanoma, lung, and even urothelial bladder cancer. We’ve also seen the promise fo combining two different checkpoints such as nivolumab and ipilimumab together in metastatic melanoma, albeit with an increase in toxicities.

This is all very well and good, although the challenge remains that the majority of patients either respond to therapy and relapse, or do not respond at all, depending on the circumstances, the tumour type and the regimen. We still have a long way to go in moving the needle and creating a new paradigm shift on a broad scale.

So what happens when we start to combine modalities – such as targeted therapies with immunotherapies?

Uh-oh, I hear the distant cries of disagreement erupt…

  • Remember vemurafenib plus ipilimumab in metastatic melanoma was scuppered by severe hepatitis?
  • What about osimertinib plus durvalumab in NSCLC and the increased incidence of ILD?

Both of these statements are true, and yet… we should not assume that all mixed therapy combination approaches are doomed on the basis of a mere n of 2. What happens if some are synergistic or additive? What happens of there are hidden gems that teach us new ways of doing things rather than doing the same old thing just because it’s always been done that way?

With this in mind, I’d like to open the door on our first ASCO 2016 Preview series with a look at novel combination approaches in development that caught my eye.

What are the early hints and signals that we can learn from the data? Which companies are evaluating imaginative new ideas that may turn the tables on traditional thinking?  The ideas discussed here may well surprise a few people.

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ASH Exhibit HallIn recent years, there’s been a lot of progress in the treatment of chronic lymphocytic leukemia (CLL). New targeted therapies such as ibrutinib (Imbruvica) and idelalisib (Zydelig) have been approved and have helped extend the lives of patients with this disease further. However, there still remains a need for new treatment options.

Several new drugs are on the horizon for CLL.  At ASH there were a number of presentations for venetoclax, formerly known as ABT-199/GDC-0199, it’s a BCL-2 inhibitor, which is being co-developed by AbbVie and Genentech.  We’ve written extensively about it on the blog.  One of the challenges with venetoclax is the potential for Tumor Lysis Syndrome (TLS) – we heard at ASH that starting a patient on the drug needs to be carefully managed and monitored, with high risk patients hospitalized.

Other new drugs on the longer term horizon for CLL include acalabrutinib (Acerta) and BGB-3111 (BeiGene), both next generation BTK inhibitors and potential competitive threats to ibrutinib. The CLL market is becoming interesting again!

At ASH 2015, I spoke with Ian W. Flinn, MD, PhD. Director, Blood Cancer Research Program at the Sarah Cannon Research Institute in Nashville, TN. At ASH, Dr Flinn presented data for a CLL trial of venetoclax combined with obinutuzumab, a CD20 targeted monoclonal antibody; data was obtained in both the upfront and relapsed/refractory setting.

In a wide ranging conversation, we talked about some of the data of note in Orlando, what the future direction is in CLL, and what to look forward to at ASH 2016.

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