NantWorks’ Patrick Soon-Shiong has a very good idea about advancing cancer immunotherapy combinations- but this work is already being done. The billionaire’s Cancer Moonshot 2020 initiative is pushing for thousands of patients to be enrolled in trials combining such agents as checkpoint inhibitors with chemotherapies and other approaches in four years.
Surely Dr Soon-Shiong must know that the sector looks like it might already be at least halfway there without his help. EP Vantage noted the first emergence of combination PD-1 trials two years ago, and the space has mushroomed since, counting no fewer than 170 combination studies of PD-1/PD-L1agents along as of last September (Merck & Co shows the way in immuno-oncology combinations, November 23, 2015).
Dr Soon-Shiong and his collaborators took the annual JP Morgan healthcare meeting in San Francisco as an opportunity to launch the National Immunotherapy Coalition, comprising big cap biotechs like Amgen (NASDAQ:AMGN) and Celgene (NASDAQ:CELG), smaller players like NantWorks, and insurers and employers.
Fresh from a December meeting with US Vice President Joe Biden, whose son died of brain cancer last year, the coalition wants 20,000 patients to be enrolled in immunotherapy combination trials in 20 cancer types within 36 months.
Absent from the scene were Bristol-Myers Squibb, Merck & Co and Roche, the undisputed leaders in the field of immunotherapies and combination trials. EP Vantage’s report, PD-1/PD-L1 Combination Therapies, found that these companies and others have already launched combination trials of their immunotherapies in at least 10 cancer types, and new indications seem to be added frequently.
Steven King, chief executive of Peregrine Pharmaceuticals (NASDAQ:PPHM), sees the potential for this initiative to offer an opportunity for smaller companies to run more combination trials. While Peregrine is planning a trial in combination of its immuno-oncology agent bavituximab with AstraZeneca’s durvalumab and is collaborating with the National Comprehensive Cancer Network for other combination trials, this coalition might serve to stimulate an expansion of clinical work.
“It’s often access to drugs. If you want to run a combination with Keytruda or Opdivo, you’re going to have to buy the drug,” he told EP Vantage in an interview on the sidelines of the JP Morgan meeting. “It becomes a cost issue. You’re not going to be able to run as many studies.”
Where the rubber meets the road
Merck & Co’s (NYSE:MRK) Keytruda and Bristol’s (NYSE:BMY) Opdivo already accounted for around 96 separate combination trials, as of last September, covering such burdensome diseases as breast and lung cancer. AstraZeneca’s (NYSE:AZN) durvalumab and Roche’s (OTCQX:RHHBY) atezolizumab added another 46.
Where the Moonshot initiative is innovative is in what it calls the quantitative integrative lifelong trial (QUILT) approach, in which academic centres, oncologists, government agencies like the NIH and pharma groups will co-ordinate trials in patients who have undergone genome, transcriptome and quantitative proteomic analysis.
While the strength in this approach will no doubt deliver some of the most robust analysis of immunotherapy combinations, the weakness is that these consortia studies often take more time to deliver their data than commercial counterparts.
In the pursuit of a cure for cancers, having more allies, particularly in the payer community and at the highest levels in government, cannot be said to be a bad thing. However, while Dr Soon-Shiong has been busy talking and organising, Merck, Bristol and others have been doing the heavy lifting.
As an elaborate public relations event for Dr Soon-Shiong’s companies this might have been a success. But the sector was already well on its way.
EP Vantage's report on the landscape for anti-PD-1/PD-L1 combination therapeutics is available for free by download.