World’s Top Ten Cancer Drugs by 2020 (million USD)
Reporter: Aviva Lev-Ari, PhD, RN
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Opdivo Setback May Yield Lessons for Pharma – Advancing Immunotherapies With PD-L1 Testing
Sep 12, 2016 | Turna Ray
The anti-PD-1/PD-L1 drug market is estimated to be worth around $30 billion by 2020. The negative Phase III results for Opdivo in first-line NSCLC shocked market analysts, and pharmaceutical companies developing drugs in this space “are taking stock of the situation” and surely assessing whether they have the right test methods in place in their drug studies, said Peter Keeling, CEO of consulting firm Diaceutics.
Most drugmakers developing anti-PD-1/PD-L1 drugs are evaluating whether their therapies work especially well in patients whose tumor cells express PD-L1, a protein that cancer cells use to hide from an immune system attack. But studies have demonstrated that PD-L1 expression status doesn’t neatly bucket responders and non-responders in the same way that testing for EGFR mutations or ALK rearrangements can, making it difficult for pharmaceutical companies to integrate PD-L1 testing for patient stratification in clinical trials.
In the absence of a universal diagnostic, Cancer Genetics is one lab that does offer all the FDA-approved companion and complementary PD-L1 tests, but also spends a lot of time educating doctors and pathologists on the differences between these tests and which to order for a particular immunotherapy. “There’s a big need for our pharma cousins to really push more knowledge about the associated diagnostics and tests and how to use them,” Sharma said. “That’s the only way they’re going to get uptake in the community setting.”
Despite the muddled messages around PD-L1 testing, healthcare providers and researchers nonetheless seem interested in PD-L1 testing as part of the tumor profiling workup for patients. Diaceutics’ surveys show a sharp uptick in the number of labs offering PD-L1 testing over the past year-and-a-half and 52 labs in the US offer at least one PD-L1 test. The company also reviewed biomarkers being studied in 95 Phase II/III NSCLC, and found that approximately half are incorporating patients’ PD-L1 status either alone or in combination with other markers, such as EGFR and ALK mutations.
At Cancer Genetics over the past year, there has also been a notable ramp up in orders for PD-L1 testing for lung cancer patients, but also for melanoma and head and neck cancer patients. “One our biggest volume increased tests this year has been PD-L1 testing,” Sharma said. “We think there is a lot of opportunity for significant additional growth.”