December 2015 Edition Vol.11, Issue 12

The Evolving Role of PD-L1 Testing in Immunotherapy of Metastatic Melanoma and Non-Small Cell Lung Cancer

Where Do We Go From Here? 

As noted in Figure 1, historical data for more established biomarkers (e.g., EGFR mutations and ALK in mNSCLC and BRAF mutations for mM) may well lead us to expect that over time oncologists will test for PD-L1 expression in a growing proportion of their mNSCLC and mM patients. Factors that should contribute to an increase in PD-L1 testing will include the availability of companion diagnostics and in the case of mNSCLC, the requirement in Keytruda’s label limiting its use to patients who are PD-L1 positive.

The growing acceptance of precision medicine and the increasing prevalence of testing across a range of biomarkers will also likely spill over into PD-L1. Yet, how PD-L1 testing will influence the oncologist’s treatment choice is a question that remains to be answered. Some observers believe that the clarity introduced by the requirement for PD-L1 testing will actually prove to be an advantage and will ultimately lead to greater usage of Keytruda.

In a similar vein, numerous clinical trials with PD-L1 inhibitors in development (such as Genentech’s atezolizumab) are incorporating PD-L1 testing into their protocols and one might anticipate that as new agents come to market, they will likewise carry a testing requirement in their respective labels. Conversely, the absence of a requirement for PD-L1 testing in the Opdivo label may prove to be a benefit for this brand, as it can be marketed to a broader patient population.

Many oncologists may indeed be inclined to use PD-1 inhibitors more widely, in light of the lack of a consensus on testing, a perceived favorable benefit-to-risk ratio for these agents, and a high level of need for new treatment options in mNSCLC and mM. Only time will tell which of these treatment strategies is likely to prevail. The role of PD-L1 testing in oncology treatment is still evolving. It will be fascinating to watch the immuno-oncology market dynamics continue to unfold moving forward.



  1. BrandImpact data (AlphaImpactRx)
  2. Ibid; Barclays reports
  3. Ibid
  4. 2015 AACR General Meeting, Abstract CT104
  5. Ibid; NEJM, 373(2): 123-135 (2015); Bristol-Myers Squibb
  6. 2015 ASCO General Meeting, Abstract 9005
  7. Clinical Advances in Hematology & Oncology, 13(10): 676-683 (2015); Keytruda prescribing information
  8. BrandImpactDx (AlphaImpactRx)
  9., September 2 (2014); BrandImpactDx (AlphaImpactRx)
  10. Keytruda prescribing information


About the Contributor

Bill Bowman is Senior Manager, Product Management, at AlphaImpactRx.

AlphaImpactRx is the leading provider of primary research-based insights, analytics and solutions to biopharmaceutical, consumer health and medical device companies.  Through the combination of its consulting expertise, innovative technology, proprietary physician panels and syndicated data assets, AlphaImpactRx provides market research to help its global healthcare clients make informed and timely business decisions to develop and market their products.

BrandImpact® is fueled by data captured through a mobile, longitudinal research model and AlphaImpactRx’s proprietary research app across a range of key therapeutic areas.  BrandImpact’s longitudinal panels of high-value physicians collect detailed information at the point of engagement for both patient and sales visits.  BrandImpact captures physician treatment decisions at the point-of-care and at a chart audit-level of granularity, including patient and disease-specific characteristics such as biomarkers.  BrandImpact’s Oncology panel has 450 oncologists and hematologists and was built to align with clients’ target lists. 

AlphaImpactRx also has a Promotional Response Practice that leverages our longitudinal and normative data assets with advanced analytics, to empower clients in improving brand performance by making more informed and effective decisions with respect to marketing strategy, message execution and field force deployment.  BrandImpactDx® is fueled by a proprietary survey fielded monthly that reaches approximately 1,200 oncologists and 600 pathologists per year.  BrandImpactDx provides in-depth information on the role of molecular diagnostics in the management of cancer and covers testing rates, methodologies used and interpretation of test results.  Linking BrandImpactDx with BrandImpact provides unprecedented insights into precision medicine and the impact of biomarker testing on treatment choice among oncologists.

For more information, please visit, or contact Stacy Mecham at or Bill Bowman at

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