Agilent companion diagnostics for cancer immunotherapy

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1 Agilent companion diagnostics for cancer immunotherapy Annika Eklund, PhD Global Product Manager Companion Diagnostics Agilent Technologies Aalborg 1

2 Agilent Trusted Answers. Together OUR FOCUS life sciences, diagnostics and applied chemical markets OUR CUSTOMERS analytical and diagnostics laboratories around the world OUR PASSION helping customers solve real-world problems We provide complete workflow solutions custom packages of equipment, software, services, informatics, consumables, and most of all, knowledgeable people who partner with customers to achieve their goals. 2

3 New treatment options provide hope for cancer patients Surgery Radiation Cytotoxic and Targeted Therapies Immuno-oncology Cancer treatment Immuno-oncology therapies work directly with the body s immune system to fight cancer 3

4 Lung cancer treatment is changing January 31, 2017 European commission approved KEYTRUDA (pembrolizumab) for first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression with no EGFR or ALK positive tumor mutations The data demonstrate that KEYTRUDA provided meaningful improvements in survival versus the current standard of care in patients whose tumors express high levels of PD-L1 Dr. Luis Paz-Ares, Chair of the medical oncology department, Hospital Universitario Doce de Octubre, Madrid, Spain. 4

5 The PD-L1 assay landscape PD-L1 IHC 28-8 pharmdx OPDIVO, nivolumab PD-L1 IHC 22C3 pharmdx KEYTRUDA, pembrolizumab Ventana PD-L1 (SP142) Assay Ventana PD-L1 (SP263) Assay TECENTRIQ, atezolizumab IMFINZI, durvalumab Scoring and interpretation methods are different Expression levels and cutoffs are different IASLC ATLAS OF PD-L1, IMMUNOHISTOCHEMISTRY, TESTING IN LUNG CANCER, Lynette Other Anti PD-L1 Clones: Alternative Assays and Laboratory-Developed Tests. M. Sholl, Mari Mino-Kenudson, Reinhard Buettner, and Ignacio Wistuba 5

6 Analytical comparison of PD-L1 assays, NSCLC tumor cells Study Samples Assays Conclusion Rimm et al SP142 LDT E1L3N LDT 22C3 pharmdx 28-8 pharmdx Adam et al SP142 SP263 22C3 pharmdx 28-8 pharmdx Hirsch et al 2016, Blueprint project 3 39 SP142 SP263 22C3 pharmdx 28-8 pharmdx Appears to be minimal difference between E1L3N, 28-8 and 22C3 SP142 is an outlier 22C3, 28-8 and SP263 assays performed in several centers were highly concordant 22C3, 28-8 and SP263 were aligned with regard to PD-L1 expression on TCs, whereas SP142 consistently had fewer TCs expressing PD-L1 Ratcliffe et al SP263 22C3 pharmdx 28-8 pharmdx High analytical correlation 1. Rimm et al 2017 JAMA Oncol. doi: /jamaoncol Adam et al 2016, Multicentric French harmonization study for PD-L1 IHC testing in non-small cell lung cancer, WLCLC Hirsch et al 2016, PD-L1 Immunohistochemistry Assays for Lung Cancer: Results from Phase 1 of the Blueprint PD-L1 IHC Assay Comparison Project 4. Ratcliffe et al. A Comparative Study of PD-L1 Diagnostic Assays and the Classification of Patients as PD-L1 Positive and PD-L1 Negative, Poster at AACR

7 Analytical correlation is not evidence of clinical predictive power Rimm et al: As such, we can only evaluate this work in the context of assay comparisons and not clinical concordance. Hirsch et al: The only PD-L1 IHC testing approach for which the likely outcome for patients is known is for the test that was performed and validated in the respective clinical trials for each drug. Any deviation from that practice brings with it unknown consequences for the patient. Hirsch et al: By comparing assays and cutoffs, the study indicated that despite similar analytical performance of PD-L1 expression for three assays, interchanging assays and cutoffs would lead to misclassification of PD-L1 status for some patients. Ratcliffe et al: Currently, direct clinical efficacy data supporting a specific diagnostic test should still be considered as the highest standard of proof for diagnostic clinical utility. 1. Rimm et al 2017 JAMA Oncol. doi: /jamaoncol Hirsch et al 2016, PD-L1 Immunohistochemistry Assays for Lung Cancer: Results from Phase 1 of the Blueprint PD-L1 IHC Assay Comparison Project 3. Ratcliffe et al. A Comparative Study of PD-L1 Diagnostic Assays and the Classification of Patients as PD-L1 Positive and PD-L1 Negative, Poster at AACR

8 First NordiQC PD-L1 assessment Pooling results from the approved assays 22C3 pharmdx, 28-8 pharmdx and SP263 gave a pass rate of 80% (28 of 35) Pooling results from the laboratory developed assays gave a pass rate of 20% (6 of 30) 8

9 Multiple indications validated PD-L1 IHC 22C3 pharmdx PD-L1 IHC 28-8 pharmdx nsnsclc Melanoma NEW SCCHN NSCLC NEW Melanoma 9

10 Clinical Validation of PD-L1 IHC 22C3 pharmdx Treatment naïve NSCLC patients selected with PD-L1 IHC 22C3 pharmdx survive longer with KEYTRUDA treatment patients from 142 sites in 16 countries screened for enrollment submitted samples tested with PD-L1 IHC 22C3 pharmdx patients randomized to receive either KEYTRUDA or investigators choice of platinum based chemotherapy 1. Reck, M., et al "Pembrolizumab versus Chemotherapy for PD-L1 Positive Non Small-Cell Lung Cancer." New England Journal of Medicine 375(19):

11 Patient safety is highest priority When one test is essential for a treatment decision, that one result must be reliable. Using a test that lacks evidence of patient benefit may potentially lead to patient harm.

12 Agilent PD-L1 pharmdx is a complete workflow solution Interpretation guidelines Interactive interpretation training Reagents and instructions Clinically validated solution Instrument software Validated protocol Software Automated staining instrument 12

13 Standardized and evidence-based PD-L1 solutions Trusted Answers