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Non-Small-Cell Lung Cancer (NSCLC)
Formalin-fixed, paraffin-embedded tissue block or slides
One formalin-fixed, paraffin-embedded (FFPE) tissue block or four unstained positively charged slides sectioned from FFPE tissue block at 4 to 5 microns and be less than 2 months after sectioning if stored at 15-30°C.
Recommended handling and processing conditions are: Recommended fixative is 10% neutral buffered formalin for a fixative time of at least 6 hours. Fixative times less than 6 hours results in a significant loss of staining intensity. Other fixatives are not recommended.
Pertinent clinical diagnosis, including a pathology report, should be included with the specimen.
Causes for Rejection
Insufficient tissue; inappropriate tissue source; incorrect specimen type; tumor other than urothelial/bladder cancer
Urothelial Carcinoma (Bladder Cancer)
An ongoing Phase II clinical trial (IMvigor 210 trial) has shown that patients' tumor PD-L1 IHC expression levels correlated with overall response rates with the therapy TECENTRIQ® (atezolizumab) and that the response was durable. The FDA approved the VENTANA anti-PD-L1 (SP142) IHC assay as a complementary diagnostic assay that may help identify patients with locally advanced or metastatic urothelial carcinoma more likely to respond to treatment with Tecentriq.
Non-Small Cell Lung Cancer (NSCLC)
TECENTRIQ is FDA-approved for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. The VENTANA anti-PD-L1 (SP142) is a complementary diagnostic test to detect PD-L1 protein expression levels, and although not required, is a tool that helps physicians determine which patients may benefit most from treatment.
atezolizumab, Programmed Death Ligand 1
- Hoffman-Censits, JH et al., IMvigor 210, a phase II trial of atezolizumab (MPDL3280A) in platinumtreated locally advanced or metastatic urothelial carcinoma (mUC). J Clin Oncol 34, 2016 (suppl2S; abstr 355).
- Genitourinary Cancers Symposium Daily News. IMvigor 210: Atezolizumab Offers Potential of Durable mUC Suppression After Failure of Platinum-Based Treatment. Website http://gucasym.org/daily-news/imvigor-210-atezolizumab-offers-potential-durable-muc-suppression-after-failure-platinum . Accessed 4/11/2016.
- Roche Press Release. October 27, 2016. Accessed on Roche website on 5/3/17.
- 7. VENTANA PD-L1 (SP142) assay package insert. 1015005EN Rev A.