I haven't yet caught up with the most current literature, but it looks as if last week Ventana received FDA approval for their PDL-1 IHC. Anyone using it or planning on using it? If so, in what way (which specimens)? Auto-reflex or by clinician request only?
PDL-1?
- Thread starter musom
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Dako has an FDA approved kit for PDL-1 as well.
So far pembrolizumab and nivolumab have only been FDA approved for melanoma (both), NSCLC (both), and RCC (nivolumab). Only using pembro for NSCLC requires the companion PDL-1 IHC diagnostic. While subgroup analyses have shown that nivo works better in NSCLC patients who overexpress PDL-1 (as one would expect), it's not required to prove overexpression of PDL-1 to administer Nivo at this point in time.
We have an onc that works with our group who is on the paid Merck lecture circuit and so prefers pembro. I don't send anything reflex (except breast markers), so when I get requests from him for his lung NSCLC patients and all the patients he's trying to get compassionate use exceptions for (breast, urothelial, etc.), I send the tissue off to LabCorp for the PDL-1 stain and interpret it myself (it's not worth our while to bring on the IHC at this point in time).
So far pembrolizumab and nivolumab have only been FDA approved for melanoma (both), NSCLC (both), and RCC (nivolumab). Only using pembro for NSCLC requires the companion PDL-1 IHC diagnostic. While subgroup analyses have shown that nivo works better in NSCLC patients who overexpress PDL-1 (as one would expect), it's not required to prove overexpression of PDL-1 to administer Nivo at this point in time.
We have an onc that works with our group who is on the paid Merck lecture circuit and so prefers pembro. I don't send anything reflex (except breast markers), so when I get requests from him for his lung NSCLC patients and all the patients he's trying to get compassionate use exceptions for (breast, urothelial, etc.), I send the tissue off to LabCorp for the PDL-1 stain and interpret it myself (it's not worth our while to bring on the IHC at this point in time).
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We don't reflex; if it's late stage / stage 4 we may inquire if they want the test, or the onc will request it (the therapies are for end stage/metastatic settings only currently, so reflex would overutilize).
And because we don't reflex, we don't have it in house...volume doesn't justify it.
We do reflex the ALK and EGFR though, so unless otherwise told we just put a comment that ROS and/or PD-L1 can be tested for upon request in the appropriate clinical setting.
And because we don't reflex, we don't have it in house...volume doesn't justify it.
We do reflex the ALK and EGFR though, so unless otherwise told we just put a comment that ROS and/or PD-L1 can be tested for upon request in the appropriate clinical setting.
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You could, but utilization management is the mantra of the day. Atezo was just approved last week as the first PD pathway chemo for urothelial carcinoma, but like nivo and pembro for NSCLC indications, atezo is only approved for locally advanced or metastatic disease that has failed first-line (in the case of TCC--platinum) agents. Also, while subgroup analysis demonstrated that atezo showed better response in PDL-1 overexpressers, like nivo, the language of the FDA approval does not require that PDL-1 overexpression be proven to administer the drug--it only recommends the companion diagnostic to identify individuals who will have the highest chance of responding.
If you have the volume and your bean-counters want to restrict those eligible for PD-1/PDL-1 therapy to those who are likely to respond, then I can see that it might be worthwhile to bring on the kit and go through the validation and inspection headaches (which will be just as bad as HER2 IMO). But as for reflexive testing... I get into this fight with a particular oncologist at every tumor board who wants everything ordered reflexively so that he doesn't have to think about it until I remind the bean-counters that most of the new agents are second-line and lower which means that if the patient croaks during the initial course of chemotherapy or decides after a chemotherapy course that he's done evading the reaper that the money for all the reflexive tests is wasted. And for good measure I remind the bean-counters that "lean" design principles adhere to a "just in time" philosophy and that the tissue isn't going anywhere and can be sent for the testing when the patient is ready to move to the next line of therapy. Then I get my way.
I can see that the Ventana reps are busy. As an individual who holds a position in RHHBY, I am pleased.