Predicting If an Immune Checkpoint Drug Will Work

Drugs that activate the immune system to attack cancer in a process known as immune checkpoint blockade (ICB) are a focus of intense investigation. A number of them are already approved by the U.S. Food and Drug Administration (FDA) for various cancers; namely, the anti-CTLA4 antibody ipilimumab (Yervoy), two anti-PD-1 antibodies: pembrolizumab (Keytruda) and nivolumab (Opdivo), and three anti-PD-L1 drugs: atezolizumab (Tecentriq), avelumab (Bavencio) and durvalumab (Imfinzi). These ICB drugs have the potential to induce durable cancer regressions, but the majority of cancer patients just do not respond to them at all.

Biomarkers, signature molecules in the blood or other tissue, can sometimes be used to predict a patient’s response to a given treatment. But no reliable biomarkers exist for ICB, and this is a serious concern. Patients who may really benefit from ICB could be overlooked, and patients who are not likely to respond may receive useless (and very expensive) ICB treatment.

Most potential response predictors that have already been identified are not yet useful for one or all of the following reasons: they are not extensively validated, their significance is still uncertain and may differ from one cancer (or even one patient) to another, or they are technically challenging for routine use. These markers are addressed below. Continue reading…

Avelumab Does Not Improve OS Over Docetaxel in NSCLC, Phase III Trial Shows


“The primary endpoint of improving overall survival (OS) was not met in the phase III JAVELIN Lung 200 Trial of avelumab (Bavencio) in patients with non–small cell lung cancer (NSCLC), according to Merck KGaA and Pfizer, the co-developers of avelumab.

“According to results of the study, the PD-L1 inhibitor did not improve OS for patients with PD-L1-positive (≥1%) unresectable, recurrent or metastatic NSCLC compared with docetaxel in patients who had progressed on platinum-containing doublet chemotherapy (hazard ratio [HR], 0.90; 96% CI, 0.72-1.12; one-sided P = .1627).”

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