April 2020—IMpassion130 was the first phase three trial to demonstrate a clinical benefit of cancer immunotherapy in patients with PD-L1-positive metastatic triple-negative breast cancer, and based on the data, atezolizumab plus nab-paclitaxel is approved for this indication. In the trial, the Ventana SP142 PD-L1 assay with a one percent or greater cutoff was used to evaluate PD-L1 expression in immune cells. But questions remained about how to best identify patients who could benefit from the drug combination, Hope S. Rugo, MD, professor of medicine and director of breast oncology and clinical trials education at the University of California San Francisco Comprehensive Cancer Center, said in a CAP TODAY webinar last November.
Read More »Path to importance of PD-L1 status in breast cancer
June 2019—New data support testing patients for their PD-L1 immune cell status when they are diagnosed with metastatic or unresectable locally advanced triple-negative breast cancer to determine if they might benefit from a checkpoint inhibitor.
Read More »Scoring gastric, GEJ cancers for PD-L1 expression
February 2018—To some ears, perhaps, the scientific method connotes a process that is standardized and unimaginative. But inventions like Velcro, vulcanization, and the microwave—all stemming from accidental discoveries—testify to the role of luck and leaps of intuition in formulating and modifying a hypothesis.
Read More »Recent approvals and the pipeline
December 2016—Pembrolizumab (Keytruda) is now FDA approved as monotherapy for patients with untreated metastatic NSCLC, both squamous and nonsquamous histologies, that express PD-L1 at a high level of 50 percent or more, says Dr. Roger Dansey, who headed up Keytruda development at Merck Research Laboratories. “We do not have data at this point that would say whether a cutpoint lower than 50 percent in the first-line setting would be of equal value in terms of response to Keytruda,” he says.
Read More »Big hopes, bigger questions with PD-L1
November 2016—Progress is a complicated minuet. One popular adage talks of “one step forward, two steps back,” which is not only discouraging but, in an even less-gleaming light, happens to be the title of one of Vladimir Lenin’s books, published in 1904. A more optimistic version (and one less centered on the crisis facing communists in turn-of-the-century Russia) suggests advances occur with two steps forward, mitigated by only one step back.
Read More »Making the best of PD-L1 IHC testing
July 2016—When Keith Kerr, MB ChB, describes the ideal biomarker, he isn’t hesitant about what pathologists and clinicians need. “Ideally, the biomarker would always be correct. It would be easy and practical to measure. It would either be present or absent, with no gray zone or doubt.
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