The test identifies patients with platinum-resistant ovarian cancer eligible for immunotherapy.
Labcorp announced the nationwide availability of Agilent Technologies’ PD-L1 IHC 22C3 pharmDx, a companion diagnostic approved by the US Food and Drug Administration (FDA) to identify patients with platinum-resistant ovarian cancer who may be eligible for pembrolizumab (Keytruda).
Keytruda and Keytruda Qlex are the first FDA-approved PD-1 inhibitors available as part of a treatment regimen for eligible patients with platinum-resistant ovarian cancer, according to a company release.
Approximately 80% of individuals with ovarian cancer experience recurrence after initial therapy. Many of these patients develop resistance to platinum-based chemotherapy, which leads to limited treatment options and poor survival outcomes. The availability of the PD-L1 IHC 22C3 pharmDx enables clinicians to identify patients who may benefit from these treatments, which have been found to reduce the risk of disease progression and improve overall survival.
“Platinum-resistant ovarian cancer is incurable, and current treatment options offer limited and short-lived benefits for patients—making it one of the most challenging forms of the disease to treat,” says Marcia Eisenberg, PhD, chief scientific officer at Labcorp, in a release. “By making this companion diagnostic available nationwide, Labcorp is helping clinicians rapidly identify eligible patients and connecting them with a therapy that offers new hope.”
Supporting Early Access
Following the FDA approval of the therapies and the companion diagnostic in February, Labcorp participated in Agilent Technologies’ Early Validation Program to support rapid testing availability. This program included standardized training and readiness activities, allowing the company to expand nationwide access.
The FDA approved the test to detect PD-L1 expression in epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. It serves as an aid in identifying patients for treatment with Merck’s anti-PD-1 therapy.
The Phase 3 KEYNOTE-B96 trial demonstrated that Keytruda plus paclitaxel, with or without bevacizumab, showed a statistically significant improvement in progression-free survival and overall survival for patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1, according to the release.
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