European Union Green Lights PD-L1 Companion Diagnostic for Adjuvant Atezolizumab in NSCLC
CE label expansion was granted to the Ventana PD-L1 (SP263) assay for use as a companion diagnostic to identify patients with non–small cell lung cancer (NSCLC) who are eligible for treatment with adjuvant atezolizumab (Tecentriq).1
“With early detection of lung cancer, it is possible to give patients more treatment options and potentially improve a patient's outcome,” Jill German, head of Pathology Lab at Roche Diagnostics, said in a press release. “We are proud to offer a PD-L1 test that may qualify lung cancer patients for [atezolizumab] therapy. With this latest expansion, clinicians can consider multiple targeted immunotherapy options with one test to quickly determine the right treatment for each patient.”
On June 14, 2022, the European Commission approved atezolizumab for use as adjuvant therapy following complete resection and platinum-based chemotherapy in adult patients with NSCLC at high risk of recurrence whose tumors do not have EGFR mutations or ALK alterations but have a PD-L1 expression of 50% or higher.2
The approval was based on findings from an interim analysis of the phase 3 IMpower010 trial (NCT02486718), in which adjuvant atezolizumab led to a 57% reduction in the risk of disease recurrence or death vs best supportive care (BSC) in patients with stage II to IIIA NSCLC with PD-L1 expression of 50% or higher (n = 229; unstratified HR, 0.43; 95% CI, 0.26-0.71).
The global, multicenter, open-label, phase 3 trial enrolled patients with completely resected, stage IB to IIIA NSCLC. Eligible patients had undergone lobectomy or pneumonectomy, had an ECOG performance status of 0 to 1, and had tumor tissue available for PD-L1 analysis.
A total of 1280 patients received 1 to 4 cycles of cisplatin plus pemetrexed, gemcitabine, docetaxel, or vinorelbine. Subsequently, 1005 of these patients were randomly assigned 1:1 to receive 1200 mg of atezolizumab every 21 days for 16 cycles or BSC.
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