Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to a PD-1 inhibitor for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC), and also granted Priority Review to a HER2-directed antibody-drug conjugate for patients with HER2-positive metastatic gastric cancer.
Priority Review for Cemiplimab-rwlc in Patients With Advanced NSCLC and ≥ 50% PD-L1 Expression
The FDA accepted for Priority Review a supplemental biologics license application for PD-1 inhibitor cemiplimab-rwlc to treat patients with first-line locally advanced or metastatic NSCLC with ≥ 50% PD-L1 expression. The target action date for the FDA decision is February 28, 2021.
Cemiplimab-rwlc is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells. By binding to PD-1, cemiplimab-rwlc has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.
The application is supported by results from a phase III open-label, randomized, multicenter trial that investigated the first-line treatment of cemiplimab-rwlc monotherapy compared to platinum doublet chemotherapy in patients with locally advanced or metastatic NSCLC whose tumor cells expressed PD-L1, including those whose cancers had confirmed PD-L1 expression of ≥ 50% using the PD-L1 IHC 22C3 pharmDx kit. Results were recently presented during the European Society for Medical Oncology Virtual Congress 2020 (Abstract LBA52).
The European Medicines Agency is also assessing cemiplimab-rwlc in patients with advanced NSCLC and ≥ 50% PD-L1 expression; a decision is expected in the second quarter of 2021.
Priority Review for Fam-trastuzumab Deruxtecan-nxki in HER2-Positive Metastatic Gastric Cancer
The FDA accepted a supplemental biologics license application and granted Priority Review to fam-trastuzumab deruxtecan-nxki for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. A target action date has been set for the first quarter of 2021.
Fam-trastuzumab deruxtecan-nxki is a HER2-directed antibody-drug conjugate. It comprises a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload by a tetrapeptide-based linker.
The application is based on results from the randomized phase II DESTINY-Gastric01 trial, which demonstrated a statistically significant and clinically meaningful improvement in objective response rate (the primary endpoint) and overall survival (a key secondary endpoint) for patients treated with fam-trastuzumab deruxtecan-nxki vs chemotherapy (paclitaxel or irinotecan monotherapy). The results from the trial were presented during the ASCO20 Virtual Scientific Program (Abstract 4513) and simultaneously published by Shitara et al in The New England Journal of Medicine.
Approval for cobas EGFR Mutation Test v2
On October 29, the FDA approved expanded claims for the cobas EGFR Mutation Test v2 as a companion diagnostic for a broader group of therapies in the treatment of NSCLC. This claim expansion allows the test to be used as a companion diagnostic for all five currently FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor therapies targeting EGFR L858R mutations and exon 19 deletions in accordance with the approved therapeutic product labeling. The group claim will also enable the test to be used as a companion diagnostic for any future approved EGFR tyrosine kinase inhibitors targeting the same mutations, without the need to conduct individual clinical studies with the test for each new therapy.
The cobas EGFR Mutation Test v2 is a real-time polymerase chain reaction test for the qualitative detection of defined mutations of the EGFR gene in patients with NSCLC. Defined EGFR mutations are detected using DNA isolated from either formalin-fixed paraffin-embedded tumor tissue, or circulating tumor DNA from plasma derived from ethylenediamine tetraacetic acid anticoagulated peripheral whole blood.
