Roche’s VENTANA PD-L1 (SP263) Assay Receives FDA Approval as Companion Diagnostic for Tecentriq in NSCLC

October 22, 2021 /BioonBIOON/ -- Roche recently announced that the U.S. Food and Drug Administration (FDA) ApprovedVENTANA PD-L1 (SP263) Assay, as a companion diagnostic for the anti-PD-L1 therapy Tecentriq (generic name: atezolizumab) in the treatment of non-small cell lung cancer (NSCLC)DiagnosisTesting.This assay, by analyzing the ... within the tumor microenvironment,# Tumorand stain and score immune cells to assess the PD-L1 expression levels in patients, providing clinicians with information to guide treatment decisions and improve the quality of life and survival for NSCLC patients.

Lung cancer remains the leading cause of cancer-related deaths worldwide, with over 2.2 million cases diagnosed globally in 2020. Currently, the standard of care for patients with early-stage lung cancer is surgical resection.Tumor, followed by chemotherapy. Unfortunately, approximately half of these patients will experience recurrence after surgery.

Tecentriq received U.S. approval on October 15, 2021FDAApproved for:TumorFor adult patients with stage II–IIIA non-small cell lung cancer (NSCLC) with PD-L1 expression ≥1%, as adjuvant therapy following surgery and platinum-based chemotherapy. This approval is based on results from the Phase 3 IMpower010 study, which demonstrated that in patients with PD-L1-positive stage II–IIIA NSCLC, adjuvant treatment with Tecentriq improved disease-free survival (DFS) by more than one-third compared with best supportive care (BSC).

As an adjuvantDiagnosisTool,VENTANA PD-L1 (SP263) Assay is used for the detection of PD-L1 in non-small cell lung cancer (NSCLC)TumorExpression of tumor cells and immune cells, assisting clinicians in evaluating the patient's PD-L1 status.. It is reported that this test is applicable to Roche.DiagnosisBenchMark ULTRA Fully Automated Immunohistochemistry Staining Platform.

Based on the results of the Phase III IMpower010 study,The VENTANA PD-L1 (SP263) Assay can help identify which NSCLC patients may benefit from Tecentriq immunotherapy.

Thomas Schinecker, CEO of Roche Diagnostics, stated: “Early detection of lung cancer can alter patients' treatment pathways, providing them with more treatment options. We are proud to offer a companion diagnostic PD-L1 test to identify lung cancer patients who may be eligible for Tecentriq therapy. WithFDAFor the said concomitantDiagnosisWith the approval of the diagnostic test, clinicians now have an effective tool to deliver better patient care through targeted immunotherapy.”

The purpose of adjuvant therapy is to reduce the risk of recurrence and provide the best chance of cure. Nevertheless, approximately half of patients with early-stage (Stage I–II) or locally advanced (Stage III) NSCLC ultimately experience disease recurrence following curative-intent treatment. Adjuvant platinum-based chemotherapy is currently the standard of care for patients with early-stage NSCLC (Stage IB–IIIA) at high risk of disease recurrence following complete resection. Compared with observation, adjuvant platinum-based chemotherapy modestly improves the 5-year survival rate by 4–5%. Therefore, there remains a significant unmet medical need for new adjuvant treatment options in this field.

It is worth noting that Tecentriq is the first and only cancer immunotherapy approved for the adjuvant treatment of NSCLC, ushering in a new era: patients diagnosed with early-stage lung cancer will have the opportunity to receive cancer immunotherapy to improve their chances of a cure. This landmark approval provides physicians and patients with a new treatment option for early-stage lung cancer that has the potential to significantly reduce the risk of cancer recurrence, following more than a decade of limited treatment advances in early-stage lung cancer.

Lung cancer is the leading cause of cancer death worldwide. Each year, 1.8 million people die from the disease; this means that more than 4,900 deaths occur globally every day. Lung cancer can be broadly classified into two main categories: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC is the most common type, accounting for approximately 85% of all cases. Approximately 50% of NSCLC cases areDiagnosisFor early-stage (Stage I–II) or locally advanced (Stage III) disease. Currently, approximately 50% of patients with early-stage lung cancer still experience cancer recurrence after surgery. Early treatment before lung cancer spreads may help prevent disease recurrence and provide patients with the best chance of cure.

Previously,Tecentriq has demonstrated clinically meaningful benefits across various types of lung cancer and currently has six approved indications for lung cancer treatment in the United States.In addition to being the first cancer immunotherapy for the adjuvant treatment of NSCLC, Tecentriq is also the first cancer immunotherapy approved for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (in combination with chemotherapy [carboplatin + etoposide]). Tecentriq has been approved for four treatment indications in advanced NSCLC: as monotherapy, or in combination with targeted therapy and/or chemotherapy. Tecentriq offers three dosing regimens, allowing flexible dosing every 2, 3, or 4 weeks.

Tecentriq is a PD-(L)1 tumor immunotherapy that targets and binds to tumor cells andTumorBinds to a protein called PD-L1 expressed on infiltrating immune cells, blocking its interaction with PD-1 and B7.1 receptors. By blocking PD-L1, Tecentriq can activate T cells. The drug has the potential to serve as a backbone combination therapy for cancer immunotherapies, targeted agents, and various cancer chemotherapy regimens.

To date, Tecentriq has been approved in the United States, the European Union, and other countries worldwide as a monotherapy, and in combination with targeted therapy and/or chemotherapy, for the treatment of various types of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), certain types of metastatic urothelial carcinoma (mUC), and PD-L1-positive metastatic triple-negativeBreast Cancer(mTNBC), hepatocellular carcinoma (HCC). In the United States, Tecentriq is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of advanced BRAF V600 mutation-positiveMelanoma。

Roche has established a comprehensive development program for Tecentriq, including multiple ongoing and planned Phase III studies involving various types of lung cancer, genitourinary cancers, skin cancer, breast cancer, gastrointestinal cancers, gynecological cancers, and head and neck cancers. This includes studies evaluating Tecentriq as monotherapy or in combination with other therapeutic agents. (Bioon.com)

Original Source:Roche’s VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab)