Roche’s Tecentriq Achieves Success in Phase III Trial as First-Line Monotherapy for PD-L1-High NSCLC

September 13, 2019/BioValleyBIOON/--Swiss pharmaceutical giant Roche recently announced PD-L1TumorPositive Data from the Phase III IMpower110 Clinical Study of Tecentriq (atezolizumab) Immunotherapy in Lung Cancer

IMpower110 is a randomized, open-label Phase III study in programmed death-ligand 1 (PD-L1)BiomarkersThe study was conducted in selected patients with advanced non-squamous or squamous non-small cell lung cancer (NSCLC) who were chemotherapy-naïve (previously untreated with chemotherapy) and lacked ALK or EGFR mutations (wild-type, WT). It aimed to evaluate the efficacy and safety of Tecentriq as monotherapy for first-line (initial) treatment, compared with chemotherapy. A total of 572 patients (555 WT) were enrolled and randomized in a 1:1 ratio to receive either: (1) Tecentriq monotherapy until loss of clinical benefit (as assessed by the study investigator); or (2) cisplatin or carboplatin (at the investigator’s discretion) combined with pemetrexed (for non-squamous histology) or gemcitabine (for squamous histology), followed by pemetrexed monotherapy (for non-squamous histology) or best supportive care (for squamous histology) until disease progression, unacceptable toxicity, or death. The primary efficacy endpoint was overall survival (OS) in PD-L1 subgroups (TC3/IC3-WT; TC2/3/IC2/3-WT; TC1,2,3/IC1,2,3-WT), determined using the SP142 assay. Key secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR), all assessed by the study investigator.

The results showed that the study had already reached its primary endpoint at the interim analysis: compared with chemotherapy, Tecentriq monotherapy as first-line treatment achieved a statistically significant improvement in OS in patients with high PD-L1 expression (TC3/IC3-WT). In the study, the safety profile of Tecentriq was consistent with its known safety characteristics, and no new safety signals were identified. The study will continue to conduct final analyses in patients with low PD-L1 expression.

Roche is now set to include the United States,FDASubmit these data to global regulatory authorities, including the European Medicines Agency (EMA), and discuss how best to bring this option to patients as soon as possible. Detailed study data will be presented at the upcoming medicalMeetingPublished above.

Sandra Horning, Chief Medical Officer and Global Head of Product Development at Roche, stated, “In this study, Tecentriq monotherapy demonstrated a significant survival benefit compared with chemotherapy in patients with PD-L1-high squamous or non-squamous NSCLC, which is highly encouraging. These findings reinforce the potential for Tecentriq to play an important role in the treatment of various types of lung cancer, and we look forward to discussing these data with regulatory authorities.”

Lung cancer is the leading cause of cancer-related deaths worldwide. Each year, 1.76 million people die from this disease, meaning that more than 4,800 people die every day across the globe. 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. NSCLC includes non-squamous cell lung cancer and squamous cell lung cancer; squamous cell carcinoma is characterized by flat cells covering the airway surface when viewed under a microscope.

Tecentriq is a PD-(L)1 cancer immunotherapy that targets and binds to tumor cells andTumorTecentriq blocks the interaction of PD-L1, a protein expressed on infiltrating immune cells, with its receptors PD-1 and B7.1. By inhibiting PD-L1, Tecentriq can activate T cells. Tecentriq has the potential to serve as a foundational combination therapy in cancer immunotherapy, targeted drug regimens, and various chemotherapy protocols for cancer. To date, Tecentriq has been approved in the United States, the European Union, and other countries worldwide, as monotherapy and in combination with targeted therapies and/or chemotherapy, for the treatment of multiple 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 triple-negativeBreast Cancer（TNBC）。

In the field of lung cancer, Roche is conducting nine Phase III studies to evaluate the efficacy of Tecentriq as monotherapy or in combination with other drugs for the treatment of various types of lung cancer. The company has established an extensive development program for Tecentriq, including multiple ongoing and planned Phase III trials across lung cancer, genitourinary cancers, skin cancer, breast cancer, gastrointestinal cancers, gynecologic cancers, and head and neck cancers. This includes studies of Tecentriq both as monotherapy and in combination with other agents. (Bioon.com)

Original Source:Roche’s Tecentriq as a first-line monotherapy helped certain people with advanced non-small cell lung cancer live longer compared with chemotherapy