CHMP Adopts Positive Opinion for Roche’s Tecentriq in Combination with Chemotherapy as First-Line Treatment for Metastatic Non-Squamous NSCLC

Jul 30, 2019 15:33 CST Updated 15:33

Roche

Oncology Drug Research, Development, and Manufacturing

European Medicines Agency

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

Compiled by: Violet

Roche recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of its blockbuster immunotherapy Tecentriq in combination with carboplatin and Abraxane (albumin-bound paclitaxel, i.e., nab-paclitaxel) chemotherapy for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) without EGFR or ALK positive mutations.

This recommendation is based on the phase III IMpower130 study, a multicenter, open-label, randomized trial that enrolled 723 patients who were assigned to receive either Tecentriq in combination with carboplatin and nab-paclitaxel or carboplatin and nab-paclitaxel alone, to evaluate the efficacy and safety of Tecentriq plus carboplatin and nab-paclitaxel versus chemotherapy alone in patients with stage IV non-squamous NSCLC.

Research results indicate:

The median overall survival was 18.6 months in the Tecentriq treatment group, compared with 13.9 months for chemotherapy alone. The treatment group also demonstrated a significant reduction in the risk of disease progression or death, with a progression-free survival (PFS) of 7 months versus 5.5 months for chemotherapy alone.

Tecentriq in combination with chemotherapy prolonged patient survival, with a median overall survival of 18.6 vs. 13.9 months (HR=0.79; 95% CI: 0.64-0.98; p=0.033).

Tecentriq in combination with chemotherapy significantly reduced the risk of disease progression or death by 36%, with a median PFS of 7 months vs. 5.5 months (HR=0.64; 95% CI: 0.54-0.77; p<0.0001).

Tecentriq in combination with chemotherapy reduced tumor size, with an overall response rate (ORR) of 49.2% (95% CI: 44.49–53.96), compared to an ORR of 31.9% (95% CI: 25.84–38.36) for chemotherapy alone.

The median duration of response was 8.4 months (95% CI: 6.9–11.8) in the treatment group, compared with 6.1 months (95% CI: 5.5–7.9) in patients receiving chemotherapy alone.

To date, Tecentriq has been approved in more than 50 countries, including the European Union and the United States, for patients with previously treated metastatic non-small cell lung cancer (NSCLC), as well as for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-based chemotherapy or have experienced disease progression.

Based on the CHMP's positive opinion, the European Commission is expected to make a final decision on this Tecentriq-based combination regimen in the near future.

Reference Source:

1.Roche's Tecentriq combo recommended in Europe for non-small cell lung cancer

2.TECENTRIQ^® (atezolizumab)

3.Roche receives CHMP positive opinion for new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer

*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.