Roche's Tecentriq Granted First and Only Approval in Canada for First-Line Extensive-Stage Small Cell Lung Cancer

Hoffmann-La Roche Limited (Roche Canada) announced on the 14th that Health Canada has approved Tecentriq® (atezolizumab, or T-drug), Roche’s PD-L1 monoclonal antibody, in combination with carboplatin and etoposide (chemotherapy) for first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Tecentriq is the first and only cancer immunotherapy approved in Canada for the first-line treatment of small cell lung cancer.

On December 5, 2018, the U.S. FDA accepted the supplemental Biologics License Application (sBLA) for Tecentriq (hereinafter referred to as "T-drug") in combination with carboplatin and etoposide (chemotherapy) as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC), and granted it Priority Review. On March 19, 2019, this treatment regimen was approved for first-line therapy in ES-SCLC, making T-drug the first new early-line treatment approved by the FDA for ES-SCLC patients in two decades, thereby ending the 20-year drought in new drug approvals for SCLC.

Lung cancer is the most common cancer in Canada, with an average of 78 Canadians diagnosed each day. It is also the leading cause of cancer-related deaths. Small cell lung cancer (SCLC) is the most aggressive form of lung cancer, characterized by rapid tumor growth and early metastasis. It accounts for approximately 15% of all lung cancer cases in Canada, equivalent to 4,300 new patients annually. Two-thirds of all new SCLC cases are diagnosed at the extensive stage.

Furthermore, since non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases, while small cell lung cancer (SCLC) constitutes the remaining 15%, numerous pharmaceutical companies have prioritized the development of therapies targeting NSCLC due to its larger market share. For a prolonged period, chemotherapy has remained the first-line treatment for SCLC patients, who often experience relapse within months, followed by rapid and uncontrollable disease progression. Historically, the prognosis for patients with extensive-stage small cell lung cancer (ES-SCLC) has been extremely poor, with a five-year survival rate of only approximately 3%.

“Since most patients are diagnosed with lung cancer at a late stage, the needs of those with small cell lung cancer (SCLC) remain unmet,” said Shem Singh, Executive Director of Lung Cancer Canada. “There is an urgent need for new treatment options. The approval of Tecentriq provides a new tool for Canadian patients with SCLC to help manage their disease and extend survival.”

This approval is based on the results of the Phase III clinical trial named IMpower133, in which 403 patients with extensive-stage small cell lung cancer (ES-SCLC) participated in this multicenter, randomized, double-blind, placebo-controlled study. The results showed that, compared with chemotherapy alone, first-line treatment of ES-SCLC with Tecentriq in combination with carboplatin and etoposide prolonged patient survival, meeting the co-primary endpoints of the trial. In the intent-to-treat population, overall survival (OS) was significantly improved (12.3 months vs. 10.3 months in the control group; HR=0.70, 95% CI: 0.54–0.91; p=0.0069). The combination therapy of Tecentriq plus chemotherapy also significantly reduced the risk of disease progression and death. Progression-free survival (PFS) was 5.2 months versus 4.3 months in the control group (HR=0.77; 95% CI: 0.62–0.96; p=0.017). Currently, the IMpower133 regimen has been included in the 2019 NCCN Clinical Practice Guidelines in Oncology as the preferred treatment option for previously untreated ES-SCLC.

Prioritize the development of therapies for lung cancer and bladder cancer.

Lung cancer is a key area of focus and investment for Roche, which is committed to developing new approaches, medicines, and tests to help patients. Currently, Roche has 12 Phase III clinical studies in lung cancer evaluating Tecentriq as a monotherapy or in combination with other drugs.

The Approval Path of Tecentriq:

In May 2016, Tecentriq received accelerated approval from the U.S. Food and Drug Administration (FDA) for the second-line treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) who had previously undergone chemotherapy. It is indicated for patients with locally advanced or metastatic urothelial carcinoma (mUC) who experienced disease progression during or after platinum-containing chemotherapy, or whose disease worsened within 12 months after receiving neoadjuvant or adjuvant platinum-based chemotherapy. Tecentriq became the first PD-L1 inhibitor to be marketed globally.

In October 2016, the U.S. FDA approved Tecentriq for second-line treatment of non-small cell lung cancer (NSCLC) in patients with disease progression following platinum-based chemotherapy or after targeted therapy with EGFR or ALK inhibitors.

In April 2017, the U.S. FDA granted accelerated approval to Tecentriq as a first-line treatment for patients with advanced or metastatic urothelial carcinoma (mUC) who are ineligible for cisplatin-based chemotherapy.

In December 2018, the U.S. FDA approved Tecentriq in combination with Avastin (bevacizumab), paclitaxel, and carboplatin (chemotherapy) (the Tecentriq triple-drug regimen) for the first-line treatment of metastatic non-squamous NSCLC without EGFR or ALK mutations.

On March 8, 2019, the triple-drug regimen containing Tecentriq was approved by the European Commission (EC) for first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC). For NSCLC patients harboring EGFR mutations or ALK positivity, the combination of Tecentriq, Avastin, and chemotherapy (paclitaxel plus carboplatin) is indicated only after failure of appropriate targeted therapy.

On March 9, 2019, the FDA granted accelerated approval to Tecentriq in combination with Abraxane (albumin-bound paclitaxel) as a first-line treatment for adult patients with PD-L1-positive, unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This combination regimen is the first cancer immunotherapy approved for the treatment of breast cancer.

Additionally, Roche is currently conducting four Phase III clinical trials in bladder cancer to evaluate Tecentriq as a monotherapy and in combination with other agents for the treatment of early-stage and advanced bladder cancer.

On August 5, 2019, Roche announced positive results from the Phase III study of the PD-L1 monoclonal antibody Tecentriq (atezolizumab) as a first-line treatment for patients with advanced bladder cancer. The study, codenamed IMvigor130, met its co-primary endpoint of progression-free survival (PFS) as assessed by investigators. The combination therapy of Tecentriq plus platinum-based chemotherapy significantly reduced the risk of disease progression or death (PFS) compared with chemotherapy alone in previously untreated locally advanced or metastatic urothelial carcinoma (mUC). Positive overall survival (OS) outcomes were observed in an interim analysis. IMvigor130 is the first Phase III clinical study of an immunotherapy-based combination regimen to demonstrate positive results in previously untreated advanced bladder cancer.

Conclusion

In February 2019, Roche submitted a marketing application for Tecentriq® (atezolizumab) in China, which was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. We look forward to the launch of Tecentriq in China and its application in broader indications, bringing treatment opportunities to more cancer patients.

Reference source: https://www.biospace.com/article/releases/health-canada-approves-tecentriq-and-174-atezolizumab-first-new-treatment-in-20-years-for-aggressive-form-of-lung-cancer-1-/