Roche's Tecentriq Approved in Japan as First-Line Immune Therapy for Extensive-Stage Small Cell Lung Cancer

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Roche Holding’s Japanese pharmaceutical affiliate, Chugai Pharmaceutical Co., Ltd., recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved a new indication for Tecentriq:First-line Combination Chemotherapy (Carboplatin + Etoposide) for Adult Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC). This approval makes Tecentriq the first cancer immunotherapy approved in Japan for the treatment of aggressive and refractory extensive-stage small cell lung cancer (ES-SCLC).

Currently, the aforementioned indications for Tecentriq are also under review by the European Union. In July this year, the Committee for Medicinal Products for Human Use (CHMP) issued its assessment opinion, recommending approval of these indications. The European Commission will refer to the CHMP’s opinion and make a final regulatory decision in the coming months. In the United States, these indications were approved by the FDA in March this year, making Tecentriq in combination with chemotherapy (carboplatin plus etoposide) the first cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC), as well as the first new first-line treatment regimen for ES-SCLC in the past 20 years.

This approval is based on the results of the Phase III clinical study IMpower133, which is the first Phase III clinical trial to demonstrate that a combination regimen based on cancer immunotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) significantly improves overall survival (OS) and progression-free survival (PFS). This was a multicenter, randomized, double-blind, placebo-controlled study conducted in adult patients with previously untreated (chemotherapy-naïve) ES-SCLC, evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin plus etoposide) versus chemotherapy alone (carboplatin plus etoposide). A total of 403 patients were enrolled and randomized in a 1:1 ratio to two treatment groups: Tecentriq plus chemotherapy (Group A) and chemotherapy alone (Group B). During the induction phase, patients received four cycles (21 days per cycle) of chemotherapy, followed by maintenance treatment with Tecentriq or placebo until disease progression.

The results showed that, in the intent-to-treat population, Group A had significantly prolonged OS compared with Group B (median OS: 12.3 months vs 10.3 months; HR=0.70, 95% CI: 0.54–0.91, p=0.0069) and a substantially higher 1-year OS rate (51.7% vs 38.2%). Furthermore, compared with Group B, Group A had a significant 23% reduction in the risk of disease progression or death (median PFS: 5.2 months vs 4.3 months; HR=0.77, 95% CI: 0.62–0.96, p=0.017) and a twofold higher 1-year PFS rate (12.6% vs 5.4%). In the study, the safety profile of Tecentriq in combination with chemotherapy was consistent with the known safety profile of Tecentriq.

Tecentriq is a PD-(L)1 cancer immunotherapy that targets and binds to the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells, blocking its interaction with PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq can activate T cells. To date, Tecentriq has been approved in multiple countries as monotherapy, as well as 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 triple-negative breast cancer.

Currently, Merck’s Keytruda holds an absolute dominant position in the treatment of non-small cell lung cancer (NSCLC). Small cell lung cancer (SCLC) represents another increasingly competitive segment within lung cancer therapy. According to the FDA Hematology/Oncology New Drug Approvals database, three cancer immunotherapies have been approved for the treatment of SCLC: Bristol-Myers Squibb’s Opdivo (August 2018), Roche’s Tecentriq (March 2019), and Merck’s Keytruda (June 2019). Among these, Opdivo and Keytruda received accelerated approval for third-line treatment of metastatic SCLC, while Tecentriq was approved for first-line treatment of extensive-stage SCLC (ES-SCLC).

Furthermore, in June this year, the Phase III CASPIAN clinical trial evaluating Imfinzi (astrazeneca) in combination with chemotherapy as first-line treatment for ES-SCLC met its primary endpoint of overall survival early at an interim analysis. Another Phase III study, ADRIATIC, is assessing Imfinzi in patients with limited-stage SCLC following concurrent chemoradiotherapy (CCRT). In July, Imfinzi was also granted orphan drug designation by the FDA for the treatment of SCLC.

References:

1、Tecentriq, an Anti-PD-L1 Antibody, Receives Approval for Additional Indication of Extensive-Stage Small Cell Lung Cancer

2、Roche’s Tecentriq in combination with chemotherapy helped people live significantly longer as an initial treatment for people with extensive-stage small cell lung cancer

3、Hematology/Oncology (Cancer) Approvals & Safety Notifications Subscribe to Email Updates