Roche on Friday announced that the European Commission has approved Tecentriq (atezolizumab) as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adults with non-small cell lung cancer (NSCLC) with a high risk of recurrence whose tumours express PD-L1=50% and who do not have EGFR mutant or ALK-positive NSCLC.
“Today’s approval represents an important advance, as Tecentriq becomes the first cancer immunotherapy approved in Europe for the treatment of certain types of early-stage NSCLC. Since approximately half of all people with early NSCLC develop recurrence after surgery, which in some cases is no longer curable, treating this cancer at an earlier stage offers the best chance to prevent recurrence,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development.
According to the company’s press statement, this approval is based on results from an interim analysis of the phase III IMpower010 study. “The results showed treatment with Tecentriq, following complete resection and platinum-based chemotherapy, reduced the risk of disease recurrence or death (DFS) by 57% (hazard ratio [HR]=0.43, 95% CI: 0.26-0.71) in people with resected Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours express PD-L1=50%, who do not have EGFR mutant or ALK-positive NSCLC, compared with best supportive care (BSC). A DFS benefit was consistently seen across most subgroups including histology or stage of disease with adjuvant Tecentriq, compared with BSC. Overall survival (OS) data for patients with PD-L1 high resected Stage II-III NSCLC, and who do not have EGFR mutant or ALK-positive disease are immature and were not formally tested at the DFS interim analysis, however, a trend towards OS improvement with Tecentriq was seen, with a stratified HR of 0.39 (95% CI: 0.18-0.82),” the company said in a press statement.
Moreover, follow-up will continue with planned analyses of more mature OS data later this year. Meanwhile, safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified.
“Today’s approval now offers patients in Europe, whose tumours express high levels of PD-L1, the opportunity to reduce their risk of disease recurrence following surgery and chemotherapy. This milestone reinforces the need for biomarker testing at diagnosis for all people with NSCLC, irrespective of disease stage, to ensure they receive optimal treatment,” said Professor Enriqueta Felip, head of the Thoracic Cancer Unit at Vall d’Hebron Institute of Oncology, Barcelona, Spain.
The company also informed that Tecentriq has been approved in 19 countries, including the US and China, as adjuvant treatment, following complete resection and chemotherapy, for adults with Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours express PD-L1=1%. Additionally, in three countries, including Canada and the UK, Tecentriq has been approved as adjuvant, treatment following complete resection and chemotherapy, for adult patients with Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours have PD-L1 expression on =50 percent of tumour cells.
“Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in countries around the world. It was the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced or metastatic NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks,” the company stated.
Lung cancer is one of the leading causes of cancer death globally. Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day. According to experts, treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.
The company claims that Tecentriq is a cancer immunotherapy approved for some of the most aggressive and difficult-to-treat forms of cancer. According to Roche, Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC).
Meanwhile, Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma.
A monoclonal antibody, Tecentriq is designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.
“By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. In addition to intravenous infusion, the formulation of Tecentriq is also being investigated as a subcutaneous injection to help address the growing burden of cancer treatment for patients and healthcare systems,” the company stated on Friday.