Roche Korea said Friday that its combination therapy -- Tecentriq and Alecensa – has won the Ministry of Food and Drug Safety’s approval as the first-line therapy for metastatic non-squamous non-small cell lung cancer (NSCLC).

Roche's Gaucher cancer immunotherapy Tecentriq

With this approval, the immunotherapy and anti-cancer drug combination has become the first and only treatment that medical professionals can use as first-line treatment for patients with metastatic non-squamous non-small cell lung cancer by administering Tecentriq in combination with Avastin, a targeted therapy for vascular endothelial growth factor (VEGF), and chemotherapeutic agents – paclitaxel and carboplatin.

Also, approved indications include patients with positive EGFR or anaplastic lymphoma kinase (ALK) mutations that have progressed to disease even after target therapy with a tyrosine kinase inhibitor (TKI). The company expects that the additional indication will become a new treatment option for EGFR or ALK mutation-positive patients.

The ministry approved the combination therapy based on the results of the IMpower150, a multicentre, open-label, randomized, controlled phase 3 clinical study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and paclitaxel) with or without Avastin in 1,202 patients with stage IV or recurrent metastatic non-squamous NSCLC who had not been treated with chemotherapy.

As a result, overall survival (OS) was 19.8 months, regardless of whether PD-L1 expression was present, in the Tecentriq combination therapy group which was 4.9 months longer than the control group -- Avastin and chemotherapy.

Tecentriq combination therapy also demonstrated significant OS improvement in patients with EGFR or ALK mutations and patients with liver metastases.

As a result of the sub-analysis of the study, the control group showed a median OS of 17.5 months in the EGFR or ALK mutation-positive patients, whereas the Tecentriq combination therapy group did not reach the OS median at the time of analysis.

In patients with EGFR-positive patients who failed EGFR-TKI treatment, the progression-free-survival (PFS) period of the combination therapy was 9.7 months, showing a significant PFS improvement of 6.1 months compared to the control group.

Also, the OS median of liver metastases patients treated with the combination therapy was 13.2 months compared to 9.1 months in the control group.

The safety profile of the Tecentriq combination regimen was consistent with that reported in previous individual drug studies.

“The approval of the combination therapy is significant as it provides a new first-line treatment option for patients with metastatic non-squamous non-small cell lung cancer who had unmet medical needs,” Roche Korea CEO Nic Horridge said.

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