Roche's Tecentriq gains two new lung cancer approvals in Europe

Roche announced Friday that the European Commission approved the use of Tecentriq (atezolizumab) in combination with chemotherapy for the first-line treatment of adults with metastatic non-squamous non-small-cell lung cancer (NSCLC) who do not have EGFR mutant or ALK-positive disease. The regulator also authorised use of the PD-L1 inhibitor in combination with chemotherapy for the first-line treatment of adults with extensive-stage small-cell lung cancer (ES-SCLC).

Sandra Horning, Roche's chief medical officer, noted that the second approval "makes Tecentriq the first cancer immunotherapy available in Europe for the initial treatment of extensive-stage small-cell lung cancer." Horning added "the combination of Tecentriq and chemotherapy has been shown to improve survival compared to the current standard-of-care – an advance that, until now, has been difficult to achieve due to the refractory nature of this disease."

Approval in ES-SCLC was based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with carboplatin and etoposide helped people live significantly longer compared with chemotherapy alone, with median overall survival (OS) of 12.3 months and 10.3 months, respectively. Meanwhile, the Tecentriq-based combination also significantly reduced the risk of disease worsening or death, with progression-free survival (PFS) of 5.2 months versus 4.3 months for chemotherapy alone.

Roche added that approval of Tecentriq for the first-line treatment of adults with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK-positive disease was based on data from the Phase III IMpower130 trial. The company announced last year that the study met its main goals, with results later showing that median OS in patients given Tecentriq plus carboplatin and Celgene's Abraxane (nab-paclitaxel) was 18.6 months, compared to 13.9 months for those who received carboplatin and Abraxane alone. In addition, median PFS in the two groups was 7 months and 5.5 months, respectively.

The drugmaker is currently conducting nine late-stage studies evaluating Tecentriq alone or in combination with other medicines across different types of lung cancer. The product, which gained European clearance last month for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumours have PD-L1 expression and who have not received prior chemotherapy for metastatic disease, generated sales of CHF 782 million ($789 million) in the first half of the year.

For related analysis, see Spotlight On: Pharma’s key drug battlegrounds - PD-(L)1 inhibitors; a post Q2 2019 analysis.

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