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news.Roche’s Tecentriq (atezolizumab) and chemotherapy combination has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of two types of lung cancer.
Image: Roche secures positive CHMP opinion for Tecentriq, chemotherapy combo for NSCLC and ES-SCLC. Photo: courtesy of F. Hoffmann-La Roche Ltd.
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The committee has recommended the approval of Tecentriq plus chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) for the initial treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC). The recommendation is for the combination to be used in such patient population who do not have EGFR mutant or ALK-positive NSCLC.
The other recommendation is for Tecentriq plus chemotherapy (carboplatin and etoposide) for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC) in adults.
For the non-small cell lung cancer indication, the Tecentriq-based combination therapy was recommended on the findings of a phase 3 trial called IMpower130. The combo therapy was shown to have helped people live significantly longer in comparison to chemotherapy alone.
Also, the Tecentriq-based combination brought down the risk of disease worsening or death (progression-free survival) compared with chemotherapy alone to a significant extent.
Roche chief medical officer and global product development head Sandra Horning said: “We are pleased to receive a positive opinion from the CHMP for this Tecentriq-based lung cancer combination for people living with non-squamous non-small cell lung cancer.
“Lung cancer is a complex disease that requires a range of treatment options. We are now one step closer to providing another important alternative for this difficult-to-treat form of cancer”.
The CHMP recommendation for the ES-SCLC indication was driven by the results of phase 3 IMpower133 trial. The late-stage study demonstrated that Tecentriq in combination with chemotherapy helped people live significantly longer, in comparison to chemotherapy alone.
The Tecentriq-based combination therapy also reduced the chances of disease worsening or death (progression-free survival) significantly when compared with chemotherapy alone.
In March 2019, the US Food and Drug Administration (FDA) approved Tecentriq in combination with carboplatin and etoposide chemotherapy as a first-line treatment for adults with ES-SCLC.
Tecentriq is a monoclonal antibody that inhibits the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells. By inhibiting PD-L1, the monoclonal antibody could enable the activation of T cells.
The drug is approved in the US, European Union and other countries, either alone or in combination with targeted therapies and/or chemotherapies in different types of non-small cell and small cell lung cancer, certain forms of metastatic urothelial cancer, and in PD-L1-positive triple-negative breast cancer.
