CHMP recommends Tecentriq, chemotherapy combo for NSCLC and ES-SCLC

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.