Roche said its PD-L1 (programmed death-ligand 1) inhibitor Tecentriq (ingredient: atezolizumab) has become the first immunotherapy approved for triple negative breast cancer (TNBC), known to be aggressive and malignant.

As MSD is trailing to release clinical data on PD-L1 inhibitor Keytruda’s monotherapy and combination therapy within the year, pharmaceutical firms are expected to use more immunotherapies for breast cancer in earnest shortly.

Roche’s immunotherapy Tecentriq

On Monday, Roche announced that the U.S. Food and Drug Administration granted accelerated approval for Tecentriq plus Abraxane (nab-paclitaxel) therapy for adult patients with unresectable locally advanced or metastatic TNBC. The FDA also gave the nod for companion diagnostic test VENTANA PD-L1 (SP142).

The FDA’s accelerated approval was based on positive progression-free survival (PFS) data from the phase-3 trial Impassion130. Roche must show the therapy’s clear clinical benefits in additional trials to maintain the license.

The study compared Tecentriq plus nab-paclitaxel with nab-paclitaxel alone on 902 patients with unresectable locally advanced or metastatic TNBC. The primary endpoints of the study were PFS of the intent-to-treat (ITT) PD-L1 positive patients and the overall survival (OS) of the ITT group.

The result showed that the median of PFS in the group treated with the combo therapy was 7.4 months, whereas that of the nap-paclitaxel monotherapy group was 4.8 months. In other words, Tecentriq plus nab-paclitaxel lowered the risk of disease worsening or death by 40 percent, compared with nab-paclitaxel alone.

Rival drug Keytruda of MSD has still a chance to catch up with Tecentriq, which was approved to treat patients whose tumors express PD-L1.

MSD’s immunotherapy Keytruda

MSD is to complete the phase-3 trial Keynote-119 on Keytruda versus single-agent chemotherapy (capecitabine, eribulin, gemcitabine, and vinorelbine) for metastatic TNBC in April.

In December, the drugmaker will also finish the phase-3 study Keynot-355, which compares Keytruda with other chemotherapies (nap-paclitaxel or paclitaxel or gemcitabine plus carboplatin).

Researchers said that although it may be difficult to anticipate Keytruda’s monotherapy effect regardless of the PD-L1 expression, its combo treatment with chemotherapy could yield better results.

MSD said on Jan. 8 during JP Morgan Global Healthcare Conference that interim data of Keytruda for treatment of TNBC were “quite encouraging.” The company expected that there would be significant data available for TNBC treatment at the end of this year or early next year.

kym@docdocdoc.co.kr

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