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29 Dec 2020

Chugai received MHLW, Japan marketing authorization for humanized anti-PD-L1 monoclonal antibody, Tecentriq to treat unresectable advanced/recurrent NSCLC

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Chugai Pharmaceutical announced that it has obtained regulatory approval for its humanized anti-PD-L1 monoclonal antibody, Tecentriq Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)] from the Ministry of Health, Labour and Welfare (MHLW) for additional dosing for the treatment of chemotherapy-naïve PD-L1-positive unresectable advanced or recurrent non-small cell lung cancer (NSCLC).

Ventana OptiView PD-L1 (SP142), a pathological testing kit marketed by Roche Diagnostics K.K., should be used to detect PD-L1 expression. Expanded use of Ventana OptiView PD-L1 (SP142) as a companion diagnostic of Tecentriq was approved on December 15, 2020 to allow physicians to identify patients with PD-L1-positive NSCLC who could benefit from Tecentriq.

Basis of approval

This approval is based on the results from the phase III IMpower110 study. The study met its primary endpoint in an interim analysis showing that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy alone in patients with high PD-L1 expression (TC3/IC3-WT) (median OS = 20.2 versus 13.1 months; hazard ratio = 0.595, 95%CI: 0.398 – 0.890; p = 0.0106 [stratified log-rank test]; two-sided significance level: 0.0413). The most common adverse events (=5%) were fatigue, asthenia, nausea, decreased appetite, hypothyroidism, rash, increased ALT, and diarrhea.

As a leading company in the field of oncology in Japan, Chugai will continue to promote the proper use of Tecentriq so that it can contribute to the treatment of unresectable advanced or recurrent NSCLC as a new therapeutic option.

Tecentriq is approved in patients with chemotherapy-naïve unresectable advanced or recurrent NSCLC for three combination therapies with other anti-neoplastic drugs, including carboplatin + paclitaxel + bevacizumab, carboplatin or cisplatin + pemetrexed, and carboplatin + paclitaxel (albumin-bound), in addition to a newly approved monotherapy.

Development stages of Tecentriq

Tecentriq was launched in April 2018 with an indication of unresectable, advanced or recurrent non-small cell lung cancer (NSCLC), followed by an approval for the additional dosing for the treatment of untreated unresectable, advanced or recurrent NSCLC in December 2018. In addition, an approval of extensive-stage small cell lung cancer has been obtained in August 2019, an approval of PD-L1 positive hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer has been obtained in September 2019, and an approval for the additional dosing for the treatment of chemotherapy-naïve unresectable advanced or recurrent non-squamous NSCLC has been obtained in November 2019. In September 2020, Tecentriq was approved for the treatment of unresectable hepatocellular carcinoma.

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