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On May 5, Roche announced that the European Commission had approved Techentriq® as a metastatic non-small tumor with high PD-L1 expression, no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations The first-line (initial) treatment for cell lung cancer (NSCLC).
This approval is based on data from the IMpower110 study, which is a randomized, open phase 3 clinical study that evaluates Tecentriq monotherapy and cisplatin or carboplatin, pemetrexed or gemcitabine (chemotherapy) in PD-L1 selection , Efficacy and safety in subjects with stage IV non-squamous cell carcinoma or squamous NSCLC without chemotherapy.
The study included 572 people, of which 554 intend to treat the WT population, exclude the population with EGFR or ALK genomic tumor aberrations, and receive at a 1:1 ratio: Tecentriq monotherapy until disease progression (or loss of clinical benefit assessed by the investigator) ), unacceptable toxicity or death; or cisplatin or carboplatin (at the discretion of the investigator) combined with pemetrexed (non-scaly) or gemcitabine (scaly), and then pemetrexed (non-scaly) alone ) Or the best supportive treatment (squamous) for maintenance treatment until the disease progresses, unacceptable toxicity or death.
The primary efficacy endpoint is the overall survival (OS) of patients in the PD-L1 subgroup (TC3/IC3-WT; TC2,3/IC2,3-WT; and TC1,2,3/IC1,2,3-WT), Determined by SP142 analysis test.
The study showed that compared with chemotherapy, Tecentreq monotherapy improved overall survival by 7.
At the 2020 World Lung Cancer Conference (January 2021), the latest exploratory OS analysis of PD-L1 high (TC3 or IC3) WT population showed that OS continued to benefit at a median follow-up of 31.