Roche's Tecentriq Approved by European Commission as First-Line Monotherapy for PD-L1-High Metastatic NSCLC
Roche
Oncology Drug Research, Development, and Manufacturing
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Compiled by Ke Ke
On May 5, Roche announced that the European Commission had approved Techentriq® as a first-line (initial) treatment for metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression and no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
This approval is based on data from the IMpower110 study, a randomized, open-label, Phase 3 clinical trial evaluating the efficacy and safety of Tecentriq monotherapy versus cisplatin or carboplatin plus pemetrexed or gemcitabine (chemotherapy) in patients with PD-L1-selected, chemotherapy-naïve Stage IV non-squamous or squamous non-small cell lung cancer (NSCLC). The study enrolled 572 patients, of whom 554 comprised the intention-to-treat wild-type (WT) population, excluding those with EGFR or ALK genomic tumor aberrations. Patients were randomized in a 1:1 ratio to receive either: Tecentriq monotherapy until disease progression (or loss of clinical benefit as assessed by the investigator), unacceptable toxicity, or death; or cisplatin or carboplatin (at the investigator’s discretion) combined with pemetrexed (for non-squamous NSCLC) or gemcitabine (for squamous NSCLC), followed by maintenance therapy with pemetrexed alone (for non-squamous NSCLC) or best supportive care (for squamous NSCLC) until disease progression, unacceptable toxicity, or death.
The primary efficacy endpoint was overall survival (OS) in PD-L1 subgroups (TC3/IC3-WT; TC2,3/IC2,3-WT; and TC1,2,3/IC1,2,3-WT), as determined by SP142 assay. Key secondary endpoints included investigator-assessed progression-free survival, objective response rate, and duration of response.
This study demonstrated that, compared with chemotherapy, Tecentriq monotherapy improved overall survival (OS) by 7.1 months (20.2 vs. 13.1 months; hazard ratio [HR]=0.59, 95% CI: 0.40–0.89; p=0.0106). In the population with high PD-L1 expression (TC3 or IC3 wild-type [WT]), the safety profile of Tecentriq was consistent with its known safety characteristics, and no new safety signals were identified. Among patients receiving Tecentriq, 12.9% experienced grade 3–4 treatment-related adverse events, compared to 44.1% in those receiving chemotherapy.
At the 2020 World Conference on Lung Cancer (January 2021), the latest exploratory overall survival (OS) analysis in patients with high PD-L1 expression (TC3 or IC3) in the wild-type (WT) population demonstrated a sustained OS benefit at a median follow-up of 31.3 months (HR=0.76, 95% CI: 0.54–1.09). The median OS in the Tecentriq group remained consistent with that observed in the previous analysis (20.2 months); in the chemotherapy group, the median OS was 14.7 months. Data from this exploratory OS analysis were also submitted to the European Commission.
Reference: Roche’s Tecentriq Approved by European Commission as a First-Line Monotherapy Treatment for People with a Type of Metastatic Non-Small Cell Lung Cancer
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