Roche Receives Positive CHMP Opinion for Tecentriq as First-Line Monotherapy in Metastatic NSCLC with High PD-L1 Expression

Compiled by Keke

Recently, Roche announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Tecentriq® (atezolizumab) as first-line (initial) treatment for metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression and without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

Based on this recommendation, the European Commission is expected to make a final decision regarding the approval of Tecentriq for this indication, along with all details of the approval, in the near future.

If approved, Tecentriq will provide a new treatment option that does not cause chemotherapy-related adverse reactions. It is also the first and only single-agent cancer immunotherapy with three dosing regimens, allowing for administration every two, three, or four weeks, thereby providing physicians and patients with flexibility in managing their treatment.

The CHMP’s recommendation is based on data from the Phase 3 clinical study IMpower110, which demonstrated that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy in patients with high PD-L1 expression (TC3 or IC3 wild-type [WT]) (OS: 20.2 vs. 13.1 months; hazard ratio [HR]=0.59, 95% CI: 0.40–0.89; p=0.0106). The safety profile of Tecentriq appeared consistent with its known safety profile, with no new safety signals identified. Grade 3–4 treatment-related adverse events occurred in 12.9% of patients receiving Tecentriq, compared with 44.1% of patients receiving chemotherapy.

IMpower110 is a randomized, open-label, phase 3 study evaluating the efficacy and safety of Tecentriq monotherapy versus cisplatin or carboplatin plus pemetrexed or gemcitabine (chemotherapy) in patients with previously untreated, PD-L1-selected stage IV non-squamous or squamous NSCLC. The study enrolled 572 patients, of whom 554 constituted the intention-to-treat wild-type (WT) population, excluding those with EGFR or ALK genomic tumor alterations, and were randomized in a 1:1 ratio to receive:

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) in combination with pemetrexed (for non-squamous histology) or gemcitabine (for squamous histology), followed by maintenance therapy with pemetrexed alone (for non-squamous histology) or best supportive care (for squamous histology), until disease progression, unacceptable toxicity, or death. The primary efficacy endpoint was overall survival (OS) in the PD-L1 subgroups (TC3/IC3-WT; TC2,3/IC2,3-WT; and TC1,2,3/IC1,2,3-WT), as determined by the SP142 assay. Key secondary endpoints included investigator-assessed progression-free survival, objective response rate, and duration of response.

At the 2020 World Conference on Lung Cancer (held in January 2021), the latest exploratory overall survival (OS) analysis in patients with wild-type (WT) tumors and high PD-L1 expression (TC3 or IC3) 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 arm was consistent with that observed in previous analyses (20.2 months), whereas the median OS in the chemotherapy arm was 14.7 months. Data from this exploratory OS analysis were also submitted to the Committee for Medicinal Products for Human Use (CHMP).

Tecentriq has demonstrated clinically meaningful benefits in the treatment of various types of lung cancer. It currently has five approved indications globally, including its use as a cancer immunotherapy in combination with carboplatin and etoposide (chemotherapy) for the first-line treatment of adult patients with extensive-stage small cell lung cancer (SCLC). Tecentriq also has four approved indications in non-small cell lung cancer (NSCLC), either as a monotherapy or in combination with targeted therapies and/or chemotherapy.

Tecentriq has been approved in the United States, the European Union, and countries worldwide for use as monotherapy or in combination with targeted therapies and/or chemotherapy for various forms of non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), certain types of metastatic urothelial carcinoma, PD-L1-positive metastatic triple-negative breast cancer, and hepatocellular carcinoma. In the United States, Tecentriq is also approved in combination with Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of advanced melanoma with BRAF V600 mutation positivity.

Reference source: Roche receives positive CHMP opinion for Tecentriq as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer