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European Commission: Tecentriq approved as a first-line monotherapy treatment for people with metastatic non-small cell lung cancer whose tumours have high PD-L1 expression, with no EGFR or ALK genomic tumour aberrations


European Commission has approved Tecentriq ( Atezolizumab ) as a first-line treatment for adults with metastatic non-small cell lung cancer ( NSCLC ) whose tumours have high PD-L1 expression, with no epidermal growth factor receptor ( EGFR ) or anaplastic lymphoma kinase ( ALK ) genomic tumour aberrations.

The approval is based on data from the phase III IMpower110 study, which has shown that Atezolizumab monotherapy has improved overall survival ( OS ) by 7.1 months compared with chemotherapy ( median OS=20.2 versus 13.1 months; hazard ratio [ HR ]=0.59, 95% CI: 0.40–0.89; p=0.0106 ) in people with high PD-L1 expression ( TC3 or IC3-wild-type [ WT ] ).

Safety for Tecentriq was consistent with its known safety profile, with no new safety signals identified.
Grade 3–4 treatment-related adverse events were reported in 12.9% of people receiving Tecentriq, compared with 44.1% of people receiving chemotherapy.

Atezolizumab is a monoclonal antibody designed to bind with PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Atezolizumab may enable the activation of T-cells.

In Europe, Tecentriq now has four approved indications in NSCLC, including as a single agent or in combination with targeted therapies and/or chemotherapies. It was also the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer ( SCLC ) in combination with Carboplatin and Etoposide ( chemotherapy ).

IMpower110 is a phase III, randomised, open-label study evaluating the efficacy and safety of Atezolizumab monotherapy compared with Cisplatin or Carboplatin and Pemetrexed or Gemcitabine ( chemotherapy ) in PD-L1-selected, chemotherapy-naïve participants with stage IV non-squamous or squamous NSCLC.
The study enrolled 572 people, of whom 554 were in the intention-to-treat WT population, which excluded people with EGFR or ALK genomic tumour aberrations, and were randomised 1:1 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 ( per investigator discretion ) combined with either Pemetrexed ( non-squamous ) or Gemcitabine ( squamous ), followed by maintenance therapy with Pemetrexed alone ( non-squamous ) or best supportive care ( squamous ) until disease progression, unacceptable toxicity or death.
The primary efficacy endpoint was overall survival by PD-L1 subgroup ( TC3/IC3-WT; TC2,3/IC2,3-WT; and TC1,2,3/IC1,2,3-WT ), as determined by the SP142 assay test.
Key secondary endpoints included investigator-assessed progression-free survival, objective response rate and duration of response.

At the World Conference on Lung Cancer 2020 ( January 2021 ), an updated, exploratory overall survival analysis in the PD-L1 high ( TC3 or IC3 )-WT population showed a continued overall survival benefit at a median follow-up of 31.3 months ( HR=0.76, 95% CI: 0.54–1.09 ).
Median overall survival in the Tecentriq arm was the same as observed at the previous analysis ( 20.2 months ); in the chemotherapy arm, median overall survival was 14.7 months.

PD-L1 is a protein expressed on tumour cells and tumour-infiltrating cells, which suppresses the immune response and enables tumour cells to avoid detection by binding to proteins on the surface of immune cells.
Immunotherapies such as Tecentriq block PD-L1 from binding to immune cells, allowing the immune system to detect and destroy tumour cells.
In IMpower110, patients were classified as PD-L1 high if they had PD-L1 on at least 50% of tumour cells or if PD-L1 expressing tumour-infiltrating cells were covering at least 10% of the tumour area.

Lung cancer is the one of the leading causes of cancer death globally. Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.
Lung cancer can be broadly divided into two major types: NSCLC and SCLC.
NSCLC is the most prevalent type, accounting for around 85% of all cases. NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope. ( Xagena )

Source: Roche, 2021

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