Roche Tecentriq Approved By European Commission As A First-line Monotherapy Treatment For People With A Type Of Metastatic Non-small Cell Lung Cancer

Roche announced that the European Commission has approved Tecentriq® (atezolizumab) as a first-line (initial) 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. “We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Tecentriq monotherapy has been shown to improve overall survival in people with high PD-L1 expression, when compared to chemotherapy, and therefore represents a new treatment option for people living with this difficult-to-treat disease.” Tecentriq is now the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks, giving physicians and patients greater flexibility on how they manage their treatment. This approval is based on data from the Phase III IMpower110 study, which showed that Tecentriq monotherapy 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]).1 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.2 Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in markets around the world. 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). Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across different settings in lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types. About the IMpower110 studyIMpower110 is a Phase III, randomised, open-label study evaluating the efficacy and safety of Tecentriq 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 OS 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 OS analysis in the PD-L1 high (TC3 or IC3)-WT population showed a continued OS benefit at a median follow-up of 31.3 months (HR=0.76, 95% CI: 0.54–1.09). Median OS in the Tecentriq arm was the same as observed at the previous analysis (20.2 months); in the chemotherapy arm, median OS was 14.7 months.3 Data from this exploratory OS analysis were also submitted to the European Commission. 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.

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