- Recommendation is based on the Phase III IMpower110 study showing that Tecentriq significantly improved overall survival in people with high PD-L1 expression, compared with chemotherapy
- If approved, Tecentriq could offer people with a specific type of lung cancer a chemotherapy-free option in the first-line treatment setting
Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of 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. Based on this recommendation, a final decision regarding the approval of Tecentriq in this disease setting, along with the full details of the approved indication, is expected from the European Commission in the near future.
“Today’s CHMP recommendation is a significant step forward in bringing a new chemotherapy-free treatment with flexible treatment schedules to people in Europe with certain types of lung cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We remain committed to providing effective and tailored lung cancer treatment options, and this announcement is an important step toward this goal.”
If approved, Tecentriq would provide a new treatment option, free from chemotherapy-related adverse effects. It will also be the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks, giving physicians and patients flexibility to manage their treatment.
The recommendation from the CHMP 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 appeared to be consistent with its known safety profile, and no new safety signals were 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. It was the first approved cancer immunotherapy for first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies.
Furthermore, Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across different 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.
References
[1] Herbst RS, et al. Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC. N Engl J Med 2020:383:1328–39.
[2] Supplement to: Herbst RS, et al. Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC. N Engl J Med 2020;383:1328–39.
*High PD-L1 expression in the indication statement is defined as PD-L1 stained ≥50% of tumour cells [TC] [TC ≥50%] or PD-L1 stained tumour-infiltrating cells [IC] covering ≥10% of the tumour area [IC ≥10%]. PD-L1 staining is the process by which the PD-L1 protein is visualised during testing.
