TECENTRIQ (atézolizumab)

Key points

Unfavourable opinion for reimbursement in three indications:

- in combination with nab-paclitaxel for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease,

- as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) after prior platinum-containing chemotherapy, or who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5%,

- as monotherapy for the treatment of patients with locally advanced or metastatic NSCLC with ALK gene rearrangement (ALK+), after prior chemotherapy.

Favourable opinion for reimbursement in an indication within a restricted scope: in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, with patients with activating EGFR mutation also having to have received a prior targeted therapy.

What therapeutic improvement?

No clinical added value compared to the presentation already listed (TECENTRIQ 1,200 mg) in the treatment of locally advanced or metastatic NSCLC after prior chemotherapy, with patients with activating EGFR mutation also having to have received a prior targeted therapy.

In the other indications: not applicable.

Role in the care pathway?

• Triple-negative breast cancer

In the absence of a treatment having specifically demonstrated its benefit with an optimal level of evidence in triple-negative breast cancer, patients are currently treated in accordance with the guidelines for the treatment of HER2-negative breast cancer. At an advanced stage, treatment is mainly based on sequential mono-chemotherapy with, as first-line treatment, anthracyclines and taxanes (docetaxel or paclitaxel) for patients not previously treated with these treatments. The use of platinum salts recommended in the treatment of advanced-stage triple-negative breast cancer following treatment with a taxane or an anthracycline may be discussed as a first-line treatment for metastatic disease, particularly in the event of BRCA gene mutation.

Role of TECENTRIQ (atezolizumab) in combination with nab-paclitaxel in the care pathway for triple-negative breast cancer:

Given the impossibility of determining the clinical benefit of combination of TECENTRIQ (atezolizumab) with nab-paclitaxel in view of the current treatment in France in the absence of a relevant comparison, the role of this combination in the care pathway cannot be determined. Consequently, the Committee considers that TECENTRIQ (atezolizumab) in combination with nab-paclitaxel has no role in the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

• Urothelial carcinoma

The first-line treatment of metastatic urothelial cancers is based on multi-agent chemotherapy containing platinum salts with, in particular, for cisplatin eligible patients, GC (gemcitabine, cisplatin) or MVAC-HD [MVAC (methotrexate, vinblastine, adriamycin and cisplatin) combined with G-CSF] protocols, or MVAC or PCG (paclitaxel, cisplatin, gemcitabine) protocols. For cisplatin ineligible patients, the first-line treatment of metastatic disease depends on the patient’s characteristics (in particular, renal function and ECOG status). Carboplatin-based chemotherapy is recommended (in particular, the protocol combining carboplatin and gemcitabine). In the event of cancer with PD-L1 expression, pembrolizumab (KEYTRUDA) and atezolizumab (TECENTRIQ) have an MA but are not reimbursed in France (in the absence of an application for reimbursement submitted by the pharmaceutical companies^3,24). Other treatment options are the paclitaxel and gemcitabine combination or single-agent chemotherapies based on taxanes or gemcitabine.

As second-line therapy following treatment with platinum salts, immunotherapies such as pembrolizumab (KEYTRUDA), atezolizumab (TECENTRIQ) and nivolumab (OPDIVO) have an MA. However, only pembrolizumab (KEYTRUDA) is reimbursed at present. For patients for whom immunotherapy cannot be envisaged, chemotherapy is recommended. Vinflunine (JAVLOR) has an MA at this stage of the disease in the event of urothelial carcinoma with transitional cells, and other chemotherapies may be used off-label (paclitaxel, docetaxel, gemcitabine).

Role of TECENTRIQ (atezolizumab) in the care pathway for urothelial carcinoma:

As the dossier currently stands and considering:

- non-significant results for overall survival compared to chemotherapy as second-line treatment following the failure of chemotherapy in a phase 3 study,

- the absence of comparative data versus clinically relevant comparators, despite this comparison being possible, in the first-line treatment of patients who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5%,

the Committee considers that TECENTRIQ (atezolizumab) has no role in the care pathway for the treatment of locally advanced or metastatic urothelial carcinoma.

• NSCLC

Refer to the Transparency Committee opinion of 30 May 2018 relative to the proprietary medicinal product TECENTRIQ 1,200 mg.

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