TECENTRIQ (atézolizumab) - Cancer bronchique non à petites cellules (CBNPC)

Key points

Disapproval of reimbursement as monotherapy for adjuvant treatment, after complete resection and platinum-based chemotherapy, of adult patients with non-small cell lung cancer (NSCLC) with a high risk of recurrence, presenting with PD-L1 tumour expression ≥ 50% on tumour cells (TC) and not presenting with EGFR-mutated or ALK-gene rearranged (ALK-positive) NSCLC.

Role in therapeutic strategy?

The therapeutic management of NSCLC particularly depends on the stage of the disease at the time of diagnosis. At localised stages (stages I and II), immediate surgical treatment may be proposed for patients deemed eligible (complete excision deemed possible, no contraindication to excision surgery). At the locally advanced stage IIIA, a number of therapeutic strategies may be proposed, depending on tumour resectability and patient operability: immediate surgery, neoadjuvant chemotherapy followed by surgery, or radio-chemotherapy followed by immunotherapy.

At stages II or III, platinum-based adjuvant chemotherapy is recommended for cases of immediate surgery with complete resection, particularly the cisplatin-vinorelbine or cisplatin-pemetrexed association (only for non-epidermoid NSCLC) Adjuvant chemotherapy is not recommended for stage I cases.

In the absence of EGFR mutation, the follow-up treatment consists of monitoring.

Role of the medicinal product

Considering:

• the major methodological limitations associated with the efficacy analyses conducted in the cohort finally selected for the marketing authorisation (particularly sub-group, post-hoc analyses, not adjusted for multiplicity, with no tested interaction, using a different stratification criterion from those used for randomisation), meaning that no formal conclusion can be drawn;
• the adjuvant context, in which an estimated proportion of between 37% and 63% will not relapse (almost equivalent to recovery), without additional treatment;
• the increased toxicity associated with the use of TECENTRIQ (atezolizumab), versus monitoring, in the adjuvant context mentioned above;

the Committee deems that TECENTRIQ (atezolizumab) has no role in the current therapeutic strategy.