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TECENTRIQ 840 - 1200 mg (atezolizumab) (monothérapie CBNPC)

Opinions on drugs - Posted on Nov 22 2021

Reason for request

New indication

Key points

Favourable opinion for reimbursement, as monotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC.

What therapeutic improvement?

Therapeutic improvement compared to chemotherapy.

Role in the care pathway?

The current management for metastatic non-small cell lung cancer (NSCLC) in first line-treatment, in the absence of molecular abnormalities (EGFR mutations, or ALK or ROS-1 rearrangements), in patients whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC), is based on immunotherapy, for eligible patients.

Pembrolizumab (anti-PD1 immunotherapy) is a first-line treatment:

  • as monotherapy, in patients, and
  • in combination with chemotherapy:
  • pemetrexed and platinum chemotherapy, in non-squamous NSCLC,
  • carboplatin and paclitaxel (or nab-paclitaxel) chemotherapy, in squamous NSCLC.

In the event of contraindication to immunotherapy, or to one of the chemotherapy drugs combined with pembrolizumab, chemotherapy is indicated. This involves dual therapy combining a platinum (cisplatin or carboplatin) with one of the following substances: vinorelbine, gemcitabine, docetaxel, paclitaxel or pemetrexed (only in non-squamous NSCLC for the latter). In non-squamous NSCLC, in the absence of contraindications, bevacizumab can be added to the dual chemotherapy regimen; and atezolizumab can be combined with bevacizumab + paclitaxel + carboplatin.

The OPDIVO/YERVOY (nivolumab/ipilimumab) combination, in combination with 2 cycles of platinum-based chemotherapy, is an alternative first-line treatment.

Role of the medicinal product in the care pathway

TECENTRIQ (atezolizumab) as monotherapy is an alternative as a first-line treatment in adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC.

The indirect comparison data provided does not enable TECENTRIQ (atezolizumab) to be positioned compared to the current standard of care. No significant difference in terms of overall survival has been demonstrated between TECENTRIQ (atezolizumab) and the other first-line treatment strategies (including pembrolizumab as monotherapy, the pembrolizumab + chemotherapy combination, and chemotherapy alone) via these indirect comparisons. The Committee points out that this absence of difference does not constitute demonstration of equivalence.

 

 


Clinical Benefit
Substantial

The Committee deems that the clinical benefit of TECENTRIQ (atezolizumab) is substantial in the MA indication.

Clinical Added Value
minor

Considering

  • demonstration of the superiority of TECENTRIQ (atezolizumab) as monotherapy compared to chemotherapy, in terms of overall survival: mean increase of 0.7 and 5.2 months respectively over the first 12 and 33.3 months of follow-up (RMST method), in a phase 3 randomised, open-label study, and
  • the safety profile marked by a lower frequency of grade 3-4 adverse events, a similar frequency of serious adverse events and a higher frequency of adverse events of particular interest (identified as important risks in the RMP);

and despite:

  • the follow-up analysis suggesting less benefit than that demonstrated in the primary analysis;
  • the increased deaths in the atezolizumab group compared to chemotherapy, during the first 2 to 3 months of follow-up;
  • the absence of any formal conclusion that can be drawn based on the quality-of-life results;

the Transparency Committee considers that TECENTRIQ (atezolizumab) as monotherapy provides a minor clinical added value (CAV IV) compared to chemotherapy in the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC.

 

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