OPDIVO/YERVOY (nivolumab/ipilimumab) - Cancer bronchique non à petites cellules (CBNPC)

Key points

Favourable opinion for reimbursement in combination with 2 cycles of platinum-based chemotherapy for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.

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), is based on immunotherapy, for eligible patients.

Pembrolizumab (anti-PDL1 immunotherapy) is a first-line treatment:

• as monotherapy, in PD-L1 ≥ 50% patients, and
• in combination with chemotherapy, irrespective of PD-L1 expression:
  • in combination with pemetrexed and platinum chemotherapy, in non-squamous NSCLC,
  • in combination with 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.

Role of the medicinal product in the care pathway

Combination of OPDIVO/YERVOY (nivolumab/ipilimumab) and 2 cycles of platinum-based chemotherapy is an alternative in the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.

However, the Committee regrets the absence of data enabling the role of the OPDIVO/YERVOY (nivolumab/ipilimumab) combination to be positioned compared to current standard of care therapies: pembrolizumab as monotherapy, only if PD-L1 ≥ 50%, as well as the pembrolizumab + chemotherapy combination, irrespective of PD-L1 expression.

Considering these elements, the role of the nivolumab/ipilimumab combination plus 2 cycles chemotherapy compared to these different protocols is not known therefore. The Committee considers that the therapeutic decision should be taken after a documented proposal resulting from a multidisciplinary team meeting. This choice should take into account the efficacy and safety results of each protocol, along with the patient’s general condition and preferences. The Committee highlights the fact that patients with an ECOG score > 1 were not included in the study.