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

Key points

Approval of continued reimbursement in combination with two cycles of platinum-salt-based chemotherapy, as a first-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours lack the EGFR sensitising mutation or the ALK translocation.

Therapeutic improvement?

Therapeutic improvement with respect to chemotherapy.

Role in therapeutic strategy?

The current management of metastatic 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 is a first-line treatment: 

• as a single agent in PD-L1 ≥ 50% patients, 
• in combination with chemotherapy, regardless of PD-L1 expression:
  • in combination with pemetrexed and platinum-salt chemotherapy in non-squamous NSCLC,
  • in combination with carboplatin and paclitaxel (or nab-paclitaxel) chemotherapy in squamous NSCLC.

Other immunotherapies provide alternatives to pembrolizumab as first-line treatments. However, their positioning vis-à-vis pembrolizumab cannot be determined. These are:

• OPDIVO/YERVOY (nivolumab/ipilimumab) in combination with two cycles of platinum-salt-based chemotherapy,
• LIBTAYO (cemiplimab) as a monotherapy,
• TECENTRIQ (atezolizumab) as a monotherapy (any histology) or in combination (non-squamous NSCLC only),

In case of contraindication to immunotherapy, or to one of the associated chemotherapy molecules, chemotherapy is indicated. This is a combination of a platinum salt (cisplatin or carboplatin) and one of the following: vinorelbine, gemcitabine, docetaxel, paclitaxel or pemetrexed (only in non-squamous NSCLC). In non-squamous NSCLC, bevacizumab can be combined with dual therapy if there are no contraindications.

Role of the medicinal product:

OPDIVO/YERVOY (nivolumab/ipilimumab), in combination with two cycles of platinum-salt-based chemotherapy, remains an alternative first-line treatment for adult patients with metastatic non-small cell lung cancer whose tumours do not have the EGFR sensitising mutation or ALK translocation.

Given the major methodological limitations of the indirect comparisons provided, its role vis-à-vis current treatment standards (notably pembrolizumab as monotherapy only if PD-L1≥50%, and pembrolizumab + chemotherapy regardless of PD-L1 expression) cannot be determined. The Committee reiterates that the inability to determine its role vis-à-vis pembrolizumab does not constitute a recognition of equivalence.

The Committee considers that the therapeutic decision must be made after a documented proposal from a multidisciplinary consultation meeting. This choice should take into account the efficacy and safety results of each protocol, as well as the patient's general condition and choice. The Committee reiterates that patients with an ECOG score > 1 were not included in the study.