Nivolumab, Ipilimumab Plus Chemotherapy Shows Long-Term OS Benefit in Metastatic NSCLC

The combination of nivolumab and ipilimumab plus chemotherapy showed a long-term, durable overall survival (OS) benefit in patients with metastatic non-small cell lung cancer (NSCLC) compared with chemotherapy alone, according to follow-up data from the CheckMate 9LA clinical trial.

Furthermore, survival outcomes were better with the immunotherapy/chemotherapy regimen regardless of tumor PD-L1 expression or histology.

“Adding a limited chemotherapy course to an immunotherapy regimen may help provide early disease control and directly boost antitumor immunity, while minimizing the adverse events (AEs) associated with prolonged chemotherapy,” the researchers said.

In the international, phase 3 trial, patients with stage IV/recurrent NSCLC who had no sensitizing EGFR or ALK alterations were randomly selected to receive either nivolumab plus ipilimumab with 2 cycles of chemotherapy (n=361) or 4 cycles of chemotherapy alone (n=358). Patients in the immunotherapy cohort were treated for a median duration of 6.1 months and 2.5 months in the chemotherapy cohort. Those with brain metastases were also included in the patient population.

The 5-year follow-up data, published in the European Journal of Cancer, showed a continued OS advantage in patients who received nivolumab/ipilimumab with chemotherapy (18%) versus chemotherapy alone (11%).

In addition, the OS benefit was higher in the PD-L1 < 1% subgroup (22% nivolumab and ipilimumab plus chemotherapy vs 8% chemotherapy alone). In patients who had PD-L1 ≥ 1%, the OS rate was 18% in the immunotherapy cohort versus 11% in the chemotherapy cohort. A survival advantage was also observed in patients regardless of histology (squamous, 18% vs 7%; non-squamous, 19% vs 12%).

Furthermore, nivolumab plus ipilimumab with chemotherapy helped patients with brain metastases live longer versus chemotherapy alone (20% vs 6%, respectively).

The 5-year duration of response rates (DOR) were 19% versus 8%, respectively.

Follow-up data also provided progression-free survival (PFS) rates. Compared with chemotherapy alone (38%), PFS with nivolumab/ipilimumab plus chemotherapy was 55%. The DOR rates were 46% versus 59%, respectively.

The safety profile remained consistent regardless of the number of ipilimumab doses a patient received. Moreover, treatment discontinuation from treatment-related AEs had no negative effect on efficacy.

“These results highlight the durable benefit provided by dual immunotherapy plus chemotherapy regimens that include the anti–CTLA-4 antibody ipilimumab and further reinforce the benefit of nivolumab plus ipilimumab combined with chemotherapy in patient populations with high unmet needs,” the researchers said.

Source: European Journal of Cancer