FDA Approves Opdivo-Yervoy Plus Chemo as Frontline Therapy for NSCLC

The Food and Drug Administration (FDA) approved the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) with two cycles of platinum-doublet chemotherapy for treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) who have no EGFR or ALK genomic tumor mutations.

The approval is based on findings of the phase 3 CheckMate 9LA trial that enrolled 719 patients with metastatic NSCLC. Patients eligible for enrollment in the trial had to have confirmed stage 4 or recurrent NSCLC with squamous or non-squamous histology, with no prior treatment received. Patients were enrolled regardless of their tumor PD-L1 statu. Those who had either the EGFR or ALK mutation that were sensitive to other available treatments were excluded from the trial. Patients treated with Opdivo plus Yervoy with platinum-doublet chemotherapy were treated until the disease progressed or patients encountered unacceptable toxicity, or for up to two years.

The trial showed that Opdivo given with a low dose of Yervoy (1 mg/kg) and two cycles of chemotherapy improved median overall survival compared to patients who had up to four cycles of chemotherapy with optional follow-up maintenance therapy for eligible non-squamous patients (14.1 months versus 10.7 months, respectively). Based on CheckMate -227 study Part 1, which was presented at the 2019 European Society of Medical Oncologists Congress, blinded independent review of the data found a median duration of response (the length of time the tumor responds to treatment without growing or spreading) of 23.2 months for patients treated with Opdivo and Yervoy. This is compared to 6.2 months for patients on chemotherapy alone and 15.5 months for patients on single-agent Opdivo.

Regardless of PD-L1 expression, the one-year overall survival rate for Opdivo and Yervoy plus chemotherapy was 62% compared to 54% in chemotherapy alone. The two-year overall survival rates were 40% and 30%, respectively. Among patients in the trial whose tumors express PD-L1 (≥1%), the one year rates are 63% and 56%, the two year rates are 40% and 33%.

No new safety findings from the initial findings were reported; however, 33% of patients in the Opdivo and Yervoy arm of the trial experienced grade 3 or 4 side effects compared to 36% in the chemotherapy arm and 19% in the single-agent Opdivo arm.

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