The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for cemiplimab-rwlc (Libtayo®; Regeneron Pharmaceuticals), a programmed death receptor-1 (PD-1) blocking antibody, for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with 50% or more PD-L1 expression.

The sBLA is supported by data from an open-label, randomized phase 3 trial in which patients received either cemiplimab-rwlc (n=356) or platinum-doublet chemotherapy (n=354) for up to 32 months. The primary end point of the trial was overall survival; key secondary end points included progression-free survival (PFS) and objective response rate (ORR).

Topline results showed that compared with chemotherapy, treatment with cemiplimab-rwlc reduced the risk of death by 32% in the overall trial population (hazard ratio [HR] 0.68; 95% CI, 0.53-0.87; P =.0022). Median overall survival in the cemiplimab-rwlc arm was observed to be 22 months (95% CI, 18 months – not yet evaluable) vs 14 months in the chemotherapy arm (95% CI, 12-19 months). Moreover, among patients with confirmed PD-L1 expression of 50% or more (n=563), cemiplimab-rwlc treatment was associated with a 43% reduction in the risk of death when compared with chemotherapy (HR 0.57; 95% CI, 0.42-0.77; P =.0002).

Additionally, in the overall trial population, treatment with cemiplimab-rwlc reduced the risk of disease progression by 41% (HR 0.59; 95% CI, 0.49-0.72; P <.0001) with a median PFS of 6.2 months (95% CI, 4.5-8.3 months) vs 5.6 months for chemotherapy (95% CI, 4.5-6.1 months). The ORR for cemiplimab-rwlc was 37% (95% CI, 32-42), with 3% of patients achieving complete response (CR) and 33% achieving partial response (PR) vs an ORR of 21% (95% CI, 17-25) for chemotherapy, with 1% of patients achieving CR and 20% achieving PR.


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Findings from the study also showed a direct link between tumor response and PD-L1 expression level in patients treated with cemiplimab-rwlc. The ORR was highest in tumors with 90% or more PD-L1 expression, with target tumors shrinking by more than 40% after 6 months of treatment.

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Cempilimab-rwlc is marketed under the brand name Libtayo and is currently approved for the treatment of metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC in patients who are not candidates for curative surgery or curative radiation.

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References

  1. FDA Accepts for Priority Review Libtayo® (cemiplimab-rwlc) for Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50%. [press release]. Tarrytown, NJ: Regeneron Pharmaceuticals; October 29, 2020. 
  2. Late-breaking esmo presentation shows Libtayo® (cemiplimab) monotherapy increases overall survival in first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%. [press release]. Tarrytown, NJ: Regeneron Pharmaceuticals; September 21, 2020.