FDA Accepts Review of Supplemental Biologics License Application for First-Line Cemiplimab/Chemo in Advanced NSCLC

The supplemental biologics license application for cemiplimab plus chemotherapy for patients with advanced non–small cell lung cancer was based on findings from the phase 3 EMPOWER-Lung 3 study and was accepted for review by the FDA.

A supplemental biologics license application for first-line PD-1 inhibitor cemiplimab-rwlc (Libtayo) plus chemotherapy for patients with advanced non–small cell lung cancer (NSCLC) was accepted for review by the FDA, according to a press release from developer Regeneron Pharmaceuticals.1

The application was supported by findings from the phase 3 EMPOWER-Lung 3 trial (NCT03409614), the results of which were presented at the 2021 European Society for Medical Oncology Congress.2 Investigators reported that patients treated with the cemiplimab/chemotherapy combination achieved a 12-month overall survival (OS) rate of 65.7% (95% CI, 59.9%-70.9%) compared with 56.1% (95% CI, 47.5%-63.8%) for those treated with placebo and chemotherapy. Moreover, after a median follow-up duration of 16.4 months, patients in the investigational arm had a median OS of 21.9 months (95% CI, 15.5–not evaluable [NE]) compared with 13.0 months (95% CI, 11.9-16.1) in the control arm.

The FDA has a target action date of September 19, 2022.

Those in the experimental arm were treated with 350 mg of cemiplimab ever 3 weeks plus investigator's choice of platinum doublet chemotherapy every 3 weeks for 4 cycles. In the placebo arm, patients received the same chemotherapy backbone plus placebo. A total of 466 patients with treatment-naive advanced stage IIIb/c NSCLC with non-squamous and squamous histology were enrolled on the study.

Additional findings from the study indicated that patients in the cemiplimab arm had a 12-month progression-free survival (PFS) rate of 38.1% (95% CI, 32.4%-43.8%) compared with 16.4% (95% CI, 10.5%-23.4%) with chemotherapy. After a median follow-up duration of 16.4 months, the median PFS was 8.2 months (95% CI, 6.4-9.3) and 5.0 months (95% CI, 4.3-6.2) in the experimental and control arms, respectively.

Investigators observed an overall response rate of 43.3% (95% CI, 37.7%-49.0%) and 22.7% (95% CI, 16.4%-30.2%) in the cemiplimab and chemotherapy arms, respectively (OR, 2.68; 95% CI, 1.72-4.19; P <.0001). Patients in both arms had a median duration of response of 15.6 months (12.4-NE) and 7.3 months (95% CI, 4.3-12.6), respectively.

In terms of safety, 3% of patients discontinued treatment due to any grade adverse effects (AEs) and 4% due to grade 3 to 5 AEs in the cemiplimab arm vs 3% and 3%, respectively, in the placebo arm. Moreover, 3% and 2% of patients in the cemiplimab arm discontinued treatment due to any grade and grade 3 to 5 treatment-related AEs compared with 1 patient each in the placebo arm, respectively.

The most common any grade treatment-emergent AEs (TEAEs) in the cemiplimab arm were anemia (44%), decreased appetite (17%), and fatigue (12%), and grade 3 to 5 TEAEs included anemia (10%), neutropenia (6%), and thrombocytopenia (3%). In the placebo arm, the most common any grade TEAEs were alopecia (43%), anemia (40%), and nausea (16%), with grade 3 to 5 TEAEs including anemia (7%) and neutropenia (6%).

References

  1. FDA accepts for review LIBTAYO® (cemiplimab-rwlc) in combination with chemotherapy for first-line treatment of advanced NSCLC. News release. Regeneron Pharmaceuticals. January 19, 2022. Accessed January 19, 2022. https://bit.ly/3GMkjKo
  2. Gogishvili M, Melkadze T, Makharadze T, et al. EMPOWER-Lung 3: cemiplimab in combination with platinum doublet chemotherapy for first-line (1L) treatment of advanced non-small cell lung cancer (NSCLC). Ann Oncol. 2021;32(suppl 5):S1283-S1346. doi:10.1016/annonc/annonc741