November 2022: The combination of cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) and platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 abnormalities has been approved by the Food and Drug Administration.
Study 16113 (NCT03409614), a randomised, multicenter, international, double-blind, active-controlled trial in 466 patients with advanced NSCLC who had not previously undergone systemic treatment, assessed the effectiveness in this regard. Cemiplimab-rwlc plus platinum-based chemotherapy every 3 weeks for 4 cycles, followed by cemiplimab-rwlc and maintenance chemotherapy, or placebo plus platinum-based chemotherapy every 3 weeks for 4 cycles, followed by placebo and maintenance chemotherapy, were the two treatment options offered to patients who were randomly assigned (2:1).
Overall survival was the primary efficacy outcome measurement (OS). Progression-free survival (PFS) and overall response rate (ORR), as determined by a blinded independent central review, were additional efficacy outcome measures (BICR).
In comparison to placebo plus chemotherapy, cemiplimab-rwlc plus platinum-based chemotherapy showed a statistically significant and clinically significant improvement in overall survival (OS) (hazard ratio [HR] of 0.71 [95% CI: 0.53, 0.93], two-sided p-value = 0.0140). In the cemiplimab-rwlc plus chemotherapy arm, the median OS was 21.9 months (95% CI: 15.5, not evaluable), compared to 13.0 months (95% CI: 11.9, 16.1) in the placebo plus chemotherapy group. In the cemiplimab-rwlc plus chemotherapy arm, the median PFS per BICR was 8.2 months (95% CI: 6.4, 9.3), while it was 5.0 months (95% CI: 4.3, 6.2) in the placebo plus chemotherapy arm (HR 0.56; 95% CI: 0.44, 0.70, p0.0001). Confirmed ORR per BICR for the two treatments was 43% (95% CI: 38, 49) and 23% (95% CI: 16, 30).
Alopecia, musculoskeletal pain, nausea, exhaustion, peripheral neuropathy, and decreased appetite were the most frequent side effects (15%).
350 mg IV every three weeks is the suggested dose of cemiplimab-rwlc. For recommended dose information, as necessary, see the prescribing information for the medications used in conjunction with cemiplimab-rwlc.
View full prescribing information for Libtayo
Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.
Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.
Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.
Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.
These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.
Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.
