Cemiplimab-rwlc is approved by FDA in combination with platinum-based chemotherapy for non-small cell lung cancer

Share This Post

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.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

PiggyBac Transposon System
AI & Technology

PiggyBac Transposon System: A Revolutionary Tool in Cancer Gene Therapy

The PiggyBac Transposon System is revolutionizing genetic engineering in cancer research, especially in CAR T-cell therapy. With its high integration efficiency and large cargo capacity, it provides a powerful, non-viral alternative to traditional gene delivery methods. Learn how PiggyBac is advancing personalized cancer treatment and shaping the future of oncology.

Breakthrough 2025 Treatments for Advanced Breast Cancer
Biotech Innovations

Breakthrough Treatments for Advanced Breast Cancer in 2025

In 2025, advanced breast cancer treatment has entered a new era. Precision medicine and targeted therapies are enabling doctors to tailor care based on genetic profiles. Immunotherapy and antibody-drug conjugates are delivering more effective tumor targeting, while experimental cellular treatments like CAR T-cell therapy show immense promise. These cutting-edge options are transforming outcomes and quality of life for patients facing metastatic breast cancer. Explore the latest innovations driving hope and progress.

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

We Are Online! Chat With Us!
Scan the code