Libtayo (cemiplimab) vs Augtyro (repotrectinib)

Libtayo (cemiplimab) is a monoclonal antibody used primarily for the treatment of certain types of skin cancers, such as advanced cutaneous squamous cell carcinoma, and has recently been approved for non-small cell lung cancer. It works by targeting the PD-1 pathway, which is a checkpoint that often prevents the immune system from attacking cancer cells. On the other hand, Ayvakyt (avapritinib) is a kinase inhibitor specifically designed for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. It is important to note that while both drugs are used in cancer treatment, they are indicated for different types of cancer and work through different mechanisms. The choice between Libtayo and Ayvakyt would depend on the specific type of cancer a patient has and the genetic mutations present within the cancer cells, as determined by a healthcare professional. Patients should consult with their oncologist to determine the most appropriate treatment based on their unique medical condition and the specific characteristics of their cancer.

Difference between Libtayo and Augtyro

Metric	Libtayo (cemiplimab)	Augtyro (repotrectinib)
Generic name	Cemiplimab	Repotrectinib
Indications	Cutaneous squamous cell carcinoma, Basal cell carcinoma, Non-small cell lung cancer	Advanced solid tumors with NTRK or ROS1 gene fusions
Mechanism of action	PD-1/PD-L1 checkpoint inhibitor	Tyrosine kinase inhibitor
Brand names	Libtayo	Augtyro
Administrative route	Injection (intravenous)	Oral
Side effects	Fatigue, rash, diarrhea, musculoskeletal pain	Dizziness, constipation, fatigue, edema
Contraindications	Severe hypersensitivity to cemiplimab or its excipients	Not established
Drug class	Monoclonal antibody	Tyrosine kinase inhibitor
Manufacturer	Regeneron Pharmaceuticals, Inc.	Turning Point Therapeutics, Inc.

Efficacy

Libtayo (Cemiplimab) Efficacy in Lung Cancer

Libtayo (cemiplimab) is a fully human monoclonal antibody designed to block the activity of the immune checkpoint receptor PD-1 on T cells. By doing so, it may help the body’s immune system to fight cancer cells. The efficacy of Libtayo in lung cancer has been evaluated in a number of clinical trials. Specifically, in patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression and who were either previously untreated or had disease progression on or after platinum-based chemotherapy, Libtayo has shown a significant improvement in overall survival compared to chemotherapy alone.

In a pivotal phase 3 trial, Libtayo demonstrated a 32% reduction in the risk of death compared to chemotherapy in individuals with advanced NSCLC with a PD-L1 expression of ≥50%. The median overall survival was significantly longer for patients treated with Libtayo compared to those who received chemotherapy. Additionally, the safety profile of Libtayo was found to be consistent with that of other PD-1 inhibitors, with immune-mediated side effects being the most common adverse events.

Augtyro (Repotrectinib) Efficacy in Lung Cancer

Augtyro (repotrectinib) is a next-generation tyrosine kinase inhibitor (TKI) that targets ROS1 and TRK, as well as ALK-positive cancers. While Augtyro is relatively new and still undergoing clinical evaluation, early-phase trials have shown promise in treating lung cancer patients with these specific genetic alterations. In particular, repotrectinib has demonstrated potent activity against ROS1-positive NSCLC, offering a potential new treatment option for patients who have developed resistance to prior ROS1 inhibitors or who are treatment-naïve.

Although detailed phase 3 trial results are pending, phase 1/2 studies indicate that repotrectinib has an acceptable safety profile and has shown preliminary efficacy in patients with ROS1-positive advanced NSCLC, including those with central nervous system (CNS) metastases. The drug is designed to overcome resistance mutations that can limit the effectiveness of other TKIs, and it has been observed to provide durable responses in a subset of lung cancer patients. As research continues, Augtyro may become an important addition to the therapeutic arsenal against lung cancer with specific genetic profiles.

Regulatory Agency Approvals

Libtayo

European Medical Agency (EMA), European Union
Food and Drug Administration (FDA), USA
Health Canada

Augtyro

Food and Drug Administration (FDA), USA

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