On February 22nd, Regeneron Pharmaceuticals, Inc. and Sanofi announced that Libtayo, their PD-1 inhibitor, has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced non-small-cell lung cancer (NSCLC) having high PD-L1 expression in tumors, as deemed appropriate by an FDA-approved test. With NSCLC forming approximately 84% of all lung cancers and an estimated 2.2 million cases reported globally last year, this news is sure to renew hopes among patients.
This is Libtayo’s third approval and was based on the data from the clinical study, EMPOWER-Lung 1. Previously, Libtayo grabbed its first FDA approval in 2018 for advanced cutaneous squamous cell carcinoma, and just two weeks ago, it further added basal cell carcinoma (BCC) to its name, making it the first immunotherapy approved for BCC. This helped them secure approximately $348 million in sales last year alone with an 80% year-over-year growth.
“The approval of Libtayo to treat first-line advanced non-small cell lung cancer with high PD-L1 expression means physicians and patients have a potent new treatment option against this deadly disease,” said Naiyer Rizvi, M.D., Price Family Professor of Medicine, Director of Thoracic Oncology and Co-director of Cancer Immunotherapy at Columbia University Irving Medical Center, as well as a steering committee member of the trial.
Dr. Rizvi further added, “Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases, or who had locally advanced disease and were not candidates for definitive chemoradiation. This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice”.
Libtayo is a humanized monoclonal antibody that targets the human PD-1 protein. Inhibition of the PD-1 pathway blocks the cancer cells’ ability to suppress T-cell activation. EMPOWER-Lung 1 is a Phase 3 multicenter clinical trial aimed at demonstrating the safety and efficacy of Libtayo as monotherapy in lung cancer patients with >50% PD-L1 expression in tumor cells. A total of 710 patients with NSCLC were enrolled for this study. Libtayo reduced the risk of death by 32% compared to chemotherapy. The major adverse reactions observed were rashes, cough, and pneumonia.
Positioning in the Market
Libtayo enters the lung cancer market, which is dominated by Merck’s blockbuster drug Keytruda. Having been approved for not only NSCLC, but melanoma, head, and neck squamous cell cancer, Hodgkin lymphoma, large B-cell lymphoma, urothelial carcinoma, among many others, Keytruda has managed to rake in $14.4 billion, a 30% worldwide growth in 2020. It is going to be an uphill task for Libtayo to capture market-share from Merck.
Market analysts are debating whether Libtayo holds a slight edge over Keytruda by comparing the reductions in death risk and have concluded that data from EMPOWER-Lung 1 does not have the potential to shake off Keytruda’s market dominance.
However, both Regeneron and Sanofi think otherwise and have claimed that Libtayo has performed significantly well in varied patients at different stages of prognosis and have presented doctors with situations that they encounter in daily practice. Additionally, the companies plan to evaluate the use of Libtayo with other chemotherapy agents and intend to present the data soon. If all this falls into place, Regeneron and Sanofi are looking to chip into Merck’s dominance over the NSCLC market and gain momentum in sales.
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