Positive Phase 3 Clinical Data for Sanofi/Regeneron's PD-1 Inhibitor Libtayo as First-Line Monotherapy in Advanced NSCLC

Recently, Regeneron announced that interim data analysis demonstrated that Libtayo (cemiplimab), a PD-1 inhibitor co-developed with Sanofi, exhibited significantly superior efficacy compared to chemotherapy as a monotherapy in a Phase 3 clinical trial for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). Currently, Libtayo is being evaluated in two Phase 3 clinical trials as a monotherapy or in combination with chemotherapy for the treatment of patients with advanced NSCLC.

Lung cancer is the leading cause of cancer-related deaths both worldwide and in China. Each year, more than 780,000 people in China are diagnosed with lung cancer, and over 620,000 die from it. Lung cancer can be broadly classified into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with NSCLC being the most common type, accounting for 80%–85% of all lung cancer cases. Among patients with NSCLC, 25%–30% have squamous NSCLC, while 70%–75% have non-squamous NSCLC. Most NSCLC patients are diagnosed at an advanced stage, with a five-year survival rate of only 10%.

Libtayo is a fully humanized anti-PD-1 monoclonal antibody developed through a collaboration between Sanofi and Regeneron. It works by blocking the PD-1 signaling pathway, thereby helping the body’s immune system to destroy tumor cells. Previously, it has been approved in the United States, the European Union, Canada, and Brazil for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or radiation therapy. Additionally, Libtayo is being evaluated in clinical trials for the treatment of cervical cancer, head and neck squamous cell carcinoma, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma, and non-Hodgkin lymphoma.

In the Phase 3 clinical trial of Libtayo as monotherapy for patients with NSCLC expressing PD-L1 at levels ≥50%, enrolled patients had stage IIIB, IIIC, or IV squamous or non-squamous NSCLC, were ineligible for chemotherapy and radiation therapy, and had not received prior systemic therapy for advanced disease. Interim analysis of the trial showed that patients treated with Libtayo achieved an objective response rate (ORR) of 42%, which is closely comparable to the ORR of 39% observed with Keytruda—a therapy increasingly becoming the standard of care for certain lung cancer patients—in previous Phase 3 trials. The ORR in the chemotherapy group was 22%.

We look forward to this PD-1 inhibitor bringing more positive news and providing more treatment options for the vast number of lung cancer patients!

References:

[1] Regeneron Provides Updates on Phase 3 Libtayo® (cemiplimab) Development Program in Advanced Non-small Cell Lung Cancer, Retrieved November 6, 2019, from https://www.prnewswire.com/news-releases/regeneron-provides-updates-on-phase-3-libtayo-cemiplimab-development-program-in-advanced-non-small-cell-lung-cancer-300951372.html

[2] Regeneron’s Libtayo shows response rate in line with Keytruda’s in first-line NSCLC, Retrieved November 6, 2019, from https://www.biocentury.com/bc-extra/clinical-news/2019-11-05/regeneron’s-libtayo-shows-response-rate-line-keytruda’s-first-

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