Regeneron (REGN) Phase 3 Trial of Libtayo® Stopped Early Due to Significant Improvement in Overall Survival
- S&P ends modestly lower as rising Treasury yields offset robust retail data
- Electronic Arts (EA) Rebounds on Reaffirmed Guidance Despite Battlefield 2042 Delay, Be Concerned But Not Worried Says Analyst
- U.S. retail sales surprise to upside in strong boost to economy
- Chat Platform Discord Raises $500 Million, Valuation More Than Doubled In Less Than a Year
- Dollar index climbs after U.S. retail sales show surprise rebound
Get inside Wall Street with StreetInsider Premium. Claim your 1-week free trial here.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the Phase 3 trial of PD-1 inhibitor Libtayo in combination with platinum-doublet chemotherapy was stopped early after meeting its overall survival (OS) primary endpoint in patients with advanced non-small cell lung cancer (NSCLC). Adding Libtayo to chemotherapy significantly improved OS, compared to chemotherapy alone, in the trial that enrolled patients with metastatic or locally advanced disease and tumors with either squamous or non-squamous histology and across all PD-L1 expression levels. These data are planned to form the basis of regulatory submissions in the U.S. and European Union.
"Libtayo in combination with chemotherapy increased median overall survival to 22 months in patients with advanced non-small cell lung cancer, compared to 13 months with chemotherapy alone," said Miranda Gogishvili, M.D., an oncologist at the High Technology Medical Center, University Clinic, in Tbilisi, Georgia and a trial investigator. "Notably, the Phase 3 trial enrolled patients with a variety of challenging-to-treat disease characteristics, as well as those with locally advanced disease. These data add to the growing body of evidence supporting Libtayo in advanced non-small cell lung cancer, which also include the pivotal results for Libtayo monotherapy in cases of high PD-L1 expression."
The decision to stop the trial early was based on a recommendation by the Independent Data Monitoring Committee (IDMC) during a protocol-specified interim analysis. In this top-line initial analysis of 466 patients, combining Libtayo with chemotherapy reduced the risk of death by 29% compared to chemotherapy alone (hazard ratio: 0.71; 95% confidence interval [CI]: 0.53-0.93; p=0.014). Median OS was 22 months (95% CI: 16 months to not evaluable) for Libtayo and chemotherapy, and 13 months (95% CI: 12 to 16 months) for chemotherapy alone. No new Libtayo safety signals were identified in the IDMC analysis, and additional detailed efficacy and safety data will be presented at an upcoming medical meeting.
Lung cancer is the leading cause of cancer death worldwide. In 2020, an estimated 2.2 million and 225,000 new cases were diagnosed globally and in the U.S., respectively. Approximately 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages. While PD-1 inhibitor monotherapy has primarily advanced the treatment of NSCLC with ≥50% PD-L1 expression, approximately 70% of all NSCLC cases will have <50% PD-L1 expression, making it the most common treatment setting.
The use of Libtayo in combination with chemotherapy for advanced NSCLC is currently under clinical investigation, and its safety and efficacy have not been fully evaluated by any regulatory authority.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Intellia Therapeutics (NTLA) Announces U.S. FDA Acceptance of IND for NTLA-5001, its CRISPR/Cas9-Engineered TCR-T Cell Candidate for Acute Myeloid Leukemia
- Soligenix, Inc. (SNGX) to Advance Synthetic Hypericin Development in Psoriasis
- Co-Diagnostics (CODX) JV CoSara Receives Clearance from Indian FDA for Chikungunya and Dengue Tests
Create E-mail Alert Related CategoriesCorporate News, FDA
Related EntitiesTwitter, Earnings, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!