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NEW YORK - Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), a prominent biotechnology company with a market capitalization of $57.9 billion and strong financial health according to InvestingPro analysis, reported Tuesday that its immunotherapy drug Libtayo, when combined with platinum-based chemotherapy, demonstrated a 19.4% five-year overall survival rate in advanced non-small cell lung cancer (NSCLC) patients, compared to 8.8% with chemotherapy alone.
The five-year follow-up data from the Phase 3 EMPOWER-Lung 3 trial were presented at the International Association for the Study of Lung Cancer’s 2025 World Conference on Lung Cancer. The trial evaluated Libtayo (cemiplimab) plus chemotherapy versus chemotherapy alone in patients with locally advanced or metastatic NSCLC without EGFR, ALK or ROS1 mutations. The company, which generated $14.2 billion in revenue over the last twelve months with a healthy 47% gross margin, continues to demonstrate its research capabilities.
With a median follow-up of 60.9 months, patients receiving the Libtayo combination achieved a median overall survival of 21.1 months compared to 12.9 months for those on chemotherapy alone, representing a 34% reduction in the risk of death.
The data showed consistent efficacy across different tumor types, with particularly strong results in squamous NSCLC patients who achieved a median overall survival of 22.3 months versus 13.8 months with chemotherapy alone.
The trial enrolled 466 patients who were randomized 2:1 to receive either Libtayo or placebo plus platinum-doublet chemotherapy. Patients in the study represented diverse baseline characteristics, including 43% with squamous histology and 67% with tumors expressing less than 50% PD-L1.
The safety profile remained consistent with previously reported data. The most common adverse events in the Libtayo combination group included anemia (46%), alopecia (38%), and nausea (25%).
Libtayo is a fully human monoclonal antibody that targets the PD-1 receptor on T cells and has been approved in more than 30 countries for various cancer indications, including advanced NSCLC.
The findings were based on a company press release statement. Trading at a P/E ratio of 13.3 and showing strong financial metrics, Regeneron appears undervalued according to InvestingPro Fair Value calculations. Investors seeking detailed analysis can access comprehensive Pro Research Reports covering Regeneron and 1,400+ other top stocks through InvestingPro, which transforms complex Wall Street data into actionable intelligence.
In other recent news, Regeneron Pharmaceuticals Inc. reported positive results from two Phase 3 trials evaluating antibody-blockers targeting cat and birch allergies. These trials successfully met their primary and secondary endpoints, showing significant reductions in allergy symptoms such as ocular itch and conjunctival redness. The treatments were well-tolerated with no serious adverse events, marking a promising development in allergy treatments. Additionally, Raymond James reiterated its Outperform rating for Regeneron, maintaining a price target of $673.00, while UBS kept its Neutral rating with a $595.00 price target following positive trial data for an experimental myasthenia gravis treatment. The Phase 3 NIMBLE trial for cemdisiran showed statistically significant improvements in patients with generalized myasthenia gravis. Meanwhile, Sanofi’s Phase III trial results for amlitelimab in atopic dermatitis met all primary and key secondary endpoints but fell short of investor expectations compared to previous benchmarks. These developments highlight ongoing advancements and evaluations in pharmaceutical treatments.
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