Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. REGN and partner Sanofi (NASDAQ:SNY) SNY announced positive results on oncology drug Libtayo (cemiplimab) from a late-stage study.
The phase III study evaluating the PD-1 inhibitor Libtayo monotherapy compared to chemotherapy in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic, demonstrated an overall survival (OS) benefit.
The study enrolled patients with advanced cervical cancer regardless of the PD-L1 status.Patients in the study were randomized to receive Libtayo monotherapy (350 mg every 3 weeks) or an investigator's choice of commonly used chemotherapy (pemetrexed, vinorelbine, topotecan, irinotecan or gemcitabine). Notably, the subjects receiving Libtayo experienced 31% reduced risk of death. Among these, patients with squamous cell carcinoma experienced 27% reduced risk of death while adenocarcinoma experienced 44% reduced risk of death.
Significantly, based on a unanimous recommendation by the Independent Data Monitoring Committee (IDMC), the study will be stopped early and the data will form the basis of regulatory submissions in 2021. Per a protocol-specified interim analysis, the IDMC reviewed OS data when approximately 85% of events had occurred among patients with squamous cell carcinoma.
We note that Libtayo is indicated as the first systemic treatment for certain patients with advanced cutaneous squamous cell carcinoma (CSCC) in the United States. Its label was recently expanded with the approval of monotherapy for certain patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression in the United States.
The FDA also recently approved the use of Libtayo as the first immunotherapy indicated for patients with basal cell carcinoma (BCC), previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate.
Approval for additional indications will boost the growth potential of the drug, which raked in sales of $348.2 million in 2020. Regeneron records net product sales of Libtayo in the United States. Sanofi records net product sales of Libtayo outside the United States. The uptake of the drug has been encouraging since its approval in 2018.
Regeneron’s stock has lost 1.1% in the year so far against the industry’s growth of 1.7%.
The company is looking to build a portfolio in the oncology space and diversify its revenue bade. Ophthalmology drug Eylea, developed in collaboration with Bayer (OTC:BAYRY) BAYRY, and Dupixent in collaboration with Sanofi maintain the momentum for the company.
Moreover, the company has been in news since the onset of the pandemic as it is developing an antibody cocktail for COVID-19. REGEN-COV, a cocktail of two monoclonal antibodies (casirivimab and imdevimab), received an Emergency Use Authorization from the FDA in November 2020 for the treatment of mild-to-moderate COVID-19 in certain patients at high risk of progressing to severe COVID-19 and/or hospitalization.
Regeneron currently has a Zacks Rank #3 (Hold). A better-ranked stock in this space is Moderna (NASDAQ:MRNA) MRNA, which presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Current-year earnings estimates for Moderna have been revised upward to $21.51 from $12.72 in the past 30 days.
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