FDA priority review of Regeneron sBLA for Libtayo in NSCLC

The sBLA is supported by results from a Phase 3 open-label, randomized, multi-center trial that investigated the first-line treatment of Libtayo monotherapy compared to platinum-doublet chemotherapy in patients with locally advanced or metastatic NSCLC whose tumor cells expressed PD-L1, including those whose cancers had confirmed PD-L1 expression of ≥50% using the PD-L1 IHC 22C3 pharmDx kit. Results were recently presented at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress in September.

The European Medicines Agency (EMA) is also assessing Libtayo in advanced NSCLC with ≥50% PD-L1 expression and a decision is expected in the second quarter of 2021. Libtayo is the first systemic treatment approved in the U.S. and European Union (EU) for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

Libtayo is being jointly developed and commercialized by Regeneron and Sanofi under a global collaboration agreement. The use of Libtayo to treat advanced NSCLC is investigational and has not been fully evaluated by any regulatory authority.

Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

Lung cancer is the leading cause of cancer death worldwide, with more than 2.2 million new cases expected globally, and 228,000 new cases expected in the U.S. in 2020. Approximately 85% of all lung cancers are NSCLC, and an estimated 25% to 30% of these cases are expected to test positive for PD-L1 in ≥50% of tumor cells. While immunotherapies have transformed advanced NSCLC treatment in recent years, there remains an unmet need to optimize the identification and treatment of patients with high PD-L1 expression and offer additional treatment options.

Antibody cocktail Immazeb from Regeneron becomes the first FDA approved treatment for Ebola

The safety and efficacy of Inmazeb was established through the 681-patient PALM Trial, a randomized, multicenter, controlled trial initiated in 2018 in the DRC. The WHO, the National Institutes of Health (NIH) and the Institut National de Recherche Biomédicale (INRB) in the DRC jointly sponsored and served as co-principal investigators of the trial. In 2019, as reported in the New England Journal of Medicine, the PALM Trial was stopped early following a pre-specified interim analysis that showed superiority of Inmazeb to ZMapp and remdesivir with respect to mortality. Adverse events that occurred in at least 10% of Inmazeb patients were chills, elevation in fever (pyrexia), rapid heartbeat (tachycardia), rapid breathing (tachypnea), vomiting, low blood pressure (hypotension), diarrhea and inadequate oxygen supply to the tissue (hypoxia); of these, only chills occurred more frequently with Inmazeb than ZMapp. The evaluation of AEs in Inmazeb patients may have been confounded by the signs and symptoms of the underlying Zaire ebolavirus infection.

As part of an agreement announced in July 2020, Regeneron will deliver an established number of Inmazeb treatment doses over the course of six years to the Biomedical Advanced Research and Development Authority (BARDA), as part of the U.S. Department of Health and Human Services’ (HHS) goal of building national preparedness for public health emergencies.

Sanofi to develop dupilumab in type 2 inflammatory diseases

Sanofi executives will provide an overview of the growth and development strategy for Dupixent (dupilumab) in the third of its five-part series to highlight Sanofi’s progress. Sanofi co-develops and co-commercializes Dupixent with Regeneron ().

The company is targeting the below additional indications. 

  • Eosinophilic Esophagitis (EoE)
  • Chronic Obstructive Pulmonary Disease (COPD) with Evidence of Type 2 Inflammation
  • Prurigo Nodularis (PN)
  • Chronic Spontaneous Urticaria (CSU)
  • Bullous Pemphigoid (BP)

All of these potential uses are investigational, and the safety and efficacy of Dupixent in any of these indications has not been evaluated yet.

While additional data contribute to the growing body of evidence demonstrating Dupixent’s best in class safety profile combined with strong efficacy benefit for atopic dermatitis and further validate it as a standard of care treatment for asthma; Dupixent’s unique mechanism of action simultaneously inhibits IL-4 and IL-13, which play a key role in type 2 inflammation in multiple diseases. 

Regeneron reports 1Q 2020 financial and operating results

Regeneron Pharmaceuticals, Inc. () today announced financial results for Q1 2020 and provided a business update. […]
The company has revised the accounting presentation to better reflect the nature of revenues earned and costs incurred, and simplify the financial reporting. The company has also closed the Praluent restructuring transaction with Sanofi, which is expected to be accretive beginning in Q2 2020.
  • Q1 2020 revenues increased 33% to $1.83 billion versus Q1 2019
  • Q1 2020 EYLEA U.S. net sales increased 9% to $1.17 billion versus Q1 2019
  • Q1 2020 Dupixent global net sales, which are recorded by Sanofi, increased 129% to $855 million versus Q1 2019
  • Q1 2020 GAAP diluted EPS was $5.43 and non-GAAP diluted EPS was $6.60
  • The Company generated $528 million in free cash flow for Q1 2020, compared to $823 million for Q1 2019.
  • Effective January 1, 2020, Regeneron has implemented changes in the presentation of its financial statements related to certain reimbursements and other payments for products developed and commercialized with collaborators.
  • Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications.
  • In February 2020, the Company announced positive two-year results from the Phase 3 PANORAMA trial evaluating EYLEA in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The two-year data demonstrated that EYLEA reduced the likelihood of developing vision-threatening events by at least 75% in patients with NPDR.
  • The U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental Biologics License Application (sBLA) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis, with a target action date of May 26, 2020. In addition, a Marketing Authorization Application (MAA) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis has also been submitted in the European Union (EU). The sBLA for the 300 mg auto-injector is under review by the FDA, with a target action date of June 20, 2020.
  • In April 2020, the Company and Sanofi announced that the primary endpoint was met in the Phase 3 trial of Libtayo® (cemiplimab) as monotherapy in first-line non-small cell lung cancer (NSCLC). The Independent Data Monitoring Committee recommended that the trial be stopped early due to highly significant improvement in overall survival. The data from the trial will form the basis of regulatory submissions in the U.S. and EU in the second half of 2020.
  • In March 2020, the Company announced that the Phase 3 trial in adult patients with homozygous familial hypercholesterolemia (HoFH) met its primary endpoint and plans to submit an sBLA in mid-2020.
  • In March 2020, the Company presented positive, detailed results from the Phase 3 trial in patients with HoFH. The Company has also initiated a rolling BLA submission for HoFH and plans to submit an MAA in the EU in the second half of 2020.
  • The FDA accepted for priority review the BLA submission for -EB3, a multi-antibody therapy to Ebola virus infection, with a target action date of October 25, 2020.