ROCKLAND, MA and New York, NY, USA I March 13, 2020 I EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced an update from the Phase III JAVELIN Head and Neck 100 study evaluating avelumab in addition to chemoradiotherapy (CRT) versus standard-of-care CRT in patients with untreated locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). The alliance has accepted the recommendation of the independent Data Monitoring Committee (DMC) to terminate the JAVELIN Head and Neck 100 trial, as the study is unlikely to show a statistically significant improvement in the primary endpoint of progression-free survival (PFS) based on a preplanned interim analysis. A detailed analysis of the Phase III JAVELIN Head and Neck 100 study is being conducted and study findings will be shared with the scientific community.
There has been limited innovation for patients with locally advanced SCCHN over the past 10 years.1 Despite aggressive standard-of-care treatment with high-dose chemotherapy combined with radiotherapy, LA SCCHN will ultimately recur in a large proportion of patients.2 In recognition of the unmet need for additional treatment options that can prevent recurrence or metastatic disease,3 the alliance initiated the JAVELIN Head and Neck 100 trial, which is the first Phase III study to report topline results for an immune checkpoint inhibitor in combination with CRT in LA SCCHN.
About JAVELIN Head and Neck 100
JAVELIN Head and Neck 100 (NCT02952586) is a Phase III, randomized, double-blind, placebo-controlled, parallel-arm study investigating treatment with avelumab plus standard-of-care CRT followed by avelumab maintenance versus CRT alone in patients with previously untreated LA SCCHN. A total of 697 patients who had not received prior therapy for locally advanced SCCHN and were eligible for CRT with curative intent were randomly assigned to receive avelumab plus CRT or CRT alone. The primary endpoint was PFS per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary endpoints included overall survival (OS), time to locoregional failure, time to distant metastatic failure, overall response, duration of response and pathologic complete response.
About Head and Neck Cancer
Head and neck cancer is the sixth most common cancer worldwide.4 In 2016, there were nearly 150,000 newly diagnosed cases in the United States, Japan and Europe.4 Approximately 60% of people are diagnosed with head and neck cancer when their disease has already progressed to the locally advanced stage (Stage III-IVB).5 At this stage, the cancer has spread from its site of origin to local lymph nodes, but not another part of the body.6 Standard of care for these patients includes high-dose chemotherapy combined with radiotherapy.7
About BAVENCIO® (avelumab)
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.8-10 In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.
BAVENCIO Approved Indications
BAVENCIO® (avelumab) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
Avelumab is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.
About Merck KGaA, Darmstadt, Germany-Pfizer Alliance
Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany and Pfizer. The global strategic alliance between Merck KGaA, Darmstadt, Germany and Pfizer enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of BAVENCIO, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance is jointly developing and commercializing BAVENCIO. The alliance is focused on developing high-priority international clinical programs to investigate BAVENCIO as a monotherapy as well as combination regimens, and is striving to find new ways to treat cancer.
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About EMD Serono, Inc.
EMD Serono – the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada – is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company’s home state of Massachusetts. www.emdserono.com.
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany, generated sales of € 16.2 billion in 66 countries.
The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.
Pfizer Inc.: Breakthroughs that change patients’ lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
References
1. Mandal R, et al. The head and neck cancer immune landscape and its immunotherapeutic implications. JCI Insight. 2016;1(17):e89829.
2. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines: Head and Neck Cancers. https://www.nccn.org/professionals/physician_gls/default.aspx. Accessed March 2020.
3. Porceddu SV, et al. Treating patients with locally advanced squamous cell carcinoma of the head and neck unsuitable to receive cisplatin-based therapy. Frontiers in Oncology. 2020;22.
4. Tzong K. Head and neck cancer: Epidemiology. Datamonitor. August 2017.
5. Oksuz DC, et al. Recurrence patterns of locally advanced head and neck squamous cell carcinoma after 3D conformal (chemo)-radiotherapy. Radiation Oncology. 2011;6(54).
6. Deschler DG, Moore MG, Smith RV, eds. Quick Reference Guide to TNM Staging of Head and Neck Cancer and Neck Dissection Classification, 4th ed. Alexandria, VA: American Academy of Otolaryngology–Head and Neck Surgery Foundation, 2014.
7. Argiris A, et al. Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck. Frontiers in Oncology. 2017;7:72.
8. Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the landscape of cancer immunotherapy. Cancer Control. 2014;21(3):231-237.
9. Dahan R, Sega E, Engelhardt J, et al. FcγRs modulate the anti-tumor activity of antibodies targeting the PD-1/PD-L1 axis. Cancer Cell. 2015;28(3):285-295.
10. Boyerinas B, Jochems C, Fantini M, et al. Antibody-dependent cellular cytotoxicity activity of a novel anti-PD-L1 antibody avelumab (MSB0010718C) on human tumor cells. Cancer Immunol Res. 2015;3(10):1148-1157.
SOURCE: EMD Serono
