DARMSTADT, Germany and NEW YORK, September 27, 2017 /PRNewswire/ --
Not intended for US, Canadian and UK-based media
- First-ever treatment indicated for curatively unresectable Merkel cell carcinoma (MCC) and first anti-PD-L1 to be available in Japan - Japanese Ministry of Health, Labour and Welfare (MHLW) decision based on Javelin Merkel 200 study, the largest registrational trial for an immunotherapy in MCC - First Asian approval for BAVENCIO follows approvals in the US and Europe
Merck and Pfizer Inc. today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved BAVENCIO(R) (avelumab, genetically recombinant Injection 200mg/mL for intravenous use) as the first and only treatment indicated for curatively unresectable Merkel cell carcinoma (MCC), a rare and aggressive skin cancer, in Japan.
(Logo: http://mma.prnewswire.com/media/477506/M...)
"Today marks the approval of the first-ever treatment indicated for Merkel cell carcinoma in Japan, making this a significant milestone for patients living with a devastating type of skin cancer," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck. "This decision by the MLHW also signifies the first approval of an anti-PD-L1 in Japan."
"This is the fifth approval for Bavencio in 2017 and the first in an Asian market," said Andreas Penk, M.D., Regional President Oncology International Developed Markets, Pfizer Oncology. "Today's announcement demonstrates our continued determination to provide access to our immunotherapy for people around the world living with hard-to-treat cancers such as Merkel cell carcinoma."
MCC is a designated rare disease in Japan and is estimated to affect fewer than 100 patients.[2],[3] BAVENCIO previously received Orphan Drug Designation from the MHLW in December 2016.
"Until now, there were no licensed treatments for MCC in Japan," said Dr Naoya Yamazaki, Chief of the Department of Dermatologic Oncology, National Cancer Center Hospital, Japan. "As a cancer that progresses quickly and has, for so many, a poor prognosis, today's approval is a huge step forward for people impacted by this destructive disease."
This approval is based on data from JAVELIN Merkel 200, an international, multicenter, single-arm, open-label, Phase II study in patients with metastatic MCC.[1]
The JAVELIN Merkel 200 study is the largest registrational clinical trial for an immunotherapy in metastatic MCC. The results of this study were previously presented at the June 2016 American Society of Clinical Oncology annual congress and published in the October 2016 edition of Lancet Oncology.
The MHLW's decision follows BAVENCIO's recent approval by the European Commission on September 18, 2017, as a monotherapy for the treatment of adult patients with metastatic MCC (mMCC). BAVENCIO was also granted marketing authorization by Swissmedic on September 05, 2017, for the treatment of patients with mMCC, whose disease has progressed after at least one chemotherapy treatment. Earlier this year, the US Food and Drug Administration (FDA) granted accelerated approval* for BAVENCIO for the treatment of mMCC and patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy.
The clinical development program for BAVENCIO, known as JAVELIN, involves at least 30 clinical programs and more than 6,300 patients evaluated across more than 15 different tumor types. In addition to mMCC, these cancers include breast, gastric/gastro-esophageal junction, head and neck, Hodgkin's lymphoma, melanoma, mesothelioma, non-small cell lung, ovarian, renal cell carcinoma and urothelial carcinoma.
About Merkel Cell Carcinoma
MCC is a rare and aggressive disease in which cancer cells form in the top layer of the skin, close to nerve endings.[4],[5] MCC, which is also known as neuroendocrine carcinoma of the skin or trabecular cancer, often starts in those areas of skin that are most often exposed to the sun, including the head and neck, and arms.[4],[6] Risk factors for MCC include sun exposure and infection with Merkel cell polyomavirus. Caucasian males older than 50 are at increased risk.[4],[6] MCC is often misdiagnosed as other skin cancers and grows at an exponential rate on chronically sun-damaged skin.[6-8] Current treatment options for MCC include surgery, radiation and chemotherapy.[5] Treatment for metastatic or Stage IV MCC is generally palliative.[5]
About JAVELIN Merkel 200
The efficacy and safety of BAVENCIO was demonstrated in the JAVELIN Merkel 200 trial, a Phase II, open-label, single-arm, multicenter study, in metastatic MCC.[1] The trial excluded patients with active or a history of central nervous system (CNS) metastasis, prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, active or a history of autoimmune disease, a history of other malignancies within the last 5 years, organ transplant, and conditions requiring therapeutic immune suppression or active infection with HIV, or hepatitis B or C. Patients received BAVENCIO 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
The JAVELIN Merkel 200 study is the largest registrational clinical trial for an immunotherapy in metastatic MCC. The results of this study were previously presented at the June 2016 American Society of Clinical Oncology annual congress and published in the October 2016 edition of Lancet Oncology.
About BAVENCIO
BAVENCIO(R) (avelumab) is a human antibody specific for a protein called PD-L1, or programmed death ligand-1. BAVENCIO is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, BAVENCIO is thought to prevent tumor cells from using PD-L1 for protection against white blood cells, such as T cells, exposing them to anti-tumor responses. BAVENCIO has been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.
*Indications in the US[9]
The US Food and Drug Administration (FDA) granted accelerated approval for BAVENCIO for the treatment of (i) mMCC in adults and pediatric patients 12 years and older and (ii) patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications were 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.
Important Safety Information from the US FDA Approved Label
The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO for mMCC and patients with locally advanced or metastatic UC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.
About Merck-Pfizer Alliance
(CONTINUA)
Andalucía
