FDA Grants Approval for BAVENCIO(R) (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma

Merck and Pfizer

2017/3/24 11:41

PR67931

DARMSTADT, Germany and NEW YORK, Mar. 24 /PRNewswire=KYODO JBN / -

Not intended for UK-based media

- Only FDA-approved treatment for metastatic Merkel cell carcinoma, a rare and

aggressive skin cancer

- First indication for BAVENCIO, a human anti-PD-L1 antibody

Merck and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug

Administration (FDA) has approved BAVENCIO(R) (avelumab) Injection 20 mg/mL,

for intravenous use, for the treatment of adults and pediatric patients 12

years and older with metastatic Merkel cell carcinoma (mMCC). This indication

is approved under accelerated approval based on tumor response and duration of

response. Continued approval for this indication may be contingent upon

verification and description of clinical benefit in confirmatory trials.[1]

BAVENCIO will be co-commercialized by EMD Serono, the biopharmaceutical

business of Merck in the US and Canada, and Pfizer. BAVENCIO was developed,

reviewed and approved through the FDA's Breakthrough Therapy Designation and

Priority Review programs.

BAVENCIO, a human anti-PD-L1 antibody, is the first FDA-approved therapy for

patients with mMCC.[2] Metastatic MCC is a rare and aggressive skin cancer,

with fewer than half of patients surviving more than one year and fewer than

20% surviving beyond five years.[3]

"At the heart of this FDA approval is our drive to make a meaningful difference

for patients with hard-to-treat cancers like metastatic Merkel cell carcinoma,"

said Belen Garijo, CEO Healthcare and Member of the Executive Board of Merck.

"BAVENCIO's journey has included years of hard work - from the scientists who

discovered this molecule in our labs, to our alliance with Pfizer and to the

study participants and investigators worldwide. We are grateful to all who have

made it possible for us to bring this important new treatment option to

patients."

"Today is a significant milestone for people fighting metastatic Merkel cell

carcinoma, who until now have not had any options beyond chemotherapy," said

Albert Bourla, Group President, Pfizer Innovative Health. "This approval

demonstrates the power of collaboration to accelerate meaningful new choices

for cancer patients."

"Merkel cell carcinoma is rarer than some of the more well-known skin cancers,

however, it's very aggressive and the proportion of people who die from MCC is

much higher than that of people with melanoma," said Deborah S. Sarnoff, MD,

President of the Skin Cancer Foundation. "With this approval, I believe there

is new hope for people and their families touched by this rare form of skin

cancer."

The efficacy and safety of BAVENCIO was demonstrated in the JAVELIN Merkel 200

trial, an open-label, single-arm, multi-center study conducted in 88 patients

with histologically confirmed metastatic MCC whose disease had progressed on or

after chemotherapy administered for distant metastatic disease. Sixty-five

percent of patients were reported to have had one prior anti-cancer therapy for

metastatic MCC and 35% had two or more prior therapies. The major efficacy

outcome measures were confirmed overall response rate (ORR) according to

Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by a

blinded independent central review committee (IRC) and IRC-assessed duration of

response.

The overall response rate (ORR) was 33% (95% confidence interval [CI]:

23.3-43.8%).[1] Eleven percent of patients experienced a complete response (95%

CI: 6.6-19.9%) and 22% of patients experienced a partial response (95% CI:

13.5-31.7%). Tumor responses were durable, with 86% of responses lasting for at

least six months (n=25).[1] Forty-five percent of responses lasted at least 12

months (n=13).[1] Duration of response ranged from 2.8 to over 23.3 months.

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. The most common adverse reactions (reported in at

least 20% of patients) included fatigue (50%), musculoskeletal pain (32%),

diarrhea (23%), nausea (22%), infusion-related reactions (22%), rash (22%),

decreased appetite (20%) and peripheral edema (20%).[1] For more information,

please see Important Safety Information for BAVENCIO below.

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.[1] BAVENCIO has been shown to induce

antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.[1]

BAVENCIO is available for order now in the US. The alliance is committed to

providing industry-leading patient access and reimbursement support through its

CoverOne(TM) program in the US. This program provides a spectrum of patient access

and reimbursement support services intended to help patients receive

appropriate access to BAVENCIO in the United States.

About JAVELIN Merkel 200