CHMP Adopts Positive Opinion for BAVENCIO® (avelumab) Plus Axitinib for First-Line Treatment of Patients with Advanced Renal Cell Carcinoma - Seite 2

"Kidney cancer represents a significant burden in Europe, where
incidence rates are among the highest in the world," said Chris
Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer
Global Product Development. "Pfizer has been a leader in the
development of kidney cancer treatments for more than a decade, and
it is a privilege to continue our efforts to bring a new treatment
option to this community."

The U.S. Food and Drug Administration (FDA) approved BAVENCIO in
combination with axitinib for the first-line treatment of patients
with advanced RCC in May 2019.10 A supplemental application for
BAVENCIO in combination with axitinib in unresectable or metastatic
RCC was submitted in Japan in January 2019.

About the JAVELIN Renal 101 Study

The Phase III JAVELIN Renal 101 study is a randomized,
multicenter, open-label study of BAVENCIO in combination with
axitinib in 886 patients with untreated advanced or metastatic RCC.
The major efficacy outcome measures were PFS as assessed by a Blinded
Independent Central Review (BICR) using RECIST v1.1 and overall
survival (OS) in the first-line treatment of patients with advanced
RCC who have PD-L1-positive tumors (PD-L1 expression level >=1%). If
PFS was statistically significant in patients with PD-L1-positive
tumors, it was then tested in all patients irrespective of PD-L1
expression. PFS based on BICR assessment per RECIST v1.1 and OS
irrespective of PD-L1 expression, objective response, time to
response (TTR), duration of response (DOR) and safety are included as
secondary endpoints. The study is continuing for OS.

About the JAVELIN Clinical Development Program

The clinical development program for avelumab, known as JAVELIN,
involves at least 30 clinical programs and more than 10,000 patients
evaluated across more than 15 different tumor types. In addition to
RCC, these tumor types include gastric/gastro-esophageal junction
cancer, head and neck cancer, Merkel cell carcinoma, non-small cell
lung cancer and urothelial carcinoma.

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.11-13 BAVENCIO has also been shown to
induce NK cell-mediated direct tumor cell lysis via
antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.13-15