Analyses from the Phase III JAVELIN Renal 101 study support efficacy of 
BAVENCIO plus axitinib across multiple subgroups of patients with advanced 
renal cell carcinoma (RCC) 

Abstracts highlight data on BAVENCIO as a monotherapy and in combination in 
multiple advanced cancers
 
Not intended for US, Canada and UK-based media 

Merck and Pfizer Inc. (NYSE: PFE) today announced the presentation of multiple 
analyses from the JAVELIN clinical development program assessing BAVENCIO (r) 
(avelumab) alone or as part of combination regimens for the treatment of 
advanced cancers, including renal cell carcinoma (RCC), metastatic Merkel cell 
carcinoma (mMCC) and some other solid tumors at the European Society for 
Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain. 

"These data at ESMO underscore the clinical activity of treatment with BAVENCIO 
across multiple tumor types and patient populations," said Chris Boshoff, M.D., 
Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. 
"Furthermore, these presentations demonstrate our commitment to identifying the 
patients most likely to benefit from this immunotherapy as a single agent, or 
in combination approaches." 

"The immunotherapy era has led to vast progress in the treatment of cancer, yet 
we know that many patients with advanced or aggressive cancers still need 
additional treatment options," said Luciano Rossetti, M.D., Executive Vice 
President, Head of Global Research & Development at the Biopharma business of 
Merck. "We are committed to continued research of BAVENCIO as we seek to 
further advance treatment options for patients with certain cancers."

Data to be presented at ESMO include three subgroup analyses of the Phase III 
JAVELIN Renal 101 study (NCT02684006), a randomized, multicenter, open-label 
study of BAVENCIO in combination with axitinib in 886 patients with untreated 
advanced RCC from patients across all International Metastatic RCC Database 
Consortium (IMDC) risk groups. This study, results of which were published in 
The New England Journal of Medicine in February 2019, demonstrated that 
BAVENCIO in combination with axitinib significantly improved progression-free 
survival (PFS) compared with sunitinib in patients with advanced RCC, with a 
generally acceptable safety tolerability profile, including serious adverse 
events.[1]

Results from new analyses of JAVELIN Renal 101 being presented at ESMO, which 
assessed the effect of BAVENCIO in combination with axitinib in subgroups 
including patients who did not undergo cytoreductive nephrectomy, patients with 
sarcomatoid histology, and Japanese patients, are consistent with findings from 
the overall JAVELIN Renal 101 study population and provide a better 
understanding of the combination in a broad range of patients with advanced 
RCC. In May 2019, the U.S. Food and Drug Administration (FDA) approved BAVENCIO 
in combination with axitinib for the first-line treatment of patients with 
advanced RCC.[2] The Committee for Medicinal Products for Human Use (CHMP) of 
the European Medicines Agency (EMA) adopted a positive opinion recommending 
approval of BAVENCIO in combination with axitinib for the first-line treatment 
of adult patients with advanced RCC in September 2019.  

Presentation #908PD: Phase III JAVELIN Renal 101 Study Subgroup Analysis of 
Patients with Advanced RCC who did not Undergo Upfront Cytoreductive Nephrectomy
-Sunday, September 29, 15:20 – 15:20: Pamplona Auditorium (Hall 2)
A post-hoc analysis of JAVELIN Renal 101 evaluated patients with advanced RCC 
who did not undergo prior surgery to remove as much of the visible tumors on 
the kidneys as possible (cytoreductive nephrectomy), which comprised 20.2% of 
participants in the study. The findings showed that patients with advanced RCC 
treated with BAVENCIO in combination with axitinib who did not undergo an 
upfront cytoreductive nephrectomy experienced greater shrinkage of the primary 
renal tumor versus sunitinib (≥30% shrinkage for best percent change in 
renal target lesions from baseline in 34.5% versus 9.7%, respectively).[3] The 
majority of patients with advanced RCC undergo nephrectomy before starting 
systemic treatment,[4] and those who do undergo nephrectomy may experience 
complications or delays in treatment.[5] These results are the first of their 
kind to report the efficacy of an immunotherapy plus a tyrosine kinase 
inhibitor in patients with advanced RCC when there is still a primary tumor 
present.[3]

Presentation #910PD: Phase III JAVELIN Renal 101 Study Subgroup Analysis of 
Patients with Advanced RCC with Sarcomatoid Histology 

- Sunday, September 29, 15:20 – 15:20: Pamplona Auditorium (Hall 2)

A post-hoc analysis of JAVELIN Renal 101 in patients with advanced RCC with 
sarcomatoid histology, an aggressive subtype of RCC[6] that carries the worst 
prognosis for patients with renal tumors,[7],[8] included 12.2% of participants 
in the trial. The results presented at ESMO showed that BAVENCIO plus axitinib 
improved PFS and objective response rate (ORR) versus sunitinib in patients 
with advanced RCC with sarcomatoid histology (median PFS: 7.0 months versus 4.0 
months, HR 0.57 [95% CI, 0.325-1.003]; median ORR: 46.8% versus 21.3%). These 
findings provide insight into the biology of sarcomatoid histology and 
treatment with this immunotherapy in this subgroup of patients.[9]

Presentation #956P: Phase III JAVELIN Renal 101 Study Subgroup Analysis of 
Japanese Patients with Advanced RCC
  
- Monday, September 30, 12:20 - 12:20: Poster Area (Hall 4)

An analysis assessing the efficacy and safety of Japanese patients with 
advanced RCC (n=67) in JAVELIN Renal 101 study showed that BAVENCIO in 
combination with axitinib improved median PFS compared to sunitinib in Japanese 
patients with advanced RCC regardless of PD-L1 expression (16.6 months versus 
11.2 months, respectively; HR, 0.66; [95% CI, 0.30-1.46]). Common 
treatment-emergent adverse events (grade ≥3) in each arm included 
hand-foot syndrome (9% versus 9%), hypertension (30% versus 18%), and platelet 
count decreased (0% versus 32%).[10] A supplemental application for BAVENCIO in 
combination with axitinib in unresectable or metastatic RCC was submitted in 
Japan in January 2019.
 
Additional presentations at ESMO show the potential impact of BAVENCIO as a 
monotherapy and as a component of novel combinations:

- An analysis of health-related quality of life (HRQoL) from the Phase II 
JAVELIN Merkel 200 study, in which patients with mMCC, an aggressive form of 
skin cancer with poor outcomes,[11] treated with BAVENCIO reported stable or 
improved HRQoL across various time points (presentation #1320P).[12] 
- Interim results from the Phase Ib JAVELIN IL-12 study evaluating BAVENCIO in 
combination with M9241, Merck's investigational IL-12 fusion protein containing 
an anti-DNA antibody, in patients with solid tumors, which informed the 
recommended dosing for Phase II of this study (presentation #1224P).[13]
- Post-hoc analyses from the JAVELIN Solid Tumor Phase I trial (presentation 
#1493P)14 and Phase III JAVELIN Lung 200 study (presentation #1492P)15 that 
further elucidate the effects of BAVENCIO in patients with advanced non-small 
cell lung cancer. 

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.[16]-[18] BAVENCIO has also 
been shown to induce NK cell-mediated direct tumor cell lysis via 
antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.[18]-[20] In 
November 2014, Merck and Pfizer announced a strategic alliance to co-develop 
and co-commercialize BAVENCIO. 

BAVENCIO Approved Indications

In September 2017, the European Commission granted conditional marketing 
authorization for BAVENCIO (R) (avelumab) as a monotherapy for the treatment of 
adult patients with metastatic Merkel cell carcinoma (MCC). BAVENCIO 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.

In the US, BAVENCIO in combination with axitinib is indicated for the 
first-line treatment of patients with advanced renal cell carcinoma (RCC). 
Additionally, the US 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 Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO (r)) include 
immune-mediated adverse reactions (such as pneumonitis and hepatitis, colitis, 
endocrinopathies, nephritis and renal dysfunction and other adverse reactions), 
infusion-related reactions, hepatotoxicity, major adverse cardiovascular events 
(MACE), and embryo-fetal toxicity.

The most common adverse reactions (all grades, ≥ 20%) in patients with 
metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain 
(32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash 
(22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, ≥ 20%) 
in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased 
aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine 
aminotransferase (20%).

The most common adverse reactions (all grades, ≥ 20%) in patients with 
locally advanced or metastatic urothelial carcinoma (UC) were fatigue (41%), 
infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), 
decreased appetite/hypophagia (21%), and urinary tract infection (21%).

Selected laboratory abnormalities (Grades 3-4, ≥ 3%) in patients with 
locally advanced or metastatic UC were hyponatremia (16%), increased 
gamma-glutamyltransferase (12%), lymphopenia (11%), hyperglycemia (9%), 
increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), 
hyperkalemia (3%), and increased aspartate aminotransferase (3%).

Fatal adverse reactions in patients occurred in 1.8% of patients with advanced 
renal cell carcinoma (RCC) receiving BAVENCIO in combination with axitinib. 
These included sudden cardiac death (1.2%), stroke (0.2%), myocarditis (0.2%), 
and necrotizing pancreatitis (0.2%).

The most common adverse reactions (all grades, ≥20%) in patients with 
advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) 
were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), 
musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), 
palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), 
decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 
16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), 
abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities (all grades, ≥20%) worsening from 
baseline in patients with advanced RCC receiving BAVENCIO in combination with 
axitinib (vs sunitinib) were blood triglycerides increased (71% vs 48%), blood 
creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), 
alanine aminotransferase increased (ALT) (50% vs 46%), aspartate 
aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 
37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), 
platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), 
and hemoglobin decreased (21% vs 65%).

Axitinib Important Safety Information from the US FDA-Approved Label

In the study of advanced RCC after failure of one prior systemic therapy, the 
warnings and precautions for axitinib include hypertension, including 
hypertensive crisis, arterial and venous thrombotic events, hemorrhagic events, 
cardiac failure, gastrointestinal perforation and fistula, hypothyroidism, 
wound healing complications, reversible posterior leukoencephalopathy syndrome 
(RPLS), proteinuria, liver enzyme elevation, hepatic impairment and fetal harm 
during pregnancy.

Common adverse events (reported in at least 20% of patients) in patients 
receiving axitinib were diarrhea, hypertension, fatigue, decreased appetite, 
nausea, dysphonia, hand-foot syndrome, weight decreased, vomiting, asthenia and 
constipation.

About Merck-Pfizer Alliance

Immuno-oncology is a top priority for Merck and Pfizer. The global strategic 
alliance between Merck 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. 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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Pfizer Disclosure Notice

The information contained in this release is as of September 27, 2019. Pfizer 
assumes no obligation to update forward-looking statements contained in this 
release as the result of new information or future events or developments.
This release contains forward-looking information about BAVENCIO (avelumab), 
including a new indication approved in the U.S. for BAVENCIO in combination 
with axitinib for the treatment of patients with advanced renal cell carcinoma, 
the alliance between Merck and Pfizer involving BAVENCIO and clinical 
development plans, including their potential benefits, that involves 
substantial risks and uncertainties that could cause actual results to differ 
materially from those expressed or implied by such statements. Risks and 
uncertainties include, among other things, uncertainties regarding the 
commercial success of BAVENCIO and axitinib; the uncertainties inherent in 
research and development, including the ability to meet anticipated clinical 
endpoints, commencement and/or completion dates for our clinical trials, 
regulatory submission dates, regulatory approval dates and/or launch dates, as 
well as the possibility of unfavorable new clinical data and further analyses 
of existing clinical data and uncertainties regarding whether the other primary 
endpoint of JAVELIN Renal 101 will be met; risks associated with interim data; 
the risk that clinical trial data are subject to differing interpretations and 
assessments by regulatory authorities; whether regulatory authorities will be 
satisfied with the design of and results from our clinical studies; whether and 
when any drug applications may be filed for BAVENCIO in combination with 
axitinib in any other jurisdictions or in any jurisdictions for any other 
potential indications for BAVENCIO or combination therapies; whether and when 
the pending applications in the European Union and Japan for BAVENCIO in 
combination with axitinib may be approved and whether and when regulatory 
authorities in any jurisdictions where any other applications are pending or 
may be submitted for BAVENCIO or combination therapies, including BAVENCIO in 
combination with axitinib may approve any such applications, which will depend 
on myriad factors, including making a determination as to whether the product's 
benefits outweigh its known risks and determination of the product's efficacy, 
and, if approved, whether they will be commercially successful; decisions by 
regulatory authorities impacting labeling, manufacturing processes, safety 
and/or other matters that could affect the availability or commercial potential 
of BAVENCIO or combination therapies, including BAVENCIO in combination with 
axitinib; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's 
Annual Report on Form 10-K for the fiscal year ended December 31, 2018, and in 
its subsequent reports on Form 10-Q, including in the sections thereof 
captioned "Risk Factors" and "Forward-Looking Information and Factors That May 
Affect Future Results", as well as in its subsequent reports on Form 8-K, all 
of which are filed with the U.S. Securities and Exchange Commission and 
available at www.sec.gov and www.pfizer.com.

References

1. Motzer R, et al. Avelumab plus axitinib versus sunitinib for advanced 
renal-cell carcinoma. N Engl J Med 2019; 380:1103-1115 
2. BAVENCIO Prescribing Information. Rockland, MA: EMD Serono Inc.; 2019. 
3. Albiges L, et al. Primary renal tumour shrinkage in patients (pts) who did 
not undergo upfront cytoreductive nephrectomy (uCN): subgroup analysis from the 
phase 3 JAVELIN Renal 101 trial of first-line avelumab + axitinib (A + Ax) vs 
sunitinib (S) for advanced renal cell carcinoma (aRCC). Annals of Oncology. 
2019. TBD. 
4. Culp S. Cytoreductive nephrectomy and its role in the present-day period of 
targeted therapy. Ther Adv Urol. 2015;7(5):275-285. 
5. Silberstein J, et al. Systemic classification and prediction of 
complications after nephrectomy in patients with metastatic renal cell 
carcinoma (RCC). BJU Int. 2012;110(9):1276-1282. 
6. Pichler, Renate et al. "Renal Cell Carcinoma with Sarcomatoid Features: 
Finally New Therapeutic Hope?" Cancers. 2019;11(3):422. 
7. Al-Juhaishi, T et al. "Survival outcomes in sarcomatoid renal cell 
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advanced renal cell carcinoma (aRCC) with sarcomatoid histology (sRCC): 
subgroup analysis from the phase 3 JAVELIN Renal 101 trial of first-line 
avelumab plus axitinib (A+ Ax) vs sunitinib (S). Annals of Oncology. 2019. TBD. 
10. Uemura M, et al. Randomized phase 3 trial of avelumab + axitinib vs 
sunitinib as first-line treatment for advanced renal cell carcinoma: JAVELIN 
Renal 101 Japanese subgroup analysis. Annals of Oncology. 2019. TBD. 
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12. D'Angelo S, et al. Health-related quality of life in patients with 
metastatic Merkel cell carcinoma receiving second-line or later avelumab 
treatment: 36-month follow up data. Annals of Oncology. 2019. TBD. 
13. Strauss J, et al. Phase 1b, open-label, dose-escalation study of M9241 
(NHS-IL12) plus avelumab in patients (pts) with advanced solid tumors. Annals 
of Oncology. 2019. TBD. 
14. Hrinczenko B, et al. Long-term avelumab treatment in patients with advanced 
non-small cell lung cancer (NSCLC): post hoc analyses from JAVELIN Solid Tumor. 
Annals of Oncology. 2019. TBD. 
15. Barlesi F, et al. Assessing the impact of subsequent checkpoint inhibitor 
(CPI) treatment on overall survival: post hoc analyses from the phase 3 JAVELIN 
Lung 200 study of avelumab vs docetaxel in platinum-treated locally 
advanced/metastatic non-small cell lung cancer (NSCLC). Annals of Oncology. 
2019. TBD. 
16. Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the landscape of 
cancer immunotherapy. Cancer Control. 2014;21(3):231-237. 
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activity of antibodies targeting the PD-1/PD-L1 axis. Cancer Cell. 
2015;28(3):285-295. 
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cytotoxicity activity of a novel anti-PD-L1 antibody avelumab (MSB0010718C) on 
human tumor cells. Cancer Immunol Res. 2015;3(10):1148-1157. 
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