New Data for BAVENCIO® (avelumab) for Advanced Cancers to Be Presented at ESMO 2019

Not intended for US, Canada and UK-based media

DARMSTADT, Germany, and NEW YORK, Sept. 27, 2019 /PRNewswire/ -- Merck and Pfizer Inc. today announced the presentation of multiple analyses from the JAVELIN clinical development program assessing BAVENCIO(®) (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(®) (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(®)) 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.

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