Authorization

Pivotal Phase III Data for BAVENCIO (avelumab) Plus INLYTA (axitinib) in Advanced Renal Cell Carcinoma Published in the New England Journal of Medicine

DARMSTADT, Germany and NEW YORK, Feb. 16, 2019 /PRNewswire/ --

JAVELIN Renal 101 shows significant improvement in progression-free survival with a hazard ratio of 0.69 in patients regardless of PD-L1 expression



US FDA has granted Priority ReviewAto BAVENCIO plus INLYTA for patients with advanced renal cell carcinoma



Data at 2019 Genitourinary Cancers Symposium reinforce consistency of PFS and ORR benefits across broad population of patients with advanced RCC, including all prognostic risk groups, and show increased time to progression on next-line therapy

Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada,Aand Pfizer Inc. (NYSE: PFE) today announced the publication of results from an interim analysis of the pivotal JAVELIN Renal 101 trial online in the New England Journal of Medicine.1AThe combination of BAVENCIOA (avelumab) and INLYTAA (axitinib)* significantly extended median progression-free survival (PFS) by more than five months compared with SUTENTA (sunitinib) as a first-line treatment for patients with advanced renal cell carcinoma (RCC), irrespective of PD-L1 expression (HR: 0.69 [95% CI: 0.56a??0.84]; BAVENCIO+INLYTA: 13.8 months [95% CI: 11.1-NE]; SUTENT: 8.4 months [95% CI: 6.9-11.1]; p<0.001). Further, the objective response rate (ORR) was doubled with BAVENCIO+INLYTA versus SUTENT in this population (51.4% [95% CI: 46.6-56.1] vs. 25.7% [95% CI: 21.7-30.0]). The study is continuing for the other primary endpoint of overall survival (OS). "There is a significant need for patients with advanced RCC to prolong the time until the disease worsens beyond what tyrosine kinase inhibitors alone offer," said Robert J. Motzer, M.D., Jack and Dorothy Byrne Chair in Clinical Oncology, Memorial Sloan Kettering Cancer Center, New York, US, and principal investigator for JAVELIN Renal 101. "The magnitude and consistency of PFS and response rates seen thus far across populations in the JAVELIN Renal 101 study suggest that many different types of patients, including those with a favorable prognosis, could potentially derive benefit from this particular combination." Additional data presented today at the 2019 Genitourinary Cancers Symposium reinforce the consistency of the PFS and ORR results across patient subgroups, including patients with favorable, intermediate and poor prognoses as well as those with PD-L1-positive or negative tumors. In subgroup analyses, approximately two-thirds of patients with favorable risk (66% of patients using the Memorial Sloan Kettering Cancer Center risk model and 68% with the International Metastatic Renal Cell Carcinoma Database Consortium risk model) achieved a complete or partial response with BAVENCIO+INLYTA. Median PFS for these patients is not yet estimable. BAVENCIO+INLYTAAalso extended median PFS2, defined as the time from randomization to disease progression on next-line therapy (HR: 0.56 [95% CI: 0.42-0.74]; NE [95% CI: 19.9-NE] vs. 18.4 months [95% CI: 15.7-23.6]) and increased median duration of response by more than four months (95% CI: 2.9-5.1) in the overall population. "In this study, the combination of avelumab plus axitinib not only prolonged the initial response in treated patients compared to sunitinib, but for patients who went on to subsequent therapy, reduced the risk of disease progression or death on the next treatment," said Toni K. Choueiri, M.D., Director of the Lank Center for Genitourinary Oncology at Dana-Farber, Boston, US, senior and co-corresponding author of JAVELIN Renal 101, and presenter. "Together with the progression-free survival results and objective response rates, these findings show the potential of this combination regimen to be an important new treatment option for patients with advanced RCC."The Phase III JAVELIN Renal 101 study is evaluating the combination of BAVENCIO+INLYTA compared with SUTENT in 886 patients with previously untreated advanced RCC. BAVENCIO+INLYTA significantly reduced the risk of disease progression or death by 39% in patients with PD-L1-positive (a??1%) tumors, a primary endpoint (HR: 0.61 [95% CI: 0.47a??0.79], p80 kinases) and was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRI and PDGFRI?), vascular endothelial growth factor receptors (VEGFR1, VEGFR2 and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor Type 1 (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET).SUTENT is indicated in the US for the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate; the treatment of advanced RCC; the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy; and the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease.SUTENT Important Safety InformationBoxed Warning/Hepatotoxicity has been observed in clinical trials and postmarketing experience. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended.AFatal liver failure has been observed. Monitor liver function tests before initiation of treatment, during each cycle of treatment, and as clinically indicated. Interrupt SUTENT for Grade 3 or 4 drug-related hepatic adverse reactions and discontinue if there is no resolution. Do not restart SUTENT if patients subsequently experience severe changes in liver function tests or have signs and symptoms of liver failure.Cardiovascular events,Aincluding myocardial ischemia, myocardial infarction, left ventricular ejection fraction declines to below the lower limit of normal and cardiac failure including death have occurred. Monitor patients for signs and symptoms of congestive heart failure. Discontinue SUTENT for clinical manifestations of congestive heart failure. In patients without cardiac risk factors, a baseline evaluation of ejection fraction should be considered. Baseline and periodic evaluations of left ventricular ejection fraction should also be considered while these patients are receiving SUTENT.SUTENT can causeAQT ProlongationAin a dose-dependent manner, which may lead to an increased risk for ventricular arrhythmias includingATorsades de Pointes, which has been seen in <0.1% of patients. Monitor patients that are at a higher risk for developing QT interval prolongation, including those with a history of QT interval prolongation, patients who are taking antiarrhythmics, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances. Consider monitoring of electrocardiograms and electrolytes. Concomitant treatment with strong CYP3A4 inhibitors may increase sunitinib plasma concentrations and dose reduction of SUTENT should be considered. HypertensionAmay occur. Monitor blood pressure and treat as needed with standard antihypertensive therapy. In cases of severe hypertension, temporary suspension of SUTENT is recommended until hypertension is controlled.Hemorrhagic events, including tumor-related hemorrhage, and viscus perforation (both with fatal events) have occurred. These events may occur suddenly, and in the case of pulmonary tumors, may present as severe and life-threatening hemoptysis or pulmonary hemorrhage. Perform serial complete blood counts (CBCs) and physical examinations.Cases ofAtumor lysis syndrome (TLS)A(some fatal) have been reported. Patients generally at risk of TLS are those with high tumor burden prior to treatment. Monitor these patients closely and treat as clinically indicated.Thrombotic microangiopathy (TMA),Aincluding thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, sometimes leading to renal failure or a fatal outcome, has been reported in patients who received SUTENT as monotherapy and in combination with bevacizumab. Discontinue SUTENT in patients developing TMA. Reversal of the effects of TMA has been observed after treatment was discontinued.Proteinuria and nephrotic syndrome have been reported. Some of these cases have resulted in renal failure and fatal outcomes. Monitor patients for the development or worsening of proteinuria. Perform baseline and periodic urinalysis during treatment, with follow-up measurement of 24-hour urine protein as clinically indicated. Interrupt treatment for 24-hour urine protein a??3 grams. Discontinue for repeat episodes of protein a??3 grams despite dose reductions or nephrotic syndrome.Dermatologic toxicities:ASevere cutaneous reactions have been reported, including cases of necrotizing fasciitis, erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), some of which were fatal. If signs or symptoms of EM, SJS, or TEN are present, discontinue SUTENT treatment. If a diagnosis of SJS or TEN is suspected, treatment must not be restarted.Necrotizing fasciitis,Aincluding fatal cases, has been reported, including of the perineum and secondary to fistula formation. Discontinue SUTENT in patients who develop necrotizing fasciitis.Thyroid dysfunctionAmay occur. Monitor thyroid function in patients with signs and/or symptoms suggestive of thyroid dysfunction, including hypothyroidism, hyperthyroidism, and thyroiditis, and treat per standard medical practice.HypoglycemiaAmay occur. SUTENT can result in symptomatic hypoglycemia, which may lead to a loss of consciousness or require hospitalization. Reductions in blood glucose levels may be worse in patients with diabetes. Check blood glucose levels regularly during and after discontinuation of treatment with SUTENT. Assess if antidiabetic drug dosage needs to be adjusted to minimize the risk of hypoglycemia.AOsteonecrosis of the jaw (ONJ)Ahas been reported. Consider preventive dentistry prior to treatment with SUTENT. If possible, avoid invasive dental procedures, particularly in patients receiving intravenous bisphosphonate therapy.Impaired wound healingAhas occurred with SUTENT. Temporary interruption of therapy with SUTENT is recommended in patients undergoing major surgical procedures. There is limited clinical experience regarding the timing of reinitiation of therapy following major surgical intervention. Therefore, the decision to resume SUTENT therapy following a major surgical intervention should be based upon clinical judgment of recovery from surgery.AEmbryo fetal toxicity and reproductive potential FemalesA- SUTENT can cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with SUTENT and for 4 weeks following the final dose.MalesA- Based on findings in animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment with SUTENT and for 7 weeks after the last dose.Male and female infertilityA- based on findings in animals, male and female fertility may be compromised by treatment with SUTENTLactation: Because of the potential for serious adverse reactions in breastfed infants from SUTENT, advise a lactating woman not to breastfeed during treatment with SUTENT and for at least 4 weeks after the last dose.VenousAthromboembolic events:AIn patients treated with SUTENT (N=7527) for GIST, advanced RCC, adjuvant treatment of RCC and pNET, 3.5% of patients experienced a venous thromboembolic event; 2.2% Grade 3-4.There have been (<1%) reports, some fatal, of subjects presenting with seizures and radiological evidence ofAreversible posterior leukoencephalopathy syndrome (RPLS).APatients with seizures and signs/symptoms consistent with RPLS, such as hypertension, headache, decreased alertness, altered mental functioning, and visual loss, including cortical blindness, should be controlled with medical management including control of hypertension. Temporary suspension of SUTENT is recommended; following resolution, treatment may be resumed at the discretion of the treating healthcare provider.Pancreatic function:AIn a trial of patients receiving adjuvant treatment for RCC, 1 patient (<1%) on SUTENT and none on placebo experienced pancreatitis.CYP3A4 inhibitors and inducers:ADose adjustments are recommended when SUTENT is administered with CYP3A4 inhibitors or inducers. During treatment with SUTENT, patients should not drink grapefruit juice, eat grapefruit, or take St. John's Wort.AMost common ARs & most common grade 3/4 ARs (adjuvant RCC):AThe most common ARs reported in a??20% of patients receiving SUTENT for adjuvant treatment of RCC and more commonly than in patients given placebo (all grades, vs placebo) were mucositis/stomatitis (61% vs 15%), diarrhea (57% vs 22%), fatigue/asthenia (57% vs 34%), hand-foot syndrome (50% vs 10%), hypertension (39% vs 14%), altered taste (38% vs 6%), nausea (34% vs 15%), dyspepsia (27% vs 7%), abdominal pain (25% vs 9%), hypothyroidism/TSH increased (24% vs 4%), rash (24% vs 12%), hair color changes (22% vs 2%). The most common grade 3/4 ARs reported in a??5% of patients receiving SUTENT for adjuvant treatment of RCC and more commonly than in patients given placebo (vs placebo) were hand-foot syndrome (16% vs <1%), fatigue/asthenia (8% vs 2%), hypertension (8% vs 1%), and mucositis/stomatitis (6% vs 0%).Most common grade 3/4 lab abnormalities (adjuvant RCC): The most common grade 3/4 lab abnormalitiesA(occurring in a?? 2% of patients receiving SUTENT) included neutropenia (13%), thrombocytopenia (5%), leukopenia (3%), lymphopenia (3%), elevated alanine aminotransferase (2%), elevated aspartate aminotransferase (2%), hyperglycemia (2%), and hyperkalemia (2%).Most common ARs & most common grade 3/4 ARs (advanced RCC): TheAmost common ARs reported in a??20% of patients receiving SUTENT for treatment-naA?ve metastatic RCC (all grades, vs IFNI) were diarrhea (66% vs 21%), fatigue (62% vs 56%), nausea (58% vs 41%), anorexia (48% vs 42%), altered taste (47% vs 15%), mucositis/stomatitis (47% vs 5%), pain in extremity/limb discomfort (40% vs 30%), vomiting (39% vs 17%), bleeding, all sites (37% vs 10%), hypertension (34% vs 4%), dyspepsia (34% vs 4%), arthralgia (30% vs 19%), abdominal pain (30% vs 12%), rash (29% vs 11%), hand-foot syndrome (29% vs 1%), back pain (28% vs 14%), cough (27% vs 14%), asthenia (26% vs 22%), dyspnea (26% vs 20%), skin discoloration/yellow skin (25% vs 0%), peripheral edema (24% vs 5%), headache (23% vs 19%), constipation (23% vs 14%), dry skin (23% vs 7%), fever (22% vs 37%), and hair color changes (20% vs <1%). TheAmost common grade 3/4 ARsAreported in a??5% of patients with RCC receiving SUTENT (vs IFNI) were fatigue (15% vs 15%), hypertension (13% vs <1%), asthenia (11% vs 6%), diarrhea (10% vs <1%), hand-foot syndrome (8% vs 0%), dyspnea (6% vs 4%), nausea (6% vs 2%), back pain (5% vs 2%), pain in extremity/limb discomfort (5% vs 2%), vomiting (5% vs 1%), and abdominal pain (5% vs 1%). Most common grade 3/4 lab abnormalities (advanced RCC):ATheAmost common grade 3/4 lab abnormalities (occurring in a??5% of patients with RCC receiving SUTENT vs IFNI) included lymphocytes (18% vs 26%), lipase (18% vs 8%), neutrophils (17% vs 9%), uric acid (14% vs 8%), platelets (9% vs 1%), hemoglobin (8% vs 5%), sodium decreased (8% vs 4%), leukocytes (8% vs 2%), glucose increased (6% vs 6%), phosphorus (6% vs 6%), and amylase (6% vs 3%).Most common ARs & most common grade 3/4 ARs (imatinib-resistant or -intolerant GIST):ATheAmost common ARsAreported in a??20% of patients with GIST and more commonly with SUTENT than placebo (all grades, vs placebo) were diarrhea (40% vs 27%), anorexia (33% vs 29%), skin discoloration (30% vs 23%), mucositis/stomatitis (29% vs 18%), asthenia (22% vs 11%), altered taste (21% vs 12%), and constipation (20% vs 14%). TheAmost common grade 3/4 ARs reported in a??4% of patients with GIST receiving SUTENT (vs placebo) were asthenia (5% vs 3%), hand-foot syndrome (4% vs 3%), diarrhea (4% vs 0%), and hypertension (4% vs0%).Most common grade 3/4 lab abnormalities (imatinib-resistant or - intolerant GIST):ATheAmost common grade 3/4 lab abnormalitiesA(occurring in a??5% of patients with GIST receiving SUTENT vs placebo) included lipase (10% vs 7%), neutrophils (10% vs 0%), amylase (5% vs 3%), and platelets (5% vs 0%).Most common ARs & most common grade 3/4 ARs (advanced pNET): TheAmost common ARs reported in a??20% of patients with advanced pNET and more commonly with SUTENT than placebo (all grades, vs placebo) were diarrhea (59% vs 39%), stomatitis/oral syndromes (48% vs 18%), nausea (45% vs 29%), abdominal pain (39% vs 34%), vomiting (34% vs 31%), asthenia (34% vs 27%), fatigue (33% vs 27%), hair color changes (29% vs 1%), hypertension (27% vs 5%), hand-foot syndrome (23% vs 2%), bleeding events (22% vs 10%), epistaxis (21% vs 5%), and dysgeusia (21% vs 5%).AThe most common grade 3/4 ARsAreported in a??5% of patients with advanced pNET receiving SUTENT (vs placebo) were hypertension (10% vs 1%), hand-foot syndrome (6% vs 0%), stomatitis/oral syndromes (6% vs 0%), abdominal pain (5% vs 10%), fatigue (5% vs 9%), asthenia (5% vs 4%), and diarrhea (5% vs 2%).Most common grade 3/4 lab abnormalities (advanced pNET):ATheAmost common grade 3/4 lab abnormalities (occurring in a??5% of patients with advanced pNET receiving SUTENT vs placebo) included decreased neutrophils (16% vs 0%), increased glucose (12% vs 18%), increased alkaline phosphatase (10% vs 11%), decreased phosphorus (7% vs 5%), decreased lymphocytes (7% vs 4%), increased creatinine (5% vs 5%), increased lipase (5% vs 4%), increased AST (5% vs 3%), and decreased platelets (5% vs 0%). Please see full Prescribing Information, including BOXED WARNING and Medication Guide, for SUTENTA (sunitinib malate) at www.SUTENT.com.Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany, and Pfizer. The global strategic alliance between Merck KGaA, Darmstadt, Germany, 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 MerckAKGaA, Darmstadt, Germany. 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. All MerckAKGaA, Darmstadt, Germany, Press Releases are distributed by e-mail at the same time they become available on the MerckAKGaA, Darmstadt, Germany, Website. Please go to www.emdgroup.com/subscribe to register online, change your selection or discontinue this service. About Merck KGaA, Darmstadt, GermanyMerck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 51,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices a?? the company is everywhere. In 2017, Merck KGaA, Darmstadt, Germany, generated sales of a? 15.3 billion in 66 countries.The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.Pfizer Inc.: Working together for a healthier worldAAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website atAwww.pfizer.com. In addition, to learn more, please visit us onAwww.pfizer.comAand follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.Pfizer Disclosure NoticeThe information contained in this release is as of February 16, 2019. Pfizer assumes no obligation to update forward-looking statementsAcontained 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 potential new indication for BAVENCIO in combination with INLYTA (axitinib) for the treatment of patients with advanced renal cell carcinoma, the alliance between Merck KGaA, Darmstadt, Germany, 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; 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 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 whenAany drug applications may be filed for BAVENCIOA in combination with INLYTA for the potential new indication 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 U.S. and Japan for BAVENCIO in combination with INLYTA for the potential new indication 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 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 and/or other matters that could affect the availability or commercial potential of BAVENCIO or combination therapies, including BAVENCIO in combination with INLYTA for the potential new indication; 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, 2017, 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

Motzer R, Penkov K, Haanen J, et al. Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. NEJM. February 16, 2019. Published online ahead of print.A



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Escudier B, Porta C, Schmidinger M et al Renal cell carcinoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Annal Oncol. 2014; 25(Suppl3):iii49-iii56.



American Cancer Society. Cancer facts and figures 2019. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2019/cancer-facts-and-figures-2019.pdf. Accessed February 2019.



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Boyerinas B, Jochems C, Fantini M, et al. Antibody-dependent cellular 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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Pivotal Phase III Data for BAVENCIO (avelumab) Plus INLYTA (axitinib) in Advanced Renal Cell Carcinoma Published in the New England Journal of Medicine


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Pivotal Phase III Data for BAVENCIO (avelumab) Plus INLYTA (axitinib) in Advanced Renal Cell Carcinoma Published in the New England Journal of Medicine
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