In March 2018, Eisai and Merck, known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. INDICATIONS for LYNPARZA in the United States. The most frequently reported hemorrhagic events (all grades and occurring in at least 5% of patients) were epistaxis and hematuria. The most common adverse reactions (20%) in patients receiving KEYTRUDA in combination with chemotherapy were fatigue (48%), nausea (44%), alopecia (34%), diarrhea and constipation (28% each), vomiting and rash (26% each), cough (23%), decreased appetite (21%), and headache (20%). Dose interruptions of LENVIMA, pembrolizumab, or both due to an adverse reaction occurred in 78% of patients receiving LENVIMA in combination with pembrolizumab. KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. Dose reductions of LENVIMA due to adverse reactions occurred in 67% of patients. Use of WELIREG may reduce the efficacy of hormonal contraceptives. The most common serious adverse reactions (2%) were pneumonia (4%), hypertension (3%), and dehydration (3%). V. Makker. Abstracts | ESMO Congress 2022 The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (1%) were pneumonitis (1.6%), acute kidney injury (1.1%), and pneumonia (1.1%). The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. Serious adverse reactions occurred in 16% of patients; those 1% were pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. In KEYNOTE-811, when KEYTRUDA was administered in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 6% of 217 patients with locally advanced unresectable or metastatic HER2+ gastric or GEJ adenocarcinoma. Merck to Present New Data at ESMO 2022 Congress From Its Broad Oncology Portfolio and Promising Pipeline, Demonstrating Commitment to Improving Long-Term Survival in Multiple Types of Cancer - Merck.com Media > News releases > News release Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Let's share, debate and celebrate all the new developments that we can bring to our practice. The most common (2%) adverse reactions leading to interruption of LENVIMA were hypertension (11%), diarrhea (11%), proteinuria (6%), decreased appetite (5%), vomiting (5%), increased alanine aminotransferase (3.5%), fatigue (3.5%), nausea (3.5%), abdominal pain (2.9%), weight decreased (2.6%), urinary tract infection (2.6%), increased aspartate aminotransferase (2.3%), asthenia (2.3%), and palmar-plantar erythrodysesthesia (2%). Pembrolizumab With Or Without Chemotherapy For First-Line Treatment Of Recurrent/Metastatic (R/M) Head And Neck Squamous Cell Carcinoma (HNSCC): 5-Year Results From KEYNOTE-048. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. LENVIMA concentrations may increase in patients with DTC, RCC, or EC and severe (CLcr 15-29 mL/min) renal impairment. In Study 004, hypoxia occurred in 1.6% of patients. WELIREG can render some hormonal contraceptives ineffective. Abstract submission is free of charge and must be completed online only via the ESMO website. ADVERSE REACTIONSFirst-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab. Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. The most common adverse reactions (20%) were fatigue (29%), diarrhea (24%), and rash (24%). Control blood pressure prior to initiation. KEYTRUDA, as a single agent, is indicated for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. P. Hammel. KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%). In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose. Monitor electrocardiograms in patients with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, or those who are taking drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics. About KEYTRUDA (pembrolizumab) injection, 100 mg. KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. The incidence is higher in patients who have received prior thoracic radiation. WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Most common laboratory abnormalities (Grades 1-4) in 25% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%). Consequently, the company will not update the information contained in the website and investors should not rely upon the information as current or accurate after the presentation date. PD-L1 Expression and Outcomes Of Pembrolizumab And Placebo In Completely Resected Stage IB-IIIA NSCLC: Subgroup Analysis Of PEARLS/KEYNOTE-091. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials. Withhold or permanently discontinue KEYTRUDA depending on severity. For patients with hemoglobin (Hb) <9g/dL, withhold WELIREG until Hb9g/dL, then resume at reduced dose or permanently discontinue depending on the severity of anemia. Females and Males of Reproductive Potential. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. EmbryoFetal Toxicity. Serious adverse reactions occurred in 44% of patients receiving KEYTRUDA; those 2% were febrile neutropenia (15%), pyrexia (3.7%), anemia (2.6%), and neutropenia (2.2%). Osteonecrosis of the Jaw (ONJ). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) 1] as determined by an FDA-approved test. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose. This indication is approved under accelerated approval based on tumor response rate and durability of response. None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients. J. Rosenberg. Fistula Formation and Gastrointestinal Perforation. Meeting programme Next/upcoming meetings Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys Annual Report on Form 10-K for the year ended December 31, 2022 and the companys other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site (www.sec.gov). The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr 30 mL/min). Advise patients to report signs and symptoms of hypoxia immediately to a healthcare provider. Study EV-103 Cohort K: Antitumor Activity Of Enfortumab Vedotin (EV) Monotherapy Or In Combination With Pembrolizumab (P) In Previously Untreated Cisplatin-Ineligible Patients (Pts) With Locally Advanced Or Metastatic Urothelial Cancer (la/mUC). The most common adverse reaction leading to discontinuation of KEYTRUDA (1%) was increased ALT (1.2%). Let's share, debate and celebrate all the new developments that we can bring to our practice. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. Across clinical trials in 799 patients with DTC, RCC, and HCC, grade 3 or higher cardiac dysfunction occurred in 3% of LENVIMA-treated patients. KEYTRUDA in combination with axitinib can cause hepatic toxicity. Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding. The most common adverse reactions (2%) resulting in permanent discontinuation of KEYTRUDA, LENVIMA, or the combination were pneumonitis (3%), myocardial infarction, hepatotoxicity, acute kidney injury, and rash (3% each), and diarrhea (2%). Abstract Book of ESMO Breast Cancer 2022, Berlin, Germany, 03-05 May 2022 Publication of this Abstract book is supported by the European Society for Medical Oncology Volume 33, Supplement 3, R. Finn. Increased Mortality in Patients With Multiple Myeloma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Monitor blood pressure after 1 week, then every 2 weeks for the first 2 months, and then at least monthly thereafter during treatment. Lenvatinib also exhibited antiproliferative activity in hepatocellular carcinoma cell lines dependent on activated FGFR signaling with a concurrent inhibition of FGF-receptor substrate 2 (FRS2) phosphorylation. For patients treated with KEYTRUDA in combination with chemotherapy with or without bevacizumab, the most common adverse reactions (20%) were peripheral neuropathy (58%), alopecia (56%), fatigue (47%), nausea (40%), diarrhea (36%), constipation (28%), arthralgia (27%), vomiting (26%), hypertension and urinary tract infection (24% each), and rash (22%). Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys Annual Report on Form 10-K for the year ended December 31, 2021 and the companys other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site (www.sec.gov). The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%). We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the PD-1 or the PD-L1, blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. F. Saad. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Primary Results Of The Phase 3 KEYNOTE-412 Study: Pembrolizumab (Pembro) With Chemoradiation (CRT) Vs Placebo Plus CRT For Locally Advanced (LA) Head And Neck Squamous Cell Carcinoma (HNSCC). The ESMO 2022 Scientific Committee will select abstracts for presentation during the Congress based on the following possibilities: Presidential Symposium - Oral presentations by authors presenting cutting-edge and significant clinical practice-changing studies, followed by expert discussion and perspectives. Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. KEYTRUDA can cause immune-mediated nephritis. There are no contraindications for LYNPARZA. Serious adverse reactions occurred in 51% of patients, the most common (2%) were hemorrhagic events (5%), diarrhea (4%), hypertension (3%), myocardial infarction, pneumonitis, and vomiting (3% each), acute kidney injury, adrenal insufficiency, dyspnea, and pneumonia (2% each). Consider the risk of severe or fatal hemorrhage associated with tumor invasion or infiltration of major blood vessels (eg, carotid artery). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%). Treatment of these patients with an antiPD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Grade 4 hypertension was not reported in HCC. Monitor for signs and symptoms of infusion-related reactions. The most common adverse reactions (5%) resulting in dose reductions were diarrhea (21%), fatigue (8%), thrombocytopenia (6%), vomiting (6%), nausea (5%), and proteinuria (5%). Necessary cookies enable core functionality. LENVIMA may impair fertility in males and females of reproductive potential. In RCC (renal cell carcinoma), hypertension occurred in 42% of patients on LENVIMA + everolimus (13% grade 3). Pneumonitis resolved in 59% of the 94 patients. Presentations will feature new or updated findings from Mercks growing pipeline and broad portfolio of cancer medicines: KEYTRUDA; WELIREG (belzutifan); LYNPARZA (in collaboration with AstraZeneca); LENVIMA (lenvatinib, in collaboration with Eisai); and ODM208, an investigational steroid synthesis inhibitor (in collaboration with Orion). Dose interruptions of LENVIMA due to an adverse reaction occurred in 58% of these patients. Withhold and resume at reduced dose upon recovery or permanently discontinue for renal failure or impairment based on severity. Concomitant exposure to other risk factors, such as bisphosphonates, denosumab, dental disease, or invasive dental procedures, may increase the risk of ONJ. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. S. Patel. About LENVIMA (lenvatinib); available as 10 mg and 4 mg capsules. Based on findings in animals, WELIREG may impair fertility in males and females of reproductive potential and the reversibility of this effect is unknown. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. In Study 001, a clinical trial in patients with advanced solid tumors (n=58) treated at the recommended dose, the following additional adverse reactions have been reported: edema, cough, musculoskeletal pain, vomiting, diarrhea, and dehydration. In Study 001, a clinical trial in patients with advanced solid tumors (n=58) treated at the recommended dose, hypoxia occurred in 29% of patients; 16% were Grade 3 hypoxia. The most common adverse reactions (reported in 20%) in patients receiving KEYTRUDA in combination with chemotherapy were fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss, abdominal pain, arthralgia, myalgia, and insomnia. Abstracts and ePosters are open access. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. In Study 004, anemia occurred in 90% of patients and 7% had Grade 3 anemia. http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf, http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf, https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_pi.pdf, https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_mg.pdf, http://www.lenvima.com/pdfs/prescribing-information.pdf, https://www.businesswire.com/news/home/20220829005222/en/, Environmental, Social & Governance (ESG) Report. Serious and fatal cardiac dysfunction can occur with LENVIMA. The median duration of therapy in patients who developed MDS/AML was 2 years (range: <6 months to >10 years). Pembrolizumab (Pembro) Vs Placebo (Pbo) As Second-Line Treatment For Sorafenib-Treated Advanced Hepatocellular Carcinoma (aHCC): 4.5-Year Follow-Up From KEYNOTE-240. This site uses cookies. We are called MSD everywhere, except in the United States and Canada where we are known as Merck & Co Inc, Rahway, NJ USA. ADVERSE REACTIONSMaintenance Recurrent Ovarian Cancer. Merck has the industrys largest immuno-oncology clinical research program. Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients. The use of erythropoiesis stimulating agents (ESAs) for treatment of anemia is not recommended in patients treated with WELIREG. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Withhold and resume at reduced dose upon recovery or permanently discontinue depending on severity and persistence of neurologic symptoms. In KEYNOTE-355, when KEYTRUDA and chemotherapy (paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin) were administered to patients with locally recurrent unresectable or metastatic TNBC who had not been previously treated with chemotherapy in the metastatic setting (n=596), fatal adverse reactions occurred in 2.5% of patients, including cardio-respiratory arrest (0.7%) and septic shock (0.3%). The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%). KEYTRUDA can cause immune-mediated hypophysitis. KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. From Nov 2011 until Aug2013, the randomized, phase III, double-blind APHINITY trial enrolled 2400 patients with HER2+, operable breast cancer assigned to receive pertuzumab (P) added to adjuvant trastuzumab (T) and chemotherapy and 2405 to receive placebo plus T and chemotherapy. Private Securities Litigation Reform Act of 1995. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. In postmarketing surveillance, serious and fatal carotid artery hemorrhages were seen more frequently in patients with anaplastic thyroid carcinoma (ATC) than other tumors. R. Dent. Private Securities Litigation Reform Act of 1995. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. The most common adverse reactions for KEYTRUDA in combination with LENVIMA (reported in 20% patients) were hypothyroidism and hypertension (67% each), fatigue (58%), diarrhea (55%), musculoskeletal disorders (53%), nausea (49%), decreased appetite (44%), vomiting (37%), stomatitis (35%), abdominal pain and weight loss (34% each), urinary tract infections (31%), proteinuria (29%), constipation (27%), headache (26%), hemorrhagic events (25%), palmar-plantar erythrodysesthesia (23%), dysphonia (22%), and rash (20%). Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. By continuing, you will be directed to a site intended only for residents of the United States and Canada. Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). Avoid coadministration with sensitive CYP3A4 substrates. The most frequently reported adverse reaction which required dose reduction was fatigue (7%). KEYNOTE-189 5-Year Update: First-Line Pembrolizumab (Pembro) + Pemetrexed (Pem) And Platinum Vs Placebo (Pbo) + Pem And Platinum For Metastatic Nonsquamous NSCLC. Monitor for anemia before initiation of and periodically throughout treatment. LENVIMA (lenvatinib) Indications in the U.S. For life-threatening or recurrent symptomatic hypoxia, permanently discontinue WELIREG. The safety of resumption of LENVIMA after resolution of wound healing complications has not been established.
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