{"id":48084,"date":"2022-09-08T01:02:05","date_gmt":"2022-09-07T23:02:05","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/merck-to-highlight-data-at-esmo-2022-with-potential-for-transformative-impact-on-cancer-patients\/"},"modified":"2022-09-08T01:02:05","modified_gmt":"2022-09-07T23:02:05","slug":"merck-to-highlight-data-at-esmo-2022-with-potential-for-transformative-impact-on-cancer-patients","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/merck-to-highlight-data-at-esmo-2022-with-potential-for-transformative-impact-on-cancer-patients\/","title":{"rendered":"Merck to Highlight Data at ESMO 2022 with Potential for Transformative Impact on Cancer Patients"},"content":{"rendered":"<div>\n<p>\n<b><span class=\"bwuline\">Not intended for US- or Canada-based media<\/span><\/b>\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220907005443\/en\/1563239\/5\/11127HIGH_MERCKLOGOBLUERGB-PROIMG.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220907005443\/en\/1563239\/21\/11127HIGH_MERCKLOGOBLUERGB-PROIMG.jpg\"><\/a><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nLate-breaking data highlight 5-year survival results from Phase II study of the investigational IAP inhibitor xevinapant in the curative setting of unresected LA SCCHN\n<\/li>\n<li>\nInitial results of Phase II INSIGHT 2 study of TEPMETKO plus osimertinib as second-line treatment in <i>EGFR-<\/i>mutant NSCLC with <i>MET <\/i>amplification showed encouraging signs of clinical activity with this targeted, oral, chemo-sparing regimen\n<\/li>\n<li>\nFirst-in-human results for potential best-in-class investigational ATR inhibitor M1774\n<\/li>\n<\/ul>\n<p>DARMSTADT, Germany&#8211;(BUSINESS WIRE)&#8211;Merck, a leading science and technology company, today announced the latest research from the Company\u2019s oncology portfolio and pipeline to be presented at this year\u2019s European Society of Medical Oncology (ESMO) Annual Meeting, September 9-13, 2022. A total of 29 abstracts, including 5 late-breaking oral presentations and 2 additional mini-oral presentations, will feature data from company- and investigator-sponsored studies across six approved or investigational medicines in multiple tumor types.\n<\/p>\n<p>\n\u201cOur ESMO 2022 data will highlight the strong potential of our innovative pipeline for patients with cancers with significant unmet needs,\u201d said Victoria Zazulina, M.D., Head of Development Unit, Oncology, for the Healthcare business of Merck. \u201cFrom our IAP inhibitor xevinapant, studied in a curative setting in locally advanced head and neck cancer; through to new data in NSCLC patients with <i>MET<\/i> amplification and <i>EGFR<\/i> mutations; to our potentially best-in-class oral ATR inhibitor; we are focused on unlocking novel mechanisms of action that exploit the vulnerabilities of cancer.\u201d\n<\/p>\n<p>\nThe company\u2019s late-breaking data at the congress feature<b> <\/b>five-year overall survival (OS) results from a Phase II study of the IAP (Inhibitor of Apoptosis Protein) inhibitor xevinapant in patients with unresected locally advanced squamous cell carcinoma of the head and neck [Mini Oral #LBA33]. Patients who received xevinapant plus<b> <\/b>chemoradiotherapy (CRT) had improved efficacy outcomes compared with those who received placebo with CRT.\n<\/p>\n<p>\nAdditional late-breaking results include initial results from the Phase II INSIGHT 2 trial of TEPMETKO<sup>\u00ae<\/sup> (tepotinib) plus osimertinib in the treatment of patients with <i>EGFR<\/i>-mutant non-small cell lung cancer (NSCLC) with <i>MET<\/i> amplification (<i>MET<\/i>amp) after progression on first-line treatment with osimertinib [Proffered Paper #LBA52]. The confirmed overall response rate (ORR) was 54.5% (95% CI, 32.2, 75.6) in 22 patients with <i>MET<\/i>amp detected by FISH (MET GCN \u22655 and\/or MET\/CEP7 \u22652) in tissue biopsy who received tepotinib plus osimertinib and were followed for at least nine months, with six of 12 responders still on treatment. Among the 48 patients followed for at least three months, ORR was 45.8% (95% CI, 31.4, 60.8). The most common treatment-related adverse events of any grade in greater than 15% of patients were diarrhea (40.9%), peripheral edema (23.9%) and paronychia (17.0%).\n<\/p>\n<p>\nFurther late-breaking data to be presented at ESMO 2022 include translational data for BAVENCIO<sup>\u00ae<\/sup> (avelumab) characterizing genomic biomarkers in peripheral blood from patients enrolled in the Phase III JAVELIN Bladder 100 trial [Proffered Paper #LBA74].\n<\/p>\n<p>\nAdditional key data to be presented:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nA mini-oral presentation from the first-in-human Phase I study of M1774, the Company\u2019s potentially best-in-class potent and selective inhibitor of ataxia telangiectasia and Rad3-related (ATR) showing a favorable safety profile and pharmacologically relevant exposure, in patients with advanced solid tumors (DDRiver Solid Tumors 301) [#457MO] exemplifying the Company\u2019s commitment to advancing understanding of DNA Damage Response (DDR) inhibition mechanisms.\n<\/li>\n<li>\nExploratory analyses from JAVELIN Bladder 100 that examine clinical outcomes in long-term responders with advanced urothelial carcinoma treated with BAVENCIO first-line maintenance for \u226512 months [#1760P]. Long-term follow-up data presented earlier this year reinforced the benefit of BAVENCIO plus best supportive care (BSC) in the first-line maintenance setting, with a continued improvement in OS versus BSC alone for patients with locally advanced or metastatic urothelial carcinoma whose tumors had not progressed on a platinum-based chemotherapy.<sup>1<\/sup>\n<\/li>\n<li>\nResults from cohorts A and C in the Phase II VISION trial demonstrated robust and durable efficacy in treatment-na\u00efve and previously treated patients with metastatic NSCLC with <i>MET<\/i>ex 14-skipping. In previously treated patients, efficacy was observed regardless of prior therapies including IO and\/or platinum-based CT [#985P].\n<\/li>\n<\/ul>\n<p>\nOther company-sponsored events at ESMO 2022 include:\n<\/p>\n<p>\n<b>Medical Symposia:<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\n<b>From Complex to Simple: The Journey to Strategic Sequencing in the Management of mCRC<\/b> (Friday, September 9, 6:00\u20137:30 PM CEST, 7.3Q Quimper Auditorium, Hall 7, Level 7.3)\n<\/li>\n<li>\n<b>New Approaches to Optimize Treatment Outcomes in Advanced Urothelial Carcinoma<\/b> (Saturday, September 10, 1:00-2:30 PM CEST, 7.3.U Urval Auditorium, Hall 7, Level 7.3)\n<\/li>\n<li>\n<b>Evolution of SCCHN Treatment <\/b>(Sunday, September 11, 6:30-8:00 PM CEST, 7.3.0 Orleans Auditorium, Hall 7, Level 7.3).\n<\/li>\n<\/ul>\n<p>\n<b>Continuing Medical Education (CME):<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\n<b>Navigating Treatment Decisions in Advanced NSCLC: Update on Molecular Testing and New Targeted Treatment Options <\/b>(Friday, September 9, 10:15-11:45 AM CEST, Quimper Auditorium, Hall 7, Level 7.3)\n<\/li>\n<\/ul>\n<p>\nSelect presentations (all times CEST):\n<\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl\">\n<tr>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwleftsingle bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTitle\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nLead Author\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nAbstract\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nSession Title\/Date\/Time\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPIPELINE\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n5-year overall survival (OS) in patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) treated with xevinapant+chemoradiotherapy (CRT) vs placebo+CRT in a randomized, phase 2 study\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nJ Bourhis\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nLBA33\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nMini Oral Session: Head and Neck Cancer\n<\/p>\n<p class=\"bwcellpmargin\">\nSaturday, 10 September\n<\/p>\n<p class=\"bwcellpmargin\">\n10:55 AM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nA First-in-Human Phase I Study of ATR Inhibitor M1774 in Patients with Advanced Solid Tumors\n<\/p>\n<p class=\"bwcellpmargin\">\n(DDRiver Solid Tumors 301)\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTA Yap\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n457MO\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nMini Oral Session:\n<\/p>\n<p class=\"bwcellpmargin\">\nDevelopmental Therapeutics\n<\/p>\n<p class=\"bwcellpmargin\">\nMonday, 12 September\n<\/p>\n<p class=\"bwcellpmargin\">\n4:55 PM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPhase 1 study of TIGIT inhibitor M6223 as monotherapy or in combination with bintrafusp alfa (BA) in patients (pts) with metastatic\/locally advanced solid unresectable tumours\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nLL Siu\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n750P\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nInvestigational immunotherapy\n<\/p>\n<p class=\"bwcellpmargin\">\nMonday, 12 September\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nBAVENCIO (avelumab)\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nCharacterization of genomic biomarkers in peripheral blood (PB) from patients (pts) enrolled in the JAVELIN Bladder 100 trial of avelumab first-line (1L) maintenance in advanced urothelial carcinoma (aUC)\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nT Powles\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nLBA74\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nProffered Paper Session 1: GU tumours, non-prostate\n<\/p>\n<p class=\"bwcellpmargin\">\nSaturday, 10 September\n<\/p>\n<p class=\"bwcellpmargin\">\n11:10 AM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nAvelumab versus standard second line treatment chemotherapy in metastatic colorectal cancer (mCRC) patients with microsatellite instability (MSI): the SAMCO-PRODIGE 54 randomised phase II trial\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nJ Ta\u00efeb\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nLBA23\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nProffered Paper Session 1: GI lower digestive\n<\/p>\n<p class=\"bwcellpmargin\">\nSunday, 11 September\n<\/p>\n<p class=\"bwcellpmargin\">\n11:15 AM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nAvelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): results from patients with \u226512 mos of treatment in JAVELIN Bladder 100\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nJ Aragon-Ching\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n1760P\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nUrothelial Cancer\n<\/p>\n<p class=\"bwcellpmargin\">\nMonday, 12 September\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPreliminary results from AVENANCE, an ongoing, noninterventional real-world, ambispective study of avelumab first-line (1L) maintenance treatment in patients (pts) with locally advanced or metastatic urothelial carcinoma (la\/mUC)\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP Barth\u00e9l\u00e9my\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n1757P\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nUrothelial Cancer\n<\/p>\n<p class=\"bwcellpmargin\">\nMonday, 12 September\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nAvelumab added to FOLFIRI plus cetuximab followed by avelumab maintenance in patients with previously\n<\/p>\n<p class=\"bwcellpmargin\">\nuntreated RAS wild-type colorectal cancer\u2013The phase-II FIRE-6 (AIO KRK-0118)\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nS Stintzing\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n424P\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nColorectal Cancer\n<\/p>\n<p class=\"bwcellpmargin\">\nSunday, 11 September\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTEPTMETKO (tepotinib)\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTepotinib+osimertinib for <i>EGFR<\/i>-mutant(m) NSCLC after progression on first-line (1L) osimertinib due to <i>MET<\/i> amplification: Initial results from the INSIGHT 2 study\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nJ Mazieres\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nLBA52\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nProffered Paper Session: NSCLC, metastatic\n<\/p>\n<p class=\"bwcellpmargin\">\nSunday, 11 September\n<\/p>\n<p class=\"bwcellpmargin\">\n2:55 PM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTepotinib outcomes according to prior therapies in patients with <i>MET<\/i>exon14 (<i>MET<\/i>ex14) skipping NSCLC\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nE Smit\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n985P\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nNSCLC, metastatic\n<\/p>\n<p class=\"bwcellpmargin\">\nMonday, 12 September\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nERBITUX (cetuximab)\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPhase III study with FOLFIRI\/Cetuximab versus FOLFIRI\/Cetuximab followed by Cetuximab (Cet) alone in first-line therapy of RAS and BRAF wild type (wt) metastatic colorectal cancer (mCRC) patients: the ERMES Study (NCT02484833)\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nA Orlandi\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nLBA22\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nProffered Paper Session 1: GI, lower digestive\n<\/p>\n<p class=\"bwcellpmargin\">\nSunday, 11 September\n<\/p>\n<p class=\"bwcellpmargin\">\n10:25 AM\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\nAll Merck press releases are distributed by e-mail at the same time they become available on the Merck website. Please go to <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.merckgroup.com%2Fen%2Fmedia-center%2Fpress-release-subscription.html&amp;esheet=52862970&amp;newsitemid=20220907005443&amp;lan=en-US&amp;anchor=www.merckgroup.com%2Fsubscribe&amp;index=1&amp;md5=422b860ab72cb08a318b5122d77133ba\" rel=\"nofollow noopener\" shape=\"rect\">www.merckgroup.com\/subscribe<\/a> to register online, change your selection or discontinue this service.\n<\/p>\n<p>\n<b>About BAVENCIO<sup>\u00ae <\/sup>(avelumab)<\/b>\n<\/p>\n<p>\nBAVENCIO 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. In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.\n<\/p>\n<p>\n<b>BAVENCIO Approved Indications<\/b>\n<\/p>\n<p>\nThe European Commission (EC) has authorized the use of BAVENCIO as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. BAVENCIO in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). BAVENCIO is also authorized by the EC for use as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).\n<\/p>\n<p>\nIn the US, BAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC 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.\n<\/p>\n<p>\nBAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced RCC. Additionally, the US Food and Drug Administration (FDA) granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic MCC. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.\n<\/p>\n<p>\nBAVENCIO is currently approved for at least one indication for patients in more than 50 countries.\n<\/p>\n<p>\n<b>BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC)<\/b>\n<\/p>\n<p>\nThe special warnings and precautions for use for BAVENCIO monotherapy include infusion-related reactions, as well as immune-related adverse reactions that include pneumonitis and hepatitis (including fatal cases), colitis, pancreatitis (including fatal cases), myocarditis (including fatal cases), endocrinopathies, nephritis and renal dysfunction, and other immune-related adverse reactions. The special warnings and precautions for use for BAVENCIO in combination with axitinib include hepatotoxicity.\n<\/p>\n<p>\nThe SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia.\n<\/p>\n<p>\n<b>About TEPMETKO<sup>\u00ae<\/sup> (tepotinib)<\/b>\n<\/p>\n<p>\nTEPMETKO is a once-daily oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by <i>MET<\/i> (gene) alterations. Discovered and developed in-house at Merck, TEPMETKO has a highly selective mechanism of action, with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations.\n<\/p>\n<p>\nTEPMETKO was the first oral MET inhibitor to receive a regulatory approval anywhere in the world for the treatment of advanced NSCLC harboring <i>MET<\/i> gene alterations, with its approval in Japan in March 2020. In February 2021, the US Food and Drug Administration granted accelerated approval to TEPMETKO, making it the first and only once-daily oral MET inhibitor approved for patients in the U.S. with metastatic NSCLC with <i>MET<\/i>ex14 skipping alterations.\n<\/p>\n<p>\nTEPMETKO is available in a number of countries. To meet an urgent clinical need, TEPMETKO is also available in a pilot zone of China in line with the government policy to drive early access for innovative medicines approved outside of China.\n<\/p>\n<p>\nMerck is also investigating the potential role of tepotinib in treating patients with NSCLC and acquired resistance due to <i>MET<\/i> amplification in the Phase II INSIGHT 2 study of tepotinib in combination with osimertinib in <i>MET<\/i> amplified, advanced or metastatic NSCLC harboring activating EGFR mutations that has progressed following first-line treatment with osimertinib.\n<\/p>\n<p>\n<b>TEPMETKO<\/b><sup> <\/sup><strong>Safety Profile from the EU Summary of Product Characteristics (SmPC)<\/strong>\n<\/p>\n<p>\nThe special warnings and precautions for use for TEPMETKO monotherapy include Interstitial lung disease (ILD) or ILD-like adverse reactions including pneumonitis, increase of Liver enzymes (ALT and AST), QTc prolongation, and embryo-foetal toxicity.\n<\/p>\n<p>\nThe most common adverse reactions in \u2265 20% of exposed to tepotinib at the recommended dose in the target indication are oedema, mainly peripheral oedema, nausea, hypoalbuminaemia, diarrhoea and increase in creatinine. The most common serious adverse reactions in \u2265 1% of patients are peripheral oedema, generalised oedema and ILD.\n<\/p>\n<p>\n<b>About ERBITUX<sup>\u00ae <\/sup>(cetuximab)<\/b>\n<\/p>\n<p>\nERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on <i>in vitro<\/i> evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).\n<\/p>\n<p>\nERBITUX has already obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.\n<\/p>\n<p>\n<b>About Xevinapant<\/b>\n<\/p>\n<p>\nXevinapant (formerly known as Debio 1143) is an investigational first-in-class potent oral small-molecule IAP (inhibitor of apoptosis protein) inhibitor for the treatment of LA SCCHN. In preclinical studies, xevinapant restored sensitivity to apoptosis in cancer cells, thereby enhancing the effects of chemotherapy and radiotherapy. Xevinapant, the most clinically advanced IAP inhibitor, improved efficacy outcomes in combination with chemoradiotherapy (CRT), including three-year progression-free survival and five-year survival, compared with placebo plus CRT in a Phase II study in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). In March 2021, Merck gained exclusive rights from Debiopharm to develop and commercialize xevinapant worldwide. Xevinapant is not approved for any use anywhere in the world.\n<\/p>\n<p>\n<b>About Merck<\/b>\n<\/p>\n<p>\nMerck, a leading science and technology company, operates across life science, healthcare and electronics. More than 60,000 employees work to make a positive difference to millions of people\u2019s 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 \u2013 the company is everywhere. In 2021, Merck generated sales of \u20ac 19.7 billion in 66 countries.\n<\/p>\n<p>\nScientific exploration and responsible entrepreneurship have been key to Merck\u2019s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics.\n<\/p>\n<p>\n<b>Reference:<\/b>\n<\/p>\n<p>\n<sup>1<\/sup> Powles T, Park SH, Voog E, et al. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Long-term follow-up results from the JAVELIN Bladder 100 trial. <i>J Clin Oncol <\/i>40, 2022 (suppl 6; abstr 487).\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<a target=\"_blank\" href=\"&#x6d;&#x61;&#105;l&#x74;&#x6f;&#58;&#78;o&#x65;&#x6c;&#108;&#101;&#46;&#x50;&#x69;&#115;ci&#x74;&#x65;&#108;l&#x69;&#x40;&#101;&#109;d&#x73;&#x65;&#114;&#111;n&#x6f;&#x2e;&#99;om\" rel=\"nofollow noopener\" shape=\"rect\">&#x4e;o&#x65;&#108;&#x6c;&#x65;&#46;&#x50;&#105;&#x73;&#x63;i&#x74;&#101;&#x6c;&#x6c;i&#x40;&#101;&#x6d;&#x64;s&#x65;&#114;&#x6f;&#x6e;o&#x2e;&#99;&#x6f;&#x6d;<\/a><b><br \/><\/b>Phone: +1 (781) 427-4351\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Not intended for US- or Canada-based media Late-breaking data highlight 5-year survival results from Phase II study of the investigational IAP inhibitor xevinapant in the curative setting of unresected LA SCCHN Initial results of Phase II INSIGHT 2 study of TEPMETKO plus osimertinib as second-line treatment in EGFR-mutant NSCLC with MET amplification showed encouraging signs &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/merck-to-highlight-data-at-esmo-2022-with-potential-for-transformative-impact-on-cancer-patients\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-48084","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Merck to Highlight Data at ESMO 2022 with Potential for Transformative Impact on Cancer Patients - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/merck-to-highlight-data-at-esmo-2022-with-potential-for-transformative-impact-on-cancer-patients\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Merck to Highlight Data at ESMO 2022 with Potential for Transformative Impact on Cancer Patients - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Not intended for US- or Canada-based media Late-breaking data highlight 5-year survival results from Phase II study of the investigational IAP inhibitor xevinapant in the curative setting of unresected LA SCCHN Initial results of Phase II INSIGHT 2 study of TEPMETKO plus osimertinib as second-line treatment in EGFR-mutant NSCLC with MET amplification showed encouraging signs ... 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