Merck to Present Latest Research From Oncology Portfolio at ASCO 2022
Merck, a leading science and technology company, today announced the latest research representing the Company’s innovative oncology portfolio has been accepted for presentation at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting, June 3-7, 2022. Data encompass Company-sponsored, investigator-sponsored, and external collaboration studies.
Abstracts to be shared at the meeting include data for the Company’s licensed medicines BAVENCIO® (avelumab), TEPMETKO® (tepotinib) and ERBITUX® (cetuximab), and its oncology pipeline. The presentations span key tumor types including advanced urothelial carcinoma (UC), advanced renal cell carcinoma (RCC), metastatic non-small cell lung cancer (NSCLC), metastatic colorectal cancer (CRC), and head and neck cancer (SCCHN).
“We look forward to coming together with the scientific community at ASCO 2022, where we will share the latest data from our portfolio, which demonstrate our determination to make a real difference in the lives of patients with some of the most challenging cancers,” said Victoria Zazulina, Head of Development Unit, Oncology, for the Healthcare business of Merck.
Select presentations include:
- BAVENCIO® (avelumab): New analyses of long-term data from the Phase III JAVELIN Bladder 100 study of BAVENCIO as first-line maintenance treatmentin advanced UC, including data from subgroups defined by best response to first-line chemotherapy and in patients who did or did not receive second-line treatment after BAVENCIO maintenance.
- TEPMETKO® (tepotinib): Data for the oral MET inhibitor TEPMETKO include two poster presentations from the VISION trial reporting efficacy, safety and quality-of-life results of TEPMETKO in Asian patients with METex14 skipping NSCLC, and updated efficacy and safety results of TEPMETKO and exploratory biomarker analyses in patients with NSCLC with high-level MET amplification enrolled into Cohort B of the VISION trial based on liquid biopsy.
- ERBITUX® (cetuximab): Abstracts from key investigator-sponsored studies (ISS) exploring ERBITUX-based combinations, including the Phase III FIRE-4 study of early switch-maintenance fromERBITUX/FOLFIRI to bevacizumab/5-FU and rechallenge in later lines for RAS wild-type mCRC patients, and the Phase II AVETUXIRI study evaluating BAVENCIO combined with ERBITUX and irinotecan for refractory microsatellite stable metastatic colorectal cancer.
- Berzosertib: Results from research collaborations assessing the intravenous ataxia telangiectasia-mutated and Rad3-related protein kinase (ATR) inhibitor berzosertib, including the National Cancer Institute’s (NCI) Cancer Therapy Evaluation Program 9938 Phase I study of berzosertib plus irinotecan in patients with advanced solid tumors and NCI single-arm Phase II data of berzosertib plus topotecan in patients with relapsed extra-pulmonary small cell neuroendocrine carcinomas.
Below is a selection of key Merck-related abstracts accepted for presentation at ASCO 2022:
Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): long-term outcomes from JAVELIN Bladder 100 in subgroups defined by response to 1L chemotherapy
Genitourinary Cancer—Kidney and Bladder
Saturday, June 4, 2022
1:15 PM-4:15 PM CDT
Long-term outcomes in patients with advanced urothelial carcinoma (UC) who received avelumab first-line (1L) maintenance with or without second-line (2L) treatment: exploratory analyses from JAVELIN Bladder 100
Genitourinary Cancer—Kidney and Bladder
Saturday, June 4, 2022
1:15 PM-4:15 PM CDT
Tepotinib in Asian patients with advanced NSCLC with MET exon 14 (METex14) skipping
Lung Cancer—Non-Small Cell Metastatic
Monday, June 6, 2022
8:00 AM-11:00 AM CDT
Clinical response to tepotinib according to circulating tumor (ct) DNA biomarkers in patients with advanced NSCLC with high-level MET amplification (METamp) detected by liquid biopsy (LBx)
Lung Cancer—Non-Small Cell Metastatic
Monday, June 6, 2022
8:00 AM-11:00 AM CDT
Randomized study to investigate a switch maintenance concept with 5-FU plus Bevacizumab after FOLFIRI plus Cetuximab induction treatment versus continued treatment with FOLFIRI plus cetuximab: report of a secondary endpoint of the phase-III FIRE-4 study (AIO KRK-0114)
Cancer—Colorectal and Anal
Saturday, June 4, 2022
8:00 AM - 11:00 AM CDT
Targeting genomic instability in extrapulmonary small cell neuroendocrine cancers: a phase II study with ATR inhibitor berzosertib and topotecan
Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Monday, June 6, 2022
Live discussion: 12:26 PM CDT
NCI 9938: Phase I clinical trial of ATR inhibitor berzosertib (M6620, VX-970) in combination with irinotecan in patients with advanced solid tumors
Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Sunday, June 5, 2022
Live Discussion: 4:42 PM CDT
*These studies are sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, under its Cooperative Research and Development Agreement with Merck for M6620.
All Merck press releases are distributed by e-mail at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.
Commitment to Cancer
Merck is a science-led organization dedicated to delivering transformative medicines with the goal of making a meaningful difference in the lives of people affected by cancer. Our oncology research efforts aim to leverage our synergistic portfolio in oncogenic pathways, immuno-oncology, and DNA Damage Response (DDR) to tackle challenging tumor types in gastrointestinal, genitourinary, and thoracic cancers. Our curiosity drives our pursuit of treatments for even the most complex cancers, as we work to illuminate a path to scientific breakthroughs that transform patient outcomes. Learn more at www.merckgrouponcology.com.
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.7-9 In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.
BAVENCIO Approved Indications
The 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).
In 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.
BAVENCIO 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.
BAVENCIO is currently approved for at least one indication for patients in more than 50 countries.
BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC)
The 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.
The 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.
About TEPMETKO® (tepotinib)
TEPMETKO is a once-daily oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET (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.
TEPMETKO was the first oral MET inhibitor to receive a regulatory approval anywhere in the world for the treatment of advanced NSCLC harboring MET gene alterations, with its approval in Japan in March 2020. In February 2021, the U.S. 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 METex14 skipping alterations. Tepotinib is available in a number of countries, and under review by various other regulatory authorities globally. To meet an urgent clinical need, tepotinib 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.
Merck is also investigating the potential role of tepotinib in treating patients with NSCLC and acquired resistance due to MET amplification in the Phase II INSIGHT 2 study of tepotinib in combination with osimertinib in MET amplified, advanced or metastatic NSCLC harboring activating EGFR mutations that has progressed following first-line treatment with osimertinib.
TEPMETKOSafety Profile from the EU Summary of Product Characteristics (SmPC)
The 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.
The most common adverse reactions in ≥ 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 ≥ 1% of patients are peripheral oedema, generalised oedema and ILD.
About Berzosertib (M6620)
Berzosertib is an investigational, intravenous, potent and selective inhibitor of the ataxia telangiectasia and Rad3-related (ATR) protein that blocks ATR activity in cells. Berzosertib is the first ATR inhibitor evaluated in a randomized clinical trial in any tumor type, and it is the lead candidate in Merck’s DNA Damage Response (DDR) inhibitor portfolio. It is currently being investigated in a number of internal and external studies with early phase I/II data in small cell lung cancer, ovarian cancer, and various solid tumors. Berzosertib, formerly known as VX-970, was licensed from Vertex Pharmaceuticals in 2017. Berzosertib is not approved for any use anywhere in the world.
About ERBITUX® (cetuximab)
ERBITUX 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 in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).
ERBITUX 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.
Merck, a leading science and technology company, operates across life science, healthcare and electronics. Around 61,000 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 – the company is everywhere. In 2021, Merck generated sales of € 19.7 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck’s 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Phone: +1 781 427-4351
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Evolve Announces Next Phase of Development7.7.2022 17:00:00 CEST | Press release
Today Evolve Additive Solutions (“EAS”), a global leader in the manufacturing of capital equipment, announces organizational changes designed to accelerate technology developments within its production 3D printer for manufacturing customers. After 14 years of R&D investment, the company is retooling for commercialization with a focus on its highly reliable production platform and a strong customer return-on-investment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220706005781/en/ Joe Allison, CEO, Evolve Additive Solutions (Photo: Business Wire) The company is pleased to announce that current board member, Joe Allison, will join the company as CEO. Founder, Steve Chillscyzn will transition into the role of CTO and remain on the Board of Directors. “This new structure will allow me to focus my energies on accelerating technical developments within our STEP technology,” said Steve Chillscyzn. “The versatility of the platform
Mary Kay Inc. Partners With Dr. Jack Gilbert to Further Study Skin’s “Microbiome” and the Impact on the Aging Process7.7.2022 16:30:00 CEST | Press release
Mary Kay Inc., one of the world’s leading skincare research companies, has announced a new partnership with Dr. Jack Gilbert, professor of pediatrics at the University of California San Diego School of Medicine and professor of microbial oceanography at UC San Diego Scripps Institution of Oceanography. Through the partnership, scientists at Mary Kay will work in conjunction with Dr. Gilbert to study one of the most important—but least understood—areas of aging and skin health: the skin Microbiome. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220707005167/en/ Mary Kay Inc. has announced a new partnership with Dr. Jack Gilbert, professor of pediatrics at the University of California San Diego School of Medicine and professor of microbial oceanography at UC San Diego Scripps Institution of Oceanography. Through the partnership, scientists at Mary Kay will work in conjunction with Dr. Gilbert to study one of the most important
Payroll Tech Leader Mercans Appoints Tatjana Domovits as its Group CEO7.7.2022 16:00:00 CEST | Press release
Mercans’ board has appointed Tatjana Domovits, a long-serving executive, as their Global CEO. Mercans’ board expressed confidence that “Tatjana is the best person to lead Mercans into the future, building world-class payroll technology, transforming global payroll and the employer-of-record industry, and making global employment frictionless.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220707005410/en/ Tatjana Domovits – Group CEO – Mercans (Photo: AETOSWire) This announcement comes on the back of a record-breaking year for Mercans in 2021 and its ambitious plans that focus on driving revenue growth across all business lines. Mercans’ disruptive global payroll technology, which delivers native payroll processing capabilities and integrations with local tax authorities across 160 countries, has proven to be a huge success in the global payroll industry. Mercans intends to reach annual revenues in excess of $100 million fr
Tigo Energy Welcomes Bill Roeschlein as Chief Financial Officer7.7.2022 16:00:00 CEST | Press release
Tigo Energy, Inc., the solar industry’s leading Flex MLPE (Module Level Power Electronics) supplier, today announced that Bill Roeschlein has joined as its new Chief Financial Officer. In his new role, Mr. Roeschlein will lead the finance and legal teams at Tigo. He will focus on establishing the premier financial organization in the renewable energy industry, along with the processes and procedures that facilitate the growth of Tigo to the next stage of financial development. “Bill is exactly the type of Finance Executive that Tigo needs,” stated Zvi Alon, Chairman and CEO of Tigo. “His proven leadership as CFO at several different public companies combined with his experience in executing complex financial transactions including mergers, acquisitions, financings, and equity offerings will be invaluable as Tigo continues to evolve and grow.” Mr. Roeschlein brings a wealth of publicly-traded, pre-IPO, and international operations experience to the Tigo Executive Team. Mr. Roeschlein be
New Study shows Urolithin A (Mitopure®) Improves Mitochondrial Health, Reduces Joint Cartilage Damage and Alleviates Pain in Osteoarthritis7.7.2022 14:07:00 CEST | Press release
Amazentis, a spin-off of the Swiss Federal Institute of Technology (EPFL) pioneering scientific breakthroughs in cellular health and nutrition, announced today that the peer-reviewed journal Aging Cell published new pre-clinical results showing the joint health benefits of gut microbiome postbiotic Urolithin A (UA). This is the first time a compound has been shown to improve mitochondrial health in an experimental model of osteoarthritis (OA). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220707005266/en/ (Photo: Amazentis) This study showed that treatment with Amazentis’ proprietary Urolithin A, Mitopure, significantly improved mitochondrial health in human cartilage cells taken from both healthy and OA knee joints. And it showed that supplementation with Mitopure for eight weeks protected against osteoarthritis disease progression in an experimental model. These findings highlight Mitopure’s benefits for joint and mitocho