Merck's oncology product lineup data presented on ASCO21 highlights major advanc

May 24, 2021 03:25 AM Eastern Daylight Time

Darmstadt, Germany--( Business Wire )--(Business Wire)-- Not applicable to media headquartered in the United Kingdom, United States or Canada

Leading technology company Merck announced today that 40 abstracts representing the company’s innovative oncology product lineup from research (ISS) initiated by the company and researchers and external collaborations, including seven oral presentations and seven poster discussions, It will be presented at the American Society of Clinical Oncology (ASCO) annual meeting to be held from June 4 to 8, 2021.

Danny Bar-Zohar, Head of Global Development for Merck’s Healthcare Business, said: “Important new analysis from our pivotal research on urothelial cancer and non-small cell lung cancer demonstrates how our research will continue to promote certain highly unsatisfied The new standard treatment for cancers with medical needs. The above research is the basis for the recent approval of BAVENCIO ® (avelumab) and TEPMETKO ® (tepotinib) for the above-mentioned tumor types. The above analysis, together with other data on the understanding of emerging mechanisms in the known trials, is our Committed to promoting the science of cancer treatment to substantially change the latest examples of patients’ fate.”

The company's research project focuses on the synergy of immuno-oncology, carcinogenic pathways and DNA damage response (DDR), aiming to deal with some of the most challenging tumor types, including urothelial carcinoma (UC) and non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), colorectal cancer (CRC) and cervical cancer (CC).

Highlights of key information published on ASCO

BAVENCIO (avelumab)

The data on three approved indications of BAVENCIO (avelumab) provide further evidence of long-lasting benefits for patients:

• Advanced Urothelial Carcinoma (Report: 4520, 4525, 4527). The new analysis of the Phase III JAVELIN Bladder 100 study shows that BAVENCIO (avelumab) as the first-line maintenance treatment in each key subgroup has consistent survival benefits, including the treatment-free interval from the end of chemotherapy to the start of maintenance treatment, disease stage, and metastatic site Or those subgroups defined by genomic subtypes. The above data further emphasize that BAVENCIO has an effect on patients with advanced UC who have not deteriorated during 1L platinum-containing chemotherapy.

• Advanced Renal Cell Carcinoma (aRCC) (Report: 4514, 4574). The extended follow-up data of the Phase III JAVELIN Renal 101 study explored the effect of follow-up therapies on the effectiveness of BAVENCIO (avelumab) combined with axitinib in aRCC patients, and confirmed the effectiveness and benefits of the combination therapy in each risk group of the International Metastatic RCC Data Consortium (IMDC), including In the favorable risk group.

• Metastatic Merck Cell Carcinoma (mMCC) (Report : 9517). The results of more than five years of follow-up in Part A of the Phase II JAVELIN Merkel 200 study showed that among previously treated patients with metastatic MCC (mMCC), BAVENCIO (avelumab) treatment can provide clinically significant long-term overall survival (OS), 48 patients The monthly and 60-month OS rates were 30% (95% CI, 20%-40%) and 26% (95% CI, 17%-36%), respectively. The above results further support that avelumab can be used as a standard treatment for mMCC patients.

TEPMETKO (tepotinib)

Highlights of TEPMETKO (tepotinib) on ASCO include new information from the Phase II VISION study:

• Summary of MET ex14 NSCLC biomarker response detected by liquid biopsy (LBx) (Oral report: 9012). The analysis showed that the reduction in the frequency of variant alleles after tepotinib treatment is related to the improvement of treatment efficacy. In addition, the study proved that liquid biopsy may provide a reliable means to monitor treatment response, understand drug resistance mechanisms, and improve patient treatment effectiveness and quality of life.

• MET ex14 skip mutation NSCLC brain metastasis patients (report: 9084). Data show thatthe effectiveness of patients withmesenchymal transition ( MET) exon 14 (MET ex14) skip mutation NSCLC brain metastases is consistent with the overall treatment population, and retrospective analysis of brain lesions identified by CT/MRI also showed intracranial activity . It has been reported that 20% to 40% ofNSCLC patients with MET ex14 skip mutation have brain metastases, which is associated with a poor prognosis.

• NSCLC carrying MET amplification ( MET amp) (Report: 9021). VISION is the first study of MET inhibitors in the treatment of NSCLC patients with MET amp (prospectively detected through liquid biopsy) . The clinical activity observed in the B queue of this study shows that tepotinib is expected to target MET amp-driven diseases. Target, especially for naive patients with high unmet needs. MET amplification is a genetic mutation that occurs in about 1% to 5% of NSCLC patients, and there is no approved targeted therapy.

Two ongoing tepotinib studies are currently recruiting patients: INSIGHT 2 (Report: TPS9136) evaluates osimertinib combined with tepotinib for epithelial growth factor receptor (EGFR) mutant NSCLC that has developed resistance to first-line treatment of osimertinib due to MET amplification Patients; and PERSPECTIVE (report: TPS3616) to evaluate tepotinib combined with cetuximab for mCRC that develops anti-EGFR antibody target therapeutic drug resistance due to MET amplification.

ERBITUX ® (cetuximab)

Several ISS and PERSPECTIVE studies combined with TEPMETKO (tepotinib) continue to show that the company’s first biologically driven lead product, ERBITUX (cetuximab), has a constant effect in the treatment of metastatic colorectal cancer and is the treatment of head and neck squamous cell carcinoma. pillar.

• DEEPER "JACCRO CC-13" (Oral report: 3501). In 1L RAS wt mCRC, cetuximab combined with three-drug chemotherapy vs. bevacizumab combined with three-drug chemotherapy, the depth of remission was significantly greater

• FIRE 4.5 "AIO KRK-0116" (oral report: 3502). In 1L BRAF mt mCRC, the effectiveness of cetuximab is equivalent to bevacizumab

• TROG 12.01 and De-ESCALaTE (Oral presentation: 109). The pooled analysis of two phase III studies identified a potential prognostic biomarker for patients with HPV-positive oropharyngeal carcinoma (OPC) LA head and neck squamous cell carcinoma treated with cetuximab combined with radiotherapy

bintrafusp alfa (M7824)

The data of the bifunctional fusion protein bintrafusp alfa in the experiment continuously clarified the potential benefits of dual inhibition of TGF-β and PD-L1 pathways:

• Recurrent/metastatic cervical cancer (oral report: 5509). The phase I INTR @ PID solid tumor 001 study and the National Cancer Institute (NCI)-led phase II study data analysis show that bintrafusp alfa monotherapy is effective for those who have previously received platinum treatment and have never received immune checkpoint inhibitors. Patients with recurrent/metastatic cervical cancer are clinically active and safe to treat.

• HPV 16+ advanced malignant tumor (oral report: 2501). The NCI-led phase II clinical study data for patients with advanced HPV 16+ cancer provides early evidence of the clinical activity of bintrafusp alfa, NHS-IL12 and PDS0101 triple therapy, and the safety is treatable.

Merck is a science-led organization dedicated to delivering transformational medicines in order to substantially change the fate of cancer patients. Our oncology research work aims to leverage the advantages of our collaborative product lineup in the fields of carcinogenic pathways, immuno-oncology, and DNA damage response (DDR) to deal with challenging tumor types in gastrointestinal, genitourinary and thoracic cancers. Our desire for discovery drives us to seek treatments for even the most complex cancers because we are committed to illuminating the path to scientific breakthroughs that transform the effectiveness of patient treatment. For more information, please visit https://www.merckgrouponcology.com .

About BAVENCIO ® (avelumab)

BAVENCIO is a human anti-apoptotic ligand 1 (PD-L1) antibody. Preclinical models have shown that BAVENCIO can stimulate adaptive and innate immune functions. Preclinical models have shown that BAVENCIO can relax the suppression of T cell-mediated anti-tumor immune responses by blocking the interaction between PD-L1 and PD-1 receptors. In November 2014, Merck and Pfizer announced a strategic alliance to jointly develop and commercialize BAVENCIO.

BAVENCIO's approved indications

The European Commission (EC) has approved BAVENCIO monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have not worsened after platinum-containing chemotherapy. BAVENCIO combined with axitinib is suitable for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). EC also approved BAVENCIO monotherapy for the treatment of adult patients with metastatic Merck cell carcinoma (MCC).

In the United States, BAVENCIO is suitable for maintenance treatment of locally advanced or metastatic urothelial carcinoma (UC) patients who have not worsened after first-line platinum-containing chemotherapy. BAVENCIO is also suitable for the treatment of locally advanced or metastatic UC patients whose disease worsens during or after platinum-containing chemotherapy, or the disease worsens within 12 months after platinum-containing chemotherapy neoadjuvant or adjuvant treatment.

Also in the United States, BAVENCIO combined with axitinib is suitable for the first-line treatment of patients with advanced RCC. In addition, the U.S. Food and Drug Administration (FDA) has accelerated the trial of BAVENCIO for the treatment of adults with metastatic MCC and children 12 years and older. The indication is based on the tumor remission rate and duration of remission, which was approved after an accelerated trial. The long-term approval of this indication may depend on the verification and description of clinical benefits by confirmatory trials.

BAVENCIO is currently approved for at least one use in 50 countries.

Safety of BAVENCIO in EU Product Characteristics Summary (SmPC)

Special warnings and precautions for BAVENCIO monotherapy include: infusion-related reactions and immune-related adverse reactions, the latter including: pulmonary interstitial inflammation and hepatitis (including fatal cases), colitis, pancreatitis (including fatal cases), myocarditis ( Including fatal cases), endocrine diseases, nephritis and renal insufficiency, and other immune-related adverse reactions. Special warnings and precautions for BAVENCIO combined with axitinib include liver toxicity.

In the SmPC list, the most common adverse reactions of BAVENCIO monotherapy in patients with solid tumors include fatigue, nausea, diarrhea, loss of appetite, constipation, infusion-related reactions, weight loss, and vomiting. The most common adverse reactions of BAVENCIO combined with axitinib include: diarrhea, hypertension, fatigue, nausea, speech disorders, loss of appetite, hypothyroidism, cough, headache, dyspnea, and joint pain.

About TEPMETKO ® (tepotinib)

TEPMETKO is an oral MET inhibitor that inhibits oncogenic MET receptor signaling caused by MET (gene) mutations. TEPMETKO was discovered and developed internally by Merck in Darmstadt, Germany. It has a highly selective mechanism of action and is expected to improve the efficacy of the treatment of aggressive tumors with poor prognosis that carry the above-mentioned specific mutations.

TEPMETKO is the world's first oral MET inhibitor approved by the competent authority for the treatment of advanced NSCLC with mutations in the MET gene. It was approved in Japan in March 2020. In February 2021, TEPMETKO was approved in the United States for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a mesenchymal-epithelial transfer ( MET ) exon 14 skip mutation. The indication is based on the total remission rate and duration of remission, which has been approved after an accelerated trial. The long-term approval of this indication may depend on the verification and description of clinical benefits by confirmatory trials. Tepotinib is currently in clinical research and has not been approved in any markets outside of Japan and the United States.

About ERBITUX ® (cetuximab)

ERBITUX ® is an IgG1 monoclonal antibody targeting epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX ® is different from standard non-selective chemotherapy because it clearly targets and binds to EGFR. This combination can inhibit receptor initiation and subsequent signal transduction pathways, thereby simultaneously reducing tumor cell invasion to normal tissues and tumor spread to new sites. It is believed that it can also inhibit the ability of tumor cells to repair damage caused by chemotherapy and radiotherapy, and inhibit the formation of new blood vessels within the tumor, or can suppress tumor growth overall. According to in vitro evidence, ERBITUX ® can also target cytotoxic immune effector cells to tumor cells expressing EGFR (antibody-dependent cell-mediated cytotoxicity [ADCC]).

ERBITUX ® has been approved for marketing in more than 100 countries around the world for the treatment of RAS wild-type metastatic colorectal cancer and the treatment of head and neck squamous cell carcinoma. In 1998, Merck was authorized by ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, to sell ERBITUX ® (a registered trademark of ImClone LLC) outside the United States and Canada .

About bintrafusp Alfa

bintrafusp alfa (M7824) is a potential market-first bifunctional fusion protein discovered by Merck. It is designed to block the two immunosuppressive pathways of TGF-β and PD-L1 in the tumor microenvironment at the same time. Strategic alliance with GSK for clinical development. It is believed that this dual-function approach can control tumor growth by potentially restoring and enhancing anti-tumor responses. Preclinical studies have shown that bintrafusp alfa monotherapy and combination chemotherapy have anti-tumor activity. According to its mechanism of action, bintrafusp alfa is expected to respond to the basic pathophysiology of refractory cancer through targeted methods.

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About Merck

Merck is a leading technology company with operations in healthcare, life sciences and electronics. Approximately 58,000 employees are actively changing the daily lives of millions of people by creating a happier and sustainable lifestyle. From advanced gene editing technology to discovering unique methods to treat extremely challenging diseases, to empowering smart devices, the company's business is everywhere. In 2020, Merck's sales in 66 countries reached 17.5 billion euros.

Scientific exploration and responsible entrepreneurship are the keys to Merck's technological advancement. Since its establishment in 1668, Merck has been thriving in this way. The founding family is still the majority shareholder of listed companies. Merck has global rights in the Merck name and brand. The only exceptions are the United States and Canada, where Merck’s business unit is called EMD Serono in the healthcare field, MilliporeSigma in the life sciences field, and operates under the name EMD Electronics.

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Julissa Viana
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