On January 19, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer (NSCLC) (Press release, Regeneron, JAN 19, 2022, View Source [SID1234605583]). The target action date for the FDA decision is September 19, 2022.

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The sBLA is supported by results from a randomized, multicenter Phase 3 trial that investigated Libtayo in combination with a physician’s choice of platinum-doublet chemotherapy (Libtayo combination), compared to platinum-doublet chemotherapy alone. Enrolled patients (n=466) had locally advanced or metastatic NSCLC, irrespective of PD-L1 expression level or tumor histology, and with no ALK, EGFR or ROS1 aberrations. A regulatory filing has also been recently submitted to the European Medicines Agency.

The Phase 3 trial supporting the sBLA was stopped early after the Libtayo combination demonstrated a significant overall survival improvement compared to chemotherapy alone. Results were presented at the European Society for Medical Oncology Virtual Congress in 2021. Among patients in the Libtayo combination (n=312) and chemotherapy alone (n=154) groups, treatment discontinuations due to adverse events (AEs) occurred in 5% and 3% of patients, respectively. Immune-mediated AEs occurred in 19% of patients in the Libtayo combination group.

Notably, the Phase 3 trial was designed to include baseline characteristics seen in everyday clinical practice. Among those enrolled, 43% had tumors with squamous histology, 67% had tumors with <50% PD-L1 expression, 15% had inoperable locally advanced disease not eligible for definitive chemoradiation, and 7% had pretreated and clinically stable brain metastases. In addition, 84% of patients had an ECOG 1 performance status, which indicates the presence of cancer-related symptoms. ECOG performance status assesses patient ability to conduct daily living activities and prognosis on a scale of increasing severity ranging from 0 (no symptoms) to 5 (death).

In 2021, Libtayo was approved in the U.S. and European Union as first-line monotherapy treatment for adult patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations.

Libtayo, which was invented using Regeneron’s proprietary VelocImmune technology, is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. The use of Libtayo in combination with chemotherapy for advanced NSCLC is investigational, and its safety and efficacy have not been fully evaluated by any regulatory authority.

About Non-small Cell Lung Cancer
Lung cancer is the leading cause of cancer death worldwide. In recent years, more than 235,000 and 2.2 million annual new cases have been diagnosed in the U.S. and globally, respectively. Approximately 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages. Additionally, 70% of all NSCLC cases will have <50% PD-L1 expression, making it the most common treatment setting.

About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo is indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma, and advanced NSCLC.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

U.S. FDA-approved Indications
Libtayo is a prescription medicine used to treat people with:

A type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.
A type of skin cancer called basal cell carcinoma (BCC):
That cannot be removed by surgery (locally advanced BCC) and have received treatment with a hedgehog inhibitor (HHI), or cannot receive treatment with an HHI.
That has spread (metastatic BCC) and have received treatment with an HHI, or cannot receive treatment with an HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
A type of lung cancer called non-small cell lung cancer (NSCLC). Libtayo may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high "PD-L1" and your tumor does not have an abnormal "EGFR", "ALK" or "ROS1" gene.
It is not known if Libtayo is safe and effective in children.

About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved or authorized fully human monoclonal antibodies currently available. This includes REGEN-COV (casirivimab and imdevimab), Dupixent (dupilumab), Libtayo (cemiplimab-rwlc), Praluent (alirocumab), Kevzara (sarilumab), Evkeeza (evinacumab-dgnb) and Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn).

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is the most important information I should know about Libtayo?
Libtayo is a medicine that may treat certain cancers by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, or chest pain
Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach area (abdomen) pain or tenderness
Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Libtayo. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling.

Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Libtayo. Your healthcare provider will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious.
Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Libtayo if you have severe side effects.

Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. Libtayo can harm your unborn baby

Females who are able to become pregnant:
Your healthcare provider will give you a pregnancy test before you start treatment.
You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of Libtayo. Talk with your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.
are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Libtayo include muscle or bone pain, tiredness, rash, and diarrhea. These are not all the possible side effects of Libtayo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals and Sanofi at 1-877-542-8296.

On January 19, 2022 QIAGEN N.V. (NYSE: QGEN) (Frankfurt Stock Exchange: QIA) reported that it plans to release its report on results for the fourth quarter and full-year results of 2021 on Tuesday, February 8, at approximately 16:05 Eastern Standard Time (EST) / 22:05 Central European Time (CET) (Press release, Qiagen, JAN 19, 2022, View Source [SID1234605582]).

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A conference call is scheduled for Wednesday, February 9 at 15:00 Frankfurt time / 14:00 London time / 09:00 New York time. It will be hosted by Thierry Bernard, Chief Executive Officer, and Roland Sackers, Chief Financial Officer.

Conference call and webcast details

Please use the following link to have the conference call you: Connect Me. This „click to join function" will be available 15 minutes before the call starts. Please enter your name, company and phone number, and you will be connected to the call.

Alternatively, you may listen to the call by dialling:
+1 929 477 0402 (U.S.), +44 (0)330 336 9125 (UK), +49 (0) 69 2222 25574 (Germany)

To avoid waiting time, please join the event conference 5-10 minutes prior to the start time.
Conference ID: 5585677

The webcast will be accessible at:
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A conference call replay will be available by using the following link:
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On January 19, 2022 PierianDx, the global leader in clinical genomics knowledge, reported that it has partnered with Biodesix to provide its interpretation technology platform for use with the Biodesix newly launched GeneStrat NGS genomic test, a blood-based tumor profiling test to detect actionable mutations in patients with non-small cell lung cancer (NSCLC) (Press release, PierianDx, JAN 19, 2022, View Source [SID1234605580]). Biodesix (Nasdaq: BDSX) will use the PierianDx platform to provide clear, up-to-date clinical interpretations for mutations detected by the GeneStrat NGS test as part of patient test results used by physicians to help inform a personalized treatment strategy and facilitate monitoring in lung cancer.

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The GeneStrat NGS test is a key part of the IQLung testing strategy, designed to measure tumor-specific mutations and patient immune profiles with results in an unprecedented 72 hours so that physicians can assess overall prognosis and personalize treatment plans. The IQLung strategy uses genomic profiling to detect actionable mutations in lung cancer, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner.

The GeneStrat NGS test data will be analyzed and interpreted using the most current therapy approvals and oncology guideline recommendations and delivered in a physician-ready report. The technology is backed by a comprehensive clinical knowledgebase and adaptive learning algorithms that take disparate inputs and translate them into concise interpretations with supporting evidence. As a result, characteristics of patient variants, even though rare or novel, are leveraged to present the most optimal treatment possibilities.

"We are helping to meet an unmet need in the continuum of care for lung cancer," said Scott Hutton, CEO of Biodesix. "Partnering with PierianDx not only helps to deliver rapid results to physicians, but it also gives them information that can be easily interpreted and actioned, supporting them in providing precision care for their patients."

"We are thrilled to provide our interpretation technology to support the outstanding testing solution from Biodesix to treat patients with lung cancer," states Mark McDonough, CEO of PierianDx. "We are committed to democratizing clinical genomics globally and this partnership with Biodesix supports our vision to broaden access to genomic testing and provide precision care to patients everywhere."

On January 19, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, reported positive interim clinical trial safety data demonstrating 100% completion of IMX-110 planned treatment cycles in its ongoing Phase 1b/2a clinical trial (Press release, Immix Biopharma, JAN 19, 2022, View Source [SID1234605579]). Historically, 43-67% of patients have completed planned treatment cycles with approved drugs used to treat soft tissue sarcoma (STS) according to Demetri et al., 2016, and Schöffski et al., 2016. Completion of planned treatment cycles refers to lack of drug-related interruptions (cycle delays, dose reductions, or dose interruptions due to drug toxicity).

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"With standard treatments widely used today, cancer patients face a long list of drug-related debilitating side-effects that cause treatment delays, dose reductions, or dose interruptions due to toxicity, interfering with the ability to treat them effectively," said Ilya Rachman, MD PhD, CEO of ImmixBio. "In this interim clinical trial update, we are thrilled to report that IMX-110 has been well tolerated. We believe that IMX-110 could become a potentially attractive option to improve the patient experience in oncology in the future."

The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. The FDA has already approved rare pediatric disease ("RPD") designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma.

On January 20, 2022 Eisai (Headquarters: Tokyo, CEO: Haruo Naito) and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) reported the publication of results from the Phase 3 Study 309/KEYNOTE-775 trial in the January 19, 2022 edition of the New England Journal of Medicine (Press release, Eisai, JAN 19, 2022, View Source [SID1234605576]). The pivotal study evaluated the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. versus chemotherapy (treatment of physician’s choice of doxorubicin or paclitaxel) for patients with advanced endometrial carcinoma following at-least one prior platinum-based regimen in any setting.　　

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The publication includes previously reported data that was first presented in an oral plenary session at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer.1 Results showed that the LENVIMA plus KEYTRUDA combination demonstrated statistically significant improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to chemotherapy. Objective response rate (ORR) data and additional detailed efficacy and safety data, including subgroup analyses, are also featured in the publication.

"While rates of endometrial carcinoma continue to rise globally, patients with advanced or recurrent disease have limited options available to them once the disease progresses following platinum-based chemotherapy," said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck Research Laboratories. "KEYNOTE-775/Study 309 is an important Phase 3 study that supported recent approvals of KEYTRUDA plus LENVIMA for certain types of advanced endometrial carcinoma in the U.S. and other countries around the world, where it became the first immunotherapy and tyrosine kinase inhibitor combination approved for these patients."　　　　　

"The Phase 3 Study 309/KEYNOTE-775 trial demonstrates the ongoing commitment that Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. share in addressing the unmet needs of people living with difficult-to-treat cancers, including advanced endometrial carcinoma," said Corina Dutcus, M.D., Senior Vice President, Clinical Research, Oncology Business Group at Eisai Inc. "The publication of this study in the New England Journal of Medicine reflects the importance of our joint research in exploring the potential of the LENVIMA plus KEYTRUDA combination."　

The publication contains results for the all-comer population, including the mismatch repair deficient (dMMR) patient population for which LENVIMA plus KEYTRUDA is not approved in the U.S.

Based on the results from the Phase 3 Study 309/KEYNOTE-775 trial, LENVIMA plus KEYTRUDA has been approved in the U.S. for patients with advanced endometrial carcinoma that is not microsatellite instability-high or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. LENVIMA plus KEYTRUDA is also approved in the European Union and Japan for certain patients with advanced or recurrent endometrial carcinoma regardless of mismatch repair status. Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in more than 10 different tumor types across more than 20 clinical trials.

About Study 309/KEYNOTE-775 Trial

Study 309/KEYNOTE-775 (ClinicalTrials.gov, NCT03517449(New Window)) is a Phase 3 multicenter, open-label, randomized, active-controlled study conducted in 827 patients with advanced endometrial carcinoma who had been previously treated with at least one prior platinum-based chemotherapy regimen in any setting, including in the neoadjuvant and adjuvant settings. Participants may have received up to two platinum-containing therapies in total, as long as one was given in the neoadjuvant or adjuvant treatment setting. The study excluded patients with endometrial sarcoma, carcinosarcoma, pre-existing Grade ≥3 fistula, uncontrolled blood pressure (>150/90 mmHg), significant cardiovascular impairment or event within previous 12 months or patients who had active autoimmune disease or a medical condition that required immunosuppression. The primary efficacy outcome measures were OS, and PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors Version (RECIST) v1.1. Secondary efficacy outcome measures included ORR as assessed by BICR.

　　

Patients were randomized 1:1 to receive LENVIMA (20 mg orally once daily) plus KEYTRUDA (200 mg intravenously every three weeks) or investigator’s choice, consisting of either doxorubicin (60 mg/m2 every three weeks) or paclitaxel (80 mg/m2 given weekly, three weeks on/one week off). Treatment with LENVIMA plus KEYTRUDA continued until RECIST v1.1-defined progression of disease as verified by BICR, unacceptable toxicity, or for KEYTRUDA, a maximum of 24 months. Administration of LENVIMA plus KEYTRUDA was permitted beyond RECIST-defined disease progression if the treating investigator considered the patient to be deriving clinical benefit and the treatment was tolerated.

About Endometrial Carcinoma2,3,4,5,6

Endometrial carcinoma begins in the inner lining of the uterus, which is known as the endometrium and is the most common type of cancer in the uterus. In 2020, it was estimated there were more than 417,000 new cases and more than 97,000 deaths from uterine body cancers worldwide (these estimates include both endometrial carcinomas and uterine sarcomas; more than 90% of uterine body cancers occur in the endometrium, so the actual numbers for endometrial carcinoma cases and deaths are slightly lower than these estimates). In Japan, there were more than 17,000 new cases of uterine body cancer and more than 3,000 deaths from the disease in 2020. In the U.S., it is estimated there will be nearly 66,000 new cases of uterine body cancer and nearly 13,000 deaths from the disease in 2022. In Europe, it is estimated there were more than 130,000 new cases of uterine body cancer and more than 29,000 deaths in 2020. The five-year relative survival rate for metastatic endometrial carcinoma (stage IV) is estimated to be approximately 17%.

About LENVIMA (lenvatinib) Capsules

LENVIMA, discovered and developed by Eisai, is an orally available kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone.　　

Currently, LENVIMA has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including Japan, in Europe, China and in Asia, and in the United States for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. In addition, LENVIMA has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including Japan, in Europe, China and in Asia, and in the United States for first-line unresectable hepatocellular carcinoma. LENVIMA has been approved for monotherapy as a treatment for unresectable thymic carcinoma in Japan. It is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in Europe and Asia, and in the United States the treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. LENVIMA has been approved in combination with KEYTRUDA (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) in United States and in Europe. LENVIMA has been approved in combination with KEYTRUDA as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the United States, and has been approved for the similar indication (including conditional approval) in over 10 countries such as Canada and Australia. In some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials. In Europe, it has been approved in combination with KEYTRUDA (generic name: pembrolizumab) as the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. In Japan, it has been approved for the treatment of unresectable advanced or recurrent endometrial　carcinoma that progressed after cancer chemotherapy.

About KEYTRUDA (pembrolizumab) Injection, 100mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck & Co., Inc., Kenilworth, N.J., U.S.A. has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. 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.