On February 11, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) reported Rubraca data being presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Virtual Symposium 2021 (Press release, Clovis Oncology, FEB 11, 2021, View Source [SID1234574888]). These include data from the Phase 1b RAMP study evaluating Rubraca in combination with Xtandi, exploratory analyses from the pivotal TRITON2 study, and an analysis evaluating the rates of adverse events for different metastatic castration-resistant prostate cancer (mCRPC) treatments in a population of insured patients in the United States.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to share these data with the medical and scientific community to inform choices related to mCRPC treatment. The research into co-occurring alterations in mCRPC patients with a mutation of BRCA underscores the importance of genomic testing in men with mCRPC," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Additionally, we are encouraged by the results from the RAMP study, which lay the groundwork for the Phase 3 CASPAR clinical trial sponsored by the Alliance for Clinical Trials in Oncology evaluating Rubraca and Xtandi as a novel combination therapy in men with first-line metastatic castration-resistant prostate cancer."

Data from the RAMP study are presented by Arpit Rao, MD, Assistant Professor, Hematology, Oncology and Transplantation at the University of Minnesota. This Phase 1b study is investigating the combination of Rubraca and Xtandi in biomarker-unselected (including BRCA1/2 mutation negative) patients with mCRPC to assess the pharmacokinetics (PK) and safety of the combination. Treatment with rucaparib and enzalutamide had no clinically significant effect on the PK profiles of either drug, and the safety profile of the combination was consistent with that associated with each drug as monotherapy. The results presented at ASCO (Free ASCO Whitepaper) GU show that this combination is well-tolerated and without any significant drug-drug interactions. Data from the RAMP study support the randomized, placebo-controlled Phase 3 CASPAR study (Alliance A031902; NCT04455750) that is studying Rubraca and Xtandi, and is the subject of a Trial in Progress (TiP) poster being presented at the ASCO (Free ASCO Whitepaper) GU meeting. It is expected to begin enrolling mCRPC patients shortly.

The CASPAR study is sponsored by the Alliance for Clinical Trials in Oncology and will enroll approximately 1,000 patients in the United States. It is expected to open at hundreds of National Clinical Trials Network (NCTN) sites nationally. This is the only combination trial of a PARP inhibitor and novel anti-androgen with an overall survival co-primary endpoint. Patients who have received prior abiraterone/apalutamide in a non-mCRPC setting are allowed to enroll to maximize applicability in the era of rapidly changing standards-of-care. The Alliance is part of the NCTN sponsored by the National Cancer Institute (NCI).

Data from the TRITON2 clinical trial are presented by Wassim Abida MD, PhD at Memorial Sloan Kettering Cancer Center. These data underscore the antitumor activity of Rubraca among men with BRCA-mutated mCRPC and commonly co-occurring genomic alterations. Alterations in tumor suppressor genes, including TP53, PTEN and RB1, are associated with poor prognosis in patients with prostate cancer. Results from TRITON2 showed antitumor activity for Rubraca in patients with BRCA-mutated mCRPC associated with or without co-occurring alterations in these genes. There was no clear difference in radiographic and PSA response rates for patients with or without co-occurring TP53, PTEN, or RB1 alterations. Based on these results, researchers concluded that patients with mCRPC associated with a BRCA alteration should be considered for treatment with rucaparib irrespective of the presence of co-occurring alterations in these tumor suppressor genes.

In addition, data from an analysis of clinically significant events (CSEs) associated with mCRPC treatments were presented by Kelvin A. Moses, MD, PhD, Associate Professor of Urology at Vanderbilt University Medical Center. Researchers designed the analysis to better understand the association between mCRPC treatments and development of CSEs in a population of insured patients in the United States. Using an administrative claims database for the period from January 2008 to March 2019, the analysis found that among available mCRPC treatments, chemotherapy-based regimens had the highest CSE rates per treatment year. These data indicate the burden of treatment for patients and can inform treatment decisions.

Clovis Oncology-sponsored e-posters are available online at www.clovisoncology.com/pipeline/scientific-presentations.

About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Rubraca is an unlicensed medical product outside of the U.S. and Europe

Rubraca U.S. FDA Approved mCRPC Indication

Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of Rubraca. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca.

Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

On February 10, 2021 AbClon reported that the company will participate in the "CAR-TCR Europe Summit" (Press release, AbClon, FEB 10, 2021, View Source;wr_id=131&page=4 [SID1234638628]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AT101 CD19 targets disease protein B As a treatment for cell-derived blood cancer, existing CD19 CAR-T shows anticancer effect AT101 For the model)Yescata, etc., , AT101. is seeking differentiation by developing new humanized antibodies with completely different action sites, while ​FMC63Cell therapy uses mouse-derived antibodies.

AT501is HER2 an ovarian cancer treatment targeting disease protein, This is a material applied with AbClone’s original technology Switchable CAR-T (zCAR-T) . By controlling the concentration of the switch substance administered in the body CAR-T is a mechanism that regulates the activity of cells. CAR-T Disadvantage of cell therapy ​CRS (Cytokine Release Syndrome) It is possible to structurally overcome. In addition, , its platform nature has been strengthened as cross-application is possible for various cancer types by changing the switch material. Innovation CAR-T is a cell therapy.

On February 10, 2021 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported the fimaNAc focused presentation for the 12th Annual RNA Therapeutics Virtual Conference, a UK based online event taking place February 10-11, 2021 (Press release, PCI Biotech, FEB 10, 2021, View Source [SID1234585153]). The 2021 conference is set to explore the latest developments in RNA delivery agents and RNA-based therapeutics with the latest case studies on advanced mRNA technologies, oligonucleotide delivery, therapeutic applications and future trends and innovations. PCI Biotech is also a sponsor of the event.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Today, Wednesday February 10 2021, at 13:10pm (CET) Dr. Anders Høgset, CSO, will present an overview of PCI Biotech’s proprietary platform technology, focusing on the delivery of RNA molecules, including the most recent data on the use of the fimaNAc delivery technology in the exciting field of RNA based therapies.

Per Walday, CEO of PCI Biotech, comments: Encouraging collaborative preclinical results have recently been achieved with the fimaNAc technology and we are very pleased to be able to share these data now. The rapid development progress of mRNA-based vaccines against Covid-19 has generated much attention to the potential of nucleic acid therapeutics generally, and mRNA particularly. The results with fimaNAc suggests that this technology provides an appealing intracellular delivery solution for certain applications within this class of therapeutics.

An online recording of the full presentation held by Dr Høgset will be made available on PCI Biotech’s website (www.pcibiotech.com) under "Scientific publications & presentations" after the event.

On February 10, 2021 Sensei Biotherapeutics, Inc., a clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported the closing of its initial public offering of 7,000,052 shares of its common stock on February 8, 2021, as well as the issuance of an additional 1,030,243 shares pursuant to the exercise by the underwriters of their option to purchase additional shares on February 10, 2021, at a public offering price of $19.00 per share (Press release, Sensei Biotherapeutics, FEB 10, 2021, View Source [SID1234575166]). The gross proceeds to Sensei from the two closings, before deducting underwriting discounts and commissions and other offering expenses payable by Sensei, were approximately $152.6 million. All of the shares in the offering were offered by Sensei. Sensei’s common stock is listed on the Nasdaq Global Market under the ticker symbol "SNSE."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Citigroup, Piper Sandler & Co. and Berenberg acted as joint book-running managers for the offering. Oppenheimer & Co. acted as the lead manager for the proposed offering.

A registration statement relating to the securities was declared effective by the Securities and Exchange Commission on February 3, 2021. The offering of these securities is being made only by means of a prospectus. A copy of the final prospectus may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 800-831-9146 or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924 or by email at [email protected]; or Berenberg Capital Markets LLC, Attention: Investment Banking, 1251 Avenue of the Americas, 53rd Floor, New York, NY 10020, or by telephone at 646-949-9000 or by email at [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 9, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported the outcome of today’s meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA), which discussed the supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant (pre-operative) treatment, then as a single agent as adjuvant (post-operative) treatment after surgery for patients with high-risk early-stage triple-negative breast cancer (TNBC) (Press release, Merck & Co, FEB 10, 2021, View Source [SID1234575051]). The committee voted 10-0 that a regulatory decision should be deferred until further data are available from the Phase 3 KEYNOTE-522 trial. The study met one of the dual primary endpoints of pathological complete response (pCR) and is continuing to evaluate event-free survival (EFS). The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA is not bound by the committee’s guidance but takes its advice into consideration.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Triple-negative breast cancer is an aggressive disease, and we all agree that patients with early-stage disease are in need of more options," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "While we are disappointed in the outcome of today’s meeting, we believe KEYTRUDA can help meet the significant unmet medical need for these patients. We are confident in the results seen thus far from the KEYNOTE-522 trial, including the pathological complete response rates observed and the encouraging interim event-free survival data. We look forward to continuing to work with the FDA on its review of our application. We thank all of the patients, caregivers and health care providers who are participating in this study."

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of March 29, 2021. The next interim analysis is calendar-driven, and data is expected in the third quarter of 2021.

About Triple-Negative Breast Cancer

Triple-negative breast cancer is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of human epidermal growth factor receptor 2 (HER2), TNBC tests negative for all three. Approximately 15-20% of patients with breast cancer are diagnosed with TNBC.

About KEYNOTE-522

The filing was based on data from KEYNOTE-522 (ClinicalTrials.gov, NCT03036488), a Phase 3, randomized, double-blind trial evaluating a regimen of neoadjuvant KEYTRUDA in combination with chemotherapy followed by adjuvant KEYTRUDA as monotherapy versus a regimen of neoadjuvant chemotherapy followed by adjuvant placebo. The dual primary endpoints are pCR and EFS. The secondary endpoints include pCR rate using alternative definitions (i.e., no invasive or noninvasive residual cancer in breast or nodes) at the time of definitive surgery, overall survival, EFS in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1), safety and patient-reported outcomes. The study enrolled 1,174 patients who were randomized 2:1 to receive either:

KEYTRUDA (every three weeks) plus paclitaxel (weekly) and carboplatin (weekly or every three weeks) for four cycles, followed by KEYTRUDA plus cyclophosphamide and either doxorubicin or epirubicin (every three weeks) for four cycles as neoadjuvant therapy prior to surgery, followed by nine cycles of KEYTRUDA (every three weeks) as adjuvant therapy post-surgery or;
Placebo (every three weeks) plus paclitaxel (weekly) and carboplatin (weekly or every three weeks) for four cycles, followed by placebo plus cyclophosphamide and either doxorubicin or epirubicin (every three weeks) for four cycles as neoadjuvant therapy prior to surgery, followed by nine cycles of placebo (every three weeks) as adjuvant therapy post-surgery.
About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-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 has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,300 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.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS ≥10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. 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.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.