Last update 29 Nov 2024

Pembrolizumab

Last update 29 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Lambrolizumab, Pembrolizumab (Genetical Recombination), Pembrolizumab (genetical recombination) (JAN)

+ [10]

Target

PD-1

Mechanism

PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesInfectious Diseases+ [13]

Active Indication

Malignant Pleural MesotheliomaUnresectable Urothelial CarcinomaAdvanced Endometrial Carcinoma+ [507]

Inactive Indication

Acute lymphoblastic leukemia recurrentAdenocarcinoma, metastaticAdenoviridae Infections+ [67]

Originator Organization

Merck & Co., Inc.

Active Organization

Merck Sharp & Dohme Corp.

National Cancer InstituteMerck Sharp & Dohme LLC

+ [82]

Inactive Organization

Daiichi Sankyo, Inc.

Rainier Therapeutics, Inc.

Nektar Therapeutics

+ [13]

Drug Highest PhaseApproved

First Approval Date

US (04 Sep 2014),

Melanoma

RegulationPriority Review (US), Accelerated Approval (US), PRIME (EU), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (JP), Orphan Drug (AU), Priority Review (AU), Breakthrough Therapy (US), Orphan Drug (US)

Gene Sequence

Sequence Code 93660H

Source: *****

Sequence Code 93670L

Source: *****

2,335

Clinical Trials associated with Pembrolizumab

NCT05077215 / Not yet recruitingPhase 3

A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab Vs. Lenvatinib Plus Pembrolizumab in Patients with Advanced Endometrial Cancer

This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol).
Approximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors:
* Diagnosis Classification (advanced Stage III/IV vs. recurrent endometrial cancer)
* ECOG score at baseline (0 vs 1)
* Geographic region (Asia vs ROW)

Start Date01 Dec 2025

Sponsor / Collaborator

Evergreen Therapeutics, Inc

NCT05106127 / Not yet recruitingPhase 2

A Phase 2, Open-Label, Safety Lead-In with Long Term Safety Study of EG-007, Added to the Combination of Lenvatinib Plus Pembrolizumab

This is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients.
A safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. All patients enrolled in the safety lead-in study may continue long-term treatment under this protocol without interruption of dosing.

Start Date01 Aug 2025

Sponsor / Collaborator

Evergreen Therapeutics, Inc

NCT04901741 / Not yet recruitingPhase 2

An Open-label Phase 2 Study of Olaptesed Pegol (NOX-A12) Combined With Pembrolizumab and Nanoliposomal Irinotecan/5-FU/Leucovorin or Gemcitabine/Nab-paclitaxel in Microsatellite-stable Metastatic Pancreatic Cancer Patients

The purpose of this study is to provide a go/no-go decision for a randomized expansion study by assessing the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel, to assess safety and tolerability and time-to-event endpoints.

Start Date01 Jun 2025

Sponsor / Collaborator

TME Pharma NV

[+1]

100 Clinical Results associated with Pembrolizumab

100 Translational Medicine associated with Pembrolizumab

100 Patents (Medical) associated with Pembrolizumab

9,074

Literatures (Medical) associated with Pembrolizumab

01 Feb 2025·Clinical Genitourinary Cancer

Outcomes by Retrospective Eligibility for Maintenance Therapy of Patients With Advanced Urothelial Carcinoma: Post Hoc Analysis of the Phase 3 KEYNOTE-361 Trial

Article

Author: Sella, Avishay ; Mamtani, Ronac ; Gravis, Gwenaelle ; Chang, Yen-Hwa ; Joly, Florence ; Bedke, Jens ; Pino, Alvaro Montesa ; Huillard, Olivier ; Imai, Kentaro ; Şendur, Mehmet A． N. ; Lee, Hyo Jin ; Moreno, Blanca Homet ; Alva, Ajjai ; Gafanov, Rustem ; Xu, Jin Zhi ; Şendur, Mehmet A.N. ; Matsubara, Nobuaki ; Herranz, Urbano Anido ; Şendur, Mehmet A N ; Powles, Thomas

INTRODUCTION:

The phase 3 KEYNOTE-361 trial of first-line pembrolizumab with or without chemotherapy versus chemotherapy alone in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) completed enrollment before the approval of postchemotherapy maintenance avelumab for patients without progressive disease. This post hoc analysis evaluated the outcomes of patients who received chemotherapy alone in KEYNOTE-361 by retrospective eligibility for subsequent maintenance therapy.

PATIENTS AND METHODS:

Patients in the chemotherapy alone arm were retrospectively categorized as maintenance eligible (received ≥4 cycles of chemotherapy and did not die or experience disease progression within 10 weeks of chemotherapy completion), maintenance ineligible (received <4 cycles of chemotherapy or had progressive disease or died within 0-10 weeks after completion of ≥4 cycles of chemotherapy), and indeterminate eligibility for maintenance therapy (if neither maintenance eligible or ineligible). End points included progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 by blinded independent central review and overall survival from randomization (start of chemotherapy).

RESULTS:

Median follow-up was 31.7 months (range, 22.0-42.3). Among 342 patients who received chemotherapy alone, 172 (50.3%) were maintenance eligible, 108 (31.6%) were maintenance ineligible, and 62 (18.1%) had indeterminate eligibility for maintenance therapy. The median progression-free survival was 9.0 months (95% CI 8.4-10.4) in maintenance-eligible patients, 5.1 months (4.2-6.0) in maintenance-ineligible patients, and 2.3 months (1.9-3.8) in the indeterminate group; median overall survival was 23.3 months (95% CI 19.4-26.1), 10.2 months (9.1-11.6), and 5.5 months (3.7-8.5), respectively.

CONCLUSION:

This post hoc analysis suggests that a majority of patients with untreated la/mUC who initiated chemotherapy in a clinical trial may have been considered eligible for maintenance therapy and had favorable survival outcomes compared with those considered maintenance ineligible.

01 Feb 2025·CURRENT GENE THERAPY

Efficacy and Safety of Pembrolizumab Monotherapy or Combined Therapy in Patients with Metastatic Triple-negative Breast Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Review

Author: Soleimantabar, Hussein ; Alimohammadi, Mina ; Gharebakhshi, Farshad ; Mafi, Alireza ; Araghi, Mahmood ; Faramarzi, Fatemeh ; Mousavi, Tahoora

Background::

Metastatic Triple-negative Breast Cancer (mTNBC) is the most aggressive form of breast cancer, with a greater risk of metastasis and recurrence. Research studies have published in-depth analyses of the advantages and disadvantages of pembrolizumab, and early data from numerous trials suggests that patients with mTNBC have had remarkable outcomes. This meta-analysis compares the data from numerous relevant studies in order to evaluate the safety and efficacy of pembrolizumab monotherapy or combination therapies for mTNBC.

Methods::

To identify eligible RCTs, a thorough literature search was carried out using electronic databases. CMA software was utilized to perform heterogeneity tests using fixed and random-effects models.

Results::

According to our pooled data, the median Progression-free Survival (PFS) was 2.66 months, and the median overall survival (OS) was 12.26 months. Furthermore, by comparing efficacy indicators between PD-L1–positive and PD-L1–negative groups, a correlation was found between the overexpression of PD-L1 with OS, PFS, and ORR. Patients with PD-L1-positive tumors had a higher response rate, with an ORR of 21.1%, compared to the patients with PD-L1-negative tumors. The ORR for first-line immunotherapy was higher than that of ≥second-line immunotherapy. In addition, pembrolizumab plus combination treatment resulted in a pooled incidence of immune- related adverse events of 22.7%.

Conclusion::

A modest response to pembrolizumab monotherapy was detected in the mTNBC patients. Furthermore, a better outcome from pembrolizumab treatment may be predicted by PD-L1-- positive status, non-liver/lung metastases, combination therapy, and first-line immunotherapy. Pembrolizumab, in combination with chemotherapy, may be more beneficial for patients whose tumors are PD-L1 positive.

01 Jan 2025·CLINICAL ONCOLOGY

Real World Outcomes in Patients With Recurrent, Advanced, or Metastatic Endometrial Cancer Treated With Lenvatinib Plus Pembrolizumab

Article

Author: Stewart, A. ; Eminowicz, G. ; Tookman, Laura ; Counsell, N ; Counsell, N. ; Browne, R ; Eminowicz, G ; Pawsey, A. ; Ramessur, A ; Senthivel, N. ; Tookman, L. ; Usman, Sadaf ; Stewart, A ; Counsell, Nicholas ; Patel, A ; Eminowicz, Gemma ; Miller, R ; Mahalingam, P. ; Senthivel, N ; Mahalingam, Preethika ; Usman, S ; Mahalingam, P ; Turnbull, E ; Browne, Riona ; Miller, Rowan ; Ramessur, Anisha ; Nicum, S. ; Usman, S. ; Tookman, L ; Nicum, Shibani ; Turnbull, Emily ; Pawsey, Alexander ; Patel, A. ; Miller, R. ; Ramessur, A. ; Stewart, Alexandra ; Turnbull, E. ; Pawsey, A ; Nicum, S ; Browne, R. ; Patel, Apini ; Senthivel, Nishanthi

AIMS:

Patients with endometrial cancer who progress following first line therapy have improved survival outcomes with pembrolizumab and lenvatinib (pem/len) compared with standard of care chemotherapy, as demonstrated in KEYNOTE-775. This was in a group of trial patients with good performance status and excluded those with carcinosarcoma histology. In KEYNOTE-775 pem/len was associated with significant toxicity, leading to dose reductions, treatment cessation, and patient morbidity. We set out to assess the tolerability, toxicity and outcomes following pem/len for patients with recurrent, advanced or metastatic endometrial cancer in a real-world setting.

MATERIALS AND METHODS:

UK centres treating patients with pem/len for advanced endometrial cancer within the compassionate access programme were approached. Retrospective data were analysed for those treated between May 2022 and June 2023. Data on patient demographics, treatment, toxicity and outcomes were extracted from medical records. Toxicity and tolerability were compared in those over and under the age of 70.

RESULTS:

Seven centres returned data for 70 patients. Median age of patients was 68.5 years (range 45-85) with a performance status of 0-1 in 77.1% and of 2 in 22.9%. Histological subtypes included serous (34.3%), endometrioid (32.9%), carcinosarcoma (14.3%), clear cell (7.1%), mixed (2.9%) and other (8.6%). Grade ≥3 toxicity was reported in 55.7% with any-grade toxicity observed in 85.7%. In those aged ≥70 years (n = 30) the rate of grade ≥3 toxicity was 60.0%. Rates of dose reduction of lenvatinib were 64.3%, and toxicity-related treatment interruption was 45.7%. The 6-month progression-free and overall survival rates were 54.0% (95%CI: 39.0-66.8) and 70.1% (95%CI:56.5-80.1) respectively.

CONCLUSION:

This real-world, observational study of pem/len showed comparable tolerability, toxicity, and outcomes to previously reported clinical trial data. Our cohort included patients with a poorer PS and a broader range of histological subtypes including carcinosarcoma.

4,832

News (Medical) associated with Pembrolizumab

28 Nov 2024

·www.businesswire.com

Head and Neck Cancer Therapeutics Global Market Overview 2024 with Forecasts to 2030 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Head and Neck Cancer Therapeutics - A Global Market Overview" report has been added to ResearchAndMarkets.com's offering. The global market for Head and Neck Cancer Therapeutics is estimated at US$1.7 billion in 2024 and is anticipated to post a CAGR of 9.4% during the 2024-2030 analysis period and stand at a projected US$3 billion by 2030. This global report on Head and Neck Cancer Therapeutics analyzes the market based on drug class, treatment type, route of administration, and end-users. In addition to providing profiles of major companies operating in this space, the latest corporate and industrial developments have been covered to offer a clear panorama of how and where the market is progressing. The head and neck cancer market is primarily driven by increased research and development, which leads to the approval of new drugs, particularly for immunotherapy, targeted therapy, and chemotherapy. Healthcare providers are developing effective treatment options for several types of head and neck cancers, as evidenced by FDA approvals for drugs like Cetuximab and Docetaxel. Market growth is also driven by the rising incidence of HPV infections and increased consumption of alcohol and tobacco, which contribute to the prevalence of head and neck cancers. Additionally, advancements in diagnostic techniques allow for earlier detection, thereby improving treatment outcomes and increasing demand. Nevertheless, the market faces challenges such as high treatment costs limiting access for low- and middle-income patients, as well as adverse side effects like neuropathy and fatigue. Treatment resistance, where cancer cells evade therapies, and lengthy regulatory approval processes further impede market growth. Head and Neck Cancer Therapeutics Regional Market Analysis In 2024, North America led the global head and neck cancer therapeutics market, holding an estimated 46.8% market share. Growth in this region is attributed to its advanced healthcare infrastructure, strong awareness of the disease, substantial investments in research and development, and favorable reimbursement policies. The region's dominant position is supported by its robust healthcare system and the high incidence of head and neck cancer associated with tobacco, alcohol, and HPV. Conversely, the Asia Pacific region is expected to witness substantial growth with a CAGR of 10.9% during the forecast period 2024-2030, driven by the increasing number of head and neck cancer cases due to alcohol and tobacco use, growing consumer awareness, and higher healthcare spending. Market expansion in this region is further stimulated by the improving healthcare infrastructure, aging population, and rising disposable incomes. Countries such as China and India are particularly affected by a high prevalence of cancer, influenced by lifestyle factors and government efforts to improve cancer care. Head and Neck Cancer Therapeutics Market Analysis by Drug Class Programmed Cell Death (PD) Inhibitors dominate the head and neck cancer therapeutics market with an estimated share of 42.1% in 2024 and is projected to be the fastest-growing therapeutic class, with a CAGR of 10.5% during the analysis period 2024-2030. These inhibitors have shown promising results in improving survival rates and extending progression-free survival, especially in patients with advanced or recurrent cancer. Due to their effectiveness, there is increasing demand for both monotherapy and combination treatments. Current clinical trials are focused on improving treatment approaches, identifying relevant biomarkers, and exploring new combinations. Head and Neck Cancer Therapeutics Market Analysis by Treatment Type Immunotherapy is the largest market in the head and neck cancer therapeutics market, holding a share of 43.6% in 2024, and is projected to record the fastest CAGR of 10.7% during the analysis period 2024-2030. By utilizing the body's immune system to target cancer cells, immunotherapy presents promising treatment options for advanced or recurring head and neck cancers, with Pembrolizumab established as a primary therapy. Growth in this sector is expected due to increased patient awareness and the active involvement of the FDA and EMA in approving new formulations. Targeted therapy held the second-largest market share at 22% in 2024, concentrating on specific molecular changes in tumors by interrupting critical signaling pathways. The active participation of companies and healthcare organizations further bolsters the expansion of targeted therapies. Head and Neck Cancer Therapeutics Market Analysis by Route of Administration The injectable segment dominated the head and neck cancer therapeutics market in 2024, with a 67.4% share. This dominance is attributed to the effectiveness of various cancer medications, such as chemotherapy and immunotherapy, administered intravenously or through injectables to ensure better absorption and efficacy. Injectable drugs like Cisplatin are notable for their controlled delivery and improved formulations, enhancing treatment efficacy. Conversely, oral administration is anticipated to be the fastest-growing segment, with a CAGR of 10.4% during the forecast period 2024-2030, driven by advancements in oral chemotherapy formulations and patient preferences for convenient at-home treatment options. Oral medications provide flexible treatment schedules, reduce clinic visits, and contribute to personalized head and neck cancer treatment strategies, improving patients' overall quality of life. Head and Neck Cancer Therapeutics Market Analysis by End-User In 2024, hospitals dominate the head and neck cancer therapeutics end-user market, holding an estimated share of 49.1% due to their well-equipped infrastructure and advanced disease diagnosis capabilities. On the other hand, the Ambulatory Surgical Centers (ASCs) segment is anticipated to register the fastest CAGR of 10.9% during the analysis period from 2024 to 2030, propelled by the increasing demand for cost-effective outpatient surgical treatments and technological progress enabling complex procedures in ASCs. Additionally, this growth is further driven by the rising prevalence of the disease and the necessity for faster treatment options. Head and Neck Cancer Therapeutics Market Report Scope Key Attributes: Report Attribute Details No. of Pages 301 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $1.7 billion Forecasted Market Value (USD) by 2030 $3 billion Compound Annual Growth Rate 9.4% Regions Covered Global Key Global Players AbbVie Inc. AstraZeneca plc Bayer AG Bristol-Myers Squibb Company Eli Lilly and Company F. Hoffmann-La Roche AG Merck & Co., Inc. Novartis AG Pfizer Inc. Sanofi S.A. Takeda Pharmaceutical Company Limited Teva Pharmaceutical Industries Ltd. Head and Neck Cancer Therapeutics Market by Geographic Region North America (The United States, Canada, and Mexico) Europe (Germany, France, United Kingdom, Italy, Spain, and Rest of Europe) Asia-Pacific (Japan, China, India, South Korea, and Rest of Asia-Pacific) South America (Brazil, Argentina, and Rest of South America) Rest of World Head and Neck Cancer Therapeutics Market by Drug Class Programmed Cell Death (PD) Inhibitors Microtubule Inhibitors Epidermal Growth Factor Receptor (EGFR) Inhibitors Head and Neck Cancer Therapeutics Market by Treatment Type Immunotherapy Targeted Therapy Chemotherapy Radiation Therapy Surgery Head and Neck Cancer Therapeutics Market by Route of Administration Injectable Oral Head and Neck Cancer Therapeutics Market by End-User Hospitals Specialty Clinics Ambulatory Surgical Centers (ASCs) For more information about this report visit https://www.researchandmarkets.com/r/iwl4td About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

ImmunotherapyRadiation Therapy

28 Nov 2024

·www.prnewswire.com

Akeso Announced the Inclusion in China's National Reimbursement Drug List of Cadonilimab and Ivonescimab

HONG KONG, Nov. 27, 2024 /PRNewswire/ -- Akeso, Inc. (9926. HK) ("Akeso" or the "Company") is pleased to announce that two of its independently developed, globally pioneering bispecific antibody drugs—cadonilimab Injection (PD-1/CTLA-4 bispecific antibody) and ivonescimab Injection (PD-1/VEGF bispecific antibody)—have both been included in the most recent National Reimbursement Drug List (NRDL) released by China's National Healthcare Security Administration. The most recent NRDL will become effective on January 1, 2025. Cadonilimab is included for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy. Ivonescimab is included for the treatment of epidermal growth factor receptor (EGFR) mutated locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). China's medical insurance system includes basic medical insurance, work-related injury insurance, and maternity insurance, covering over 95% of the population. The NRDL defines the medications eligible for reimbursement under the medical insurance fund. According to statistical reports, in 2023, expenditures from China's basic medical insurance, work-related injury insurance, and maternity insurance funds on drugs listed in the NRDL accounted for 90% of total hospital procurement orders. Dr. Xia Yu, the Founder, Chairwoman, President, and Chief Executive Officer of Akeso, said, " The inclusion of cadonilimab and ivonescimab in the National Reimbursement Drug List emphasizes the innovative and clinical significance of these groundbreaking biologics, both of which are developed by Akeso. The inclusion marks a significant milestone in improving patient access to innovative treatments. It will substantially reduce the financial burden on patients, allowing more individuals to benefit from globally leading therapies. This development aligns perfectly with Akeso's core philosophy of advancing public health through scientific and technological innovation." Cadonilimab: Global First Approved Cancer Immunotherapy Bispecific Antibody Cadonilimab is an innovative bispecific antibody that simultaneously targets PD-1 and CTLA-4, leveraging a synergistic antitumor effect. This unique mechanism significantly enhances therapeutic outcomes, offering superior efficacy while greatly reducing toxicity. The latest data on cadonilimab for R/M CC shows that cadonilimab benefits both PD-L1 positive and negative patient populations, especially addressing an unmet need from PD-L1 negative patients, which previously lacked effective treatment options. For R/M CC, cadonilimab demonstrated a median overall survival (mOS) of over 18 months (NR), with an objective response rate (ORR) of 31.3% and a complete response (CR) rate of 13.1% in In the PD-L1 positive subgroup, the ORR reached 43.8%, with a median progression-free survival (mPFS) of 6.34 months, and the mOS is yet to be reached. On September 2024, cadonilimab was approved by NMPA for first-line treatment of advanced gastric cancer. The sNDA for first-line treatment of advanced cervical cancer is under review. Cadonilimab has been strongly recommended in 16 clinical treatment guidelines and consensus statements, covering a variety of cancers, including gastric cancer, gynecological cancers, liver cancer, esophageal cancer, and nasopharyngeal cancer. Furthermore, cadonilimab is currently undergoing more than 23 clinical trials across 16 indications, including gastric, lung, liver, cervical, and pancreatic cancers. Among these trials, 8 are registration Phase III trials. Ivonescimab: Global First Approved PD-1/VEGF Bispecific Antibody Ivonescimab is the world's first bispecific antibody that integrates "cancer immunotherapy and anti-angiogenesis" into a synergistic mechanism. In the Phase III HARMONi-A trial, for 2L+ EGFRm NSCL, ivonescimab combination therapy reduced the risk of disease progression or death by a record 54%, with a significant trend towards long-term survival benefits. Additionally, the Phase III HARMONi-2 trial comparing ivonescimab monotherapy with pembrolizumab in first-line treatment of PD-L1-positive non-small cell lung cancer (NSCLC) showed ivonescimab's superiority. Ivonescimab is the only drug globally to have demonstrated significantly better efficacy than pembrolizumab in a Phase III head-to-head trial. The sNDA for Ivonescimab in the first-line treatment of PD-L1-positive NSCLC is currently under regulatory review, with priority review status granted. Ivonescimab has already been robustly recommended within six major clinical treatment guidelines and consensus statements. Additionally, ivonescimab has been engaged in over 25 clinical trials spanning more than 17 varieties of cancers, namely lung cancer, head and neck squamous cell carcinoma, biliary tract cancer, pancreatic cancer, breast cancer, hepatocellular carcinoma, and colorectal cancer. Nearly 10 Phase III trials of ivonescimab are progressing efficiently in China and the rest of the World, with one of them being on head and neck squamous cell carcinoma. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin, and X (formerly Twitter). SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 3Clinical ResultDrug ApprovalPriority Review

27 Nov 2024

·www.globenewswire.com

Updated MDNA11 Monotherapy and Combination Clinical Data from the Ongoing Phase 1/2 ABILITY-1 Study to be Presented at the 2024 Immunotherapy Bridge Conference

TORONTO and HOUSTON, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines, announced today that updated clinical data from the ongoing Phase 1/2 ABILITY-1 study will be presented as part of an oral podium presentation at the 2024 Immunotherapy Bridge Conference, taking place from December 4-5, 2024 in Naples, Italy. The oral presentation will include updated clinical data from the monotherapy and combination arms of the ongoing Phase 1/2 ABILITY-1 Study evaluating MDNA11, a long-acting ‘beta-enhanced not-alpha’ interleukin-2 (“IL-2”) super-agonist, in patients with advanced or metastatic solid tumors. Presentation Details: Title: Updated Safety and Efficacy Results from the First-in-Human Study of MDNA11 (ABILITY-1), a Next Generation ‘Beta-Enhanced Not-Alpha’ IL-2 Superkine, Show Single-Agent Activity in Patients with Advanced Solid TumorsPresentation Date: Thursday, December 5, 2024 8:45 AM CET (2:30 AM EST)Presenter: Dr. Arash Yavari, MBBS, DPhil; Director of Clinical Strategy Following the presentation, a copy of the presentation will be available on the “Scientific Presentations” page of Medicenna’s website. About MDNA11 MDNA11 is an intravenously administered, long-acting ‘beta-enhanced not-alpha’ IL-2 Superkine specifically engineered to overcome the shortcomings of aldesleukin and other next generation IL-2 variants by preferentially activating immune effector cells (CD8+ T and NK cells) responsible for killing cancer cells, with minimal or no stimulation of immunosuppressive Tregs. These unique proprietary features of the IL-2 Superkine have been achieved by incorporating seven specific mutations and genetically fusing it to a recombinant human albumin scaffold to improve the pharmacokinetic (PK) profile and pharmacological activity of MDNA11 due to albumin’s natural propensity to accumulate in highly vascularized sites, in particular tumor and tumor draining lymph nodes. MDNA11 is currently being evaluated in the Phase 1/2 ABILITY-1 study as both monotherapy and in combination with pembrolizumab. About the ABILITY-1 Study The ABILITY-1 study (NCT05086692) is a global, multi-center, open-label study that assesses the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MDNA11 as monotherapy or in combination with pembrolizumab. In the combination dose escalation portion of the Phase 2 study, approximately 20 patients are expected to be enrolled and administered ascending doses of MDNA11 intravenously in combination with pembrolizumab. This portion of the study includes patients with a wide range of solid tumors with the potential for susceptibility to immune modulating therapeutics. Upon identification of an appropriate dose regimen for combination, the study will proceed to a combination dose expansion cohort. About Medicenna Therapeutics Medicenna is a clinical-stage immunotherapy company focused on developing novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first-in-class Empowered Superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior affinity toward CD122 (IL-2 receptor beta) and no CD25 (IL-2 receptor alpha) binding, thereby preferentially stimulating cancer-killing effector T cells and NK cells. MDNA11 is being evaluated in the Phase 1/2 ABILITY-1 Study (NCT05086692) as a monotherapy and in combination with pembrolizumab. Medicenna’s IL-4 Empowered Superkine, bizaxofusp (formerly MDNA55), has been studied in 5 clinical trials enrolling over 130 patients, including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained FastTrack and Orphan Drug status from the FDA and FDA/EMA, respectively. Medicenna’s early-stage high-affinity IL-2β biased IL-2/IL-15 Super-antagonists, from its MDNA209 platform, are being evaluated as potential therapies for autoimmune and graft-versus host diseases. Medicenna’s early-stage BiSKITs™ (Bifunctional SuperKine ImmunoTherapies) and the T-MASK™ (Targeted Metalloprotease Activated SuperKine) programs are designed to enhance the ability of Superkines to treat immunologically “cold” tumors. For more information, please visit www.medicenna.com, and follow us on Twitter and LinkedIn. Forward-Looking Statements This news release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, express or implied statements regarding the future operations of the Company, estimates, plans, strategic ambitions, partnership activities and opportunities, objectives, expectations, opinions, forecasts, projections, guidance, outlook or other statements that are not historical facts, such as statements on the therapeutic potential and safety profile of MDNA11 (both as monotherapy and in combination with pembrolizumab), and the timing and/or release of any additional clinical updates. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage pre-clinical or clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expect”, “believe”, “seek”, “potentially” and similar expressions. and are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the risks detailed in the latest annual information form of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date hereof and except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements. This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this new release. Investor and Company Contact: Christina CameronInvestor Relations, Medicenna Therapeuticsir@medicenna.com(647) 953-0673 Daniel ScarrInvestor Relations & Business Development, Medicenna Therapeuticsdscarr@medicenna.com(647) 220-4509

ImmunotherapyOrphan DrugPhase 2Clinical Result

100 Deals associated with Pembrolizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10574	Pembrolizumab	L01XC18	DB09037

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Malignant Pleural Mesothelioma	US	Merck & Co., Inc.	17 Sep 2024
Malignant Pleural Mesothelioma	US	Merck Sharp & Dohme LLC	17 Sep 2024
Unresectable Urothelial Carcinoma	EU	Merck Sharp & Dohme BV	25 Jul 2024
Unresectable Urothelial Carcinoma	IS	Merck Sharp & Dohme BV	25 Jul 2024
Unresectable Urothelial Carcinoma	LI	Merck Sharp & Dohme BV	25 Jul 2024
Unresectable Urothelial Carcinoma	NO	Merck Sharp & Dohme BV	25 Jul 2024
Advanced Endometrial Carcinoma	US	Merck Sharp & Dohme LLC	17 Jun 2024
Microsatellite instability-high Endometrial Carcinoma	US	Merck Sharp & Dohme LLC	17 Jun 2024
Mismatch repair-deficient Endometrial Carcinoma	US	Merck Sharp & Dohme LLC	17 Jun 2024
Unresectable Biliary Tract Carcinoma	CA	Merck Sharp & Dohme Corp.	09 May 2024
Locally Advanced Cholangiocarcinoma	CN	MSD R&D (China) Co. Ltd.	04 Feb 2024
HER2 negative Gastric Cancer	US	Merck Sharp & Dohme LLC	16 Nov 2023
Resectable Lung Non-Small Cell Carcinoma	US	Merck Sharp & Dohme Corp.	16 Oct 2023
HER2 Positive Stomach Adenocarcinoma	EU	Merck Sharp & Dohme BV	06 Sep 2023
HER2 Positive Stomach Adenocarcinoma	IS	Merck Sharp & Dohme BV	06 Sep 2023
HER2 Positive Stomach Adenocarcinoma	LI	Merck Sharp & Dohme BV	06 Sep 2023
HER2 Positive Stomach Adenocarcinoma	NO	Merck Sharp & Dohme BV	06 Sep 2023
Metastatic HER2 positive gastroesophageal junction cancer	LI	Merck Sharp & Dohme BV	06 Sep 2023
Metastatic HER2 positive gastroesophageal junction cancer	NO	Merck Sharp & Dohme BV	06 Sep 2023
HER2-negative breast cancer	JP	MSD KK	26 Sep 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	NDA/BLA	CN	Merck Sharp & Dohme LLC	08 Nov 2023
Small intestine carcinoma	NDA/BLA	EU	Merck Sharp & Dohme Corp.	25 Mar 2022
Glioblastoma	Phase 3	US	Merck Sharp & Dohme LLC	01 Nov 2024
Glioblastoma	Phase 3	US	NovoCure GmbH	01 Nov 2024
Malignant Fibrous Histiocytoma	Phase 3	US	National Cancer Institute	11 Sep 2024
KRAS G12C mutant Non-small Cell Lung Cancer	Phase 3	US	Eli Lilly & Co.	21 Dec 2023
KRAS G12C mutant Non-small Cell Lung Cancer	Phase 3	AU	Eli Lilly & Co.	21 Dec 2023
KRAS G12C mutant Non-small Cell Lung Cancer	Phase 3	AT	Eli Lilly & Co.	21 Dec 2023
KRAS G12C mutant Non-small Cell Lung Cancer	Phase 3	BE	Eli Lilly & Co.	21 Dec 2023
KRAS G12C mutant Non-small Cell Lung Cancer	Phase 3	BR	Eli Lilly & Co.	21 Dec 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024 Manual	Not Applicable	Extranodal NK-T-Cell Lymphoma First line	19	Pembrolizumab	gjszgflbid(dyuqzdosyn) = fwmpvuvlux wedyqklqij (sasfnfejma ) View more	Positive	08 Dec 2024
				Pembrolizumab (pts with ES disease)	gjszgflbid(dyuqzdosyn) = ogzdmydwte wedyqklqij (sasfnfejma ) View more
ASH2024	Not Applicable	Classical Hodgkin's Lymphoma	-	Pembrolizumab plus COPDAC-28 with RT	swxcuhomcp(jzqmsjeovb) = fjmiwooxmz eueiqtrvuq (jonkquyujz, 93 - 100) View more	-	08 Dec 2024
				Pembrolizumab plus COPDAC-28 without RT	sbbbcstiee(bhmptyefoa) = yyvltmwgql rrefreodkk (zlsvtdliij )
ASH2024	Not Applicable	Classical Hodgkin's Lymphoma	-	Pembrolizumab plus AVD and RT	kvxthceard(kibrtwcrfk) = treatment-related adverse events (AEs) were reported in 8 patients (80%); grade 3 or 4 treatment-related AEs occurred in 4 patients (40%). No patients discontinued or died due to treatment-related AEs. Seven patients (67%) had pembrolizumab-related AEs, 3 of whom (30%) had a grade 3 event (vomiting, lymphocyte count decreased, white blood cell count decreased). Immune-mediated AEs occurred in 3 patients (30%; all grade 1 or 2 hypothyroidism) nvyjrtlfst (nwwtpyqctk )	-	08 Dec 2024
ASH2024	Not Applicable	Hodgkin's Lymphoma	-	Pembrolizumab 200 mg	bvltzdpdsf(jpirdpjxga) = led to discontinuations in 2 patients (at 2 and 6 months) tfkinzfspj (xfneqnanve ) View more	-	08 Dec 2024
NCT02852655 (CTgov)	Phase 1	Glioblastoma	60	MK3475 (Group A: Neoadjuvant + Adjuvant MK3475 (Stage 1 Cohort + Stage 2 Expansion Cohort))	irtncungiv(woyfcplgok) = zlamguaczg yoaofgfzdh (fstxknxxrx, oomgulznww - nrfccwnamg) View more	-	26 Nov 2024
				MK3475 (Group B: Adjuvant MK3475 (Stage 1 Cohort))	irtncungiv(woyfcplgok) = ptfsmwhqzw yoaofgfzdh (fstxknxxrx, kgyfadtvit - gemuwxcbzq) View more
NCT03534804 (PemCab, CTgov)	Phase 2	Advanced Urothelial Carcinoma \| Bladder Cancer \| Metastatic urothelial carcinoma	37	Cabozantinib+pembrolizumab	tmbajgoywm(edufvrzljz) = zpxprlophj rzczhdiujp (lcuzofxdbt, ndtowaxwbp - tjforpzjjh) View more	-	26 Nov 2024
NCT02799095 (ARTISTRY-1, Pubmed) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	243	Nemvaleukin alfa monotherapy at 0.1-10 µg/kg/day (part A)	xgtaedrahu(abbnlxroop) = elbybnswar bsosfohjbf (fbnsxddcxq )	Positive	20 Nov 2024
				Nemvaleukin alfa monotherapy 6 µg/kg/day (part B)	xgtaedrahu(abbnlxroop) = kleasadqqp bsosfohjbf (fbnsxddcxq, 4 - 20) View more
NCT03486197 (CTgov)	Phase 2	Advanced Urothelial Carcinoma	12	Laboratory Biomarker Analysis+pembrolizumab	xqrenmcyom(sukzmjizbo) = ywzbjvtvjc xkacntmmec (yiyophnkut, vhsqwshzcl - sfxsnferfh) View more	-	20 Nov 2024
NCT03248570 (CTgov)	Phase 2	DNA Repair-Deficiency Disorders \| Metastatic castration-resistant prostate cancer \| Metastatic Prostate Carcinoma	26	Chemotherapy+pembrolizumab (DNA Damage Repair Proficient Group)	qnzrvcyzvj(bbffawmdvs) = pqwfvjwrnp zhygrxrwbw (djmciyrtcc, bvixilwqru - uqwxuwjlwj) View more	-	20 Nov 2024
				Chemotherapy+pembrolizumab (DNA Damage Repair Defective Group)	qnzrvcyzvj(bbffawmdvs) = wacwxocdgb zhygrxrwbw (djmciyrtcc, qpygghxftq - pgpcjmsfec) View more
NCT02619253 (CTgov)	Phase 1	Advanced Urothelial Carcinoma \| Renal Cell Carcinoma \| Bladder Cancer	52	pembrolizumab+vorinostat (Expansion Cohort A)	ystqvyawhv(tyvvhcptng) = eqvjarxywz epvizqtoqq (ehtvnvddmi, cyrceprvap - mqpeklkrvn) View more	-	18 Nov 2024
				pembrolizumab+vorinostat (Expansion Cohort B)	ystqvyawhv(tyvvhcptng) = qcmbzhyrvj epvizqtoqq (ehtvnvddmi, zsgmtddqrl - qjjyhdkgji) View more

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