Efficacy and Safety Study of Second-Line Prolgolimab Monotherapy or in Combination With Bendamustine for Relapsed/Refractory Classical Hodgkin Lymphoma

Prolgolimab is an anti-PD-1 inhibitor that has previously been shown to be effective and safe for the treatment of patients with melanoma. Given the mechanism of action, it is expected to be effective in patients with classical Hodgkin lymphoma (cHL).
The use of PD-1 inhibitors in 2nd line treatment, as part of PET-adapted monotherapy/combination therapy, has already demonstrated a favorable toxicity profile, as well as a high efficacy, which may lead to increased survival of patients with r/r cHL. It has been demonstrated that long-term disease remission can be achieved after PD-1 inhibitor therapy, even in a group of heavily pretreated patients with relapsed/refractory cHL. The use of prolgolimab as part of PET-adapted therapy strategy in this study may allow to achieve a prolonged remission in patients with cHL who are highly sensitive to immunotherapy while omitting the autologous stem cell transplantation.

Start Date19 Apr 2023

Sponsor / Collaborator

St. Petersburg State University

NCT05732805 / RecruitingPhase 3

A Double-Blind Placebo-Controlled Comparative Randomized Clinical Study of the Efficacy and Safety of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma

The aim of study is to investigate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy versus prolgolimab monotherapy as first-line therapy in subjects with unresectable or metastatic melanoma.

Start Date02 Aug 2022

Sponsor / Collaborator

Biocad Medical, Inc.

NCT06428487 / RecruitingPhase 2IIT

Phase II,Open-label, Non-randomized Study of Neoadjuvant Prolgolimab Monotherapy in Patients With Locally Advanced Colorectal Cancer With Microsatellite Instability (MSI)/Mismatch Repair (dMMR) Deficiency

In this phase II study patients with stage II-III MSI/dMMR colorectal adenocarcinoma with no signs of distant metastases will be treated with immunotherapy (prolgolimab). The duration of treatment is 6 months (12 cycles)

Start Date31 Mar 2022

Sponsor / Collaborator

N N Blokhin Russian Cancer Research Center

100 Clinical Results associated with Prolgolimab

100 Translational Medicine associated with Prolgolimab

100 Patents (Medical) associated with Prolgolimab

Literatures (Medical) associated with Prolgolimab

01 May 2021·European journal of cancer (Oxford, England : 1990)Q1 · MEDICINE

Novel PD-1 inhibitor prolgolimab: expanding non-resectable/metastatic melanoma therapy choice

Q1 · MEDICINE

Article

Author: Kuryshev, Ivan ; Makarova, Yuliya ; Moiseyenko, Vladimir ; Demidov, Lev ; Fadeyeva, Natalya ; Nechaeva, Marina ; Andreev, Aleksey ; Semiglazova, Tatiana ; Protsenko, Svetlana ; Lazarev, Sergey ; Tarasova, Anna ; Zukov, Ruslan ; Tjulandin, Sergey ; Sakaeva, Dina ; Shustova, Mariia ; Odintsova, Svetlana

BACKGROUND:

Prolgolimab is an IgG1 anti-PD-1 (programmed cell death protein 1) monoclonal antibody containing the Fc-silencing 'LALA' mutation. We assessed the efficacy and safety of two dosing regimens of prolgolimab in patients with advanced melanoma in a multicenter open-label parallel-arm phase II trial (MIRACULUM). We present the final analysis after 1 year of follow-up and additional efficacy results from 2 years of follow-up.

METHODS:

Patients with advanced cutaneous or non-cutaneous melanoma, including stable brain metastasis, without autoimmune disease and who underwent no prior targeted therapy, anti-PD-(L)1 or anti-CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) therapy were randomly assigned (1:1) to receive prolgolimab in 2 dosing regimens, 1 mg/kg every 2 weeks (arm 1) or 3 mg/kg every 3 weeks (arm 2), until disease progression or intolerable toxicity. Randomisation was stratified based on performance status (Eastern Cooperative Oncology Group 0 or 1), lactate dehydrogenase levels (elevated or normal) and prior systemic therapy (naive or previously treated). The primary outcome was the objective response rate, assessed as per immune-related Response Evaluation Criteria in Solid Tumours by independent central review. The hypothesis that each dosing regimen of prolgolimab has an overall response rate >28% was tested independently for each study arm comprising all patients who received at least one dose of prolgolimab. Exploratory assessment of efficacy, including subgroup analysis, at 2 years of follow-up was not specified in the protocol. This study is registered withClinicalTrials.gov(NCT03269565).

RESULTS:

Between August 2017 and March 2018, 126 patients with advanced melanoma were enrolled. At main 1-year data cut-off, the median follow-up was 13.8 and 14.5 months in arm 1 and 2, respectively. An objective response was observed in 38.1% of patients (arm 1) and in 28.6% (arm 2). Grade III-IV treatment-related adverse events occurred in 12.7% and 3.2% of patients in arm 1 and 2, respectively. For exploratory efficacy analysis, the median follow-up was 25.4 and 25.7 months in arm 1 and 2, respectively. The 2-year progression-free survival was 33.3% in arm 1 and 30.2% in arm 2, and the 2-year overall survival was 57.1% and 46.0%, respectively.

CONCLUSIONS:

The MIRACULUM study met its primary end-point in both the study arms. Prolgolimab showed significant antitumour activity and a manageable safety profile in patients with advanced melanoma.

01 Jan 2021·mAbsQ2 · MEDICINE

Antibodies to watch in 2021

Q2 · MEDICINE

Review

Author: Reichert, Janice M. ; Kaplon, Hélène

In this 12^th annual installment of the Antibodies to Watch article series, we discuss key events in antibody therapeutics development that occurred in 2020 and forecast events that might occur in 2021. The coronavirus disease 2019 (COVID-19) pandemic posed an array of challenges and opportunities to the healthcare system in 2020, and it will continue to do so in 2021. Remarkably, by late November 2020, two anti-SARS-CoV antibody products, bamlanivimab and the casirivimab and imdevimab cocktail, were authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed antibodies levilimab and itolizumab had been registered for emergency use as treatments for COVID-19 in Russia and India, respectively. Despite the pandemic, 10 antibody therapeutics had been granted the first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan. The number of approvals in 2021 may set a record, as marketing applications for 16 investigational antibody therapeutics are already undergoing regulatory review by either the FDA or the European Medicines Agency. Of these 16 mAbs, 11 are possible treatments for non-cancer indications and 5 are potential treatments for cancer. Based on the information publicly available as of November 2020, 44 antibody therapeutics are in late-stage clinical studies for non-cancer indications, including 6 for COVID-19, and marketing applications for at least 6 (leronlimab, tezepelumab, faricimab, ligelizumab, garetosmab, and fasinumab) are planned in 2021. In addition, 44 antibody therapeutics are in late-stage clinical studies for cancer indications. Of these 44, marketing application submissions for 13 may be submitted by the end of 2021. *Note added in proof on key events announced during December 1-21, 2020: margetuximab-cmkb and ansuvimab-zykl were approved by FDA on December 16 and 21, 2020, respectively; biologics license applications were submitted for ublituximab and amivantamab.

17 Feb 2019·mAbs

Antibodies to watch in 2019

Article

Author: Reichert, Janice M. ; Kaplon, Hélène

For the past 10 years, the annual 'Antibodies to watch' articles have provided updates on key events in the late-stage development of antibody therapeutics, such as first regulatory review or approval, that occurred in the year before publication or were anticipated to occur during the year of publication. To commemorate the 10th anniversary of the article series and to celebrate the 2018 Nobel Prizes in Chemistry and in Physiology or Medicine, which were given for work that is highly relevant to antibody therapeutics research and development, we expanded the scope of the data presented to include an overview of all commercial clinical development of antibody therapeutics and approval success rates for this class of molecules. Our data indicate that: 1) antibody therapeutics are entering clinical study, and being approved, in record numbers; 2) the commercial pipeline is robust, with over 570 antibody therapeutics at various clinical phases, including 62 in late-stage clinical studies; and 3) Phase 1 to approval success rates are favorable, ranging from 17-25%, depending on the therapeutic area (cancer vs. non-cancer). In 2018, a record number (12) of antibodies (erenumab (Aimovig), fremanezumab (Ajovy), galcanezumab (Emgality), burosumab (Crysvita), lanadelumab (Takhzyro), caplacizumab (Cablivi), mogamulizumab (Poteligeo), moxetumomab pasudodox (Lumoxiti), cemiplimab (Libtayo), ibalizumab (Trogarzo), tildrakizumab (Ilumetri, Ilumya), emapalumab (Gamifant)) that treat a wide variety of diseases were granted a first approval in either the European Union (EU) or United States (US). As of November 2018, 4 antibody therapeutics (sacituzumab govitecan, ravulizumab, risankizumab, romosozumab) were being considered for their first marketing approval in the EU or US, and an additional 3 antibody therapeutics developed by Chinese companies (tislelizumab, sintilimab, camrelizumab) were in regulatory review in China. In addition, our data show that 3 product candidates (leronlimab, brolucizumab, polatuzumab vedotin) may enter regulatory review by the end of 2018, and at least 12 (eptinezumab, teprotumumab, crizanlizumab, satralizumab, tanezumab, isatuximab, spartalizumab, MOR208, oportuzumab monatox, TSR-042, enfortumab vedotin, ublituximab) may enter regulatory review in 2019. Finally, we found that approximately half (18 of 33) of the late-stage pipeline of antibody therapeutics for cancer are immune checkpoint modulators or antibody-drug conjugates. Of these, 7 (tremelimumab, spartalizumab, BCD-100, omburtamab, mirvetuximab soravtansine, trastuzumab duocarmazine, and depatuxizumab mafodotin) are being evaluated in clinical studies with primary completion dates in late 2018 and in 2019, and are thus 'antibodies to watch'. We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series.

News (Medical) associated with Prolgolimab

27 Jul 2022

·www.prnewswire.com

Cervical Cancer Therapeutics Epidemiology & Pipeline Analysis 2017-2027

DUBLIN, July 27, 2022 /PRNewswire/ -- The "Cervical Cancer Therapeutics Market - Epidemiology & Pipeline Analysis 2022-2027" report has been added to ResearchAndMarkets.com's offering. The cervical cancer portfolio contains a total of 169+ assets that are in various phases of development. Most industry-sponsored drugs in active clinical development for cervical cancer are in the Phase II stage. The distribution of the pipeline drugs across Phase I-IV is dominated by Phase II (35.5%), followed by Phase I (31.36%), and then Phase III (7.10%). Cervical Cancer Therapeutics: Clinical Trials Scenario The clinical trial portfolio contains 282+ trials in various phases of development. The majority of the industry-sponsored drugs in active clinical development for cervical cancer are in Phase II, with three drugs in the NDA/BLA stage. The distribution of clinical trials across Phase I-IV indicates that the vast majority of problems for cervical cancer have been in the early and mid-phases of development, with 94% of issues in Phase I-II and only 6% in Phase III-IV. The U.S. has a substantial lead in the number of cervical cancer clinical trials globally. The U.K. leads the primary European markets, while China has the top spot in Asia. Based on the efficacy demonstrated with pembrolizumab and the significant role of PD-L1 in cervical cancer, various anti-P.D.-(L)1 agents are currently under investigation as first-line therapies in cervical cancer. For instance, Atezolizumab and prolgolimab (BCD-100) combined with chemotherapy with or without bevacizumab and pembrolizumab with chemoradiotherapy are ongoing. In addition, several trials are examining novel combinations in this space. According to estimates, the diagnosed incident cases of cervical cancer were high in China, followed by the U.S. and Japan in 2020. The increasing prevalence of HIV (Human Immunodeficiency Virus) in women is driving the growth of the cervical cancer drugs market. Women with HIV positive have a greater risk of cervical cancer than the general population. Nearly 18 million women have tested HIV positive globally; HIV weakens the immune system, which increases the likelihood of cervical cancer. Surgery is the standard of care for the treatment of early-stage, while chemoradiation is the most common treatment modality for locally advanced disease. In the U.S., the approvals of Keytruda as first-line therapy and Tivdak as second-line therapy in 2021 wholly altered the treatment paradigm for recurrent and distally metastatic disease. Before the approval of Keytruda in the first line, patients received chemotherapy with Avastin, which remains the treatment of choice outside the U.S. MARKET TRENDS & DRIVERS Early Detection of Disease: More than 90% of cervical malignancies occur due to HPV infection (human papillomavirus), which can be diagnosed through smear screening. The Pap smear test, the most effective tool for diagnosing HPV in the early stage, is the most revenue-generating segment. Increasing Prevalence of Cervical cancer: The market study has been witnessing considerable growth, attributed to the increasing prevalence of cervical cancer among women worldwide. In 2018, an estimated 570 000 women were diagnosed with cervical cancer worldwide, and about 311 000 women died due to improper detection at the early stages of the disease. MARKET SEGMENTATION Drug Class: Chemotherapeutic drugs are expected to dominate the global cervical cancer therapeutics market. However, the targeted therapies are expected to be the fastest-growing segment during the forecast period. Recently approved biological drugs such as Keytruda (pembrolizumab) and Tivdak (tisotumab-vedotin-tftv) are expected to drive the targeted therapies segment during the forecast period. Histology type: Among the histology type, Squamous cell Carcinoma is expected to account for a significant share of the global cervical cancer therapeutics market. However, Adenocarcinoma is the fastest-growing segment during the forecast period due to its aggressive nature. Age Group: Among the Age group, women aged 50 years are expected to account for a significant portion of the global cervical cancer therapeutics market share. However, women between the age of 30 - 49 years are expected to be the fastest-growing segment during the forecast period. Distribution type: Among the distribution type, Retail & Specialty pharmacy services are expected to dominate the cervical cancer therapeutics market. According to the National Comprehensive Cancer Network Specialty Pharmacy Task Force, more than 80% of managed care organizations reported contracting with specialty pharmacy providers for their oncology business, and 51.4% reported using a single, preferred specialty provider for all limited-distribution drugs. Geography: The U.S. dominates the cervical cancer therapeutics market due to the rise in the healthcare affordability in the U.S., rise in the knowledge and rise in the awareness amongst the people, and rises in the technological advancement in this region. However, China is expected to grow faster with a high CAGR in the cervical cancer drug market due to a rise in healthcare access and quality, increased awareness about disease management, and rising healthcare expenditure. The trend of biosimilars in emerging markets, such as China and Japan, could potentially alter the therapeutic landscape in this region. COMPETITIVE SCENARIO The cervical cancer treatment market is dominated by many companies offering generic drugs and particular pharma/biotech companies offering patented/commercial drugs for treating cervical cancer. The U.S. Food and Drug Administration (FDA) approved the antiangiogenic agent bevacizumab (Avastin) to treat persistent, recurrent, or metastatic cervical cancer in 2014. This marked the arrival of biologics in this treatment landscape. Avastin was approved in Europe and Japan in 2015 and 2016, respectively. The FDA approved Keytruda (pembrolizumab) in 2018 and Tivdak (tisotumab-vedotin-tftv) in 2021 to treat cervical cancer. Although generic products continue to capture significant market share, the arrival of biologics and other targeted therapies indicates a paradigm shift in this therapeutic space through the forecast period. REPORT COVERAGE Detailed overview of cervical cancer, including disease definition, classification, diagnosis, and treatment pattern. Overview of the global trends of cervical cancer in the eight major markets (8MM) Historical, current, and projected patient pool of cervical cancer in the eight primary markets (8MM) for 2018-2027. Age group, Histology, Drug Class, and Drug Distribution type segmentation of cervical cancer in the eight major markets (8MM) Market Share of the market players, Company profiles, product specifications, and competitive landscape. Comprehensive data on emerging trends, market drivers, growth opportunities, and restraints. Detailed overview of therapeutics pipeline activity and therapeutic assessment of the products by development stage, product type, route of administration, molecule type, and geography type for cervical cancer across all clinical stages. Coverage of dormant and discontinued pipelines projects along with the reasons across cervical cancer Coverage of significant milestones (products approvals/launch timelines, clinical trial result publication, regulatory designations, licensing & collaborations, research & development progress of pipeline assets) in the cervical cancer space. Key Vendors: Seagen Inc Merck Roche Pfizer Sanofi/Regeneron Lee's Pharma/Sorrenti Akesobio HengRui Medicine Co., Ltd Henlius Biotech Biocad Advenchen Laboratories EXELIXIS Novertis GSK Zeria Pharmaceuticals Other Prominent Vendors Innovent Biologics Clovis Oncology IOVANCE Biotherapeutics Genor Biopharma Co., LTD Agenusbio Qilu Pharmaceutical Astrazeneca Puma Biotechnology Genmab Takeda Incyte Corp BioAtla, Inc. Helsinn Healthcare SA Qilu Pharmaceutical BeiGene Key Topics Covered: Chapter 1: Cervical Cancer Overview Cervical Cancer - An Overview Chapter 2: Cervical Cancer Epidemiology & Overview 8Mm: Historic & Projected Volume of Incidence & Prevalence of Cervical Cancer 8Mm: Comparative Analysis of Incidence & Prevalence of Cervical Cancer 8Mm: Historic & Projected Volume of Incidence of Cervical Cancer Cases by Age Group 8Mm: Comparative Analysis of Incidence of Cervical Cancer Cases by Age Group Chapter 3: Cervical Cancer Market Size & Overview 8Mm: Historic & Projected Revenue of Cervical Cancer 8Mm: Historic & Projected Revenue of Cervical Cancer Snapshot 8Mm: Historic & Projected Revenue Segmentation by Age Group, Histology Type, Drug Class & Distribution Type Chapter 4: Cervical Cancer Marketed Drugs Overview Cervical Cancer Marketed Drugs - An Overview Cervical Cancer Marketed Drugs - Summary Chapter 5: Cervical Cancer Pipeline Drugs Overview Cervical Cancer Pipeline Drugs - An Overview Cervical Cancer Pipeline Drugs - Snapshot Cervical Cancer Pipeline Drugs Overview & Snapshot - by Disease Type Cervical Cancer Pipeline Drugs Overview & Snapshot - by Development Phase Cervical Cancer Pipeline Drugs Overview & Snapshot - by Route of Administration Cervical Cancer Pipeline Drugs Overview & Snapshot - by Mechanism of Action Cervical Cancer Pipeline Drugs Overview & Snapshot - by Molecule Type Cervical Cancer Pipeline Drugs Overview & Snapshot - by Geography Type Chapter 6: Cervical Cancer Clinical Trials Overview Cervical Cancer Clinical Trials Overview Snapshot Cervical Cancer Clinical Trials Overview - by Recruitment Status Cervical Cancer Clinical Trials Overview - by Product Type Cervical Cancer Clinical Trials Overview - by Route of Administration Cervical Cancer Clinical Trials Overview - by Molecule Type Cervical Cancer Clinical Trials Overview - by Geography Type Chapter 7: Cervical Cancer Market Dynamics Cervical Cancer Treatment Market Drivers Cervical Cancer Treatment Market Constraints Cervical Cancer Treatment Market Trends Chapter 8: Cervical Cancer Competitive Landscape Cervical Cancer Competitive Landscape - Marketed Drugs Key Company Profiles Competitive Scenario of Cervical Cancer Treatment Market Other Prominent Company Profiles Key Company Overviews Cervical Cancer Competitive Landscape - Pipeline Drugs Key Emerging Company Profiles Key Emerging Company Overviews Other Prominent Company Profiles Chapter 9: Cervical Cancer Miscellaneous Key Tentative Drug Approvals Timeline Key Regulatory Designations Key Milestones Deals & Collaborations Potential Trial Head-To-Head Comparison Inactive/Discontinued/Dormant Products Unmet Needs & Strategic Recommendations For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

100 Deals associated with Prolgolimab

External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Melanoma	RU	Biocad Medical, Inc.	01 Apr 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic melanoma	Phase 3	RU	Biocad CJSC	01 Feb 2022
Unresectable Melanoma	Phase 3	RU	Biocad CJSC	01 Feb 2022
Uterine Cervical Cancer	Phase 3	CN	Biocad CJSC	13 May 2021
Uterine Cervical Cancer	Phase 3	RU	Biocad CJSC	13 May 2021
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	CN	SPH-Biocad （HK） Limited	08 Apr 2021
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	CN	Biocad CJSC	08 Apr 2021
Advanced Cervical Carcinoma	Phase 3	CN	Biocad CJSC	01 Oct 2019
Advanced Cervical Carcinoma	Phase 3	GE	Biocad CJSC	01 Oct 2019
Advanced Cervical Carcinoma	Phase 3	RU	Biocad CJSC	01 Oct 2019
Advanced Cervical Carcinoma	Phase 3	TR	Biocad CJSC	01 Oct 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2023	Not Applicable	Classical Hodgkin's Lymphoma	4	prolgolimab	xgucgptwsh(kzortzfcjw) = <1% tgajpjpjjo (gxonqviqsc ) View more	-	08 Jun 2023
ASCO2023	Not Applicable	Melanoma \| Non-Small Cell Lung Cancer	7	Prolgolimab (anti-PD-1)	rumrqlrmza(tduzpthkfe) = upjalddntq fiftgifych (wapqfmftuc )	Positive	31 May 2023
NCT03912402 (CAESURA, ASCO2023) Manual	Phase 2	Advanced Cervical Carcinoma	58	prolgolimab+paclitaxel+platinum drug+bevacizumab	oerjnishec(dgerktpils) = lpolbrmvoh pbbsipsutn (nrhusbpfau ) View more	Positive	31 May 2023
NCT03269565 (MIRACULUM, Pubmed \| Eur J Cancer Care (Engl))	Phase 2	Metastatic melanoma	126	Prolgolimab 1 mg/kg every 2 weeks	tlnrumbfaz(kjbaxjgdfy) = ipmezrdeyy nzwvmoltvi (cbpwiwjktm ) View more	Positive	16 Apr 2021
NCT03269565 (MIRACULUM, Pubmed \| Eur J Cancer Care (Engl))	Phase 2	Metastatic melanoma	126	Prolgolimab 3 mg/kg every 3 weeks	tlnrumbfaz(kjbaxjgdfy) = eupzquxxkp nzwvmoltvi (cbpwiwjktm ) View more	Positive	16 Apr 2021

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