2024-03-29, Fri.

Top Stories       Business       Culture & Life       Science & Technology       World

Lecture

Notification

 

NEWS > Science & Technology


Merck Advances ATR Inhibitor Berzosertib in Small Cell Lung Cancer With New Published Data and Initiation of Phase II Trial With Registrational Intent

US National Cancer Institute led Phase II clinical study met its primary objective with 36% confirmed ORR, and showed durable responses
Date: 2021-04-13

A new company-sponsored, global clinical trial will further assess berzosertib in small cell lung cancer
Merck is leading more than ten clinical trials across DNA Damage Response (DDR) pathways in various tumor types

DARMSTADT, GERMANY-- April 13, 2021 -- Merck, a leading science and technology company, today announced key clinical advancements for berzosertib (M6620), an investigational, potent and selective ataxia telangiectasia and Rad3-related (ATR) inhibitor. Berzosertib is the leading asset in the company’s DNA damage response (DDR) inhibitor program and one of the most advanced ATR inhibitors in oncology clinical development industry-wide.

Results from a Phase II proof-of-concept study conducted by the US National Cancer Institute (NCI) (NCT02487095)* and published in Cancer Cell showed that berzosertib in combination with the chemotherapy topotecan resulted in an objective response rate (ORR) of 36% among patients with relapsed small cell lung cancer (SCLC), including durable responses among a majority of responding patients with platinum-resistant disease.[1] The NCI is also conducting a separate Phase II trial of berzosertib in combination with topotecan versus topotecan monotherapy in SCLC that has relapsed (NCT03896503)* which is currently the only randomized controlled trial of the combination in this population.

Merck also initiated a global Phase II study to further assess berzosertib in combination with topotecan for the treatment of relapsed, platinum-resistant SCLC (DDRiver SCLC 250). The first patient has been enrolled in the open-label, single-arm trial, which plans to include approximately 80 participants at about 41 study sites across Asia, Europe, and North America.

“Small-cell neuroendocrine cancers, including small cell lung cancer, are associated with very poor prognoses, and are a major clinical challenge with no effective therapeutic options. In this study, the combination of berzosertib and topotecan showed higher than expected response rates and durable responses in patients with platinum-resistant SCLC, highlighting the therapeutic potential of this combination for patients with this recalcitrant cancer type,” said Anish Thomas, MBBS, M.D., investigator and NIH Lasker Clinical Research Scholar at the Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, and lead investigator of the study. Dr. Thomas is collaborating with Merck KGaA, Darmstadt, Germany through a Cooperative Research and Development Agreement (CRADA).

Topotecan is the chemotherapeutic standard-of-care for second-line treatment of SCLC and is associated with low response rates, particularly in platinum-resistant disease.[1] Findings from the NCI study highlight the vulnerability of SCLC tumors to ATR inhibition as a result of high levels of replication stress and the potential for the combination of berzosertib and topotecan to enhance the efficacy of topotecan among chemotherapy-resistant patients.[1] These data build on earlier published results from Phase I of this study which also suggested a potential benefit of this combination in participants with platinum-resistant SCLC.

“We are encouraged by these promising results, and are eager to further investigate berzosertib in a potentially registrational trial in SCLC as part of our front-running leadership in the research of DNA damage response,” said Danny Bar-Zohar, M.D., Global Head of Development for the Healthcare business sector of Merck.

These results are in addition to results from an NCI-sponsored open-label, randomized, Phase II study (NCI protocol 9944) evaluating berzosertib in combination with gemcitabine versus gemcitabine alone for the treatment of recurrent, platinum-resistant high-grade serous ovarian cancer, which were published in The Lancet Oncology in 2020. The study, conducted through a separate CRADA between NCI and Merck KGaA, Darmstadt, Germany, showed a benefit of adding berzosertib to gemcitabine in this treatment setting including improvement in progression-free survival, and is the first randomized study of an ATR inhibitor in any tumor type.

As part of its new DDRiver™ Clinical Trials program, the company is investigating DDR inhibitor targeting pathways across more than ten trials in various tumor types.



 to the Top List of News

Notice of Commencement of Operation of Dexerials Photonics Solutions Corporation as Integrated Company Leading Growth in the Photonics Domain
Alphawave Semi and InnoLight Collaborate to Demonstrate Low Latency Linear Pluggable Optics with PCIe 6.0 Subsystem Solution for High-Performance AI
Medisca Opens MAZ Lab in Arizona: An Innovation and Customer Resource Center
Quectel and The Things Industries Announce Partnership to Boost Module Service Management Through LoRaWAN Integration
Efinix Rolls Out Line of FPGAs to Accelerate and Adapt Automotive Designs and Applications
StarFive¡¯s RISC-V Based JH-7110 Intelligent Vision Processing Platform Adopted VeriSilicon¡¯s Display Processor IP
Uniphore Unveils Enhanced Interaction Analytics Solution Powered by Generative AI

 

Laserfiche Announces 2024 Run Smarter Award Winners
LambdaTest and Inflectra Partner to Offer Enhanced Application Lifecyc...
The LYCRA Company joins Performance Days seminar on textile recycling
New Oracle Database Survey Shows Customers Satisfied with Current Rele...
Toshiba Adds New Position Estimation Control Technology to Its Motor C...
Cielo Debuts First Generative AI for Talent Acquisition: CLO.ai
Ventiva Announces Partnership with Clarion for Mass Production of ICE ...
FPT Software Expands Presence in South Korea With Daegu Office Launch
Quectel IoT Modules Significantly More Secure Than Industry Average Ac...
Kymeta Begins Fulfilling Customer Orders of its First Multi-Orbit, On-...

 

 

60, Gamasanro 27gil, Guro-gu, Seoul, Korea, e-mail: news@newsji.com

Copyright, NEWSJI NETWORK.