AMGEN ANNOUNCES TOPLINE DATA FROM LUMAKRAS® (SOTORASIB) PHASE 3 TRIAL IN NON-SMALL CELL LUNG CANCER

LUMAKRAS Met Primary Endpoint of Progression-Free Survival, Demonstrating Superiority Over Standard of Care Docetaxel Chemotherapy, in KRAS G12C-Mutated Non-Small Cell Lung Cancer

Detailed Data to be Presented at an Upcoming Medical Congress

Amgen( NASDAQ AMGN) moment blazoned that the global Phase 3 CodeBreaK 200 trial assessing formerly daily oral LUMAKRAS ®( sotorasib) met its primary endpoint of progression-free survival( PFS), demonstrating statistical significance and superiority over standard of care chemotherapy, intravenous docetaxel. The first randomized clinical trial for a KRASG12C asset assessed the efficacity and safety of LUMAKRAS in 345 preliminarily treated cases with KRAS G12C- shiftednon-small cell lung cancer( NSCLC) who had entered at minimum, previous platinum- grounded fellow chemotherapy and checkpoint asset remedy.

” farther analyses of the data are ongoing, and we look forward to participating detailed data at an forthcoming medical meeting,” said DavidM. Reese,M.D., administrative vice chairman of Research and Development at Amgen.” We’re thankful to all of the investigators and cases who shared in this first randomized, controlled clinical trial of a KRASG12C asset.”
About LUMAKRAS ®/ LUMYKRAS ®( sotorasib)
Amgen took on one of the toughest challenges of the last 40 times in cancer exploration by developing LUMAKRAS/ LUMYKRAS, a KRASG12C asset.1 LUMAKRAS/ LUMYKRAS has demonstrated a positive benefit- threat profile with rapid-fire, deep, and durable anticancer exertion in cases with locally advanced or metastaticnon-small cell lung cancer( NSCLC) harboring the KRAS G12C mutation with a formerly diurnal oral expression.2

Amgen is progressing the largest and broadest global KRASG12C asset development program with unequaled speed and exploring further than 10 sotorasib combination rules, including triumvirates, with clinical trial spots gauging five mainlands. To date, over,500 cases around the world have entered LUMAKRAS/ LUMYKRAS through the clinical development program, expanded access and marketable use.

In total, LUMAKRAS/ LUMYKRAS is approved in over 44 requests around the world, including the United States, the European Union, Japan, United Arab Emirates, South Korea, Hong Kong, Switzerland, Taiwan and Qatar, and in Australia, Brazil, Canada, Great Britain, Israel and Singapore under theU.S. FDA’s Project Orbis. Amgen has submitted MAAs in Argentina, Colombia, Kuwait, Malaysia, Mexico, Saudi Arabia, Thailand and Turkey.

LUMAKRAS/ LUMYKRAS is also being studied in multiple other solid excrescences.3

AboutNon-Small Cell Lung Cancer and the KRAS G12C Mutation
Lung cancer is the leading cause of cancer- related deaths worldwide, and it accounts for further deaths worldwide than colon cancer, bone cancer and prostate cancer combined.4 Overall survival rates for NSCLC are perfecting but remain poor for cases with advanced complaint, and 5- time survival is only 8 for those with metastatic complaint.5
KRAS G12C is the most common KRAS mutation in NSCLC.6 About 13 of cases with NSCLC harbor the KRAS G12C mutation.7 Unmet medical need remains high and treatment options are limited for NSCLC cases with the KRAS G12C mutation whose first- line treatment has failed to work or has stopped working. The issues with other approved curatives are sour, with a median progression-free survival of roughly four months following second- line treatment of KRAS G12C- shifted NSCLC.8

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s medicine sotorasib is designed to study cases with an advanced solid excrescence with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.

CodeBreaK 100, the Phase 1 and 2, first- by- mortal, open- marker multicenter study, enrolled cases with KRAS G12C- mutant solid excrescences.9 Eligible cases must have entered a previous line of systemic anticancer remedy, harmonious with their excrescence type and stage of complaint. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 cases, 124 of whom had centrally evaluable lesions by RECIST at birth.2 The Phase 2 trial in colorectal cancer( CRC) is completely enrolled and results have been published.10

LUMAKRAS ®( sotorasib)U.S. Indication
LUMAKRAS is indicated for the treatment of adult cases with KRAS G12C- shifted locally advanced or metastaticnon-small cell lung cancer( NSCLC), as determined by an FDA- approved test, who have entered at least one previous systemic remedy.

This suggestion is approved under accelerated blessing grounded on overall response rate( ORR) and duration of response( DOR). Continued blessing for this suggestion may be contingent upon verification and description of clinical benefit in a confirmational trial( s).

About Amgen Oncology
At Amgen Oncology, our charge to serve cases drives all that we do. That is why we are relentlessly concentrated on accelerating the delivery of drugs that have the eventuality to empower all angles of care and transfigure lives of people with cancer.

For the last four decades, we’ve been devoted to discovering the firsts that count in oncology and to chancing ways to reduce the burden of cancer. structure on our heritage, Amgen continues to advance the largest channel in the Company’s history, moving with great speed to advance those inventions for the cases who need them.
About Amgen
Amgen is committed to unleashing the eventuality of biology for cases suffering from serious ails by discovering, developing, manufacturing and delivering innovative mortal rectifiers. This approach begins by using tools like advanced mortal genetics to unravel the complications of complaint and understand the fundamentals of mortal biology.

Amgen focuses on areas of high unmet medical need and leverages its moxie to strive for results that ameliorate health issues and dramatically ameliorate people’s lives. A biotechnology colonist since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of cases around the world and is developing a channel of drugs with breakaway eventuality.

Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq- 100 indicator. In 2021, Amgen was named one of the 25 World’s Stylish Workplaces ™ by Fortune and Great Place to Work ™ and one of the 100 most sustainable companies in the world by Barron’s.

Source link:https://www.amgen.com/

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