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Long-Term Clinical Benefit and Prolonged Tumor Response Seen With 40.7% Objective Response Rate
No New Safety Signals Observed
Longest Follow-Up of Patients Treated With a KRASG12C Inhibitor
THOUSAND OAKS, Calif., April 10, 2022 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the presentation of long-term efficacy and safety data from the CodeBreaK 100 Phase 1/2 trial in patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) who received LUMAKRAS® (sotorasib)*. The two-year follow-up data will be presented orally as part of a clinical trials plenary session at the American Association for Cancer Research (AACR) annual meeting on April 10, 2022. LUMAKRAS is the first and only KRASG12C inhibitor to-date to show long-term clinical benefit and overall survival in patients with NSCLC harboring the KRAS G12C mutation.
“With regulatory approvals in nearly 40 countries and thousands of patients treated, LUMAKRAS, the only approved KRASG12C inhibitor, is a transformative targeted therapy for the treatment of patients living with KRAS G12C-mutated NSCLC,” said David M. ReeseMD, executive vice president of Research and Development at Amgen. “We are pleased with these latest results from the CodeBreaK 100 study, which represent the longest follow-up of patients treated with a KRASG12C inhibitor and confirm rapid, deep and durable responses in patients receiving LUMAKRAS.”
In this long-term, two-year analysis of 174 heavily pre-treated patients (172 with baseline measurable lesion(s)), LUMAKRAS demonstrated a centrally confirmed objective response rate (ORR) of 40.7%, disease control rate (DCR) of 83.7% and median duration of response (DOR) of 12.3 months. Five patients achieved complete responses and 65 patients achieved partial responses. The results also showed median progression-free survival (PFS) of 6.3 months and overall survival (OS) of 12.5 months with 32.5% of patients still alive at two years. No new safety signals for LUMAKRAS were identified with the long-term follow-up.
“Since the FDA approval almost a year ago, LUMAKRAS has changed the treatment paradigm for patients with advanced non-small cell lung cancer who harbor the KRAS G12C mutation,” said Grace DyMD, chief, thoracic oncology, Roswell Park Comprehensive Cancer Center. “The durable efficacy and positive benefit-risk profile seen in the two-year analysis of CodeBreaK 100 highlight the important role this innovative targeted therapy can offer long-term.”
In May 2021LUMAKRAS was the first KRASG12C inhibitor to receive regulatory approval with its approval in the US, under accelerated approval. LUMAKRAS is now approved in 39 countries.
*LUMAKRAS is marketed as LUMYKRAS® (sotorasib) in the European Union, the United Kingdom and Switzerland.
About LUMAKRAS®/LUMYKRAS® (sotorasib)
Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS/LUMYKRAS, a KRASG12C inhibitor.1 LUMAKRAS/LUMYKRAS has demonstrated a positive benefit-risk profile with rapid, deep, and durable anticancer activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation.2
Amgen is progressing the largest and broadest global KRASG12C inhibitor development program with unparalleled speed and exploring more than 10 sotorasib combination regimens, including triplets, with clinical trial sites spanning five continents. To date, over 4,000 patients around the world have received LUMAKRAS/LUMYKRAS through the clinical development program and commercial use.
In May 2021LUMAKRAS was the first KRASG12C inhibitor to receive regulatory approval with its approval in the US, under accelerated approval. LUMAKRAS/LUMYKRAS is also approved in the European Union, Japan, United Arab Emirates, South Korea and Switzerland and in Australia, Brazil, Canadaand Great Britain under the FDA’s Project Orbis. Through Project Orbis, Amgen also has Marketing Authorization Applications (MAAs) for sotorasib in review in Israel and Singapore. Additionally, Amgen has submitted MAAs in Argentina, Colombia, Hong Kong, Kuwait, Malaysia, Mexico, Qatar, Saudi Arabia, Taiwan, Thailand and Turkey.
LUMAKRAS/LUMYKRAS is also being studied in multiple other solid tumors.3
About Non-Small Cell Lung Cancer and the KRAS G12C Mutation
Lung cancer is the leading cause of cancer-related deaths worldwide, and it accounts for more deaths worldwide than colon cancer, breast cancer and prostate cancer combined.4 Overall survival rates for NSCLC are improving but remain poor for patients with advanced disease and 5-year survival is only 7% for those with metastatic disease.5
KRAS G12C is the most common KRAS mutations in NSCLC.6 About 13% of patients with NSCLC harbor the KRAS G12C mutation.7 Unmet medical need remains high and treatment options are limited for NSCLC patients with the KRAS G12C mutation whose first-line treatment has failed to work or has stopped working. The outcomes with other approved therapies are suboptimal, with a median progression-free survival of approximately four months following second-line treatment of KRAS G12C-mutated NSCLC.8
About CodeBreaK
The CodeBreaK clinical development program for Amgen’s drug sotorasib is designed to study patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.
CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors.9 Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline.2 The Phase 2 trial in colorectal cancer (CRC) is fully enrolled…
Full story available on Benzinga.com
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