AMGEN PRESENTS NEW LUMAKRAS® (SOTORASIB) PLUS CHEMOTHERAPY DATA IN FIRST-LINE KRAS G12C NSCLC AT WCLC
- Confirmed objective response rate of 65% in first-line treatment
- Disease control rate of 100%
- Phase 3 study initiated
- None.
In Phase 1b Study, Patients Treated in First-Line Demonstrated a Confirmed Objective Response Rate of
In patients treated in the first-line setting (n=20), the confirmed objective response rate (ORR) was
"We are delighted to see the positive data from the global CodeBreaK 101 trial further validate our approach to move LUMAKRAS earlier within the treatment paradigm through novel therapeutic combinations," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Notably, these results follow and further expand upon the Phase 2 investigator-led data demonstrating favorable efficacy and safety of LUMAKRAS plus carboplatin and pemetrexed in the first-line treatment of patients with KRAS G12C-mutated NSCLC."
The LUMAKRAS plus chemotherapy combination reported treatment-related adverse events (TRAEs) consistent with LUMAKRAS and other platinum doublet-based approaches. The most common TRAEs were neutropenia/neutrophil count decrease (
"Combination treatment is an important approach to prevent or delay the onset of drug resistance and improve the depth and durability of targeted response in KRAS G12C-mutated NSCLC," said Jeffrey M. Clarke, M.D., oncologist and associate professor of medicine, Duke Cancer Institute at Duke University. "The CodeBreaK 101 results show exciting efficacy with sotorasib plus chemotherapy and, importantly for a combination treatment, a safety profile consistent with the individual therapies. These data warrant continued investigation in larger trials."
Based on these results, Amgen has initiated a Phase 3 study of LUMAKRAS plus carboplatin and pemetrexed in first-line KRAS G12C-mutant and negative for programmed cell death PD-L1 advanced NSCLC (CodeBreaK 202; NCT05920356), with enrollment expected to start before the end of 2023.
About CodeBreaK 101
CodeBreaK 101 (NCT04185883) is a global Phase 1b/2 clinical trial evaluating the safety, tolerability, pharmacokinetics, and efficacy of sotorasib in combination with other anticancer therapies in patients with advanced solid tumors and the KRAS G12C mutation. Subprotocol F of the Phase 1b trial is assessing the safety, tolerability, pharmacokinetics, and efficacy of sotorasib in combination with carboplatin and pemetrexed with or without pembrolizumab maintenance, with docetaxel, or with carboplatin and paclitaxel in patients with KRAS G12C-mutated NSCLC.1
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.2 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.3
Amgen is progressing the largest and broadest global KRASG12C inhibitor development program with unparalleled speed and exploring more than 10 sotorasib combination regimens, with clinical trial sites spanning five continents. To date, over 6,500 patients around the world have received LUMAKRAS/LUMYKRAS through the clinical development program and commercial use.
In May 2021, LUMAKRAS was the first KRASG12C inhibitor to receive regulatory approval with its approval in the
LUMAKRAS/LUMYKRAS is also being studied in multiple other solid tumors.4
About Advanced 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.5 Overall survival rates for NSCLC are improving but remain poor for patients with advanced disease, and 5-year survival is only
KRAS G12C is the most common KRAS mutation in NSCLC.7 About
LUMAKRAS® (sotorasib)
LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
LUMAKRAS® (sotorasib) Important U.S. Safety Information
Hepatotoxicity
- LUMAKRAS can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis.
- Among 357 patients who received LUMAKRAS in CodeBreaK 100, hepatotoxicity occurred in
1.7% (all grades) and1.4% (Grade 3). A total of18% of patients who received LUMAKRAS had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST);6% were Grade 3 and0.6% were Grade 4. In addition to dose interruption or reduction,5% of patients received corticosteroids for the treatment of hepatotoxicity. - Monitor liver function tests (ALT, AST and total bilirubin) prior to the start of LUMAKRAS every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations.
- Withhold, dose reduce or permanently discontinue LUMAKRAS based on severity of adverse reaction.
Interstitial Lung Disease (ILD)/Pneumonitis
- LUMAKRAS can cause ILD/pneumonitis that can be fatal. Among 357 patients who received LUMAKRAS in CodeBreaK 100, ILD/pneumonitis occurred in
0.8% of patients, all cases were Grade 3 or 4 at onset, and 1 case was fatal. LUMAKRAS was discontinued due to ILD/pneumonitis in0.6% of patients. - Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS if no other potential causes of ILD/pneumonitis are identified.
Most Common Adverse Reactions
- The most common adverse reactions occurring in ≥
20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity and cough.
Drug Interactions
- Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, dietary and herbal products.
- Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS.
- If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS 4 hours before or 10 hours after a locally acting antacid.
Please see LUMAKRAS full Prescribing Information.
About Amgen Oncology
At Amgen Oncology, our mission to serve patients drives all that we do. That's why we're relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer.
For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.
For more information, follow us on www.twitter.com/amgenoncology.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2022, Amgen was named one of the "World's Best Employers" by Forbes and one of "America's 100 Most Sustainable Companies" by
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1 ClinicalTrials.gov. CodeBreaK 101. 2023. Available at: https://classic.clinicaltrials.gov/ct2/show/NCT04185883. Accessed on July 27, 2023.
2 Canon J, et al. Nature. 2019;575: 217–223.
3 Skoulidis F, et al. N Engl J Med. 2021;384:2371-2381.
4 Hong DS, et al. N Engl J Med. 2020;383:1207-1217.
5 Sung H, et al. CA Cancer J Clin. 2021;71:209-249.
6 American Cancer Society. Lung Cancer Survival Rates. 2023. Available at: https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html. Accessed on July 27, 2023.
7 Arbour KC, et al. Clin Cancer Res. 2018;24:334-340.
8 Nassar AF, et al. N Engl J. Med. 2021;384:185-187.
9 Spira Al, et al. Lung Cancer. 2021;159:1-9.
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