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).
CodeBreaK 100 was a single-arm, open-label, global, multicenter clinical trial with the
Phase 2 portion evaluating LUMAKRAS in 126 patients with locally advanced or metastatic KRAS G12C–mutated
NSCLC who progressed on prior therapy. Major efficacy outcomes in patients with ≥ 1 measurable lesion (BICR
according to RECIST v1.1; n=124) were objective response rate (36% [95% CI: 28–45]; CR: 2%, PR: 35%), and duration
of response (median: 10.0 months [range 1.3+, 11.1]; ≥ 6 months: 58% of patients observed beyond landmark
time).2,8
*Prix Galien is an independent distinction that awards pharmaceutical products introduced in the public market and achievements of research teams.9 To be eligible, products must have received marketing approval in the USA by December 31 of the year preceding the awards, but not more than 5 years earlier than December 31 of that year, unless the award is for a new and innovative indication, which must have been added within the previous 5 years.10
†Cysteine proteome analysis of 6,451 peptides showed sotorasib only covalently engages with Cys12 of KRASG12C. Preclinical studies in 22 cell lines and xenograft models demonstrated that sotorasib does not inhibit KRAS wild-type or non–KRAS G12C lines/tumors.3
‡Based on IQVIA LAAD data from January 1, 2023–July 31, 2023 among patients with metastatic lung cancer and confirmed prior treatment.4
§From June 5, 2021 through June 30, 2023. Data includes unique new-to-brand prescriptions from specialty pharmacies and IQVIA prescription data. Any subsequent prescriptions (ie, refills) are not counted.5
**Based on IQVIA LAAD data from January 1, 2023–July 31, 2023 among patients with metastatic lung cancer and confirmed prior treatment.6
††NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.7
‡‡Does not include locally advanced.7
BICR, blinded independent central review; CI, confidence interval; CR, complete response; KRAS, Kirsten rat sarcoma viral oncogene homolog; LAAD, Longitudinal Access and Adjudication Data; NCCN, National Comprehensive Cancer Network; NSCLC, non-small cell lung cancer; PR, partial response; RECIST, response evaluation criteria in solid tumors.
References: 1. The Galien Foundation. https://www.prnewswire.com/news-releases/the-galien-foundation-honors-2022-prix-galien-award-recipients-301662219.html. Accessed December 6, 2022. 2. LUMAKRAS (sotorasib) prescribing information, Amgen. 3. Canon J, et al. Nature. 2019;575(7781):217-223. 4. FDA press release. https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-lung-cancer-mutation-previously-considered-resistant-drug. Accessed March 11, 2022. 5. Data on file, Amgen; [Unique patients]. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer v.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 13, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. 7. Data on file, Amgen; [Unique prescribers]. 8. Sotorasib CSR. Amgen; 2021. 9. The Galien Foundation. https://www.galienfoundation.org/what-you-must-know. Accessed December 6, 2022. 10. The Galien Foundation. https://candidates.prix-galien-usa.com/submissions/eligibility. Accessed December 1, 2022.
Hepatotoxicity
Interstitial Lung Disease (ILD)/Pneumonitis
Most common adverse reactions
Drug interactions
INDICATION
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).
Please see full Prescribing Information.
Important Safety Information
Hepatotoxicity