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 has been prescribed to over 4,000 patients in the US1,*3,†
2,300 HCPs have prescribed LUMAKRAS in the US4,‡
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).2,7
*From June 5, 2021 through October 28, 2022. Data includes unique new-to-brand prescriptions from specialty pharmacy and IQVIA prescription data. Any subsequent prescriptions (ie, refills) are not counted.1
†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
*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
†From June 5, 2021 through October 28, 2022. Data includes unique new-to-brand prescriptions from specialty pharmacy and IQVIA prescription data. Any subsequent prescriptions (ie, refills) are not counted.1
‡From June 5, 2021 through October 28, 2022. Data sources include prescriptions, claims, and patient data which are deduped to identify unique HCPs.4
§Breakthrough Therapy designation for the treatment of patients with KRAS G12C–mutated NSCLC who have progressed following prior systemic therapy.5
**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.6
††Does not include locally advanced.6
BICR, blinded independent central review; CI, confidence interval; CR, complete response; KRAS, Kirsten rat sarcoma viral oncogene homolog; NCCN, National Comprehensive Cancer Network; NSCLC, non-small cell lung cancer; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.
References: 1. LUMAKRAS (sotorasib) prescribing information, Amgen. 2. Canon J, et al. Nature. 2019;575(7781):217-223. 3. Data on file, Amgen; [Unique patients]. 4. Data on file, Amgen; [Unique prescribers]. 5. 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. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer v.5.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed September 26, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. 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. Sotorasib CSR. Amgen; 2021.
References: 1. Data on file, Amgen; [Unique patients]. 2. LUMAKRAS (sotorasib) prescribing information, Amgen. 3. Canon J, et al. Nature. 2019;575(7781):217-223. 4. Data on file, Amgen; [Unique prescribers]. 5. 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. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer v.5.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed September 26, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. 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. Sotorasib CSR. Amgen; 2021.
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