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Roswell Park’s Dr. Grace Dy Presents Long-Term Data on CodeBreaK 100 Sotorasib Study

Oncologist to share new data on KRAS inhibitor granted FDA approval for patients with non-small cell lung cancer

New data to be presented at the American Association for Cancer Research (AACR) Annual Meeting 2022 in New Orleans show that patients with non-small cell lung cancer (NSCLC) who received the targeted therapy sotorasib experienced extended survival and good quality of life. Grace Dy, MD, who led the study at Roswell Park Comprehensive Cancer Center, will present the longest-term data available from the multicenter CodeBreaK100 clinical trial in a plenary presentation today.

Sotorasib, also known as Lumakras, is a targeted anticancer therapy granted accelerated Food and Drug Administration approval in May 2021 for treatment for adult patients with NSCLC whose tumors have a specific genetic alteration — G12C mutation of the KRAS gene — and whose tumors worsened and/or persisted despite earlier treatment. This orally administered drug is the first approved targeted therapy for any KRAS-mutated malignancy. KRAS G12C mutations represent about 13% of mutations in non-small cell lung cancers.

The data to be reported at AACR 2022 are the most inclusive and long-term clinical results to date on sotorasib, providing both two-year survival analysis and biomarker analysis for 174 patients treated as part of phases 1 and 2 of CodeBreaK100. One- and 2-year overall survival for patients on the study, Dr. Dy and colleagues report, was 50.8% and 32.5%, respectively — considerably extended over a comparison to historical survival for patients treated with standard therapies for NSCLC.

 “The results we’ve seen at two years show a pronounced benefit, with more than 40% of patients on this study experiencing a partial or complete response to sotorasib,” says Dr. Dy, who is Chief of Thoracic Oncology and Professor of Oncology at Roswell Park. “While KRAS mutations are so common in lung cancer it has been notoriously hard to develop targeted therapy against these mutations. We’re very grateful to have had early access to this first-in-class therapy for our patients at Roswell Park, and eagerly look forward to the results from the randomized phase 3 CodeBreaK 200 trial comparing sotorasib to standard chemotherapy.”

Long-term treatment with sotorasib was well tolerated among patients on this study, with only mild toxicities in majority of patients and no additional safety concerns noted in the second year of follow-up.

Biomarker analyses of tumor and blood samples showed that long-term clinical benefit was seen regardless of the  tumor mutation burden, PDL1 expression or STK11 co-mutation status.

The study was sponsored by Amgen.

Dr. Dy will highlight these findings Sunday, April 10, both in an afternoon oral presentation and in an AACR press conference at 11 a.m. CT onsite at the meeting. Her talk is CT008 - Long-term outcomes with sotorasib in pretreated KRASp.G12C-mutated NSCLC: 2-year analysis of CodeBreaK100, to be presented at 4:31 p.m. CT in Great Hall AD of the Ernest N. Morial Convention Center.


Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at, or contact us at 1-800-ROSWELL (1-800-767-9355) or

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