New Data From CodeBreaK Clinical Trial Demonstrate Efficacy of Sotorasib for NSCLC, Colorectal Cancer

New data from the CodeBreaK clinical trial program further demonstrate the efficacy of sotorasib (Lumakras/Lumykras; Amgen) in individuals with KRASG12C-mutated advanced non­–small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC), according to findings presented at the American Society of Clinical Oncology Annual Meeting (ASCO) 2023.

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Additionally, data from the SCARLET trial presented at ASCO 2023 indicate the safety and efficacy of sotorasib in combination with platinum-based chemotherapy as first line treatment of individuals with advanced NSCLC with KRASG12C mutation.

"These data presented at ASCO underscore the clinical importance of [sotorasib,] including the only randomized trial of a KRASG12C inhibitor to show higher intracranial activity compared to chemotherapy, along with data validating our combination treatment approach in metastatic colorectal cancer, where new precision medicine strategies are desperately needed,” David Reese, MD, executive vice president of Research and Development at Amgen, said in a statement.

In the CodeBreaK 200 trial (NCT04303780), investigators included individuals with advanced NSCLC and treated or stable central nervous system (CNS) lesions at baseline.

The results were assessed by a blinded independent central review. A modified exploratory response assessment in neuro-oncology brain metastases was used.

In the analysis, they found that sotorasib demonstrated delayed time to progression and longer CNS progression-free survival compared to docetaxel. Further, the CNS objective response rate (ORR) to assess tumor shrinkage was 33.3% in individuals treated with sotorasis and 15.4% for those treated with docetaxel.

Investigators found that the safety profile in the analysis was similar to the overall population in CodeBreaK 200.

"In this post-hoc analysis from CodeBreaK 200, sotorasib delayed CNS progression-free survival by more than 5 months and is a potential clinically meaningful benefit for second-line NSCLC patients with KRASG12C mutations," Melissa Johnson, MD, director of Lung Cancer Research at the Sarah Cannon Research Institute at Tennessee Oncology, said in the statement.

Furthermore, in data from the CodeBreaK 101 (NCT04185883) phase 1B study, it was shown that sotorasib and panitumumab (Vectibix; Amgen) and FOLFIRI treatment demonstrated safety and efficacy in previously treated KRASG12C-mutated metastatic CRC.

There was a confirmed ORR of 55% among 42 individuals who were available for response. There was also a disease control rate of 93%, with responses observed regardless of the number of prior lines of therapy and of progression on prior irinotecan-based therapy.

Additionally, sotorasib and panitumumab with FOLFIRI reported adverse events consistent with those expected for the therapies under study.

Reference

Amgen presents new Lumakras (sotorasib) CodeBreaK 200 CNS data at ASCO 2023. News release. Amgen. June 4, 2023. Accessed June 5, 2023. https://wwwext.amgen.com/newsroom/press-releases/2023/06/amgen-presents-new-lumakras-sotorasib-codebreak-200-cns-data-at-asco-2023