CodeBreaK 200: Sotorasib (AMG510) Has Broken the KRAS G12C+ NSCLC Enigma Code

References

• Lee JK, Sivakumar S, Schrock AB, et al. Comprehensive pan-cancer genomic landscape of KRAS altered cancers and real-world outcomes in solid tumors. NPJ Precis Oncol. 2022;6(1):91.
   PubMed Web of Science ®Google Scholar
• Simanshu DK, Nissley DV, McCormick F, Proteins RAS. Their regulators in human disease. Cell. 2017;170(1):17–33. doi:10.1016/j.cell.2017.06.009
   PubMed Web of Science ®Google Scholar
• Canon J, Rex K, Saiki AY, et al. The clinical KRAS (G12C) inhibitor AMG 510 drives anti-tumour immunity. Nature. 2019;575(7781):217–223. doi:10.1038/s41586-019-1694-1
   PubMed Web of Science ®Google Scholar
• Skoulidis F, Li BT, Dy GK, et al. Sotorasib for lung cancers with KRAS p.G12C mutation. N Engl J Med. 2021;384(25):2371–2381. doi:10.1056/NEJMoa2103695
   PubMed Web of Science ®Google Scholar
• Nakajima EC, Drezner N, Li X, et al. FDA approval summary: sotorasib for KRAS G12C-mutated metastatic NSCLC. Clin Cancer Res. 2022;28(8):1482–1486. doi:10.1158/1078-0432.CCR-21-3074
   PubMed Web of Science ®Google Scholar
• De Langen AJ, Johnson ML, Mazieres J, et al. Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRASG12C mutation: a randomised, open-label, phase 3 trial. Lancet. 2023;401:733–746.
   PubMed Web of Science ®Google Scholar
• Hong DS, Fakih MG, Strickler JH, et al. KRASG12C inhibition with sotorasib in advanced solid tumors. N Engl J Med. 2020;383(13):1207–1217. doi:10.1056/NEJMoa1917239
   PubMed Web of Science ®Google Scholar
• Garon EB, Ciuleanu TE, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384(9944):665–673. doi:10.1016/S0140-6736(14)60845-X
   PubMed Web of Science ®Google Scholar
• Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016;387(10027):1540–1550.
   PubMed Web of Science ®Google Scholar
• Rittmeyer A, Barlesi F, Waterkamp D, et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017;389(10066):255–265. doi:10.1016/S0140-6736(16)32517-X
   PubMed Web of Science ®Google Scholar
• Lee CK, Davies L, Wu YL, et al. Gefitinib or erlotinib vs chemotherapy for EGFR mutation-positive lung cancer: individual patient data meta-analysis of overall survival. J Natl Cancer Inst. 2017;109(6). doi:10.1093/jnci/djw279
   Google Scholar
• Lau SCM, Ou SI. And still they come over troubled waters: can Asia’s third-generation EGFR tyrosine kinase inhibitors (Furmonertinib, Aumolertinib, Rezivertinib, Limertinib, Befotertinib, SH-1028, and Lazertinib) affect global treatment of EGFR+ NSCLC. J Thorac Oncol. 2022;17(10):1144–1154. doi:10.1016/j.jtho.2022.08.016
   PubMed Web of Science ®Google Scholar
• Solomon BJ, Mok T, Kim DW, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014;371(23):2167–2177. doi:10.1056/NEJMoa1408440
   PubMed Web of Science ®Google Scholar
• Ou SI, Nagasaka M, Brazel D, et al. Will the clinical development of 4th-generation “double mutant active” ALK TKIs (TPX-0131 and NVL-655) change the future treatment paradigm of ALK+ NSCLC? Transl Oncol. 2021;14(11):101191. doi:10.1016/j.tranon.2021.101191
   PubMed Web of Science ®Google Scholar
• Jänne PA, Riely GJ, Gadgeel SM, et al. Adagrasib in non-small-cell lung cancer harboring a KRASG12C mutation. N Engl J Med. 2022;387(2):120–131. doi:10.1056/NEJMoa2204619
   PubMed Web of Science ®Google Scholar
• Tan DS, Shimizu T, Solomon B, et al. KontRASt-01: a phase Ib/II, dose-escalation study of JDQ443 in patients (pts) with advanced, KRAS G12C-mutated solid tumors. Presented at: 2022 AACR Annual Meeting; April 8–11, 2022; New Orleans, LA. Abstract CT033.
   Google Scholar
• Sacher A, Patel MR, Miller WH, et al. Phase Ia study to evaluate GDC-6036 monotherapy in patients with non-–small cell lung cancer (NSCLC) with KRAS G12C mutation. Presented at: 2022 World Conference on Lung Cancer; August 6–9, 2022; Vienna, Austria; Abstract OA03.04.
   Google Scholar
• Jian H, Song Z, Zhang Y, et al. CT505 - Phase I study of D-1553 to assess safety and efficacy in patients with non-small cell lung cancer (NSCLC) harboring KRASG12C mutation. Cancer Res. 2022;82(12_Supplement):CT505–CT505. doi:10.1158/1538-7445.AM2022-CT505
   Google Scholar
• Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-kras-g12c-mutated-nsclc. Assessed December 13, 2022.
   Google Scholar
• Sabari JK, Velcheti V, Shimizu K, et al. Activity of adagrasib (MRTX849) in brain metastases: preclinical models and clinical data from patients with KRASG12C-mutant non-small cell lung cancer. Clin Cancer Res. 2022;28(15):3318–3328. doi:10.1158/1078-0432.CCR-22-0383
   PubMed Web of Science ®Google Scholar
• Arbour KC, Jordan E, Kim HR, et al. Effects of co-occurring genomic alterations on outcomes in patients with KRAS-mutant non-small cell lung cancer. Clin Cancer Res. 2018;24:334–340. doi:10.1158/1078-0432.CCR-17-1841
   PubMed Web of Science ®Google Scholar
• Skoulidis F, Goldberg ME, Greenawalt DM, et al. STK11/LKB1 mutations and PD-1 inhibitor resistance in KRAS-mutant lung adenocarcinoma. Cancer Discov. 2018;8(7):822–835. doi:10.1158/2159-8290.CD-18-0099
   PubMed Web of Science ®Google Scholar
• Li BT, Falchook GS, Durm GA, et al. CodeBreaK 100/101: first report of safety/efficacy of sotorasib in combination with Pembrolizumab or Atezolizumab in advanced KRAS p.G12C NSCLC. Presented at: 2022 World Conference on Lung Cancer; August 6–9, 2022; Vienna, Austria. Abstract OA03.06.
   Google Scholar
• Jänne PA, Smit EF, de Marinis F, et al. Preliminary safety and efficacy of adagrasib with pembrolizumab in patients with advanced non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. Presented at: 2022 ESMO Immuno-Oncology Annual Meeting; December 7–9, 2022; Geneva, Switzerland. Presentation LBA4.
   Google Scholar
• Zhao Y, Murciano-Goroff YR, Xue JY, et al. Diverse alterations associated with resistance to KRAS (G12C) inhibition. Nature. 2021;599(7886):679–683. doi:10.1038/s41586-021-04065-2
   PubMed Web of Science ®Google Scholar
• Awad MM, Liu S, Rybkin II, et al. Acquired resistance to KRASG12C inhibition in cancer. N Engl J Med. 2021;384(25):2382–2393. doi:10.1056/NEJMoa2105281
   PubMed Web of Science ®Google Scholar
• Fakih MG, Kopetz S, Kuboki Y, et al. Sotorasib for previously treated colorectal cancers with KRASG12C mutation (CodeBreaK100): a prespecified analysis of a single-arm, phase 2 trial. Lancet Oncol. 2022;23(1):115–124. doi:10.1016/S1470-2045(21)00605-7
   PubMed Web of Science ®Google Scholar
• Strickler JH, Satake H, George TJ, et al. Sotorasib in KRAS p.G12C-mutated advanced pancreatic cancer. N Engl J Med. 2022;388:33–43. doi:10.1056/NEJMoa2208470
   PubMedGoogle Scholar