OncoKB New Data Release - October 24, 2024
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Data Release v4.22
October 24, 2024
What's New
Update to our FDA Cleared or Approved Companion Diagnostic Devices (CDx) page
Update to our FDA-Approved Oncology Therapies page
Updated Therapeutic Implications:
New alteration(s) with a tumor type-specific level of evidence
Level R2: ROS1 G2023R in non-small cell lung cancer based on resistance response to crizotinib and lorlatinib in patients with ROS1 G2023R-mutated non-small cell lung cancer, and accompanying preclinical data (PMID: 33685866, 29333528, 23724914, 36135089, 36135089, 32918045)
Level 3A: ROS1 L2086F in non-small cell lung cancer based on clinical response to cabozantinib in patients with ROS1 L2086F-mutated non-small cell lung cancer, and accompanying preclinical data (PMID: 37012551, 26554404, 38032104, 27483357)
Level R2: ROS1 L2086F in non-small cell lung cancer based on resistance response to lorlatinib and repotrectinib in patients with ROS1 L2086F-mutated non-small cell lung cancer, and accompanying preclinical data (PMID: 37291202, 33685866, 39091594)
Level 3A: SMARCA4 Oncogenic Mutations in non-small cell lung cancer and esophageal adenocarcinoma based on clinical response to PRT3789 in patients with SMARCA4-mutated non-small cell lung cancer and esophageal adenocarcinoma, and accompanying preclinical data (Abstract: Guo, R. et al., Abstract# 603O, ESMO 2024; Abstract: Hulse, M. et al., Abstract# 3263, AACR 2022)
Promotion of tumor type-specific level of evidence for an alteration
Level 1: PIK3CA Oncogenic Mutations (excluding R88Q, N345K, C420R, E542K, E545A/D/G/K/Q, Q546E/K/R/P, M1043V/I, H1047Y/R/L, G1049R which are already Level 1) in breast cancer promoted from Level 2 to Level 1 based on FDA approval of inavolisib + palbociclib + fulvestrant in patients with PIK3CA-mutant breast cancer (Abstract: Jhaveri, K. et al., Abstract# GS03-13, SABCS 2023)
Sensitivity-associated evidence currently in OncoKB™ for PIK3CA Oncogenic Mutations (excluding R88Q, N345K, C420R, E542K, E545A/D/G/K/Q, Q546E/K/R/P, M1043V/I, H1047Y/R/L and G1049R) (Level 2 in breast cancer; Capivasertib + Fulvestrant, Alpelisib + Fulvestrant)
Addition of drug(s) associated with a tumor type-specific leveled alteration(s) currently in OncoKB™ (without changing the alteration's highest level of evidence)
Level 1: Addition of Amivantamab + Chemotherapy to the Level 1 annotation of EGFR exon 19 in-frame deletions and L858R in non-small cell lung cancer based on FDA approval of amivantamab + chemotherapy in patients with non-small cell lung cancer with EGFR L858R or exon 19 in-frame deletions (PMID: 37879444)
Sensitivity-associated evidence currently in OncoKB™ for EGFR exon 19 in-frame deletions and L858R (Level 1 in non-small cell lung cancer; Afatinib, Dacomitinib, Erlotinib, Erlotinib + Ramucirumab, Gefitinib, Osimertinib, Osimertinib + Chemotherapy, Amivantamab + Lazertinib)
Level 1: Addition of Inavolisib + Palbociclib + Fulvestrant to the Level 1 annotation of PIK3CA R88Q, N345K, C420R, E542K, E545A/D/G/K/Q, Q546E/K/R/P, M1043V/I, H1047Y/R/L and G1049R in breast cancer based on FDA approval of inavolisib + palbociclib + fulvestrant in patients with PIK3CA-mutant breast cancer (Abstract: Jhaveri, K. et al., Abstract# GS03-13, SABCS 2023)
Sensitivity-associated evidence currently in OncoKB™ for PIK3CA R88Q, N345K, C420R, E542K, E545A/D/G/K/Q, Q546E/K/R/P, M1043V/I, H1047Y/R/L and G1049R (Level 1 in breast cancer; Capivasertib + Fulvestrant, Alpelisib + Fulvestrant [for PIK3CA C420R, E542K, E545A/D/G/K, H1047Y/R/L and Q546E/R only])
Level 3A: Addition of NVL-655 to ALK Fusions in non-small cell lung cancer based on clinical response to NVL-655 in patients with ALK fusion-positive non-small cell lung cancer, and accompanying preclinical data (PMID: 39269178; Abstract: Drilon, A. et al., Abstract# 1253O, ESMO 2024)
Sensitivity-associated evidence currently in OncoKB™ for ALK fusions (Level 1 in non-small cell lung cancer; Alectinib, Brigatinib, Ceritinib, Crizotinib, Lorlatinib)
Level 3A: Addition of taletrectinib to ROS1 Fusions in non-small cell lung cancer based on clinical response to taletrectinib in patients with ROS1 fusion-positive non-small cell lung cancer, and accompanying preclinical data (PMID: 38822758, 36877099, 31399568)
Sensitivity-associated evidence currently in OncoKB™ for ROS1 fusions (Level 1 in non-small cell lung cancer; Crizotinib, Entrectinib, Repotrectinib)
Level 3A: Addition of NVL-655 to ALK G1202R in non-small cell lung cancer based on clinical response to NVL-655 in patients with ALK G1202R-mutant non-small cell lung cancer, and accompanying preclinical data (PMID: 39269178; Abstract: Drilon, A. et al., Abstract# 1253O, ESMO 2024)
Sensitivity-associated evidence currently in OncoKB™ for ALK G1202R (Level 2 in non-small cell lung cancer; Lorlatinib)
Level 3A: Addition of ASP3082 to the Level 3A annotation of KRAS G12D in non-small cell lung cancer and pancreatic adenocarcinoma based on clinical response to ASP3082 in patients with KRAS G12D-mutant non-small cell lung cancer and pancreatic adenocarcinoma, and accompanying preclinical data (Abstract: Park, W. et al., Abstract# 608O, ESMO 2024; Abstract: Nagashima, T. et al., Abstract# 5735, AACR 2023)
ASP3082 was previously Level 4 in these indications
Sensitivity-associated evidence currently in OncoKB™ for KRAS G12D (Level 3A in non-small cell lung cancer and pancreatic adenocarcinoma; RMC-6236)
Gene Curation:
Addition of 5 new genes:
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