OncoKB New Data Release - March 21, 2024
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Data Release v4.15
March 21, 2024
What's New
Updated Therapeutic Implications:
New alteration(s) with a tumor type-specific level of evidence
Level R2: Osimertinib added as a treatment with predictive resistance for EGFR L718Q in non-small cell lung cancer based on clinical responses and preclinical data (PMID: 27257132, 29506987, 33937055, 31205925, 31315676, 34926262, 32146032)
Level R2: Osimertinib added as a treatment with predictive resistance for EGFR L792F in non-small cell lung cancer based on clinical responses and preclinical data (PMID: 35932642, 28093244, 29506987, 35422503)
Addition of sensitivity-associated therapy(s) for an alteration(s) with a tumor type-specific resistance level of evidence
Demotion of tumor type-specific level of evidence for an alteration
Level 2: AKT1 Oncogenic Mutations (excluding E17K, which remains Level 1) in breast cancer demoted from Level 1 to Level 2 based on adherence to the FDA-drug label and FoundationOne CDx diagnostic indications for capivasertib plus fulvestrant and inclusion of capivasertib plus fulvestrant as a treatment recommendation for patients with “AKT1 activating mutations” in the NCCN Breast Cancer Guidelines V2.2024
Level 2: PIK3CA Oncogenic Mutations (excluding R88Q, N345K, C420R, E542K, E545A, E545D, E545Q, E545K, E545G, Q546E, Q546K, Q546R, Q546P, M1043V, M1043I, H1047Y, H1047R, H1047L and G1049R, which remain Level 1) in breast cancer demoted from Level 1 to Level 2 based on adherence to the FDA-drug label and FoundationOne CDx diagnostic indications for capivasertib plus fulvestrant and inclusion of capivasertib plus fulvestrant as a treatment recommendation for patients with “PIK3CA activating mutations” in the NCCN Breast Cancer Guidelines V2.2024
Drug(s) currently in OncoKB™: Alpelisib plus Fulvestrant (Level 2)
No Level: FGFR1 Amplification in lung squamous cell carcinoma demoted from Level 3A to No Level based on limited clinical response in patients with FGFR1-amplified lung squamous cell carcinoma in association with erdafitinib (PMID: 37909331, 37606995)
Promotion of tumor type-specific level of evidence for an alteration
Level 3A: EGFR L718V in non-small cell lung cancer promoted from Level 4 to Level 3A based on clinical responses and preclinical data in association with afatinib (Ito, T., et al., Current Prob. in cancer, 2023; PMID: 35365043, 31757379, 29571986)
Drug(s) currently in OncoKB™: Osimertinib (Level R2)
Addition of therapy(s) associated with a tumor type-specific leveled alteration(s) (without changing the alteration's highest level of evidence)
Level 1: Amivantamab plus chemotherapy added as a treatment for EGFR Exon 20 In-Frame Insertions in non-small cell lung cancer based on FDA-approval of amivantamab with carboplatin and pemetrexed for non-small cell lung cancer (PMID: 37870976)
Drug(s) currently in OncoKB™: Amivantamab, Mobocertinib (Level 1); Erlotinib, Afatinib, Gefitinib (Level R1)
Gene Curation:
Addition of 4 new genes:
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