Abstract
Sotorasib plus panitumumab for pre-treated non-small cell lung cancer with KRAS G12C mutation: A phase 1b study
Journal of clinical oncology, Vol.42(16_suppl), pp.8559-8559
06/01/2024
DOI: 10.1200/JCO.2024.42.16_suppl.8559
Abstract
8559 Background: Sotorasib, a selective and irreversible KRAS G12C inhibitor, is approved for treatment of adults with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) who received ≥ 1 prior systemic therapy. EGFR pathway alterations have been observed as an acquired resistance mechanism with sotorasib monotherapy. Treatment with sotorasib plus an EGFR inhibitor, such as panitumumab, may enhance efficacy over sotorasib monotherapy, as demonstrated in chemotherapy refractory metastatic colorectal cancer. Our current study assesses sotorasib plus panitumumab in pre-treated advanced NSCLC. Methods: Key eligibility criteria for this dose expansion cohort of the CodeBreaK 101 study (NCT04185883) included advanced NSCLC positive for KRAS G12C, ≥ 1 prior treatment for advanced disease, and no prior KRAS G12C inhibitor exposure. Patients (pts) with active brain metastases were excluded. Primary endpoint was safety. Secondary endpoints included investigator-assessed objective response rate (ORR), disease control rate (DCR), duration of response (DOR), time to response (TTR), progression free survival (PFS), as well as overall survival (OS). Results: As of January 11, 2024, 40 pts (median age, 67.5 years; 55% female) received oral sotorasib 960 mg daily and panitumumab IV 6 mg/kg every 2 weeks. 43% of pts had a history of brain metastases. Median number of prior lines of therapy was 1; 42% received ≥ 2 regimens and 38% had disease progression as their best response to last line of therapy. Most pts received anti-PD-(L)1 therapy (90%), platinum-based chemotherapy (85%), or both (78%). Most common (> 30%) treatment-related adverse events (TRAEs) attributed to any study drug were: diarrhea in 19 (48%) pts, dermatitis acneiform in 18 (45%), and dry skin in 16 (40%). Most common grade ≥ 3 TRAEs were increased ALT and AST in 7 (18%) and 4 (10%) pts, respectively, dermatitis acneiform in 5 (13%), diarrhea in 3 (8%), and hypomagnesaemia in 2 (5%) pts. Overall response rate was 45% (all partial responses), with a DCR of 90% (Table). Median PFS was 5.8 months (median follow-up 14.0 months). At a median follow-up of 11.0 months, OS data were not yet mature. Conclusions: This cohort of sotorasib plus panitumumab in pre-treated patients with KRAS G12C advanced NSCLC demonstrated safety consistent with each drug's profile. The ORR appears promising in this pretreated population and may warrant further investigation. Clinical trial information: NCT04185883 . [Table: see text]
Details
- Title: Subtitle
- Sotorasib plus panitumumab for pre-treated non-small cell lung cancer with KRAS G12C mutation: A phase 1b study
- Creators
- Corey J. Langer - University of PennsylvaniaRachel Galot - Cliniques Universitaires Saint-LucHans Prenen - Antwerp University HospitalDavid S. Hong - The University of Texas MD Anderson Cancer CenterIván Victoria - Hospital Clínic de BarcelonaRavi Salgia - City Of Hope National Medical CenterMaxime Chenard-Poirier - Université LavalMuhammad Furqan - University of IowaEmily Chan - AmgenJane Nolte-Hippenmeyer - AmgenCaihong Xia - AmgenBob T. Li - Memorial Sloan Kettering Cancer Center
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.42(16_suppl), pp.8559-8559
- DOI
- 10.1200/JCO.2024.42.16_suppl.8559
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Language
- English
- Date published
- 06/01/2024
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984651156502771
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