Abstract 585P
Background
Mobocertinib is a tyrosine kinase inhibitor (TKI) for patients with locally advanced and metastatic non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations previously treated with platinum-based chemotherapy. This study aimed to generate real-world (RW) data on the effectiveness of mobocertinib.
Methods
A retrospective chart review of patients in the compassionate use program was conducted in 3 countries (Canada, France, Hong Kong; 29 sites). Inclusion criteria: ≥18 years old; diagnosis of stage IIIB-IV NSCLC with EGFR exon20ins mutations between 1 Jan 2017 and 30 Nov 2021; received mobocertinib. Data on demographics, lung cancer characteristics, mobocertinib treatment, disease outcomes and adverse events were abstracted from medical records. RW outcomes (progression free survival [PFS], overall response rate [ORR], duration of response, time to treatment discontinuation, overall survival) were calculated.
Results
In total, 105 patients were enrolled (mean [standard deviation, SD] age at initial diagnosis: 62.4 years [11.27]; N [%]: women: 66 [62.9%]; Canada: 19 [18.1%]; France: 51 [48.6%]; Hong Kong: 35 [33.3%]; Stage IV at advanced diagnosis: 97 [94.2%]; brain metastasis during study: 57 [54.3%]). Most patients received mobocertinib as 2nd or 3rd line of therapy (78 [74.3%]); maximum daily dose (N patients (%)): 160mg: 71 (67.6%), 120mg: 16 (15.2%), 80mg: 8 (7.6%), 40mg: 6 (5.7%), unknown: 4 (3.8%). The median PFS (95% confidence interval [CI]) was 4.76 months (3.98, 6.21; N: 105). The ORR was 20.0%, and the median DOR was 8.34 months (95% CI: 3.61, 9.49; N: 21). There was cross-country variation in RW outcomes (Table). In total, 51 patients (48.6%) reported diarrhea (all grades) related to mobocertinib (treatment discontinuation due to diarrhea: 4 patients [7.8%]). Table: 585P
RW outcomes for all patients and by country (data reported as median [95% CI] months except overall response rate (ORR), presented as number (%) of patients with complete / partial response)
RW Outcome | All patients (N: 105) | Canada (N: 19) | France (N: 51) | Hong Kong (N: 35) |
Progression Free Survival | 4.76 [3.98, 6.21] | 6.05 [3.12, 8.74] | 3.75 [2.07, 5.03] | 6.41 [4.11, 11.50] |
ORR | 21 (20.0%) | 7 (36.8%) | 9 (17.6%) | 5 (14.3%) |
Duration of response | 8.34 [3.61, 9.49] | 7.95 [2.00, NA] | 9.23 [1.18, NA] | 7.72 [2.10, NA] |
Time to treatment discontinuation | 4.50 [3.45, 6.08] | 5.19 [2.50, 12.16] | 3.45 [1.91, 4.93] | 6.83 [4.14, 11.37] |
Overall survival | 26.28 [20.21, 36.44] | 36.30 [20.14, 50.04] | 19.65 [14.59, 30.75] | 37.65 [24.38, 49.97] |
Conclusions
Patients had favorable RW outcomes suggesting clinical effectiveness of mobocertinib.
Clinical trial identification
NCT05207423; 12 Jan 2022.
Editorial acknowledgement
Zaneta Stawiarska (IQVIA).
Legal entity responsible for the study
Takeda Development Center Americas, Inc., Lexington, MA, USA.
Funding
Takeda Development Center Americas, Inc.
Disclosure
T.S.K. Mok: Financial Interests, Personal, Advisory Role: AbbVie, ACEA Pharma, Alpha Biopharma, Amgen, AstraZeneca, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Blueprint Medicines, CStone Pharmaceuticals, Daiichi Sankyo, Eisai, Fishawack Facilitate, GeneDecode, Gritstone Oncology Inc., Guardant Health, Hengrui Therapeutics, Ignyta Inc., IQVIA, Incyte, Janssen, Lilly, Loxo Oncology, Lunit USA, Merck Serono, Merck Sharp & Dohme, Mirati Therapeutics, MORE Health, Novartis, OrigiMed, Pfizer, Puma Biotechnology, Roche, Sanofi-Aventis R&D, Takeda, Virtus Medical Group, Yuhan Corp., SFJ Pharmaceuticals, Curio Science, Inivata, Berry Oncology, G1 Therapeutics Inc., Qiming Development (HK) Ltd., Gilead Sciences, Vertex Pharmaceuticals, Covidien LP, Elevation Oncology, C4 Therapeutics, Amoy Diagnostics Co.; Financial Interests, Personal, Invited Speaker: ACEA Pharma, Alpha Biopharma Co, Amgen, Amoy Diagnostics, AstraZeneca, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Fishawack Facilitate, GeneDecode, InMed Medical Communication, Janssen, Lilly, Lunit USA, MD Health, Medscape/WebMD, Merck Serono, MSD, Novartis, OrigiMed, PeerVoice, Physicians’ Education Resource, P Permanyer SL, Pfizer, PrIME Oncology, Research to Practice, Roche, Sanofi-Aventis R&D, Takeda, Touch Medical Media, Daz Group, Lucence Health, Merck Pharmaceuticals HK Ltd., Shanghai BeBirds Translation & Consulting Co, Llangylhul Network Technology Co., Taiho; Financial Interests, Personal, Member of Board of Directors: Lunit USA, AstraZeneca PLC, Hutchison Chi-Med, Act Genomics-Sanomics Group, Aurora; Financial Interests, Personal, Stocks/Shares: Hutchison Chi-Med, Act Genomics-Sanomics Group, Aurora; Financial Interests, Personal, Funding, Grant: Clovis Oncology, Xcovery. G. Liu: Non-Financial Interests, Personal, Other, Honraria: Takeda, Amgen, AstraZeneca, Roche, Novartis, Merck, Pfizer, Jazz Pharmaceuticals; Financial Interests, Institutional, Funding, research grants: Takeda, AstraZeneca, Amgen, Boehringer Ingelheim. H. Curcio: Financial Interests, Personal, Other, Honoraria or consultations fees: Bristol Myers Squibb; Financial Interests, Personal, Other, Registration fees and accommodation: Sandoz. A. Cortot: Financial Interests, Personal, Advisory Board: AbbVie, Amgen, AstraZeneca, BMS, Exeliom Biosciences, InhaTarget Therapeutics, Sanofi, Roche, Pfizer, Novartis, Merck, Janssen, Takeda. R. Descourt: Financial Interests, Personal, Advisory Board: AZ, BMS, MSD, Pfizer, Sanofi, Takeda. P.K. Cheema: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Bayer, Novartis, Roche, Pfizer, Janssen, Merck; Financial Interests, Personal, Other, Honorarium: GSK, Janssen, Sanofi, Merck. J.M. Gwinnutt: Financial Interests, Personal and Institutional, Full or part-time Employment: IQVIA. E.N. Churchill, J. Nyborn, E. Curran, Y. Yin, K. Chong, Y. Tanaka-Chambers, J. Kretz: Financial Interests, Personal and Institutional, Full or part-time Employment: Takeda. J. Cadranel: Financial Interests, Personal, Advisory Board: Amgen, AZ, BI, BMS, Janssen, MSD, Novartis, Pfizer, Sanofi, Takeda. All other authors have declared no conflicts of interest.
Resources from the same session
352TiP - Randomized phase III study of daratumumab (D) versus bortezomib plus D as a maintenance therapy after D-MPB for elderly or non-elderly patients refusing transplant with untreated multiple myeloma (JCOG1911, B-DASH study)
Presenter: Tomotaka Suzuki
Session: Poster Display
Resources:
Abstract
362P - Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in head and neck squamous cell cancer (HNSCC)
Presenter: Irene Braña
Session: Poster Display
Resources:
Abstract
363P - Effect of financial distress and mental well-being of patients with early vs advanced oral cancer on informal caregiver's quality of life: A prospective real-world data from public health sector hospital
Presenter: Abhinav Thaduri
Session: Poster Display
Resources:
Abstract
364P - Artificial intelligence provides more accurately neck lymph nodes auto-segmentation in radiotherapy
Presenter: chiencheh Chen
Session: Poster Display
Resources:
Abstract
365P - Radiotherapy treatment outcomes and treatment compliance of nasopharyngeal cancer patients in Sabah: A retrospective analysis
Presenter: Anbarasan Anbazagan
Session: Poster Display
Resources:
Abstract
366P - Pre-treatment oral fungal microbiome and nasopharyngeal carcinoma prognosis: A population-based cohort study in southern China
Presenter: Yufeng Chen
Session: Poster Display
Resources:
Abstract
367P - Prevalence and association of sarcopenia with mortality in patients with head and neck cancer: A meta-analysis
Presenter: Claire Lim
Session: Poster Display
Resources:
Abstract
368P - Distinct gene expression profiling explored using nanostring tumor signalling 360 panel with validations in different clinical stages of oral submucous fibrosis patients: A first Indian study
Presenter: Yasasve Madhavan
Session: Poster Display
Resources:
Abstract
370P - Low-dose nivolumab with induction chemotherapy for inoperable HNSCC in 111 patients: Response rates, survival, and implications for LMICs
Presenter: Josh Thomas Georgy
Session: Poster Display
Resources:
Abstract
371P - The role of FDG-PET/CT in the assessment of response to radiation therapy in head and neck cancers: A systematic review and meta-analysis
Presenter: Felix Wijovi
Session: Poster Display
Resources:
Abstract