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
193P - Impact of coronavirus disease 2019 on patients with unresectable hepatocellular carcinoma treated with atezolizumab/bevacizumab
Presenter: Hongjae Chon
Session: Poster Display
Resources:
Abstract
194P - Real-world outcomes of cadonilimab (PD-1/CTLA-4 bispecific antibody) plus chemotherapy as first-line treatment in advanced gastric (G) or gastroesophageal junction (GEJ) cancer with PD-L1 CPS≤5
Presenter: Qi Xu
Session: Poster Display
Resources:
Abstract
195P - Ferroptosis signatures in pancreatic ductal adenocarcinomas and their role in patient survival: A translational unsupervised clustering analysis
Presenter: Quoc-Huy Trinh
Session: Poster Display
Resources:
Abstract
196P - Clinical significance of circulating CD8+ and CD4+ T cell proliferation in advanced gastric cancer receiving first-line chemotherapy
Presenter: In-Ho Kim
Session: Poster Display
Resources:
Abstract
197P - Treatment patterns and clinical outcomes of patients with unresectable advanced or metastatic (UAM) gastric/gastroesophageal junction adenocarcinoma (GA/GEJA) in China: A multicenter real-world study
Presenter: Yanqiao Zhang
Session: Poster Display
Resources:
Abstract
198P - Effectiveness of lenvatinib in patients with unresectable hepatocellular carcinoma: A multicenter observational study in Japan
Presenter: Namiki Izumi
Session: Poster Display
Resources:
Abstract
199P - Efficacy of endostar in combination with concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of esophagus: A randomized, open-label, phase II trial
Presenter: Yuexiao Qi
Session: Poster Display
Resources:
Abstract
200P - Prognosis of patients with hepatocellular carcinoma treated with transarterial chemoembolization: Development and validation of the ALFP score
Presenter: Baocuo Gong
Session: Poster Display
Resources:
Abstract
201P - A phase II study of serplulimab (a programmed death-1 inhibitor) with or without HLX04 (a bevacizumab biosimilar) for the treatment of advanced hepatocellular carcinoma
Presenter: Zhenggang Ren
Session: Poster Display
Resources:
Abstract
202P - Comparison of liver injury after transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy for intermediate and advanced hepatocellular carcinoma
Presenter: Yongru Chen
Session: Poster Display
Resources:
Abstract