585P - Real-world outcomes in patients with non-small cell lung cancer with EGFR exon 20 insertion mutations receiving mobocertinib

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)

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.