Abstract 1111P
Background
Mobocertinib is a first-in-class, potent, oral, irreversible tyrosine kinase inhibitor that selectively targets in-frame EGFRex20ins mutations in NSCLC. It was recently approved in the US (Sep-2021) and the UK (Mar-2022) for patients with locally advanced or metastatic NSCLC (aNSCLC) with EGFRex20ins mutations whose disease has progressed on platinum-based chemotherapy. This report describes the real-world treatment duration of mobocertinib in post-platinum EGFRexon20ins aNSCLC patients enrolled in a global EAP that provides access to mobocertinib for patients with unmet medical need.
Methods
Demographics were collected at screening. Treatment start/stop dates were estimated from shipped orders of mobocertinib. A standard shipment included a 90-day supply. Treatment discontinuation was physician-reported or assumed based on no re-orders for 120 days after the last shipment. Patients who had not discontinued treatment were censored on the date of data extraction. Time-to-treatment discontinuation (TTD) and probability of continued treatment at 6 and 12 months were estimated using Kaplan-Meier analysis.
Results
There were 556 eligible patients enrolled in the EAP between Jun-2020 and Dec-2021: 60.8% were female, median age was 62 years, and 58.1% reported ≥2 previous lines of therapy (LOT). Most patients were from Europe (47.5%) or Asia-Pacific (36.3%). Median TTD (95% CI) was 5.3 months (4.4, 6.3). Probability of continued treatment at 6 and 12 months was 48% and 32%, respectively. In patients with 1 previous LOT (n = 233) median TTD was 5.6 months (4.0, 9.0); in patients with ≥2 previous LOTs (n = 287) it was 4.8 months (4.0, 6.3). Among the 287 patients with ≥2 orders of mobocertinib (51.6%), TTD was 11.6 (8.9, 12.6) months with a 69% and 46% probability of continued treatment at 6 and 12 months, respectively.
Conclusions
Post-platinum patients with EGFRex20ins aNSCLC remained on mobocertinib for 5 months in the EAP. Over half of patients had ≥2 orders of mobocertinib and a prolonged estimated TTD of 11 months, suggesting clinical benefit (i.e., response or stable disease). Mobocertinib appears effective in a real-world setting.
Clinical trial identification
Editorial acknowledgement
Medical writing support provided by Jane Kondejewski, PhD of SNELL Medical Communication, Inc.
Legal entity responsible for the study
Takeda Development Center Americas, Inc.
Funding
Takeda Development Center Americas, Inc.
Disclosure
V.H.F. Lee: Financial Interests, Institutional, Other, Honoraria: Takeda Pharmaceutical Company Limited, Merck Sharp & Dohme, AstraZeneca, Amgen, Novartis, Boston Scientific. M. Lin, E. Curran, Y. Yin, E. Churchill, S. Allen: Financial Interests, Institutional, Full or part-time Employment: Takeda Development Center Americas, Inc. J. Abovich: Financial Interests, Institutional, Full or part-time Employment: Takeda Development Center Americas, Inc. N. Leighl: Financial Interests, Institutional, Sponsor/Funding, Institutional research funding: Takeda Pharmaceutical Company Limited; Financial Interests, Institutional, Other, Honoraria: Takeda Pharmaceutical Company Limited.