Abstract 97P
Background
EGFR inhibitors could increase MHC class-I presentation and sensitize tumor cells to CD8+ T cell–mediated killing, leading to a synergic efficacy in combination with PD-1 blockade. Afatinib also showed response as monotherapy in the treatment of refractory esophageal squamous cell carcinoma (ESCC). Herein, we report preliminary results of a phase II study of BI-754091 and afatinib in refractory ESCC patients.
Methods
Patients with refractory ESCC were eligible to receive afatinib 30 mg once daily and BI-754901 240 mg on day 1, in a 3-week cycle. With Optimal Simon’s two-stage design and (p0=0.17, p1=0.35) for objective response rate (ORR, proportion of patients with complete or partial response [CR/PR]) and given error probabilities (one-sided alpha=0.05; beta=0.2), 16 evaluable patients were needed in the first stage. If 4 or more patients with objective response, the study would be extended to the second stage. Tumor response was assessed by CT/MRI every 6 weeks according to RECIST v1.1. The PR should be confirmed by two consecutive image examinations.
Results
Between August 2021 and February 2022, a total of 19 patients were enrolled as the intention-to-treat (ITT) population. Three patients withdrew early after the first cycle of treatment. With a median follow-up of 7.4 months (95% confidence interval [CI], 5.2-7.9), 7 patients achieved confirmed PR and 7 patients (36.8%) got stable disease, with the ORR of 36.8% (95% CI, 16-62%) in ITT population. The median progression-free survival was 5.3 months (95% CI, 3.8-6.1) in 16 evaluable cases. The common all grades of adverse events were afatinib-related diarrhea (47.5%), mucositis (36.9%), acneiform rash (31.6%). One patient suffered from grade 2 pneumonitis. No treatment-related death was reported.
Conclusions
By the observation of 7 patients with confirmed PR in the first stage, the second stage would be started for final enrollment to 44 evaluable cases.
Clinical trial identification
NCT04839471.
Editorial acknowledgement
Legal entity responsible for the study
The authors without further recourse to the authors.
Funding
Boehringer Ingelheim.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
48P - Long-term clinical outcomes after the second metastasectomy in patients (pts) with resected metastatic colorectal cancer (mCRC)
Presenter: Songji Choi
Session: Poster viewing 02
49P - Ramucirumab beyond progression plus TAS 102 in patients with advanced or metastatic adenocarcinoma of the stomach or the gastroesophageal junction, after treatment failure on a ramucirumab based therapy: Final results of the phase II RE-ExPEL study
Presenter: Thorsten Goetze
Session: Poster viewing 02
50P - Linear tumor regression of rectal cancer in daily MRI during preoperative chemoradiotherapy: An insight of tumor regression velocity for personalized cancer therapy
Presenter: Sea-Won Lee
Session: Poster viewing 02
51P - Efficacy and safety of sintilimab as first-line therapy in patients with microsatellite instability-high metastatic colorectal cancer: A real-world study
Presenter: Caiyun Nie
Session: Poster viewing 02
53P - Baseline PET/CT deep radiomics signature apply for identifying bevacizumab sensitivity of RAS-mutant colorectal cancer liver metastases patients
Presenter: Wenju Chang
Session: Poster viewing 02
54P - Efficacy of total neoadjuvant therapy (TNT) in rectal cancer: A meta-analysis of randomized controlled trials
Presenter: Yakup Ergün
Session: Poster viewing 02
55P - Biodegradable and biocompatible 3D-printed scaffolds loaded with chemotherapy drugs: A new horizon for treatment of colon cancer with diffuse intraperitoneal metastasis
Presenter: Amirhosein Kefayat
Session: Poster viewing 02
56P - Clinico-pathological profile of adolescent and young adult colorectal cancer patients: Multicentre collaborative registry data from India
Presenter: Soumya Surath Panda
Session: Poster viewing 02