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Xingya Li
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OA01 - Precision Medicine and Personalized Therapy for Lung Cancer (ID 1)
- Event: NACLC 2019
- Type: Oral Abstract Session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 10/11/2019, 14:00 - 15:40, Imperial Ballroom (B2 Level)
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OA01.08 - A Phase I Study to Evaluate Safety and Antitumor Activity of BPI-7711 in EGFRm+/T790M+ Advanced or Recurrent NSCLC Patients (ID 32)
14:00 - 15:40 | Author(s): Xingya Li
- Abstract
Background:
BPI-7711 is a 3rd generation irreversible EGFR-TKI that is selectively against EGFR TKI–sensitizing mutations and T790M resistance mutations. A phase I study is conducted to determine the safety and efficacy of BPI-7711 in patients with advanced or recurrent EGFRm+/T790M+ NSCLC.
Method:
NSCLC patients who had documented disease progression after 1st/2nd generation EGFR-TKI treatment and with EGFRm+/T790M+ confirmed by central lab were enrolled in the multicenter trial (NCT03386955) into “3+3” dose escalation or expansion cohorts. BPI-7711 was orally administered at doses of 30~300 mg in capsules. Patients in dose-escalation cohorts firstly received a single dose of BPI-7711 followed by a 7-day pharmacokinetic (PK) evaluation period then received the same dose daily until disease progression or intolerable toxicity(ies). Treatment efficacy per RECIST 1.1 was evaluated every 6 weeks since daily treatment commence. Once efficacy was observed in a dose, its expansion cohort was opened to enroll patients for daily treatment.
Results:
As of 15 April 2019, 119 patients were enrolled into 6 dose escalation cohorts (30/60/120/180/240/300 mg) and 5 dose expansion cohorts (30/60/120/180/240 mg). No DLT was observed and MTD was not reached. For all safety-evaluable patients, most common treatment related treatment emergent adverse events (TEAEs) (?10%) were neutrophil count decreased (17.6%), white blood cell count decreased (17.6%), leukopenia (11.8%) and platelet count decreased (10.1%). Grade?3 TEAEs were occurred in 16.0% patients and 8.4% were treatment-related per investigators’ judgement. SAEs were reported in 8.4% of patients, and 1.7% were treatment-related. For all efficacy-evaluable patients, the overall objective response rate (ORR) of all doses was 55.4% and the disease control rate (DCR) was 92.1% per investigator review. Per independent radiological review committee (IRRC) review, the ORR of all cohorts was 61.0% and DCR was 89.0%. For patients in 180 mg cohort, the overall ORR was 62.5% and 68.1% per investigator and IRRC review respectively. PK analyses showed exposures of BPI-7711 increased dose dependently at steady state between 30 mg and 180 mg.
Conclusion:
BPI-7711 achieved a high ORR in NSCLC patients. The safety profile and antitumor activity support continued development of BPI-7711. Phase 2 studies are under preparation.
