3rd generation irreversible EGFR-TKI for the treatment of Non Small Cell Lung Cancer (NSCLC) patients.
Independently developed by Beta Pharma research team. Beta Pharma, Inc. fully owns all of the IP rights, PCT patent # WO2016094821A2.
Overcome the drug resistance and toxicity problems of 1st/2nd generation EGFR-TKIs.
Well tolerated and highly effective in NSCLC patients with advanced or recurrent EGFR/T790M mutation progressed after 1st generation EGFR-TKI treatment.
Demonstrated a promising efficacy on brain metastases.
A total of 636 patients were screened and 226 were finally enrolled. Clinical study data showed excellent efficacy (also as the only one clinical trial in the third generations of EGFR-TKI which accepted positive peripheral blood sample, which is closer to the real-world screening method of most patients), good safety and tolerability, and outstanding efficacy for patients with brain metastasis. BPI-7711 is expected to be best-in-class third-generation EGFR-TKI for the treatment of patients with brain metastases.
Pre-clinical development complete.
Chinese clinical trial application (CTA) filed and approved in 2017.
Phase I clinical trial recruitment has been completed in November, 2019. 172 patients were enrolled. Final data analysis and reports are in progress.
Pivotal phase IIb trial was launched in March 2, 2019. By December 2019, 212 patients have been enrolled and trial recruitment will complete in January 2020.
Pre-ind meeting with US FDA has been scheduled in February 2020.
Pivotal phase III trial is targeting the treatment-naive EGFR mutation NSCLC patients. Phase III trial has started and expected to be completed in 18-24 months.
Phase IIb Clinical Trial (2nd Line Treatment) Interim Analysis Data has been submitted in NDA. NDA approval is expected in Q2 or Q3 of 2022.
Phase III Clinical Trial (1st Line Treatment) patient enrolling now.