Benzinga | Oct 13, 2021 01:38PM EDT

I-Mab Reports Completion Of Patient Enrollment In Phase 3 Trial Of Felzartamab (TJ202) In Combo With Lenalidomide As Second-Line Therapy In Patients With Multiple Myeloma

* Completed patient enrollment in phase 3 registrational trial of felzartamab in combination with lenalidomide for second-line treatment of multiple myeloma (MM)

* Felzartamab for MM third-line treatment is on track for BLA submission in Q4 2021

* New IND application for combination of felzartamab with another I-Mab clinical asset as a potential first-line treatment for MM is planned in Q4 2021

SHANGHAI and GAITHERSBURG, Md., Oct. 13, 2021 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that it has completed the patient enrollment of the phase 3 clinical trial of human CD38 antibody felzartamab (also known as TJ202) in combination with lenalidomide as a second-line therapy in patients with multiple myeloma (MM).

The phase 3 trial (NCT03952091) is a randomized, open-label, parallel-controlled, multi-center study to evaluate the efficacy and safety of the combination of felzartamab, lenalidomide (LEN) and dexamethasone (DEX) versus the combination of LEN and DEX in patients with relapsed or refractory MM who received at least one prior line of treatment. The primary endpoint of the study is to evaluate the progression-free survival (PFS) comparing the efficacy of felzartamab plus LEN/DEX versus LEN/DEX. Data from this study are expected to be the major package supporting Biologics License Application (BLA) submission for second-line treatment of MM in China.

"We are delighted to have completed the patient enrollment as planned under very challenging circumstances. The results will further support the clinical program towards registration to treat patients with multiple myeloma in China," said Dr. Joan Shen, CEO of I-Mab.

I-Mab has completed the single-arm registrational trial with felzartamab and DEX as a third-line therapy for MM patients in Greater China (NCT03860038). Topline data from the study has met the primary and secondary endpoints and confirmed its clinical advantages as estimated. BLA submission is on track in Q4 2021. Further, a new IND application is planned in Q4 2021 to initiate a clinical trial for combination of felzartamab with another I-Mab clinical asset as a potential first-line treatment for MM.