Suzhou-based biotech firm Gracell Biotechnologies Inc., (Nasdaq: GRCL) has announced positive data for its pipeline candidate GC012F at the American Society of Clinical Oncology (ASCO) Annual Meeting. GC012F is a FasTCAR-T therapy targeting both B-cell maturation antigen (BCMA) and CD19, under development for the treatment of relapsed/refractory multiple myeloma (r/r MM).
GC012F Trial Results and Clinical Impact
In a single-arm, open-label, multicenter investigator-initiated trial (IIT), 29 heavily pre-treated r/r MM patients received GC012F. After a median follow-up of 30 months, the overall response rate (ORR) reached 93.1%, with minimal residual disease-stringent complete response (MRD-sCR) achieved in 82.8%, and 100% achieving MRD negativity. The durability of responses was notable, with a median duration of response at 37.0 months and median progression-free survival at 38 months.
Implications for High-Risk Patient Populations
Considering the high-risk nature of the patient population assessed, who on average had received five lines of previous therapy, the results are viewed highly favorably. They indicate GC012F’s potential to produce deep and durable treatment effects in r/r MM. Gracell has already secured IND approval to assess the molecule in r/r MM in February of this year, and IITs are also underway for lymphoma and systemic lupus erythematosus (SLE).
Market Response to Positive Clinical Data
The positive clinical data has had a significant impact on investor sentiment, with Gracell’s share price jumping 16.34% in a single day of trading following the news.-Fineline Info & Tech
