Adagene Reports P-Ib/II Trial Data on Muzastotug + Keytruda for Microsatellite Stable Colorectal Cancer (MSS CRC)
Shots:
- The P-Ib/II trial randomized 67 MSS CRC pts (65 evaluable) with no liver metastases to muzastotug (10mg/kg; Q3W or Q6W) or muzastotug (20mg/kg) followed by 10mg/kg (Q3W), or 20 mg/kg (Q6W), all in combination with Keytruda; P-II data expected in H1’27
- As of Jan 24, 2026, pts in 10mg/kg cohorts (N=39) showed ORR of 13% (0% Q6W & 17% Q3W), with PR of 13% (0% & 17%), DCR of 74% (70% & 76%), & SD of 62% (70% & 59%), informing P-II Arm A dosing; mPFS was 4.8mos., mOS was 19.8mos. (23.8mos. follow-up), with OS rates of 70.1% at 12mos. & 48% at 24mos.
- In 20mg/kg cohorts (N=26), cORR was 31% (25% Q6W; 36% loading dose), with CR of 4% (8% & 0%), PR of 27% (17% & 36%), SD of 54% (58% & 50%) & DCR of 85% (83% & 86%), informing P-II Arm B dosing; mPFS was 6.7mos. (15.4mos. in loading dose arm vs 4.9mos. in Q6W), mOS not reached (13.1mos. follow-up), with 1yr. OS rate of 80.8%
Ref: Adagene | Image: Adagene |Press Release
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