bintrafusp alfa (M7824)

P3, N=22, Completed, EMD Serono Research & Development Institute, Inc. | N=32 --> 22

Quadruplet therapy produced one objective response in unselected mCRC patients (n = 20). There were no responses with triplet therapy (n = 12). The role of ICB-based combination immunotherapy in pMMR CRC remains unclear. NCT04491955.

89Zr-bintrafusp alfa imaging is safe, feasible and provides relevant tumor targeting information for patient selection and treatment.

P1/2, N=55, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Dec 2025 --> Nov 2026

Our findings directly inform clinical guidelines, address gaps in current therapeutic decision-making. Durvalumab or pembrolizumab combined with GC are optimal first-line regimens for advanced BTC, balancing survival benefits and safety. Sintilimab plus anlotinib combined with GC demonstrates superior PFS but requires further validation. While EGFR inhibitors plus chemotherapy demonstrate potential in KRAS wild-type patients, confirmation in large-scale RCTs is required. PD-L1 expression may represent a promising predictive biomarker for response to PD-1 inhibitor therapy.

P=N/A, N=232, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2025 --> Nov 2027 | Trial primary completion date: Nov 2025 --> Nov 2027

P1/2, N=80, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Sep 2025 --> Dec 2028

P3, N=32, Completed, EMD Serono Research & Development Institute, Inc. | Active, not recruiting --> Completed

In this small study, Tri-Ad5 vaccine plus bintrafusp alfa resulted in CPD in 2/6 patients. Participants also had favorable 2-year RFS compared to historical values. Ongoing tissue and peripheral immunome analyses may provide mechanistic insight. (ClincalTrials.gov Identifier: NCT04247282; IRB Approved.).

P1/2, N=55, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=107 --> 55

PRGN-2009 was well tolerated, and immune responses were observed to PRGN-2009. Encouraging anti-tumor activity and OS were noted in the combination with BA arm, consisting mainly of checkpoint-resistant patients. Trial Registration ClinicalTrials.gov Identifier: NCT04432597.

In this trial, the combination of PDS0101, PDS01ADC, and bintrafusp alfa showed an acceptable safety profile and promising antitumor activity and improved OS in patients with HPV-16-positive cancers, in both ICB-naive and ICB-resistant patients, warranting further evaluation of the combination of PDS0101 and PDS01ADC with simultaneous PD-L1/TGF-β inhibition in these populations.