Brandon Twyford

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At the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium, Neil Segal, MD, PhD, of Memorial Sloan Kettering Cancer Center, presented the results of the phase III KEYFORM-007 trial, which evaluated the efficacy and safety of co-formulated favezelimab (an anti&ndash;lymphocyte activation gene-3 protein antibody) and pembrolizumab (a programmed cell death 1 [PD-1] inhibitor) versus standard-of-care (SOC) treatments in patients with PD ligand 1 (PD-L1)&ndash;positive microsatellite stable/mismatch repair proficient (MSS/pMMR) metastatic colorectal cancer (mCRC).Study Design and ObjectivesThe trial enrolled 441 patients with a PD-L1 combined positive score &ge;1 MSS/pMMR mCRC whose disease had progressed during standard treatment or who could not tolerate standard treatment. Participants were randomized 1:1 to receive either co-formulated favezelimab/pembrolizumab or SOC (regorafenib or TAS-102 [trifluridine and tipiracil hydrochloride]). The primary endpoint was overall survival (OS), with secondary endpoints including progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR).Key ResultsAfter a median follow-up of 28 months, the study revealed that favezelimab/pembrolizumab did not demonstrate a survival benefit over SOC. Median OS was 7.3 months with favezelimab/pembrolizumab compared with 8.5 months with SOC (hazard ratio, 0.98, P=.4183). Similarly, median PFS was 2.1 months versus 2.6 months, respectively, with no statistical significance.Despite the lack of OS and PFS benefits, the ORR was notably higher with favezelimab/pembrolizumab, with 6.8% of patients achieving a response compared with 0.9% in the SOC arm. Responses in the favezelimab/pembrolizumab arm were durable, with the median DOR not reached among responders, compared with 6.5+ months in the SOC arm.The co-formulated therapy exhibited a manageable safety profile, with fewer grade &ge;3 treatment-related adverse events than SOC (20% vs 36%). However, adverse events of special interest, such as immune-related events, were more frequent with favezelimab/pembrolizumab (38% vs 6%).The KEYFORM-007 trial authors concluded that although the safety profile was manageable, co-formulated favezelimab/pembrolizumab did not improve OS or PFS compared with SOC for patients with PD-L1&ndash;positive MSS/pMMR mCRC.

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KEYFORM-007 Results: Co-Formulated Favezelimab and Pembrolizumab in Metastatic Colorectal Cancer

Colorectal Cancer

The study showed that favezelimab/pembrolizumab did not demonstrate a survival benefit over SOC.