KEY TAKEAWAYS
- The GDFATHER phase I/II trial aimed to evaluate the potential of a novel immunotherapy combo to overcome resistance to standard anti-PD1/PD-L1 treatments in advanced cancers.
- The primary endpoint was ORR.
- The result demonstrated that adding visugromab to nivolumab in immunotherapy-resistant cancers showed durable responses, even in PD-L1+ patients who previously failed another checkpoint inhibitor.
For this study, researchers aimed to evaluate the potential of a novel immunotherapy combo to overcome resistance to standard anti-PD1/PD-L1 treatments in advanced cancers.
Patients were administered visugromab at 10 mg/kg every 2 weeks, along with nivolumab at 240 mg every 2 weeks, primarily in the 3rd-4th line of treatment. The main objective was to assess the objective response rate (ORR).
All participants strictly met the criteria for either (1) primary refractoriness or (2) relapse on continued CPI therapy following an initial response, necessitating a minimum of 12 weeks of continuous exposure to anti-PD1/-PD-L1.
About 114 patients across various cohorts initiated treatment. Most treatment-emergent adverse events (TEAE) reported were mild to moderate, with only 3.7% of patients experiencing TEAE Grade > 3.
In NSCLC and bladder cancer cohorts (N = 27 pts, each), confirmed RECIST response rates of 15% were observed in this heavily pretreated, advanced/metastatic, and checkpoint inhibitor relapsed/refractory last-line population. Responses were predominantly seen in PD-L1+ tumors.
Notably, in the bladder cancer cohort, all patients with TPS ≥ 5 in baseline tumor biopsy experienced a partial response (PR) or complete response (CR). The depth and durability of responses were significant, with several responses ongoing at 1 year and beyond, despite all patients being in a last-line situation.
The result demonstrated that adding visugromab to nivolumab in immunotherapy-resistant cancers showed durable responses, even in PD-L1+ patients who previously failed another checkpoint inhibitor.
Clinical Trial: https://clinicaltrials.gov/study/NCT04725474
Melero I. Definitive results for NSCLC and Bladder cancer cohorts in the phase 2a trial of visugromab (CTL-002) in advanced/metastatic anti-PD/PD-L1 relapsed/refractory solid tumors (GDFATHER-trial). ESMO-IO-2023. Presentation Number 118O.
