Abstract 416P
Background
At present, there is no standard treatment for PD-1 resistant R/M NPC and the prognosis is poor. AK104 combined with chemotherapy has shown promising efficacy and tolerable toxicity in in locally advanced and metastatic non-small lung cancer after failure of treatment with anti-PD-1 (NCT05816499). In this study, we report the efficacy and safety of AK104 combined with chemotherapy for the anti-PD-1 resistant R/M NPC (NCT05790200).
Methods
This is a prospective, open, single-arm, phase II clinical study about failure of treatment anti-PD-1 R/M NPC. All patients received AK104 10 mg/kg combined with chemotherapy, q3W,4-6 cycles, following with AK104 10 mg/kg, q3w until PD or unacceptable toxicity. The primary endpoint were ORR and PFS per RECIST1.1. Secondary endpoints included DoR, DCR, TTR, TTP, and OS.
Results
15 pts were enrolled from Dec 28, 2022 to Jan 17, 2024. As of Feb 1, 2024, we assessed safety in 15 pts and efficacy in 10pts with at least one tumor assessment results. TRAEs of any grade occurred in 11/15 (73.3%) pts. Grade≥3 TRAEs occurred in 4 (26.7%) pts. The most common TRAEs were hypothyroidism (20%), lymphocytopenia (20%). The most common grade ≥ 3 TRAEs were interstitial pneumonia (7%), allergy (7%), hemorrhage (7%) and direct bilirubin elevation (7%). TRSAE occurred in 3 (20%) pts. IrAEs of any grade, assessed by INV, occurred in 5 (33.3%) pts. Grade ≥ 3 irAE occurred in 2 (13.3%) pts. No deaths occurred. The response to the treatment was favorable regardless of CPS. ORR was 60% (06/10). PFS or OS data are not mature by cut-off date.
Conclusions
AK104 combined with chemotherapy was well tolerated, with encouraging antitumor activity in pts with anti-PD-1 resistant R/M NPC. Meanwhile, long-term safety evaluation still needs following up.
Clinical trial identification
NCT05790200; 2023-03-30.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.