Although PD-1/L1 inhibitors have shown efficacy in advanced/metastatic sqNSCLC, many patients (pts) do not achieve robust response or durable benefit to this treatment. Hence, novel therapies that meet this requirement are needed. The preliminary results of IBI110 combined with sintilimab and chemotherapy (paclitaxel plus carboplatin, TP) (combination therapy) in pts with treatment-naive sqNSCLC were previously presented (Caicun Zhou et al. ASCO 2022). Here, we report updated results of this phase Ib study.
Eligible pts with previously untreated, unresectable, locally advanced/metastatic sqNSCLC were enrolled. Pts received IBI110 combined with sintilimab and TP for 4-6 cycles. The primary objectives were to evaluate the safety, tolerability, and efficacy of the combination therapy.
As of 19th August, 2022, we reanalyzed the data of 20 pts previously reported. The most common TRAEs included anemia (65%), alopecia (60%), white blood cell count decreased (55%), asthenia (45%), aspartate aminotransferase increased (45%), rash (45%), neutrophil count decreased (40%). The most common TRAEs ≥ grade 3 were neutrophil count decreased (35.0%), and white blood cell count decreased (20.0%). Immune-related AEs (irAEs) occurred in 14 pts (4 pts: grade ≥ 3). The safety profile was consistent with the primary analysis. The updated ORR was also 80% (16/20, 15 patients with ≥ 2 efficacy assessments were confirmed PR and 1 pt was unconfirmed PR). The 6-month PFS rate was 75.0% (95% CI, 50.0-88.7), 9 pts reached PFS events while 11 pts had the continuous benefit (median follow-up time: 9.9 mos), and 12 pts had PFS ≥ 8 mos. The median PFS was not reached.
IBI110 combined with sintilimab and chemotherapy in advanced sqNSCLC continues showing robust anti-tumor activity and favorable safety.
NCT04085185.
Innovent Biologics, Inc., Suzhou, Jiangsu, China.
Innovent Biologics, Inc., Suzhou, Jiangsu, China.
J. Sun, H. Wang, Y. Chen: Financial Interests, Personal, Sponsor/Funding, Employment: Innovent Biologics, Inc. All other authors have declared no conflicts of interest.