Cisplatin (Cis) combined with sintilimab (Sint) and niraparib (Nir) in advanced solid tumors: Updated results.

Authors

null

TAO Haitao

Department of Oncology, Chinese PLA General Hospital, Beijing, China

TAO Haitao , Lijie Wang , Zhefeng Liu , Jinliang Wang , Guoqing Zhang , Junxun Ma , Yi Hu

Organizations

Department of Oncology, Chinese PLA General Hospital, Beijing, China, Chinese PLA General Hospital, Beijing, China, Department of Oncology, The First Medical Center of Chinese PLA General Hospital, Beijing, China

Research Funding

No funding received

Background: PARP inhibitors or chemotherapy combined with PD1/PDL1 inhibitors resulting in enhanced antitumor activity. We previously reported the part 1 result of a phase Ⅰb study exploring the safety and efficacy of Cis plus Sint and Nir. Here we presented the updated survival and safety data. Methods: Eligible pts will receive Sint and Cis on D1, plus Nir on D1-21, every 21-day for up to 4 cycles, following Sint and Nir until disease progression or intolerable toxicity. Part 1 was dose escalation phase followed 3+3 model, and part 2 was dose expansion phase enrolled more patients based on part 1. The primary objective was to determine maximum tolerated dose (MTD)/ recommended part 2 dose (RP2D). Secondary endpoints include objective response rate (ORR) per RECIST v1.1, and safety based on CTCAE v5.0. Results: PR2D of Cis and Nir were 60 mg/m2 and 100 mg, respectively when combined with sint 200mg. From 7/2019 to 9/2021, 22 pts (13 pts in part2) were enrolled, including 12 small cell lung cancer (SCLC), 7 lung squamous cell carcinoma (LUSC), 2 ovarian cancer (OC) and 1 cervical squamous cell carcinoma (CSCC). Most were male (77.3%, n=17), ECOG=1 (63.6%, n=14), current smoker(68.2%, n=15) and PDL1<1(50%, n=11). 36.4% (8/22) and 27.3% (6/22) had brain and liver metastasis at baseline, separately. Median follow-up was 6.2 months (range 2.5-10.8). ORR was 27.3% (6/22), DCR was 59.1% (13/22). Median progression-free survival (PFS) was 3.3 months (95%CI 1.9-3.9), and PFS rates at 6 months and 12 months were 28.8% and 10.8%. Median overall survival (OS) was 8.0 months (95%CI 4.9-14.1), 12 months OS rates was 28.5%. Median treatment duration was 4.7 months (range 1.9-15.1). The most common treatment-related adverse events included anemia (90.9%, 20/22, [5 Grade 3/4]), fatigue (77.3%, 17/22, [1 Grade 3/4), γ-glutamyl transpeptidase increased (72.7%, 16/22, [0 Grade 3/4]), leukopenia (68.2%, n=15, [4 Grade 3/4]) and neutropenia (59.1%, n=13, [5 Grade 3/4]). Conclusions: In this updated analysis, Cis combined with Sint and Nir showed clinically meaningful efficacy and an adequate safety profile in previously treated advanced solid tumors. Data need longer follow-up. Clinical trial information: ChiCTR1900024488.

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Developmental Therapeutics—Immunotherapy

Track

Developmental Therapeutics—Immunotherapy

Sub Track

PD1/PD-L1 Inhibitor Combinations

Clinical Trial Registration Number

ChiCTR1900024488

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 2599)

DOI

10.1200/JCO.2022.40.16_suppl.2599

Abstract #

2599

Poster Bd #

254

Abstract Disclosures