Preliminary safety and efficacy of camrelizumab plus nab-paclitaxel and carboplatin as frontline setting in extensive-stage small cell lung cancer (ES-SCLC) from a phase II trial.

Authors

null

Shengxiang Ren

Oncology Department, Shanghai Pulmonary Hospital, Shanghai, China

Shengxiang Ren , Jia Yu , Anwen Xiong , Qi Wang , Lei Wang , Bin Chen , Menghang Yang , Wei Li , Jiajia Yuan , Changhong Zhao , Caicun Zhou

Organizations

Oncology Department, Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China, Jiangsu Hengrui Pharmaceuticals Co. Ltd, Shanghai, China

Research Funding

Pharmaceutical/Biotech Company

Background: Impower133 and CASPIAN studies showed that PD-L1 antibody combined with first-line chemotherapy could prolong the overall survival. Our previous study showed that nab-paclitaxel had a promising efficacy as later line setting in ES-SCLC. This phase II trial aimed to evaluate the efficacy and safety of camrelizumab plus nab-paclitaxel and carboplatin as front-line setting in ES-SCLC. Methods: Key inclusion factors were18-75 years old, histologically or cytologically confirmed ES-SCLC, ECOG performance status 0-1, no previous systematic treatment. Patients (pts) received 4 ̃ 6 cycles of camrelizumab (200mg, D1, q3w) combined with nab-paclitaxel (230mg/kg, D1, q3w) plus carboplatin (AUC = 5, D1, q3w), then camrelizumab maintenance until disease progression or intolerable side effects. The primary endpoint was 6 months progression free survival rate. Secondary endpoints included PFS, ORR and safety. Results: From April 2021 to December 2021, 36 pts who received at least one dose of camrelizumab were included into this report. The median age was 60.5 (range: 32-73) with 30 (83.3%) males, 19 (52.8%) former smokers, and 36 (100%) ECOG performance status 1. The median drug exposure was 5 cycles, and 18 (50%) pts entered the maintenance stage. 33 pts had at least one 1 post-treatment tumor assessment. Among them, 32 partial responses (5 unconfirmed), 1 progressive disease (new lesion). The confirmed ORR was 81.8% (27/33), the unconfirmed ORR was 97% (32/33), DCR was 97% (32/33). The median PFS was 7.27 months (95% CI: 4.7 – 9.8 months). 24 (66.7%) pts had at least one adverse event, and 10 (27.8%) pts experienced grade 3 or 4 adverse events, including 10 (27.8%) neutropenia, 4 (11.1%) leukopenia, 2 (5.6%) thrombocytopenia, 2 (5.6%) anemia, 2 (5.6%) hepatic function abnormal,1(2.8%) alanine aminotransferase increased, 1(2.8%) hyperglycaemia, 1(2.8%) diabetes mellitus, and no grade 5 adverse event happened. Conclusions: Camrelizumab plus nab-paclitaxel and carboplatin had promising efficacy and safety profile as first-line setting in ES-SCLC, further validation is warranted. Clinical trial information: NCT04790539.

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Small Cell Lung Cancer

Clinical Trial Registration Number

NCT04790539

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 8564)

DOI

10.1200/JCO.2022.40.16_suppl.8564

Abstract #

8564

Poster Bd #

191

Abstract Disclosures