Biopharmaceutical company Innovent Biologics Inc (HKEX:01801) on Thursday presented the preliminary Phase Ib study results of sintilimab in combination with chemotherapy for 1L advanced or metastatic non-small cell lung cancer (NSCLC) at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO).
Sintilimab is an anti-PD-1 antibody that was co-developed with Eli Lilly and Company (NYSE:LLY).
Cohort D and E of the Phase Ib study in China are designed to evaluate the efficacy and safety of sintilimab in combination with chemotherapy for 1L unresectable locally advanced or metastatic non-squamous (nsq-) and squamous (sq-) NSCLC patients. Cohort D enrolled non-squamous NSCLC patients who received sintilimab in combination with pemetrexed platinum doublet. Cohort E enrolled squamous NSCLC patients who received sintilimab in combination with gemcitabine and cisplatin.
On 15 January 2019, 21 and 20 patients had been enrolled in cohort D and E, respectively. Objective response rate (ORR) in nsq- and sq-NSCLC was 68.4% and 64.7% respectively. Median progression-free survival was 95% and 95%, respectively. The combination of sintilimab and chemotherapy showed clinical activity with an acceptable safety profile, according to the company.
Based on the results of the Phase Ib studies, Innovent and Eli Lilly have launched two Phase III clinical trials evaluating sintilimab in combination with chemotherapy in 1L nsq- (NCT03607539) and sq-NSCLC in patients without EGFR mutations or ALK rearrangements in China.
Lung cancer is one of the malignant tumours with the highest morbidity and mortality and non-small cell lung cancer (NSCLC) accounts for approximately 80-85% of all lung cancer cases.
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