Following up on their initial announcement in January, Eli Lilly (NYSE:LLY) and China development partner Innovent Biologics (OTCPK:IVBIY) announce detailed results from a China-based Phase 3 clinical trial, ORIENT-11, evaluating the combination of PD-1 inhibitor Tyvyt (sintilimab), Alimta (pemetrexed) and platinum chemo for the first-line treatment of patients with nonsquamous non-small cell lung cancer (NSCLC) without sensitive EGFR mutation or ALK rearrangement.
The data were presented virtually at the World Conference on Lung Cancer Presidential Symposium.
The addition of Tyvyt to Alimta and chemo resulted in a statistically significant improvement in progression-free survival (PFS) compared to placebo + Alimta + chemo. At a median follow-up of 8.9 months, median PFS in the Tyvyt arm was 8.9 months compared to 5.0 months in the comparator arm with almost 52% less risk cancer progression or death (hazard ratio = 0.482) (p<0.00001).
The objective response rate (ORR) in the Tyvyt group was 51.9% compared to 29.8% in the comparator group with a shorter median time to response (1.51 months vs. 2.63 months).
No new safety signals were observed.
Another Phase 3, ORIENT-12, evaluating Tyvyt and chemo in first-line metastatic squamous NSCLC was also successful.
China’s National Medical Products Administration approved Tyvyt in December 2018 for classical Hodgkin lymphoma patients who have received at least two prior lines of therapy.
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