TyvytNon-squamous non-small cell lung cancer, ALK gene rearrangement negative, EGFR-negative - first-line
New molecular entity
Development and Regulatory status
May 21Filed in US .
Sintilimab injection (TYVYT®) approved by the China National Medical Products Administration (NMPA) in combination with pemetrexed and platinum chemotherapy as first-line therapy for the treatment of non-squamous NSCLC. Approval was based on the pre-specified interim analysis of the ORIENT-11 trial .
A fully human IgG4 monoclonal antibody targeting programmed-cell-death-1-receptor (PD-1).
There are around 47,800 new lung cancer cases in the UK every year. Lung cancer is the 3rd most common cancer in the UK, accounting for 13% of all new cancer cases (2017) .
Non-squamous non-small cell lung cancer, ALK gene rearrangement negative, EGFR-negative - first-line
Trial or other data
Aug 21Results of PIII ORIENT-11 study published in the Journal of Thoracic Oncology. With a median follow-up of 22.9 months, median OS was not yet reached in the sintilimab plus chemotherapy group vs 16.8 months in the placebo plus chemotherapy group (HR 0.60; 95% CI [0.45 to 0.79]; p=0.0003) [5,6].
Jan 20Innovent Biologics announces that the ORIENT-11 met its predefined primary endpoint .
Nov 19Collection of primary outcome data in PIII ORIENT-11 completes .
Aug 18PIII placebo-controlled ORIENT-11 study to evaluate IBI308 in patients with advanced or metastatic non-squamous NSCLC starts (NCT03607539). 397 adults will be recruited in China. Sintilimab 200mg or placebo will be given with pemetrexed/ platinum for 4 cycles then sintilimab 200mg + pemetrexed maintenance. Primary outcome is progression-free survival .