Innovent Biologics and Eli Lilly and Company have reported positive results from the ORIENT-12 Phase III trial of TYVYT, Gemzar and platinum chemotherapy combination in metastatic squamous non-small cell lung cancer (sqNSCLC).
The ORIENT-12 trial, which evaluated TYVYT (sintilimab injection) in combination with Gemzar (gemcitabine for injection) and platinum chemotherapy for sqNSCLC, met the predefined primary endpoint of progression-free survival (PFS).
Secondary endpoints of the ORIENT-12 trial include overall survival (OS) and safety profile.
Innovent noted that this is the first randomised, double-blind Phase III study evaluating the combination of the anti-PD-1 antibody with Gemzar and platinum chemotherapy in the world.
The trial showed that, in combination with gemcitabine and platinum chemotherapy, TYVYT demonstrated a statistically significant improvement in PFS compared to placebo in combination with gemcitabine and platinum chemotherapy.
Its safety profile in the trial was consistent with previously reported studies.
The trial saw a total of 357 subjects enrolled and randomised in a 1:1 ratio to receive either TYVYT 200mg or placebo in combination with Gemzar and platinum chemotherapy every three weeks for four to six cycles.
This was followed by either TYVYT or placebo maintenance therapy.
Innovent Biologics vice-president and Oncology Strategy and Medical Sciences head Dr Hui Zhou said: “Sintilimab is the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List (NRDL). It was officially approved by the NMPA in 2018 for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy.
“With the encouraging result of ORIENT-12, we are hopeful that sintilimab has the potential to benefit more patients with squamous NSCLC.”
In the near future, Innovent and Lilly plan to start regulatory discussions for registration with the National Medical Products Administration (NMPA) of China.