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Innovent Biologics has reported that its sintilimab met the prespecified primary goal in the ORIENT-31 clinical trial in epidermal growth factor receptor (EGFR)-mutated nonsquamous non-small cell lung cancer (nsqNSCLC) patients.

Co-developed by Innovent in collaboration with Eli Lilly and Company, sintilimab is an immunoglobulin G4 monoclonal antibody.

The drug attaches to programmed cell death protein 1 (PD-1) molecules present on the T-cell surface and hinders the PD-1 / PD-Ligand 1 (PD-L1) pathway, reactivating T-cells to destroy cancer cells.

The prospective, randomised, multicentre, double-blind, Phase III trial is analysing sintilimab along with or without Byvasda (bevacizumab biosimilar injection), plus chemotherapy that involves pemetrexed and cisplatin.

Approximately 480 individuals with EGFR-mutated locally advanced or metastatic nsqNSCLC who have progressed on receiving EGFR tyrosine kinase inhibitor (TKI) therapy will be part of the trial.

Subjects were categorised into a 1:1:1 ratio to receive sintilimab plus Byvasda  and chemotherapy, sintilimab plus placebo two and chemotherapy, or placebo one, placebo two, and chemotherapy.

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Progression-free survival (PFS) was the trial’s primary goal, while the secondary goals comprised overall survival (OS), investigator evaluated PFS, safety and objective response rate (ORR).

According to the latest interim analysis findings, sintilimab plus Byvasda and chemotherapy offered substantial improvement in PFS in trial subjects.

In the intent-to-treat population, it was found that sintilimab plus Byvasda and chemotherapy showed a significant and clinically meaningful improvement in PFS versus chemotherapy..

Sintilimab plus chemotherapy also demonstrated a trend of PFS benefit as against chemotherapy alone.

The safety profile of the trial was in line with those already reported from trials of sintilimab and Byvasda. No new safety signals were observed.

Innovent Biologics senior vice-president Dr Hui Zhou said: “Lung cancer has the highest mortality rate among all tumour types both in China and worldwide.

“In China, EGFR-mutated NSCLC accounts for 40% to 50% of nonsquamous NSCLC, and the treatment options for these patients after treatment with first, second and third-generation EGFR-TKIs are very limited, representing a large unmet medical need.

“Through the joint efforts of investigators, ORIENT-31 achieved these encouraging research results.”

In August this year, Innovent reported that its sintilimab plus chemotherapy met the predefined primary goal of Phase III ORIENT-16 trial as first-line therapy for unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.